Traditional chinese medical composition for treating bronchial asthma and method for preparing it

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to a formulation of a traditional Chinese medicine for treating bronchial asthma, and a method for preparing it. The traditional Chinese medical composition is prepared of pure herbal raw materials, including ephedra herb (Herba Ephedrae), ginkgo seeds (Semen Ginkgo), mulberry bark (Cortex Mori), skullcap root (Radix Scutellariae), bitter apricot seeds (Semen Armeniacae Amarum), pinellia rhinzomes (Rhizoma Pinelliae), perilla fruit (Fructus Perillae), foalfoot blossom (Flos Farfarae), red peony root (Radix Paeoniae Rubra), houttuynia herb (Herba Houttuyniae), trichosanthis root (Radix Trichosanthis), forsythia fruit (Fructus Forsythiae).

EFFECT: traditional Chinese medical composition is effective in treating bronchial asthma.

11 cl, 7 tbl, 12 ex

 

The technical field to which the invention relates.

The present invention relates to a traditional Chinese medicinal composition for the treatment of bronchial asthma and the way of its preparation and belongs to the field of Chinese medicine based on vegetable raw materials.

Background of invention

Bronchial asthma (hereinafter "asthma") is a typical chronic lung disease. Currently, about 200 million people worldwide suffer from asthma and about 20 million patients with asthma, there are in China. Data from five major cities in China show that the frequency rate incidence of asthma among students aged 3-14 years equal to from 3% to 5%. In most instances, it is believed that the incidence in children than adults, and almost the same among adult men and women. About 40% of patients have a genetic predisposition to the disease. The survey shows that 33% of patients with asthma was required hospitalization or emergency care due to last year's asthma, 58% of patients lost working time due to asthma, 79% of patients with asthma do not have the right to exercise and engage in leisure activities, 63% of patients with asthma had to change their usual way of life, 68% of patients with asthma suffered from sleep disturbance due to asthma and 74% PAC the patients with asthma had nothing to do physical labor. Asthma is a modern disease. Incidence it will not decrease with the improvement of people's health and quality of life. Instead, the incidence continues to increase.

Over the last 20 years people have been actively seeking ways to prevent and treat asthma that is the subject of ongoing studies of health care workers. Both in China and abroad commonly used in Western medicine for the treatment of this disease are divided into the following categories: inhalation corticosteroids, P2-agonists, inhalation anticholinergic medications, theophylline, receptor antagonists leukotriene antagonists other mediators of inflammation and antagonists of cytokines, inhibitors of eosinophil precursor cells of the bone marrow and allergen-specific immunotherapy and gene therapy. Recently with the help of these drugs achieved some clinical effects. However, the main goal of these drugs is the weakening of a series of attacks of bronchial inflammation and symptoms. They still do not solve the problem, usually of concern to specialists in respiratory diseases that are associated with a decrease in the frequency and duration of monitoring for clinical symptoms. In D. the addition, there are more problems in the treatment of patients with asthma, such as duration of treatment, when to reduce the dosage, how to reduce dosage when to stop giving the medicine to the patient, using any method or program you can achieve control of asthma, and that is more effective and safe for patients with asthma. These problems not only are clinicians questioned, but also add more difficulties in long-term care patients. However, some unwanted side effects of Western medicines have a significant impact on long-term treatment of patients. According to the survey, approximately half of the patients with asthma in China does not receive a normal monitor their asthma, and the majority of patients with asthma at a basic level and in rural areas do not receive effective monitoring of their disease. It is a long way to achieving the goal for the General improvement of the efficiency of methods and medicines to prevent and treat asthma.

Traditional Chinese medicine has more than a thousand years of history for the prevention and treatment of bronchial asthma. Dr. antiquity constantly explored the basics of treatment, methods, prescriptions and medicines for the treatment of asthma and found sets the effective recipes. Pharmacological trials have shown that treatment of asthma traditional Chinese medicine exerts a complex influence on the regulation of the immune system, anti-allergic effects, relieving symptoms of asthma, the prevention of cough, relief from phlegm, anti-inflammatory, etc. Traditional Chinese medicine may reduce airway inflammation and hypersensitivity of the respiratory tract. Clinical trials have shown that treatment of traditional Chinese medicine has less adverse effects than Western medicines, and can greatly ease symptoms, such as wheezing, respiratory distress syndrome, sputum, etc. For most patients could lead to remission of asthma during the treatment period or maybe a reduced dose of the hormone and to improve their quality of life.

The broth Dingchuan, described in "She Sheng Zhong Miao Fang" (book of traditional Chinese medicines), consists of baked with honey herb ephedra (Herba Ephedrae), quickly fried with constant stirring seeds gingko (Semen Ginkgo), bark of mulberry (Cortex Mori), the root of Scutellaria (radix Scutellariae), seeds of bitter apricot (Semen Armeniacae Amarum), rhizome-Pinelli (Rhizoma Pinelliae), Perilla fruit (Fructus Perillae), red peony root (radix peoniae rubra), earthworm (lumbricus), periostracum cicadas (Periostracum Cicadae), root trichosanthis (radix trichosanthis) and forsythia fruit (Fructus Forsythiae). The broth is a known recipe for the treatment of asthma. The experiments showed that the broth Dingchuan has a protective effect in experimental asthma induced by histamine and spray acetylcholine chloride, and may be antagonistic effect on caused by histamine contraction of isolated smooth muscle of the trachea from Guinea pigs [Li, Zhengmu et al., Pharmacology research of Dingchuan decoction in treating bronchial asthma. Traditional Chinese Medicinal Materials. 1999, 22 (8):411]. The decoction can also speed up the allocation of phenol red in the respiratory tract of mice. These results from a pharmacological point of view argue that the broth Dingchuan has a significant impact on the relief of asthma and sputum.

Brief description of the invention

Traditional Chinese medicinal composition of the present invention is composed of pure natural plant materials and includes the herb ephedra (Herba Ephedrae), the bark of mulberry (Cortex Mori), the root of Scutellaria (Radix Scutellariae), seeds of bitter apricot (Semen Armeniacae Amarum), rhizome-Pinelli (Rhizoma Pinelliae), Perilla fruit (Fructus Perillae), flowers, mother and stepmother (Flos Farfarae) and others. This arrangement greatly facilitates the symptoms of asthma, such as wheezing, respiratory distress syndrome, cough, delanie sputum, and its effect is certainly better than the effect of the decoction Dingchuan.

The invention

In one aspect the present invention provides a traditional Chinese medicinal composition for the treatment of bronchial asthma.

In another aspect the present invention provides a method of preparation of traditional Chinese medicinal composition for the treatment of bronchial asthma.

Traditional Chinese medicinal composition of the present invention is prepared from the following raw medical materials (by weight):

40-90 parts of the herb ephedra (Herba Ephedrae),

136-300 parts of the bark of mulberry (Cortex Mori),

146-300 parts of an earthworm (Lumbricus),

46-151 parts seeds gingko (Semen Ginkgo),

46-151 parts color mother-and-stepmother (Flos Farfarae),

46-151 parts of the rhizomes pinellia (Rhizoma Pinelliae),

46-151 parts Perilla fruit (Fructus Perillae),

146-300 parts of red peony root (Radix Paeoniae Rubra),

46-151 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),

46-151 parts of the root of Scutellaria (Radix Scutellariae),

46-151 parts periostracum cicadas (Periostracum Cicadae),

146-300 parts grass Houttuynia (Herba Houttuyniae),

146-300 root parts of trichosanthis (Radix Trichosanthis), and

46-151 parts forsythia fruit (Fructus Forsythiae).

Another traditional Chinese medicinal composition of the present invention is prepared from the following raw medical materials (by weight):

7-88 parts of the herb ephedra (Herba Ephedrae),

136-165 parts of the bark of mulberry (Cortex Mori),

255-300 parts of an earthworm (Lumbricus),

46-65 parts seeds gingko (Semen Ginkgo),

110-151 parts color mother-and-stepmother (Flos Farfarae),

46-65 parts of the rhizomes pinellia (Rhizoma Pinelliae),

105-151 parts Perilla fruit (Fructus Perillae),

146-165 parts of red peony root (Radix Paeoniae Rubra),

46-65 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),

103-151 parts of the root of Scutellaria (Radix Scutellariae),

46-65 parts periostracum cicadas (Periostracum Cicadae),

255-300 parts grass Houttuynia (Herba Houttuyniae),

255-300 root parts of trichosanthis (Radix Trichosanthis), and

103-151 parts forsythia fruit (Fructus Forsythiae).

Preferably, traditional medicinal composition of the present invention is prepared from the following raw medical materials (by weight):

50-76 parts of the herb ephedra (Herba Ephedrae),

166-253 parts of the bark of mulberry (Cortex Mori),

166-253 parts of an earthworm (Lumbricus),

66-101 parts seeds gingko (Semen Ginkgo),

66-101 parts color mother-and-stepmother (Flos Farfarae),

66-101 parts of the rhizomes pinellia (Rhizoma Pinelliae),

66-101 parts Perilla fruit (Fructus Perillae),

166-253 parts of red peony root (Radix Paeoniae Rubra),

66-101 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),

66-101 parts of the root of Scutellaria (Radix Scutellariae),

66-101 parts periostracum cicadas (Periostracum Cicadae),

166-253 parts grass Houttuynia (Herba Houttuyniae),

166-253 root parts of trichosanthis (Radix Trichosanthis), and

66-101 parts forsythia fruit (Fructus Forsythiae).

Preferably, traditional medicinal composition of the present invention is prepared from the following raw medical materials (by weight):

50 parts of the herb ephedra (Herba Ephedrae),

253 parts of the bark of mulberry (Cortex Mori),

166 parts of an earthworm (Lumbricus),

66 parts of seeds gingko (Semen Ginkgo),

101 parts of flowers mother-and-stepmother (Flos Farfarae),

101 parts of the rhizomes pinellia (Rhizoma Pinelliae),

66 parts Perilla fruit (Fructus Perillae),

166 parts of red peony root (Radix Paeoniae Rubra),

101 parts of seeds of bitter apricot (Semen Armeniacae Amarum),

66 parts of the root of Scutellaria (Radix Scutellariae),

66 parts periostracum cicadas (Periostracum Cicadae),

253 parts grass Houttuynia (Herba Houttuyniae),

253 parts of root trichosanthis (Radix Trichosanthis), and

66 parts forsythia fruit (Fructus Forsythiae).

Preferably, traditional medicinal composition of the present invention is prepared from the following raw medical materials (by weight):

76 parts of the herb ephedra (Herba Ephedrae),

166 parts of the bark of mulberry (Cortex Mori),

253 parts of an earthworm (Lumbricus),

101 parts of seeds gingko (Semen Ginkgo),

66 parts of flowers mother-and-stepmother (Flos Farfarae),

66 parts of the rhizomes pinellia (Rhizoma Pinelliae),

101 parts Perilla fruit (Fructus Perillae),

253 parts of red peony root (Radix Paeoniae Rubra),

66 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),/p>

101 parts of the root of Scutellaria (Radix Scutellariae),

101 parts periostracum cicadas (Periostracum Cicadae),

166 parts of grass Houttuynia (Herba Houttuyniae),

166 parts of root trichosanthis (Radix Trichosanthis), and

101 parts forsythia fruit (Fructus Forsythiae).

Preferably, traditional medicinal composition of the present invention is prepared from the following raw medical materials (by weight):

70 parts of the herb ephedra (Herba Ephedrae),

241 parts of the bark of mulberry (Cortex Mori),

245 parts of an earthworm (Lumbricus),

98 parts of seeds gingko (Semen Ginkgo),

94 parts of flowers mother-and-stepmother (Flos Farfarae),

95 parts of the rhizomes pinellia (Rhizoma Pinelliae),

94 parts Perilla fruit (Fructus Perillae),

230 parts of red peony root (Radix Paeoniae Rubra),

92 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),

91 parts of the root of Scutellaria (Radix Scutellariae),

97 parts periostracum cicadas (Periostracum Cicadae),

237 parts grass Houttuynia (Herba Houttuyniae),

231 parts of the root trichosanthis (Radix Trichosanthis), and

91 parts forsythia fruit (Fructus Forsythiae).

Preferably, traditional medicinal composition of the present invention is prepared from the following raw medical materials (by weight):

63 parts of the herb ephedra (Herba Ephedrae),

210 parts of the bark of mulberry (Cortex Mori),

210 parts of an earthworm (Lumbricus),

84 parts of seeds gingko (Semen Ginkgo),

84 parts of flowers mother-and-stepmother (Flos Farfarae),

84 hour is she rhizomes-Pinelli (Rhizoma Pinelliae),

84 parts Perilla fruit (Fructus Perillae),

210 parts of red peony root (Radix Paeoniae Rubra),

84 parts of seeds of bitter apricot (Semen Armeniacae Amarum),

84 parts of the root of Scutellaria (Radix Scutellariae),

84 parts periostracum cicadas (Periostracum Cicadae),

210 parts of grass Houttuynia (Herba Houttuyniae),

210 parts of the root trichosanthis (Radix Trichosanthis), and

84 parts forsythia fruit (Fructus Forsythiae).

Preferably, traditional medicinal composition of the present invention is prepared from the following raw medical materials (by weight):

61 parts of the herb ephedra (Herba Ephedrae),

198 parts of the bark of mulberry (Cortex Mori),

223 parts of an earthworm (Lumbricus),

78 parts of seeds gingko (Semen Ginkgo),

92 parts of flowers mother-and-stepmother (Flos Farfarae),

73 parts of the rhizomes pinellia (Rhizoma Pinelliae),

85 parts Perilla fruit (Fructus Perillae),

188 parts of red peony root (Radix Paeoniae Rubra),

87 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),

88 parts of the root of Scutellaria (Radix Scutellariae),

79 parts periostracum cicadas (Periostracum Cicadae),

221 parts grass Houttuynia (Herba Houttuyniae),

218 parts of the root trichosanthis (Radix Trichosanthis), and

81 parts forsythia fruit (Fructus Forsythiae).

Preferably, the raw medical materials traditional Chinese medicinal composition of the present invention are: the herb ephedra, which is a honey glazed baked grass e is edry, seeds, gingko, which are quickly fried with constant stirring seeds gingko, rhizome-Pinelli, which is processed potassium alum rhizome-Pinelli, Perilla fruit, which are quickly fried with constant stirring Perilla fruit, and seeds of bitter apricot that are quickly fried with constant stirring the seeds of bitter apricot.

Raw medical materials according to the present invention may be replaced by traditional Chinese medical materials having the same or similar functions, and these materials can be processed in accordance with the "National standard processing of traditional Chinese medicines" or "Great dictionary of traditional Chinese medicine".

Traditional Chinese medicinal composition of the present invention is prepared from raw medical materials, and the term "prepared" may be understood as any General process used in the preparation according to the tradition of Chinese medicine, such as the preparation of traditional Chinese medicinal composition after the direct crushing or concentration of the extract under standard solvent extraction. It also includes additional ways acidiphila standard solvent extraction, such as purification through a column of macroporous resins.

Moreover, the composition according to the invention can be obtained in various dosage forms, including capsule, tablet, powder, liquid for oral administration, a soft capsule, a pill, tincture, syrup, suppository, gel and spray.

Preferably, a traditional Chinese medicinal composition of the present invention is prepared using the following method:

a) take the root of Scutellaria (Radix Scutellariae) and 1/3-3/4 of the number of rhizomes-Pinelli (Rhizoma Pinelliae) in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra (Herba Ephedrae), seeds gingko (Semen Ginkgo), bark of mulberry (Cortex Mori), flowers mother-and-stepmother (Flos Farfarae), Perilla fruit (Fructus Perillae), seeds of bitter apricot (Semen Armeniacae Amarum) and grass Houttuynia (Herba Houttuyniae) in accordance with the composition and the remaining rhizome-Pinelli (Rhizoma Pinelliae), add 6-10-fold amount of 50-80% ethanol, heated and three defragment extract 1-3 hours each time under reduced pressure to produce ethanol from a solution of the extract and concentrate the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm (Lumbricus), peony root to the ACLs (Radix Paeoniae Rubra), periostracum cicadas (Periostracum Cicadae), root trichosanthis (Radix Trichosanthis) and forsythia fruit (Fructus Forsythiae) in accordance with the composition, add 7-10-fold amount of water, twice boiled within 1-4 hours each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for future use;

d) mixing a fine powder from step (a) with the combined extract from step (C) obtaining a traditional Chinese medicinal composition. This composition can be prepared in the form clinically acceptable dosage forms including capsule, tablet, powder, liquid for oral administration, a soft capsule, a pill, tincture, syrup, suppository, gel and spray, by routine methods.

As used in this application, "adding X times the number of solvent refers to the ratio of mass/volume, for example "add 6-8 times the amount of solvent to raw medical materials" refers to the addition of 6-8 liters of solvent to 1 kilogram of raw medical material.

In order to get the required dosage form, the composition of these forms, you need to add a pharmaceutical acceptable excepi the options such as fillers, agents for improving raspadaemosti, lubricants, suspendresume agents, binders, sweeteners, flavoring agents, preservatives, etc. Fillers include starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, sucrose, etc. Agents to improve raspadaemosti include starch, pregelatinized starch, microcrystalline cellulose, sodium carboximetilkrahmal, Poperechnaya polyvinylpyrrolidone, hydroxypropylcellulose with a low degree of substitution, Poperechnaya sodium carboxymethylcellulose, etc. lubricants include magnesium stearate, sodium lauryl sulphate, talc, silicon dioxide, etc. Suspendresume agents include polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hypromellose, etc. of the Binder include starch, polyvinylpyrrolidone, hypromellose, etc. Sweeteners include saccharin, aspartame, sucrose, cyclamate sodium, glitsiretovuyu acid, etc. Flavouring agents include sweeteners and flavour. Preservatives include nipagin, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalconi bromide, chlorhexidine acetate, eucalyptus oil, etc.

In another embodiment of the present from which bretania is provided a method of obtaining a tableted dosage forms of traditional Chinese medicinal composition. This method includes the following stages:

a) take the root of Scutellaria (Radix Scutellariae) and half the number of rhizomes-Pinelli (Rhizoma Pinelliae) in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra (Herba Ephedrae), seeds gingko (Semen Ginkgo), bark of mulberry (Cortex Mori), flowers mother-and-stepmother (Flos Farfarae), Perilla fruit (Fructus Perillae), seeds of bitter apricot (Semen Armeniacae Amarum) and grass Houttuynia (Herba Houttuyniae) in accordance with the composition and the remaining rhizome-Pinelli (Rhizoma Pinelliae) by proportion, add 6-10-fold amount of 50-80% ethanol, heated and three defragment extract 1-3 hours each time under reduced pressure to produce ethanol from a solution extract, concentrating the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm (Lumbricus), red peony root (Radix Paeoniae Rubra), periostracum cicadas (Periostracum Cicadae), root trichosanthis (Radix Trichosanthis) and forsythia fruit (Fructus Forsythiae) in accordance with the composition, add 7-10-fold amount of water, twice boiled within 1-4 hours each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with what xtractor from stage b) for further use;

d) mixing the fine powder with stage a) and the combined extract from step (C), add appropriate amount of adjuvant in the mixture and spray granulation receive granules, and after drying sieved granules through a sieve, leave; and

e) of the granules from step (d) receive a tablet dosage form by routine methods.

Preferably, the method of obtaining tableted dosage forms of traditional Chinese medicinal composition comprises the following stages:

a) take the root of Scutellaria (Radix Scutellariae) and half the number of rhizomes-Pinelli (Rhizoma Pinelliae) in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra (Herba Ephedrae), seeds gingko (Semen Ginkgo), bark of mulberry (Cortex Mori), flowers mother-and-stepmother (Flos Farfarae), Perilla fruit (Fructus Perillae), seeds of bitter apricot (Semen Armeniacae Amarum) and grass Houttuynia (Herba Houttuyniae) in accordance with the composition and the remaining rhizome-Pinelli (Rhizoma Pinelliae) by proportion, add 8-fold amount of 60% ethanol, heated and three defragment extract 1.5 hours each time, produce ethanol from a solution of the extract under reduced pressure, concentrate the solution to obtain an extract for further use with a relative density of 1.05-1.0 at 60°C;

c) take appropriate amount of an earthworm (Lumbricus), red peony root (Radix Paeoniae Rubra), periostracum cicadas (Periostracum Cicadae), root trichosanthis (Radix Trichosanthis) and forsythia fruit (Fructus Forsythiae) in accordance with the composition, add a 9-fold amount of water, twice boiled for 2 hours each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for future use;

d) mixing the fine powder with stage a) and the combined extract from step (C), add appropriate amount of adjuvant in the mixture and spray granulation receive granules, and after drying sieved granules through a sieve, leave; and

e) of the granules from step (d) receive a tablet dosage form by routine methods.

In accordance with the total mass of raw medical materials traditional Chinese medicinal composition of the present invention, the dosage of the composition is 15-30 g/day, and it can be taken once a day, or 2-4 times daily; preferably the dosage is 22 g/day and should be taken three times a day.

To confirm the activity of traditional Chinese medicinal composition according to the invention (here and hereinafter "composition according to the invention") is obtained by using method, described in Example 1, a tablet dosage form was crushed into powder, and were conducted pharmacological tests in order to demonstrate the influence of the composition of the invention for the treatment of bronchial asthma. Also compared therapeutic effect of the primary pharmacodynamic side of the tablet and broth Dingchuan, prepared in accordance with the published method: add 9 g of herb ephedra, flowers mother-and-stepmother, seeds of bitter apricot and rhizomes Maria, 12 g of seeds gingko (fried fast with constant stirring until the yellow), 6 g of Perilla fruit, bark of mulberry root and Scutellaria and 3 grams of licorice root to the water and boil the ingredients with obtaining broth Dingchuan [, xiaobo and Xiao, xian. Talking about Dingchuan decoction, KAI JUAN YOU YI.QIU YI WEN YAO, 2001 (11):21]. The experiment confirms that the composition according to this invention is more effective than broth Dingchuan therapeutic action in the treatment of asthma.

It was confirmed that the composition according to this invention has a good therapeutic effect in the treatment of bronchial asthma by facilitating asthma and cough, resorption of phlegm, anti-inflammatory action, etc. Bronchial asthma is a typical chronic lung disease. The composition of this invention exhibits a broad range of security games is no regulatory role in several aspects and treats the symptoms and the cause of the disease. It not only prevents the side effects associated with the unidirectionality of Western medicine, but also treats chronic diseases over a long period. The test results acute toxicity studies indicate that the composition of this invention does not show significant toxicity in mice, which is 3 times a day was administered intragastrically 254,4 g raw drugs/kg with peak concentrations and continuously monitored for 14 days. This dosage is equivalent to 687.57-fold the clinical dose of man. The experimental results of long-term toxicity studies in rats also indicate that the composition according to this invention, is introduced in doses of 22 g 11 g and 5.5 g raw medicinal/kg, did not show significant toxicity on rats over a long period (26 weeks).

The following experiments and examples are used to further illustrate but not to limit the present invention.

Experiment 1: anti-asthma study

I. effect of the compositions according to the invention the reaction of bronchial asthma in early

phase

1. The material for the experiment

1.1 Animals: white healthy Guinea-pig line Hartley weighing 200±25 g, half male and half female, were purchased in Experimenta Animal Center of National Institute for the Control of Pharmaceutical and Biological Products. License number SCXK (BJ)2002-0010.

1.2 Drugs and reagents:

(1) Testing of the medicinal product: Medicinal composition according to the invention, the batch number 20060801 was provided by Shijiazhuang Yiling Pharmaceutical Co., Ltd. 1 g of the final pharmaceutical composition corresponds to 4.5 g raw medicinal product. Clinical dose for humans is 22 g raw medicinal product/day. The drug was mixed with 0.5% CMC-Na (carboxymethylcellulose sodium) to obtain before using the solution with the required concentration.

(2) Drug positive control: Aminophylline tablet suitable for the treatment of bronchial asthma and obstructive pulmonary emphysema was produced by Beijing Zizhu Pharmaceutical Co., Ltd., the batch number 20061103.

(3) the Broth Dingchuan: provided Shijiazhuang Yiling Pharmaceutical Co., Ltd. Dosage for use in humans is 69 g raw medicinal product/day. The drug is mixed with 0.5% CMC-Na (sodium glycolate, cellulose) to obtain before using the solution with the required concentration. As used in this application, "......g raw medicinal/day" means a dosage of raw medical materials per day.

(4) Egg albumin: Product Sigma Company.

(5) Asialex: Product Sigma Company.

1.3 Ol the Bor: medical aerosol device Yadu, model YC-Y800B, production Beijing Yadu Technology Co., Ltd.

2. Methods and results

1. Group and the administration of a medicinal product to animals

After splitting into groups 80 Guinea pigs were placed under airtight cap made of organic glass (4 l) groups. The solution, causing asthma (isometric mixture of 2% azealas and 0.1% histamine phosphate), was dispersively and sprayed under the glass globe with the help of an ultrasonic atomizer with a speed of 15 seconds/time, where the volume of spray was 4 ml/min, and the particle diameter dispersion amounted to 1-5 microns. Within 6 minutes after spraying observed latent period of onset of seizures with rattling in Guinea pigs. Guinea pigs have a latent period of onset of seizures with rattling in excess of 120 seconds were excluded from further experiments. Were selected 66 Guinea pigs that meet the criteria, and randomly divided into 6 groups: group model of asthma, the group of aminophylline, the group broth Dingchuan, group, high, medium and low dosage of the composition according to the invention. The group model of asthma intragastrically injected the same volume of solvent; a group of aminophylline was administered intragastrically 0.06 g/kg of aminophylline (equivalent to 7 times the clinical dose for humans); group broth Dingchuan was administered intragastrically 8.1 g/kg broth (7 corresponds to atoi clinical dosage for humans); groups of high, medium and low dosage of the composition according to the invention was administered intragastrically composition at a dose of 5.1 g/kg, 2.6 g/kg and 1.3 g/kg, respectively (corresponding to 14.7 - and 3.5-fold the clinical dose for humans, respectively). Each group was administered the appropriate drug continuously for 4 days. The experiment started after 1 hour after the last injection.

2. Anti-asthma effect on induced drug asthma in Guinea pigs

Animals in each group were placed under the airtight organic cap, and the induction of asthma was performed using the method described above. After spraying for 6 minutes was observed latent period of occurrence of asthmatic seizures in Guinea pigs. If asthmatic seizures were observed, believed that the latent period was 6 minutes. Statistical analysis of variance and t-test was performed using SPSS 10.0. The results showed that a significant increase in latent period asthma caused by acecoleman and phosphate histamine was observed in Guinea pigs in groups of high and medium dosage of the composition according to this invention. The group, which has introduced a low dosage of the composition according to the invention also showed some effect on the increase of the latent period asthma in Guinea pigs, but the considerable statistical differences compared with group model of asthma was not, see table 1-1.

Table 1-1
Anti-asthma effect of the composition according to the invention for asthma in Guinea pigs, inducirowannoe drug ()
GroupDosage (mg/kg)The number of animalsThe latent period induced asthma Wheezing Fall
The group model of asthma1224.6±9.040.8±14.5
The group of aminophylline0.06 g/kg1238.3±13.0**74.3±36.0**
Group broth Dingchuan8.1 g/kg12At 33.91±9.1*50.3±18.3
Group composition on5.1 g/kg1042.2±11.5**81.3±38.1**
invention: 2.6 g/kg1037.7±16.9*57.1±21.9*
high, medium and low1.3 g/kg1031.6±12.547.3±17.8

Note: Compared with group model of asthma, *p<0.05,** p<0.01.

After inhalation liquid mixture of histamine and azealas asthma would be in healthy Guinea pigs. The composition according to the invention in high and medium doses (5.1 g/kg and 2.6 g/kg, respectively) can significantly increase the time of occurrence of wheezing and downs in Guinea pigs with asthma (p<0.05 and p<0.01, respectively). After sensitization Egg Albumin (OVA) Guinea pigs produce anti-OVA IgE antibody that binds to mast cells. When inhaled antigen OVA, called degranulation due to a combination of OVA and IgE on the cell surface and induced an asthma attack due to the release of inflammatory mediators. Introduction the composition of the invention in the high and medium doses (5.1 g/kg and 2.6 g/kg, respectively) can significantly increase the latent period asthma in Guinea pigs. In addition, the composition according to this invention showed the best anti-asthma effect than the effect of the decoction Dingchuan.

II. The influence of the composition is according to the invention the reaction of bronchial asthma in the late phase

1. Group and the administration of a medicinal product to animals: 60 healthy white Guinea pigs were randomly allocated into 6 groups: group model of asthma, group, high, medium and low dosage of the composition according to the invention (5.1 g/kg, 2.6 g/kg and 1.3 g/kg, respectively), the group broth Dingchuan (8.1 g/kg) and group aminophylline - positive control (intragastric administration of 0.06 g/kg of aminophylline). Animals in the group model of asthma was injected solvent in the same amount. Cavies intragastrically injected medications for 3 days prior to the occurrence of asthma and then continuously for 4 days after.

2. Anti-asthma effect of the composition according to the invention for asthma in Guinea pigs caused OVA: Guinea pigs in each group were senzibilizirani by intramuscular injection in the hind leg of 0.2 ml of 4% saline OVA and intraperitoneal injection of 0.2 ml of 4% latex with aluminum hydroxide. Guinea pigs were senzibilizirani again in the same way on the 7th day. One hour after the last injection asthma induced by spraying on animals, inducing asthma solution for 6 minutes using an ultrasonic nebulizer. The solution, inducing asthma, represented a 2% saline OVA, application volume was not less than 4 ml/min Latent period AST is adicheskogo seizure in Guinea pigs was observed within 6 minutes. If asthmatic seizures were observed, believed that the latent period was 6 minutes. The results were analyzed using variability and T-test. All analyses were performed using SPSS 10.0. The results showed that a significant increase in latent period induced asthma in Guinea pigs sensitized with OVA were observed in the groups that were administered high and medium dosage of the composition according to the invention. The group, which has introduced a low dosage of the composition according to the invention also showed some effect on the increase of the latent period of asthma, but statistically signicant differences compared with group model of asthma was not, see table 1-2.

Table 1-2
The effect on the latent period induced asthma in Guinea pigs sensitized with OVA ()
GroupDosage (ml/kg)The number of animalsThe latent period induced asthma
SnortFall
Group m is sensible asthma -1062.4±24.2104.2±53.1
The group of aminophylline0.06 g/kg10163.2±89.1**238.0±76.9**
Group broth Dingchuan8.1 g/kg1086.5±30.7*154.5±60.0*
Group composition on5.1 g/kg10166.6±87.0**206.6±99.2*
invention:2.6 g/kg10118.0±62.6*167.6±77.6*
high, medium and low dosage1.3 g/kg1071.7±26.3110.2±41.0

Note: Compared with group model of asthma, *p<0.05,** p<0.01.

Experimental model of inflammation of the respiratory tract, mainly caused by infiltration is sinophile (EOS), can be obtained by sensibilizirovannoy Guinea pigs OVA and impact on multiple animals by inhalation spray or OVA. This is known as a model of allergic bronchial asthma Guinea pigs. This experiment showed that Guinea pigs, which was introduced mid and high dosage (5.1 g/kg and 2.6 g/kg, respectively) of the composition according to the invention showed significantly prolonged the latent period of asthma induced by OVA and observed a reduced number of EOS in whole blood of animals from these two groups (p<0.05 and p<0.01, respectively). This means that the high and medium dosage of the composition according to the invention in comparison with broth Dingchuan have a superior effect on deferred bronchial asthma in Guinea pigs.

Experiment 2: the Experiment for relief of cough, sputum elimination and anti-inflammatory activity

I. Experimental study of the effect of the composition according to the invention for the relief of cough

1. The materials for experiment

1.1 Experimental animals

72 healthy mouse KM, half males and half females, weighing 18-20 g were purchased from Beijing Vital River Experimental animal Technical Co. Ltd, license number: SCXK (BJ)2002-0003. Mice were labeled with 5% picric acid and placed in captivity for 5 mice/cage. Mice were placed in the Pharmacology laboratory of Pharmaceutical Research the CSO Institute at Chabason Medical University under the following environmental conditions: 12 hours light/day, temperature between 20~23°C and relative humidity between 40-60%. Mice completely fed whole grain food product obtained from the Experimental Animal Center in the province of Heibei and give unlimited amount of water. Mice were maintained on a specified diet and under specified environmental conditions for 3 days.

1.2 Investigational medicinal product

The composition according to the invention: 1 g of dry powder corresponds to 4.5 g raw medicinal product. The dosage of the medicinal product for human clinical use is 22 g raw medicinal substance/day, that is, 0.37 g raw medicinal substance/kg standard body weight of 60 kg). The medicinal substance was provided by Shijiazhuang Yiling Pharmaceutical Co., Ltd, batch number 20060801. The drug was mixed with 0.5% CMC-Na to get before using the suspension to the desired concentration.

The broth Dingchuan: provided Shijiazhuang Yiling Pharmaceutical Co., Ltd. Clinical dosage for use in humans this medicine is 69 g raw medicinal product/day. This drug was mixed with 0.5% CMC-Na to get before using the solution with the required concentration.

Compound solution of phosphate codeine: 0.9 mg/ml, Hong Kong Aomei Pharmaceutical Factory, batch number 060115.

1.3 Reagent for exp is riment

Concentrated sulphuric acid: analytical grade, Beijing Chemical Factory, batch number: 20020809.

2. Experimental methods

2.1 the Principle of dose selection

The maximum clinical dose of the composition according to the invention is 22 g raw medicinal/day, that is, 0.37 g raw medicinal/kg standard body weight of 60 kg). Dose, injected into mice, were 5, 10 and 20 times the clinical dose, i.e. mice gave 1.85 g, 3.7 g and 7.4 g of raw drugs/kg/day (groups of low, medium and high doses, respectively). The group broth Dingchuan introduced 11.5 g raw medicinal substances/kg/day, which is 10 times the clinical dose. Control group and positive group of medicines has organized separately.

2.2 Route of administration and dosage

Between 9:00-10:00 a.m. daily to mice intragastrically injected drugs in accordance with the groups, along with orally administered, recommended in clinical practice. Medicines continuously introduced into

for 5 days in the amount of 0.1 ml/10 g body weight.

2.3 Input dosage and splitting into groups

In accordance with the above principle of dose selection the mice were divided into the following 5 groups, see table 2-1:

Table 2-1
Group and type of dosage in the experiment for the relief of cough in mice composition according to the invention
GroupThe number of animalsDosage(g raw medicinal/kg·d)Correlation to the clinical dose for humans (again)
The control group12----
Group solution120.0310
phosphate codeine
Group broth1211.510
Dingchuan
Group composition on121.855
invention: 123.7010
high, medium,127.4020
low

2.4 Experimental methods

2.4.1 Preparation of sulphur dioxide: took a 250-ml flask with a side opening, which was connected with the tank by means of the rubber hose, the flask was loaded hydrosulfite sodium; established the burette to shut the lid and in the burette was downloaded concentrated sulfuric acid; opened the valve to the burette to concentrated sulfuric acid dripping: formed gas - sulfur dioxide and filled the tank; pinched tank hemostats; before use, the syringe was selected 4-10 ml of gas.

2.4.2 Mouse KM were randomly divided into 6 groups of 12 mice in each group with a half males and half females. The group were as follows: control group, group broth Dingchuan, the group of phosphate codeine, group, high, medium and low dosage of the composition according to the invention. All groups were intragastrically injected medications at the dose of 0.1 ml/10 g continuously for 5 days. The control group was administered with 0.5% CMC-Na. Half an hour later, the donkey last injection mice from each group were subsequently placed in a 250 ml vessel with introduced there by sulfur dioxide. The latent period (time from the introduction of sulfur dioxide to the occurrence of cough) and the frequency of cough was observed within 2 minutes. Typical cough in mice is accompanied simultaneously abdominal contractions and wide opening of the mouth, and sometimes he is accompanied by the sounds of clearing. The degree of relief of cough was calculated using the following formula:

The degree of relief of cough(%)=(response time cough in the group administration of medication/response time cough in the control group)×100%.

3. Statistical method

The experimental data were analyzed using SPSS 11.5. Statistical

the results were expressed using the average number±standard deviation ();

the difference between groups was determined using one-factor analysis of variance.

4. The results of the experiment

It was observed the influence of the composition of the invention for cough caused by sulfur dioxide, which are shown in table 2.2. The results show that the latent period of cough induced in mice in the control group, was 19.58±8.17 seconds, and the frequency of cough for 2 minutes was 69.25±26.93 time. The latent period of cough in mice in groups of low, medium and high dosages of the composition according to the invention was 54.58±35.57 seconds, 57.67±30.53 seconds and 73.50±37.81 seconds respectively. The duration of latency is eriod in these groups compared with the control group was significantly increased (P< 0.05 or P<0.01); the frequency of cough for 2 minutes was 27.42±22.86 time, 27.08±17.17 time and 11.92±19.44 time, respectively. The frequency of cough is significantly reduced compared with the control group (P<0.01).

Table 2-2
The influence of the composition of the invention for cough caused by sulfur dioxide ()
GroupDose (gNumberWeightLatentFrequency
rawanimals(g)periodcough (n)
drugs/kg·d)(n)cough (sec)
The control group--1226.0±2.619.58±8.1769.25±26.93
Codeine 0.031225.8±1.848.83±22.93*23.00±18.46**
Dingchuan11.51226.1±2.354.42±39.7228.34±20.19**
Group low dose1.851226.8±2.254.58±35.5727.42±22.86**
Group average dose3.701226.3±2.457.67±30.53*27.08±17.17**

The high-dose group7.401226.9±2.673.50±37.81*11.92±19.44**

Note: Compared with control group, *P<0.05, **P<0.01.

Observed that the latent period of onset of cough and frequency of cough in groups, which were injected high and medium dosage of the composition according to the invention was significantly increased compared with group broth Dingchuan (P<0.5). This means that the compositions of this invention in comparison with broth Dingchuan have a significant effect on the relief of cough, and this effect is better than the effect of the decoction Dingchuan.

II. Experimental study of the effect of the composition according to the invention for the removal of phlegm

1. The materials for experiment

1.1 Experimental animals

72 healthy mouse KM, half males and half females, weighing 18-20 g were purchased from Beijing Vital River Experimental animal Technical Co. Ltd, license number: SCXK (BJ) 2002-0003. Mice were labeled with 5% picric acid and placed in captivity for 5 mice/cage. Mice were placed in the Pharmacology laboratory of the Pharmaceutical Research Institute at Chabason Medical University under the following environmental conditions: 12 hours light/day temperatures between 20~23°C and relative humidity between 40-60%. Mice completely fed whole grain food product obtained from the Experimental Animal Center in the province of Heibei and give unlimited amount of water. Mice were trained for 3 days.

1.2 Experimental drugs

The composition according to the invention: 1 g of the composition of the medicinal product in the form of a dry powder corresponds to 4.5 g raw medicinal product. Clinical dosage for adults is 22 g raw is about drugs/day, that is, 0.37 g raw medicinal product/kg body weight (standard body weight of 60 kg). The drug was given Shijiazhuang Yiling Pharmaceutical Co., Ltd, batch number 20060801. This drug was mixed with 0.5% CMC-Na to get before using the suspension to the desired concentration.

The broth Dingchuan: provided Shijiazhuang Yiling Pharmaceutical Co., Ltd. Clinical dosage for use in humans this medicine is 69 g raw medicinal product/day. This drug was mixed with 0.5% CMC-Na to get before using the solution with the required concentration.

Ammonium chloride: 30 mg/tablet received from Xinan Pharmaceutical Co., Ltd, batch number: 66050005.

2. Experimental methods

2.1 the Principle of selection dosages

The maximum clinical dose of the composition according to the invention is 22 g raw medicinal/day, that is, 0.37 g raw medicinal/kg standard body weight of 60 kg). Dose, injected into mice, were 5, 10 and 20 times the clinical dose, i.e. mice gave 1.85 g, 3.7 g and 7.4 g of raw drugs/kg/day (group low, medium and high doses, respectively); group broth Dingchuan introduced 11.5 g of raw drugs/kg/day, which is 10 times the clinical dose. Control is inuu group and a positive drugs were installed separately.

2.2 Route of administration and dosage

Between 9:00-10:00 a.m. daily to mice intragastrically injected drugs in accordance with the groups, along with orally administered, recommended in clinical practice. Medicines continuously introduced for 5 days in the amount of 0.1 ml/10 g body weight.

2.3 Input dosage and splitting into groups

In accordance with the above principle of dose selection the mice were divided into the following 6 groups, see table 2-3.

group
Table 2-3
Group and type of dosage in the experiment for the relief of cough in mice using the composition of the invention
GroupNumberDose (gRatio
animalsrawclinical dose
drugs/kg·d)man (again)
Control12----
The group of chloride121.0010
ammonium

Group broth1211.510
Dingchuan
The composition according to121.855
invention:
Low
Average123.7010
High127.4020

<> 2.4 Experimental methods

Mouse KM were randomly divided into 6 groups of 12 mice in each group with a half males and half females. The group were as follows: control group, group of ammonium chloride, the group broth Dingchuan, group, high, medium and low dosage of the composition according to the invention. All groups were intragastrically injected medications at the dose of 0.1 ml/10 g continuously for 5 days. The control group was administered with 0.5% CMC-Na. Half an hour after the last injection the mice from each group (after fasting for 16 hours) was administered phenol red, 0.1 ml (5 mg)/10 g weight by intraperitoneal injection. Half an hour after injection, mice were killed. Tissue around the organs removed in order to release and cut the trachea, located between the thyroid cartilage and the tracheal branch; put the trachea in a test tube with 2 ml of saline followed by the addition of 0.1 ml (or 1-2 drops) of sodium hydroxide, and then well mixed; measured OD values using enzyme labeled measuring instrument 540 nm, and used phenol red to plot a standard curve and to calculate the content of phenol red in accordance with curve (μg/ml), and compared with the control group.

2.5 Statistical method

Experimental data analyzer the Wali using SPSS 11.5. Statistical results were expressed using the average number±standard deviation (); the difference between groups was determined using one-factor analysis of variance.

3. The results of the experiment

It was observed the influence of the composition of the invention for the removal of phlegm when using the method with phenol red. The results are shown in table 2.4 indicate that the content of phenol red in the trachea of mice of the control group were 0.43±0.12 µg/ml, the content of phenol red in the trachea of mice in groups of compositions according to the invention with low, medium and high doses was 0.82±0.34 μg/ml, 1.23±0.31 μg/ml and 1.48±0.61 µg/ml, respectively.

Table 2-4
The effects of the composition according to the invention for the removal of phlegm ()
GroupDose (gRatioNumberContent
rawclinical doseanimalsphenol is Krasnogo
drugs/cap)man (again)in the trachea (µg/ml)
The control group----120.43±0.12
The group of ammonium chloride1.0010121.41±0.41**
Group broth Dingchuan11.510120.89±0.37**
The low-dose group1.855120.82±0.34**
Group average dosage3.7010121.23±0.31**
The high-dose treatment group7.4020121.48±0.61**

Note: Compared with model group, *P<0.05, **P<001.

A significant increase in the content of phenol red was observed in the group of compositions according to the invention compared with the content of phenol red in the model group and broth Dingchuan (P<0.01 and P<0.05). This means that the composition according to this invention has a significant effect on the removal of phlegm, and this effect is better than the effect of the decoction Dingchuan.

III. General anti-inflammatory effect of the composition according to this invention

1 Materials for experiment

1.1 Animals: SD Rats, half male and half female, weighing 160-180 g were purchased from Beijing Vital River Experimental animal Technical Co. Ltd, license number: SCXK (BJ)2002-0003.

1.2 Drugs and reagents

(1) the Investigational medicinal product: 1 g of the composition according to the invention in the form of a dry powder corresponds to 4.5 g raw medicinal product. Clinical dosage for an adult is 22 g raw medicinal/day, that is, 0.37 g raw medicinal product/kg body weight (standard body weight of 60 kg). The medicine was provided by Shijiazhuang Yiling Pharmaceutical Co., Ltd, batch number 20060801. The drug was mixed with 0.5% CMC-Na to get before using the suspension to the desired concentration.

(2) Drug positive control: Pills dexamethasone were produced Tianjin Tianyao Phrmaceutical Co., Ltd, batch number: 20060711. License number: guo yao zhun zi HI2020686. Before applying the drug was mixed with 0.5% CMC.

(3) Carragenin: Product Sigma Company. One day before application of the drug to grind to a fine powder, mixed with a saline solution for injection with getting 1% universal suspension and kept in the refrigerator at 4°C.

1.3 Device: an Instrument for determining the volume of the foot rats (drainage).

2. Methods and results

2.1 Group and the administration of a medicinal product: 60 rats for the experiment were randomly allocated into 6 groups: model group (intragastric administration of the same volume of 0.5% CMC), a group of broth Dingchuan (intragastric administration of 8.7 g/kg, equal to 7.5 times the clinical dose for humans), positive drug (intragastric administration of 0.1 g/kg of dexamethasone, equal to 7.5 times the clinical dose for humans), the composition according to the invention with high, medium and low doses (intragastric administration of 5.6 g/kg 2.8 g/kg and 1.4 g/kg, respectively; 15-, 7.5-, 3.75-fold the clinical dose for humans, respectively); each group contained 10 rats. Drugs were administered continuously for 3 days, and the model was established through 60 minutes after the last injection.

2.2 Method of swelling Voix Pedis: according to source [Chen, Qi. chief editor. Study Methodoogy of Pharmacology of Traditional Chinese Medicine, People's Health Publishing House, 1993, 364p] was determined and recorded the volume of each of the left rear voix pedis rats prior to the introduction of drugs; 60 minutes after the last injection in each of the left rear voix pedis was subcutaneously injected 0.1 ml/rat of 1% suspension carragenin, then measured and recorded every hour volume of each of the left rear voix pedis and continuously measured 6 times. I recorded the results and calculated the degree of swelling and the degree of inhibition in accordance with the following formula: degree of swelling(%)=(volume voix pedis after induced inflammation-volume voix pedis to induced inflammation)/volume voix pedis to induced inflammation×100%

the degree of inhibition(%)=(average swelling for the control group-average swelling for the group, which was injected drug)/average swelling for the control group×100%

Statistical analysis of variance and group T-test were performed using SPSS 10.0.

2.3 Results the overall anti-inflammatory effect of the composition according to the invention are shown in table 2-5. Swelling voix pedis in rats induced by injection carragenin, significantly inhibited when injecting composition according to the invention at doses of 5.6 g/kg and 2.8 g/kg Over 1 hour after it was installed model, the degree of inhibition was significantly different from the degree of Engibarov the deposits in the control group, and the effect of inhibition lasted for 6 hours (p<0.05 and p<0.01, respectively). The results show that the composition according to the invention in the high and medium doses significantly inhibited the swelling of the voix pedis in rats induced by injection carragenin. The composition of this invention at doses of 5.6 g/kg and 2.8 g/kg compared with the control group significantly inhibited the formation of granulomas tampon rats (p<0.01 and p<0.05, respectively). These effects of the composition according to the invention were better than the effects in the group of broth Dingchuan.

Note: Compared with model group, *p<0.05, **p<0.01. (The numbers in brackets represent the degree of inhibition of the swelling.)

3. Conclusion. The composition according to this invention has a significant inhibitory effect on the overall inflammation, and this effect is better than the effect of the decoction Dingchuan.

Bronchial asthma is a chronic inflammatory disease caused by a variety of cells and cellular components. It can cause Hyper-reactive Airways, which in turn causes wheezing, shortness of breath, respiratory distress syndrome and repetitive bouts of coughing. Etiology refers to atopic Allergy. At the same time, in some patients, the etiology is not defined. Is acceptable as Shem, the automatic treatment, and etiological treatment. Because the herbal ingredients have extensive multilateral effects, they have outstanding advantages in the treatment of bronchial asthma. For this reason, pharmacodynamic testing of the compositions of this invention were based on its influence on the distribution of qi through the lungs, alleviating asthma, removing the heat and remove sputum and is aimed at improving symptoms by removing phlegm, relieve cough and anti-inflammatory action. At the same time during these tests it was observed the influence of the composition of the invention to related mechanisms, such as allergic reactions, degranulation of mast cells, immunoregulation etc. in order to evaluate therapeutic effects and mechanisms of drugs.

Pharmacological tests have shown that the composition according to the invention in high and medium doses may significantly increase the time of occurrence of wheezing and downs in Guinea pigs with asthma induced a mixed solution of histamine and acetylcholine chloride, and significantly increase the latent period in Guinea pigs with asthma caused by OVA. Asthma in the later phase, caused by multiple impacts OVA, the composition of the invention in high and medium doses can significantly increase the latent period of the AC shall we, called OVA, to reduce the proportion of eosinophils in whole blood and in bronchoalveolar lavagno fluid. In addition, the composition according to the invention in high and medium doses can inhibit the formation of Leukotriene B4 in bronchoalveolar lavagno fluid. Histopathology bronchoalveolar also shows that all the compositions of this invention in high, medium and low doses can reduce infiltration, the number of eosinophils in the bronchial wall and improve the pathological damage caused by inflammation in the pulmonary tissue. These results show that the composition according to this invention has significant therapeutic effects on the response of bronchial asthma in the early phase and late phase, and has significant any abscopal effects on the formation of appropriate inflammatory cells and mediators.

Experiments on animals for the relief of cough, sputum elimination, anti-inflammatory action, etc. were conducted in order to study related clinical symptoms and the influence of the composition of the invention to improve symptoms. These results show that the composition according to the invention in high, medium and low doses significantly increases the latent period of onset of cough in mice, caused by sulphur dioxide, and reduced the t of the frequency of cough in mice. The results of the experiment with phenol red to show that the composition according to the invention in high, medium and low doses significantly increases the allocation of phenol red in the mouse trachea. Experiments on the anti-inflammatory effect show that the composition according to the invention in high, medium and low doses significantly inhibited the swelling of the voix pedis in rats induced by injecting carrageenin and the formation of granulomas tampon rats. One hour later, after the establishment of the model in the group composition was found significant difference from the control group, and this difference was observed within 6 hours. The above results show that the composition according to the invention has a significant effect on the relief of cough, sputum elimination and anti-inflammatory effect and has a good supporting effect on the improvement of asthma symptoms.

The preparation of traditional Chinese medicinal composition of the present invention is illustrated by the following examples, but does not restrict the scope of the present invention.

Examples

Example 1

Preparation of tablets of the composition according to the invention (temporarily named: tablets LIAN HUA, relieving asthma):

Composition:

63 g of herb ephedra (baked with honey), 210 g of the bark of mulberry, 210 g of an earthworm, 84 g of seeds gingko, 84 g of flowers mA the ü and stepmother, 84 g rhizomes-Pinelli (processed potassium alum), 84 g of Perilla fruit (quick fried with constant stirring), 210 g of peony root red, 84 g of seeds of bitter apricot (fried fast with constant stirring), 84 g of the root of Scutellaria, 84 g periostracum cicadas, 210 g of grass Houttuynia, 210 g of root trichosanthis and 84 g of the fruits of forsythia.

Method of preparation:

a) take 84 g of the root of Scutellaria and 42 g rhizomes-Pinelli, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add 8-fold amount of 60% ethanol, heated and three defragment extract for 1.5 hours each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.08 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add a 9-fold amount of water, twice boiled for 2 hours each time, filtered water broth, combine broths, the concentration of irout solution to obtain the extract with relative density of 1.08 at 60°C and combine the extract with extract from stage b) for further use;

d) mixing the fine powder with stage a) and the extract from step (C), add appropriate amount of adjuvant in the mixture and spray granulation receive granules, and after drying sieved granules through a sieve, leave; and

e) preparing granules from step d) to obtain pellets of the composition according to the invention by routine methods.

Example 2

Cooking capsules composition according to the invention is:

Composition:

61 g of herb ephedra, 198 g of the bark of mulberry, 223 g of an earthworm,

78 g of seeds gingko, 92 g color mother-and-stepmother, 73 g rhizomes-Pinelli,

85 g of Perilla fruit, 188 g of red peony root, 87 g of seeds of bitter apricot,

88 g of the root of Scutellaria, 79 g periostracum cicadas, 221 g of grass Houttuynia,

218 g of root trichosanthis and 81 g of the fruits of forsythia.

Method of preparation:

a) take 88 g of the root of Scutellaria and 36.5 g rhizomes-Pinelli, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add 6 times the amount of 50% ethanol, heated and three defragment extract for 1 hour each time under reduced pressure to produce ethanol from a solution of the extract to the center of the solution to obtain an extract for further use with a relative density of 1.05 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add 7-fold amount of water, twice boiled for 1 hour each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05 at 60°C and combine the extract with extract from stage b) for future use;

d) mixing the fine powder with stage a) and the extract from step (C), add appropriate amount of adjuvant in the mixture and spray granulation receive granules after drying sieved granules through a sieve, leave; and

e) preparing granules from step d) to obtain capsules composition according to the invention by routine methods.

Example 3

Preparation of powder compositions according to the invention is:

Composition:

50 g of herb ephedra, 253 g of the bark of mulberry, 166 g of an earthworm,

66 g of seeds gingko, 101 g color mother-and-stepmother, 101 g rhizomes-Pinelli,

66 g Perilla fruit, 166 g of red peony root, 101 g of seeds of bitter apricot,

66 g of the root of Scutellaria, 66 g periostracum cicadas, 253 g of grass Houttuynia,

253 g of root trichosanthis and 66 g of the fruits of forsythia.

Method of preparation:

a) take the root of Scutellaria and half the number of rhizomes Pinell and in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add a 10-fold amount of 80% ethanol, heated and three defragment extract for 3 hours each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.10 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add a 10-fold amount of water, twice boiled for 4 hours each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.10 at 60°C and combine the extract with extract from stage b) for further use; and

d) make a fine powder with a stage) and the combined extract from step c) into a powder by routine methods.

Example 4

Preparation of oral liquid compositions according to the invention is:

Composition:

76 g of herb ephedra, 166 g of the bark of selkowe is s, 253 g of an earthworm,

101 g of seeds gingko, 66 g color mother-and-stepmother, 66 g rhizomes-Pinelli,

101 g of Perilla fruit, 253 g of peony root, red, 66 g of seeds of bitter apricot,

101 g of the root of Scutellaria, 101 g periostracum cicadas, 166 g of grass Houttuynia,

166 g of root trichosanthis and 101 g of the fruits of forsythia.

Method of preparation:

a) take the root of Scutellaria and half the number of rhizomes-Pinelli in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add 6 times the amount of 80% ethanol, heated and three defragment extract for 1 hour each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add 7-fold amount of water, twice boiled for 1 hour each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for further use; and

d) make a fine powder from step a) and the combined extract from stage c) oral solution through routine methods.

Example 5

Preparation of soft capsules composition according to the invention is:

Composition:

70 g of herb ephedra, 241 g of the bark of mulberry, 245 g of an earthworm,

98 g of seeds gingko, 94 g color mother-and-stepmother, 95 g rhizomes-Pinelli,

94 g of Perilla fruit, 230 g of red peony root, 92 g of seeds of bitter apricot,

91 g of the root of Scutellaria, 97 g periostracum cicadas, 237 g of grass Houttuynia,

231 g root trichosanthis and 91 g of the fruits of forsythia.

Method of preparation:

a) take the root of Scutellaria and 1/3 the number of rhizomes-Pinelli in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add a 10-fold amount of 50% ethanol, heated and three defragment extract for 3 hours each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate share of the VA earthworm, the red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add a 10-fold amount of water, twice boiled for 4 hours each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for further use; and

d) make a fine powder with a stage) and the combined extract from step (C) in soft capsules by routine methods.

Example 6

Preparation of the pill composition according to the invention is:

Composition:

76 g of herb ephedra, 253 g of the bark of mulberry, 253 g of an earthworm,

101 g of seeds gingko, 101 g color mother-and-stepmother, 101 g rhizomes-Pinelli,

101 g of Perilla fruit, 253 g of red peony root, 101 g of seeds apricot bitter, 101 g of the root of Scutellaria, 101 g periostracum cicadas, 253 g of grass Houttuynia, 253 g of root trichosanthis and 101 g of the fruits of forsythia.

Method of preparation:

a) take the root of Scutellaria and 2/3 the number of rhizomes-Pinelli in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds apricot bitter grass and the gutta the Institute in accordance with the composition and the remaining rhizome-Pinelli, add 8-fold amount of 60% ethanol, heated and three defragment extract 1.5 hours each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add 8-fold amount of water, twice boiled for 3 hours each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for further use; and

d) make a fine powder from step a) and the combined extract from step (C) in the pills by routine methods.

Example 7

Preparation of tinctures compositions according to the invention is:

Composition:

50 g of herb ephedra, 166 g of the bark of mulberry, 166 g of an earthworm,

66 g of seeds gingko, 66 g color mother-and-stepmother, 66 g rhizomes-Pinelli,

66 g Perilla fruit, 166 g of peony root, red, 66 g of seeds of bitter apricot,

66 g of the root of Scutellaria, 66 g periostracum cicadas, 166 g of grass Houttuynia,

166 g of root trichosanthis and 66 g of the fruits of forsythia.

The way you need a kitchen the population:

a) take the root of Scutellaria and half the number of rhizomes-Pinelli in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add 9-fold amount of 75% ethanol, heated and three defragment extract for 2.5 hours each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add 8.5-fold amount of water, twice boiled for 2.5 hours each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for further use; and

d) make a fine powder from step a) and the combined extract from step (C) in tincture by routine methods.

Example 8

the Cooking of the syrup composition according to the invention is:

Composition:

50 g of herb ephedra, 166 g of the bark of mulberry, 166 g of an earthworm,

66 g of seeds gingko, 66 g color mother-and-stepmother, 66 g rhizomes-Pinelli,

66 g Perilla fruit, 166 g of peony root, red, 66 g of seeds of bitter apricot,

66 g of the root of Scutellaria, 66 g periostracum cicadas, 166 g of grass Houttuynia,

166 g of root trichosanthis and 66 g of the fruits of forsythia.

Method of preparation:

a) take the root of Scutellaria and half the number of rhizomes-Pinelli in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add 7.5-fold amount of 70% ethanol, heated and three defragment extract 1.5 hours each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add 8-fold amount of water, twice boiled for 2 hours each time, fil who enjoy water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for further use; and

d) make a fine powder from step a) and the combined extract from step (C) in the syrup through routine methods.

Example 9

Preparation of suppository compositions according to the invention is:

Composition:

50 g of herb ephedra, 253 g of the bark of mulberry, 166 g of an earthworm,

66 g of seeds gingko, 101 g color mother-and-stepmother, 101 g rhizomes-Pinelli,

66 g Perilla fruit, 166 g of red peony root, 101 g of seeds of bitter apricot,

66 g of the root of Scutellaria, 66 g periostracum cicadas, 253 g of grass Houttuynia,

253 g of root trichosanthis and 66 g of the fruits of forsythia.

Method of preparation:

a) take the root of Scutellaria and 2/3 the number of rhizomes-Pinelli in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add 6 times the amount of 50% ethanol, heated and three defragment extract for 3 hours each time under reduced pressure to produce ethanol ezrestore extract, concentrate the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add 7-fold amount of water, twice boiled for 1 hour each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for further use; and

d) make a fine powder from step a) and the combined extract from step (C) in the suppository through routine methods.

Example 10

Preparation of a gel composition according to the invention is:

Composition:

76 g of herb ephedra, 166 g of the bark of mulberry, 253 g of an earthworm,

101 g of seeds gingko, 66 g color mother-and-stepmother, 66 g rhizomes-Pinelli,

101 g of Perilla fruit, 253 g of peony root, red, 66 g of seeds of bitter apricot,

101 g of the root of Scutellaria, 101 g periostracum cicadas, 166 g of grass Houttuynia,

166 g of root trichosanthis and 101 g of the fruits of forsythia.

Method of preparation:

a) take the root of Scutellaria and 3/4 rhizomes-Pinelli in accordance with the proportion of the composition, grind them to a fine powder for further use in the project;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add a 10-fold amount of 50% ethanol, heated and three defragment extract for 3 hours each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add a 10-fold amount of water, twice boiled for 4 hours each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine the extract with extract from stage b) for further use; and

d) make a fine powder from step a) and the combined extract from stage c) in the gel by routine methods.

Example 11

Cooking spray compositions according to the invention is:

Composition:

70 g of herb ephedra, 241 g of the bark of mulberry, 245 g of an earthworm,

98 g of seeds gingko, 94 g color mother-and-stepmother, 95 g rhizomes Pina is Leah

94 g of Perilla fruit, 230 g of red peony root, 92 g of seeds of bitter apricot,

91 g of the root of Scutellaria, 97 g periostracum cicadas, 237 g of grass Houttuynia,

231 g root trichosanthis and 91 g of the fruits of forsythia.

Method of preparation:

a) take the root of Scutellaria and half the number of rhizomes-Pinelli in accordance with the proportion of the composition, grind them to a fine powder for further use;

b) take the appropriate amount of herbs ephedra, seeds, gingko, bark of mulberry trees, flowers mother-and-stepmother, Perilla fruit, seeds of bitter apricot and herbs Houttuynia in accordance with the composition and the remaining rhizome-Pinelli add 6 times the amount of 80% ethanol, heated and three defragment extract for 3 hours each time under reduced pressure to produce ethanol from a solution of the extract, concentrating the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;

c) take appropriate amount of an earthworm, red peony root, periostracum cicadas, root trichosanthis and the fruits of forsythia in accordance with the composition, add a 10-fold amount of water, twice boiled for 1 hour each time, filtered water broth, combine broths, concentrating the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and combine this ek is a path with an extract from stage b) for further use; and

d) make a fine powder with a stage) and the combined extract from step (C) in the spray by routine methods.

Example 12

Preparation of powder compositions according to the invention is:

82 g of herb ephedra, 150 g of the bark of mulberry, 270 g of an earthworm,

50 g of seeds gingko, 130 g color mother-and-stepmother, 55 g rhizomes-Pinelli,

130 g Perilla fruit, 155 g of peony root, red, 55 g of seeds of bitter apricot,

130 g of the root of Scutellaria, 55 g periostracum cicadas, 280 g of grass Houttuynia,

280 g root trichosanthis and 130 g of the fruits of forsythia.

Method of preparation:

Take every raw medical material according to composition, grind them to powder, sift the powder and turn them into powder.

1. Composition of traditional Chinese medicines for the treatment of asthma, which is made from the following raw medical materials:
40-90 parts of the herb ephedra (Herba Ephedrae),
136-300 parts of the bark of mulberry (Cortex Mori),
146-300 parts of an earthworm (Lumbricus),
46-151 parts seeds gingko (Semen Ginkgo),
46-151 parts color mother-and-stepmother (Flos Farfarae),
46-151 parts of the rhizomes pinellia (Rhizoma Pinelliae),
46-151 parts Perilla fruit (Fructus Perillae),
146-300 parts of red peony root (Radix Paeoniae Rubra),
46-151 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),
46-151 parts of the root of Scutellaria (Radix Scutellariae),
46-151 castelpietra cicadas (Periostracum Cicadae),
146-300 parts grass Houttuynia (Herba Houttuyniae),
146-300 root parts of trichosanthis (Radix Trichosanthis) and
46-151 parts forsythia fruit (Fructus Forsythiae).

2. The composition according to claim 1, which is prepared from the following composition of the raw medical materials:
50-76 parts of the herb ephedra (Herba Ephedrae),
166-253 parts of the bark of mulberry (Cortex Mori),
166-253 parts of an earthworm (Lumbricus),
66-101 parts seeds gingko (Semen Ginkgo),
66-101 parts color mother-and-stepmother (Flos Farfarae),
66-101 parts of the rhizomes pinellia (Rhizoma Pinelliae),
66-101 parts Perilla fruit (Fructus Perillae),
166-253 parts of red peony root (Radix Paeoniae Rubra),
66-101 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),
66-101 parts of the root of Scutellaria (Radix Scutellariae),
66-101 parts periostracum cicadas (Periostracum Cicadae),
166-253 parts grass Houttuynia (Herba Houttuyniae),
166-253 root parts of trichosanthis (Radix Trichosanthis) and
66-101 parts forsythia fruit (Fructus Forsythiae).

3. The composition according to claim 2, which is prepared from the following composition of the raw medical materials:
70 parts of the herb ephedra (Herba Ephedrae),
241 parts of the bark of mulberry (Cortex Mori),
245 parts of an earthworm (Lumbricus),
98 parts of seeds gingko (Semen Ginkgo),
94 parts of flowers mother-and-stepmother (Flos Farfarae),
95 parts of the rhizomes pinellia (Rhizoma Pinelliae),
94 parts Perilla fruit (Fructus Perillae),
230 parts of red peony root (Radix Paeoniae Rubra),
92 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),
91 parts of the root of Scutellaria (Radix Scutelariae),
97 parts periostracum cicadas (Periostracum Cicadae),
237 parts grass Houttuynia (Herba Houttuyniae),
231 parts of the root trichosanthis (Radix Trichosanthis) and
91 parts forsythia fruit (Fructus Forsythiae).

4. The composition according to claim 2, which is prepared from the following composition of the raw medical materials:
63 parts of the herb ephedra (Herba Ephedrae),
210 parts of the bark of mulberry (Cortex Mori),
210 parts of an earthworm (Lumbricus),
84 parts of seeds gingko (Semen Ginkgo),
84 parts of flowers mother-and-stepmother (Flos Farfarae),
84 parts of the rhizomes pinellia (Rhizoma Pinelliae),
84 parts Perilla fruit (Fructus Perillae),
210 parts of red peony root (Radix Paeoniae Rubra),
84 parts of seeds of bitter apricot (Semen Armeniacae Amarum),
84 parts of the root of Scutellaria (Radix Scutellariae),
84 parts periostracum cicadas (Periostracum Cicadae),
210 parts of grass Houttuynia (Herba Houttuyniae),
210 parts of the root trichosanthis (Radix Trichosanthis) and
84 parts forsythia fruit (Fructus Forsythiae).

5. The composition according to claim 2, which is prepared from the following composition of the raw medical materials:
61 parts of the herb ephedra (Herba Ephedrae),
198 parts of the bark of mulberry (Cortex Mori),
223 parts of an earthworm (Lumbricus),
78 parts of seeds gingko (Semen Ginkgo),
92 parts of flowers mother-and-stepmother (Flos Farfarae),
73 parts of the rhizomes pinellia (Rhizoma Pinelliae),
85 parts Perilla fruit (Fructus Perillae),
188 parts of red peony root (Radix Paeoniae Rubra),
87 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),
88 parts of a root of solemn the ka (Radix Scutellariae),
79 parts periostracum cicadas (Periostracum Cicadae),
221 parts grass Houttuynia (Herba Houttuyniae),
218 parts of the root trichosanthis (Radix Trichosanthis) and
81 parts forsythia fruit (Fructus Forsythiae).

6. The composition according to claim 1, where the specified composition is prepared from the following composition of the raw medical materials:
77-88 parts of the herb ephedra (Herba Ephedrae),
136-165 parts of the bark of mulberry (Cortex Mori),
255-300 parts of an earthworm (Lumbricus),
46-65 parts seeds gingko (Semen Ginkgo),
110-151 parts color mother-and-stepmother (Flos Farfarae),
46-65 parts of the rhizomes pinellia (Rhizoma Pinelliae),
105-151 parts Perilla fruit (Fructus Perillae),
146-165 parts of red peony root (Radix Paeoniae Rubra),
46-65 parts of the seeds of bitter apricot (Semen Armeniacae Amarum),
103-151 parts of the root of Scutellaria (Radix Scutellariae),
46-65 parts periostracum cicadas (Periostracum Cicadae),
255-300 parts grass Houttuynia (Herba Houttuyniae),
255-300 root parts of trichosanthis (Radix Trichosanthis) and
103-151 parts forsythia fruit (Fructus Forsythiae).

7. Composition according to any one of claims 1 to 6, where the herb ephedra is the herb ephedra, baked with honey, seeds, gingko are quickly fried with constant stirring seeds gingko, rhizome-Pinelli is a processed potassium alum rhizome-Pinelli, Perilla fruit are quickly fried with constant stirring Perilla fruit, the seeds of bitter apricot present the amount quickly fried with constant stirring the seeds of bitter apricot.

8. Composition according to any one of claims 1 to 6, where clinical dosage forms specified compositions represent a capsule, tablet, powder, oral liquid, soft capsule, pill, tincture, syrup, suppository, gel, spray or injection.

9. Composition according to any one of claims 1 to 6, where this composition is made in the following way:
a) grinding to fine powder of the root of Scutellaria (Radix Scutellariae) and 1/3-3/4 of the number of rhizomes-Pinelli (Rhizoma Pinelliae) in accordance with the proportion of the composition for further use;
b) adding to the corresponding number of the herbs ephedra (Herba Ephedrae), seeds gingko (Semen Ginkgo), bark of mulberry (Cortex Mori), flowers mother-and-stepmother (Flos Farfarae), Perilla fruit (Fructus Perillae), seeds of bitter apricot (Semen Armeniacae Amarum) and grass Houttuynia (Herba Houttuyniae) in accordance with the composition and the remaining rhizome-Pinelli (Rhizoma Pinelliae) 6-10 times the number of 50-80% ethanol, followed by heating and delegacia extract three times for 1-3 hours, with the release of the ethanol under reduced pressure from the solution of the extract and the concentration of the solution to obtain the extract with relative density of 1.05-1.10 at 60°C for further use;
c) adding the appropriate number of earthworm (Lumbricus), red peony root (Radix Paeoniae Rubra), periostracum cicadas (Periostracum Cicadae), root trichosanthis (Radix Trichosanthis) and the fruit of the Fort is icii (Fructus Forsythiae) in accordance with the composition, 7-10-fold amount of water, boiling twice for 1-4 hours, filtering the aqueous broth, combine broths obtained from two otvarivanie, the concentration of the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and the combination of the extract with extract from stage b) for future use;
d) mixing the fine powder with stage a) with the combined extract from step c) to obtain the composition of traditional Chinese medicines according to the invention.

10. A method of manufacturing tablets traditional Chinese medicinal composition according to any one of claims 1 to 6, comprising the following stages:
a) grinding the root of Scutellaria (Radix Scutellariae) and half the number of rhizomes-Pinelli (Rhizoma Pinelliae) in accordance with the proportion of the composition to a fine powder for further use;
b) adding to the corresponding number of the herbs ephedra (Herba Ephedrae), seeds gingko (Semen Ginkgo), bark of mulberry (Cortex Mori), flowers mother-and-stepmother (Flos Farfarae), Perilla fruit (Fructus Perillae), seeds of bitter apricot (Semen Armeniacae Amarum) and grass Houttuynia (Herba Houttuyniae) in accordance with the composition and the remaining rhizome-Pinelli (Rhizoma Pinelliae) by proportion, 6-10-fold amount of 50-80% ethanol, heated and delegacia extract three times for 1-3 hours with the release of the ethanol under reduced pressure from the of astora extract the concentration of the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;
c) adding the appropriate number of earthworm (Lumbricus), red peony root (Radix Paeoniae Rubra), periostracum cicadas (Periostracum Cicadae), root trichosanthis (Radix Trichosanthis) and forsythia fruit (Fructus Forsythiae) in accordance with the composition, 7-10-fold amount of water, boiling within 1-4 hours twice, filtering water broth, combine broths obtained from two otvarivanie, the concentration of the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and the combination of the extract with extract from stage b) for further use;
d) mixing the fine powder with stage a) and the combined extract from stage c), adding an appropriate amount of adjuvant in the mixture and obtaining a spray granulation granules, followed by drying, sieving of the granules through a sieve; and
e) receiving the tablets of the composition of traditional Chinese medicines of the granules from step (d).

11. Method of preparation tablets composition of traditional Chinese medicines according to claim 10, comprising the following stages:
a) grinding the root of Scutellaria (Radix Scutellariae) and half the number of rhizomes-Pinelli (Rhizoma Pinelliae) in accordance with the proportional what their composition to fine powder for further use;
b) adding to the corresponding number of the herbs ephedra (Herba Ephedrae), seeds gingko (Semen Ginkgo), bark of mulberry (Cortex Mori), flowers mother-and-stepmother (Flos Farfarae), Perilla fruit (Fructus Perillae), seeds of bitter apricot (Semen Armeniacae Amarum) and grass Houttuynia (Herba Houttuyniae) in accordance with the composition and the remaining rhizome-Pinelli (Rhizoma Pinelliae) by proportion, 8-fold amount of 60% ethanol, heated and delegacia extract 1.5 hours, with the release of the ethanol under reduced pressure from the extract solution the concentration of the solution to obtain an extract for further use with a relative density of 1.05-1.10 at 60°C;
c) adding the appropriate number of earthworm (Lumbricus), red peony root (Radix Paeoniae Rubra), periostracum cicadas (Periostracum Cicadae), root trichosanthis (Radix Trichosanthis) and forsythia fruit (Fructus Forsythiae) in accordance with the composition of, 9-fold amount of water, boiling for 2 hours twice, filtering water broth, combine broths obtained from two otvarivanie, the concentration of the solution to obtain the extract with relative density of 1.05-1.10 at 60°C and the combination of the extract with extract from stage b) for future use;
d) mixing the fine powder with stage a) and the combined extract from stage c), adding an appropriate amount of adjuvant in the mixture and the prize is l spray granulation, followed by drying and sieving of the granules through a sieve; and
e) receiving the tablets of the composition of traditional Chinese medicines of the granules from step d).



 

Same patents:

FIELD: medicine.

SUBSTANCE: inhalation formulation in the form of aerosol for treating bronchial asthma and chronic obstructive pulmonary disease containing ipratropium bromide monohydrate as an active ingredient, ethanol absolute as a solvent, an aerosol particle size regulator as an adjuvant consisting of triethyl citrate and an acid specified in a group: citric acid, hydrochloric acid, orthophosphoric acid, 1,1,1,4-tetrafluoroethane (HFA-134a) and/or 1,1,1,2,3,3,3-heptafluoropropane (HFA-227ea) as a propellant in certain proportions.

EFFECT: increasing the respirable fraction and obtaining an optimised particle size distribution profile.

7 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and pharmaceutical industry concerns a dry powder preparation containing formoterol fumarate dihydrate in the microionised form enabling bronchial and pulmonary alveolar penetration and additives, namely mixed lactose and sodium benzoate prepared in a particular way and enabling dosing and disaggregating the active ingredient effectively.

EFFECT: developing the preparation enabling dosing and disaggregating the active ingredient effectively.

4 cl, 8 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, namely to pulmonology, and concerns a drug for treating inflammatory and obstructive respiratory diseases, particularly bronchial asthma and obstructive bronchitis, based on 1,3'-dinitroglycerine ester of 11(S),15(S)-dihydroxy-9-keto-5Z,13E-prostadiene acid, possessing a pronounced bronchodilatory effect. What is considered is a method of treating the inflammatory and obstructive respiratory diseases using the drug based on 1,3'-dinitroglycerine ester of 11(S),15(S)-dihydroxy-9-keto-5Z,13E-prostadiene acid.

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2 cl, 4 ex, 1 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to pulmonology and may be used in treating the patients with chronic bronchitis in combination with secondary immunodeficiency. For this purpose, the patient with the remitting disease undergoes 6 procedures of ozone therapy every second days by the intravenous introduction of ozonised physiological saline with the ozone concentration 600 mcg/l in the ozone-oxygen gas mixture. One week after the ozone therapy, patient's venous blood is sampled and exposed to UV light for 2 procedures every 7 days. At the first procedure, the blood volume to be exposed makes 0.8 ml/kg of patient's body weight, and at the second procedure - 1 ml/kg.

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2 tbl, 2 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to medicine and pharmaceutical industry and deals with solution of high-efficient composition in form of solution of active and additional substances, which makes it possible to form aerosol of small particles aimed at penetration in bronchi and pulmonary alveoli. Solution for obtaining medication for inhalational introduction contains fenoterol hydrobromide and ipratropium bromide as active substances, and sodium benzoate, food organic acid, purified water as additional substances with specified ratio of components.

EFFECT: solution has high value of respirable fractions.

6 cl, 3 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to cardiology and pulmonology, and concerns treating the patients with chronic obstructive pulmonary disease and ischemic heart disease and cardiac failure complicated by anaemia. For this purpose, pre-treatment haemoglobin and serum iron are evaluated. In that case, if the hemoglobin level is less than 110 mm/l, and the serum iron level is less than 5.85 mmol/l, the conventional treatment involving ACE inhibitors, beta blockers, diuretics, antiaggregants, statins as well as salmeterol and berodual, is added by prescribing an anti-anaemic therapy with Epocrin and Ferrum Lek. Epocrin is administered in a dose of 50 IU/kg subcutaneously 6 times a week; Ferrum Lek is administered in a dose of Fe 100 mg in 5 ml intravenously twice a week. The therapeutic course is 3 months.

EFFECT: this dose schedule of the preparations provides reducing a length of treatment by improving the central haemodynamics, and enhancing the respiratory function.

2 ex

Novel methods // 2484821

FIELD: medicine, pharmaceutics.

SUBSTANCE: there are presented: the use of aclidinium for preparing a medicine for treating or preventing a respiratory disease or condition in a patient by inhalation, wherein said patients showed no systemic antimuscarinic actions, where the patient suffers a condition or is susceptible thereto, which may be exacerbated by systemic antimuscarinic activity (versions), and a related method of treating or preventing.

EFFECT: invention provides local therapeutic action of aclidinium in lungs and has no significant systemic antimuscarinic action as it quickly hydrolysed in blood plasma, and its main metabolites are completely deprived of affinity to muscarinic receptors.

13 cl, 3 ex

FIELD: chemistry.

SUBSTANCE: invention relates to novel isoquinolinone derivatives of formula (I) , wherein R1 is selected from H, (C1-C6)alkyl, (C2-C6)alkenyl, (CH2)a-X-Ar and (CR101R102)a-X-Ar, where said (C1-C6)alkyl is optionally substituted with 1, 2 or 3 groups independently selected from -(C1-C6)alkoxy, -halogen, -OH, -heterocycloalkyl, (C3-C7)cycloalkyl and -NR8R9; R2 is selected from H and (C1-C6)alkyl; R is selected from H, (C1-C6)alkyl and (CH2)d-Y; provided that when R3 is (CH2)d-Y, R2 is selected from H; R4 and R5 are independently selected from H, (C1-C6)alkyl and halogen; R is (C3-C7)cycloalkyl; R7 is H; Ar is phenyl or heteroaryl, optionally substituted with 1, 2 or 3 groups independently selected from -(C1-C6)alkyl, -(CH2)e-O-(C1-C6)alkyl, -(CH2)e-S(O)f(C1-C6)alkyl, -(CH2)e-N(R10)-(C1-C6)alkyl, -(CH2)e-Z-(C1-C6)alkyl, -halogen, heterocycloalkyl, -C(O)NR8R9, -NR8R9 and -C(O)OH, where (C1-C6)alkyl in each case is independently optionally substituted with 1, 2 or 3 groups, independently selected from -NRI2R13; X is selected from a single bond; Y is NR16R17, where R16 and R17 together with a nitrogen atom with which they are bonded form a 5-7-member ring, optionally containing an additional heteroatom NR27, where said ring is optionally substituted on the carbon atom with 1 or 2 substitutes independently selected from -(C1-C6)alkyl, where said -(C1-C6)alkyl is optionally substituted with -OH; and where R27 is selected from H and (C1-C6)alkyl, where said (C1-C6)alkyl is optionally substituted with -OH; Z is selected from C(O)N(R18); R8 and R9 are independently selected from H and (C1-C6)alkyl, where said (C1-C6)alkyl is optionally substituted with 1, 2 or 3 groups, independently selected from NR19R20; or R8 and R9 together with the nitrogen atom with which they are bonded form a 5-6-member ring, optionally containing an additional heteroatom, selected from NR21; R12 and R13 are independently selected from H and (C1-C6)alkyl, where said (C1-C6)alkyl is optionally substituted with -(C1-C6)alkoxy, -OH; or R12 and R13 together with the nitrogen atom with which they are bonded form a 5-6-member ring optionally containing an additional heteroatom selected from NR24; R10, R18, R19, R20, R21, R22, R23 and R24 are independently selected from H and (C1-C6)alkyl; a is selected from 1, 2, 3, 4, 5 and 6; d equals 0 or 1; e equals 0; f is independently selected from 1 and 2; where the heterocycloalkyl is a 5-6-member non-aromatic cyclic ring bonded at a C atom, having 1-2 NR28 atoms; optionally having one double bond; the heteroaryl is a 6-member aromatic ring containing 1 N atom; R is selected from H, (C1-C6)alkyl and -C(O)O-(C1-C6)alkyl; R101 is (C1-C6)alkyl; R102 is H; or pharmaceutically acceptable salts thereof or N-oxides. The invention also relates to methods of producing said compounds and use thereof as a p38 kinase inhibitor.

EFFECT: improved method.

13 cl, 4 dwg, 1 tbl, 128 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: claimed are: composition, which contains β2-agonist, except formoterol and salmoterol, and antagonist of muscarinic receptors M3, which represents 3(R)-(2-hydroxy-2,2-dithien-2-ylacetoxy)-1-(3-phenoxy-propyl)-1-azoniumbicyclo[2.2.2]octane in form of salt with anion X, which represents pharmaceutically acceptable anion of mono- or polyvalent acid (aclinidium) and its application for obtaining medication for simultaneous, joined, separate or successive introduction for treatment of respiratory disease, reacting to M3 antagonism (versions), product, set, package, including said combination and respective treatment method.

EFFECT: claimed composition does not give traditional for combination of β2-agonist and antagonist of muscarinic receptors M3 side effects (tachycardia, palpitation, complaints of pains in angina pectoris, arrhythmias) and can be used for treating patient with earlier acquired heart disease or state, which can be aggravated by tachycardia).

19 cl, 4 dwg, 1 tbl

FIELD: medicine.

SUBSTANCE: there are offered: a pharmaceutical product for treating a respiratory disease containing a combination of a first active ingredient specified in a muscarine antagonist and a second active ingredient, a β2-adrenoreceptor agonist wherein each active ingredient is prepared in the form of a preparation for inhalations, a respective kit, a pharmaceutical composition. What is shown is intensifying inhibition of the declared combination of metacholine induced tracheal ring tonus in vitro vs. separate introduction of the active ingredients, including enhancing bronchoprotection (bronchostenosis inhibition) in vivo.

EFFECT: said product is applicable for preparing a drug for treating respiratory diseases, such as chronic obstructive pulmonary disease.

12 cl, 9 dwg, 3 tbl

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine. What is described is a method for preparing a bioadhesive compacted matrix that involves preparing a homogenous mixture of powders containing at least one alkyl cellulose or one hydroxyalkyl and a water-insoluble, water-swelling cross-linked polycarboxyl polymer, using the same powder mixture to prepare compressed work pieces using direct extrusion and heating of the compressed work pieces prepared thereby to the temperatures within the range of 80-250°C for 1-60 minutes. The powder mixture may also contain at least one active substance.

EFFECT: compressed work pieces prepared thereby are characterised by the prolonged release and show the kinetics of the active substance release of substantially zero order in an aqueous solution at pH 4-8.

15 cl, 18 dwg, 5 tbl, 4 ex

FIELD: medicine.

SUBSTANCE: invention represents a hemostatic preparation containing a complex of aminocaproic acid and ferric iron stabilised with sodium chloride in the isotonic concentration. The invention aims at wound healing, small hemostasis at administering the first medical aid at the pre-hospital emergency evacuation.

EFFECT: what is provided is preparing the preparation very soluble in water and possessing high hemostatic activity, low costs and extended storage period.

FIELD: medicine, pharmaceutics.

SUBSTANCE: claimed invention relates to application of a pharmaceutical drug form for peroral introduction to reduce inter-individual variability in paracetamol-containing compositions in a diabetic patient with gastric dismotility. The said drug form contains in a form of a granulate: paracetamol in amount 60-80 wt %, calcium carbonate in amount 5-20 wt %, at least, one first binding substance and, at least, one disintegrating substance, as well as, at least, one hydrophilic colloid as an extragranular component.

EFFECT: invention ensures improvement of an active substance absorption in the patient with gastric dismotility.

13 cl, 1 tbl, 3 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to the field of cosmetology, namely to a cosmetic composition for peroral introduction, which contains a combination of lycopene, vitamin C, vitamin E and at least one polyphenol compound, obtained from pine bark, in which the ratio of weight content of polyphenol compound to the sum of weight contents of lycopene, vitamin C and vitamin E constitutes from 0.3 to 0.7, as s single active ingredient.

EFFECT: invention is intended for prevention and/or treatment of wrinkles in the area of eyes and mouth angles, small wrinkles, eye bags and dark circles under eyes.

22 cl, 2 ex, 11 tbl

FIELD: medicine.

SUBSTANCE: claimed invention relates to a pill, which has a specific shape, and a chisel, which is applied for the pill obtaining.

EFFECT: pill is applied with the purpose of laxative action and has high content of magnesium oxide particles and unusually low damage ability to abrasion and crumbling.

10 cl, 14 ex, 5 tbl, 2 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to an implantable drug depot applicable for the release, prevention or treatment of a postoperative pain in a patient in need thereof; the implantable drug depot contains a therapeutically effective amount of clonidine or its pharmaceutically acceptable salt and polymer; the drug depot is implantable into percutaneously for the release, prevention or treatment of postoperative paints; the drug depot can release: 1) approximately 5% approximately to 45% of clonidine or its pharmaceutically acceptable salt to total clonidine or its pharmaceutically acceptable salt as a part of the depot for a first period making up to 48 hours; 2) approximately 55% approximately to 95% of clonidine or its pharmaceutically acceptable salt to total clonidine or its pharmaceutically acceptable salt as a part of the depot for the following period making at least 3 days.

EFFECT: implantable form enables the easy accurate implantation of the drug depot with minimum physical and psychological traumas of the patient.

15 cl, 2 tbl, 20 dwg, 6 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, more specifically to an agent that can be used for treating the lipid storage disease. A pharmaceutical composition contains calcium rosuvastatin in the therapeutically effective amount, lactose as an excipient containing 94.7-98.3 wt % of lactose monohydrate and povidone, cross povidone as a desintegrant, colloidal silicone dioxide as a glidant, stearate as a lubricant, with the composition containing an inorganic salt with a polyvalent cation. The pharmaceutical composition according to the invention is characterised by the substantial reduction of calcium rosuvastatin storage destruction, fast disintegration, high release rate of the active agent, high breaking and abrasive strength, and has a shelf life of more than 2 years.

EFFECT: preparing the agent that can be used for treating the lipid storage disease.

5 cl, 2 tbl

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to chemical-pharmaceutical industry, particularly to a method for preparing a powder. The method involves the stages of providing at least one first ingredient that has a consistence of viscous fluid and that has an initial melting point within the temperature range of 15°C to 40°C, providing at least one second ingredient that has a melting point, particularly within the range above an ambient temperature up to 120°C, preparing a homogenous liquid mixture containing one first ingredient and one second ingredient by mixing and heating the mixture to a temperature or maintaining a temperature of the mixture within the range above the melting point. Supplying the liquid mixture to an irrigation hardening unit and extracting the powder prepared by irrigation hardening. In addition, the present invention refers to the method for preparing the solid dosage form containing the powder prepared by the method described above.

EFFECT: improvement of the method.

17 cl, 6 ex, 2 tbl

FIELD: medicine.

SUBSTANCE: invention represents a pharmaceutical composition for treating HIV infection as a solid dosage form containing at least one HIV protease inhibitor in a therapeutically effective amount specified in a group of nelfinavir, sacvinavir, tipranavir, darunavir, indinavir, ritonavir, lopinavir, palinavir or fosamprenavir, and pharmaceutically acceptable additives, differing by the fact that the pharmaceutically acceptable additives are presented by at least one water-soluble polymer in the amount of 0.4 to 49 wt % of the weight of the ready dosage form, one water-insoluble polymer in the amount of 0.39 to 28 wt % of the weight of the ready dosage form, surfactants, excipients to the weight of 100% of the ready dosage form, as well as a method of treating HIV infection.

EFFECT: composition possesses the improved technological properties and bioavailability as compared to a prototype drug.

13 cl, 7 ex, 1 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to medicine. A pharmaceutical formulation for the treating diseases associated with endothelial dysfunction contains an active ingredient presented by a methyl pyridine derivative - 1.0-6.0 wt %; purine - 10.0-80.0 wt % and additive agents - the rest. The active substance is presented by compounds of a group: 3 -(N,N-dimethyl carbamoyloxy)-2-ethyl-6-methylpyridinium succinate, 3-methylpyridinium succinate, 2-ethyl-6-methyl-3-hydroxypyridinium hydrochloride, 6-trichloromethyl-2-chloropyridine (nitrapyrin), 2-ethyl-6-methyl-3-hydroxypyridine succinate. Purine is presented by inosine, adenosine, hypoxanthine. The pharmaceutical formulation may be presented in the form of injections, lyophilisate, solid capsules, tablets and suppositories.

EFFECT: formulation according to the invention provides creating the stable drug dosage form which considerably exceeds the existing analogues in pharmacodynamics activity on the endothelial dysfunction and toxicological properties.

4 cl, 4 tbl, 9 ex

FIELD: chemistry, pharmacology.

SUBSTANCE: pharmacological composition for preparing drug forms in form of powder, solution or bandage consists of biocompatible film-generating polymer polyvinylpyrrolidone (Mm 20000), iodine and Novocain, taken in quantities, given in the invention formula. Pharmaceutical composition is intended for processing wound surface and treatment of burns. Composition possesses antiseptic, local anesthetic and wound-healing action.

EFFECT: water-soluble form of medication possesses high anti-burn activity, low cost and long storage term.

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