Preparation of anti-ulcerous and antacidal action

FIELD: pharmaceutics.

SUBSTANCE: the suggested preparation consists of basic bismuth nitrate, basic magnesium carbonate, sweet flag rhizome, buckthorn bark as water-soluble extract, water-soluble extracts of licorice root and birch leaves taken at a certain ratio. It is designed in tableted form.

EFFECT: higher efficiency of application.

1 ex, 2 tbl

 

The invention relates to pharmaceutical hiiii, namely means having antiulcer and anti-acid action., and can be used for the treatment of patients with gastric ulcer and duodenal ulcer, including that associated with Helicobacter pylori.

Ulcers of the duodenum in the analysis of gastric juice, the most characteristic hypersecretion with high numbers of hydrochloric acid. Antacids neutralize the hydrochloric acid of the gastric juice, reduce digestive activity of pepsin, including marked in respect of the gastric mucosa. Antacids protects the mucous membrane from damaging factors. With increased secretion and gastric acidity such factors are hydrochloric acid and pepsin.

Currently, in clinical practice, use large amounts of antacid drugs, the main components of which are magnesium oxide, aluminium hydroxide, sodium bicarbonate, nitrate of bismuth core and other alkaline substances as well as drugs, the mechanism of action is based on blocking of H2-histamine receptors of the gastric mucosa, which in turn leads to the suppression of production of hydrochloric acid. In addition, the above mentioned preparations contain different nature enveloping substance, which ultimately providing the em their antacid and antiulcer activity. The modern Arsenal of such funds is very high, it is enough to mention some of them, such as anacid, talcid, bimetallic, serial, ranitil, ranitidine, avalox, racial, Roxanne, testid, Famotidin, gastal, malox, Almagel, pointstotal, denol and other

Before the discovery of Helicobacter pylori bismuth preparations were used mainly as a binder, enveloping and adsorbing drugs. After the opening of this microorganism these drugs, given their expressed antimicrobial properties, was used as the base of the preparation of H. pylori therapy. An important advantage of bismuth preparations in comparison with other H. pylori tools is the lack of them resistant strains of Helicobacter pylori.

It should be noted that in vitro Helicobacter pylori is sensitive to a wide range of antibiotics, however, in vivo the effectiveness of these funds is significantly different. Even before the discovery of Helicobacter pylori in gastroenterology was widely used various preparations of bismuth. They have a protective effect, covering the mucous membrane of the thin film, the vasoconstrictor effect, preventing the development of gastrointestinal bleeding, a pronounced antimicrobial effect and promote adsorption of the products of vital activity of the intestinal microflora.

At the present time in therapy of H. pylori as the reference drug use drugs bismuth, especially in combination with the above-mentioned substances. Already there has been significant progress in developing treatment regimens for infections that are universally recognized. However, the choice of adequate treatment of peptic ulcer and today remains an important issue of gastroenterology. Worldwide is an intensive search for new drugs and Helicobacter modes with sufficient efficiency, safety and low cost.

Some preparations of bismuth with antacids and antiulcer activity, also contain herbal ingredients that extends their pharmacological action spectrum; in particular, pills Usually contain in addition to bismuth nitrate basic, magnesium basic carbonate, sodium hydrogen carbonate components, providing directly antacid and astringent effect, buckthorn bark, calamus rhizome, rutin and kellin, making in addition to antacids and the binding effect is achieved laxative, anti-inflammatory and antispasmodic action (Mashkovsky PPM Medicines. Kharkiv, Torching, 1997, vol. 1, s).

Also known tablets Vikair containing bismuth nitrate basic, magnesium basic carbonate, sodium bicarbonate, powder Acorus calamus rhizome and buckthorn bark, providing the same effect as "Usually" (Mashkovsky PPM L is drug money. Kharkiv, Torching, 1997, vol. 1, s).

The drug "Vikair is the closest in composition and pharmacological action of the claimed means and adopted as a prototype.

The lack of preparation of the prototype is its lack of raspadaemost, as also observed in some patients irritation of the digestive tract.

The present invention is the creation of antiulcer and antacid having a high therapeutic effect, soft slautering, zhelchegonnym, antiseptic and absorbent action, affordable.

The problem is solved due to the fact that the proposed antacid and antiulcer agent containing bismuth nitrate basic, magnesium basic carbonate, sodium bicarbonate, Acorus calamus rhizome, the water-soluble extracts: buckthorn bark, licorice root and birch leaves in the following ratio of components 1 pill weight 1,0 g:

Bismuth nitrate basic0,350
Magnesium carbonate basic0,400
Sodium bicarbonate0,200
The extract of the bark of buckthorn water soluble0,011
The licorice root extract water soluble0,003
The birch leaves extract of waderas wormy 0,011
Acorus calamus rhizome0,025

Know effects of buckthorn bark is laxative due to the content of anthraquinones. The bark of the buckthorn can be used after its collection not earlier than after 1 year of storage under certain conditions; in addition, different batches of raw materials is different contents of active substances - anthraquinones. The use of water-soluble extract of buckthorn bark, obtained from fresh raw materials and standardized on active substances (GF X1 ed. 2. s; Medmaravis Medicines. M: New wave, 2000, vol. 1, s), allows on the one hand to improve the technological aspects - ease of use, the storage stability of the extract for 3 years, a more accurate dosing, and transportation, on the other hand, in pharmacological terms, eliminate the negative irritant effect buckthorn bark on the intestine of the patient, to achieve a more mild laxative effect. Mild laxative effect necessary due to the fact that peptic ulcer of the duodenum is often accompanied by constipation.

Licorice root acts as an antispasmodic and anti-inflammatory agent, increases the production of protective mucus, increases the effects of antacids in the presence of active substances, saponins, action antrage the ones buckthorn bark becomes more gentle to the intestines, in addition, licorice root contains a large number of bioflavonoids.

Known diuretic and choleretic effect of birch leaves, containing as active substances also flavonoids, and therefore the introduction into the composition of birch leaves extract also provides a wide range of pharmacological effects of the composition on the gastrointestinal tract of the patient.

In the claimed tool used extracts from plant materials with known content of active substances:

for licorice - the amount of saponins

for birch - the amount of flavonoids

for buckthorn - the amount of anthraquinones.

The technical result to be obtained by the use of the invention is expressed in enhancing therapeutic effect, reducing unwanted side effects, including due to good raspadaemosti, dissolution, sufficient strength tablets, increase the accuracy of the dosage of active substances of plant components, as well as LECHEBNO actions at all stages of the pathological process of peptic ulcer disease.

The invention is illustrated in the following example,

Example. Antiulcer and anti-acid agent containing 1 tablet weighing 1.0 g of the following components:

Bismuth nitrate basic0,350
Mage the Oia carbonate main 0,400
Sodium bicarbonate0,200
The water-soluble extract
buckthorn bark0,011
Extract vodorastvorimyi
licorice root0,003
The water-soluble extract
birch leaves0,011
Calamus rhizomes0,025

Stated the vehicle was prepared as follows. The technological process includes stages: screening of raw material; mixing and hydrating ingredients; wet granulation with fractional introduction of dry water-soluble extracts of buckthorn, birch, licorice, pre-mixed in the amount of 70% of the total mass, and then introducing the other 30%; drying of wet weight, dry granulation and dusting; tabletting and dust control; packaging and packing.

It was experimentally confirmed that the stated qualitative and quantitative composition ensures the achievement of the claimed technical result. The claimed means assign inside 1-2 tablets 3 times a day after meals, the tablets should be crushed or dissolved in 1/4-1/2 Cup of warm water). Treatment 1-2 months.

The data presented in table 1.

Ka is evident from the presented data, ulceration in the mucosa of the stomach and duodenum occurred in the control group, 90% of the animals (9 of 10) and 5% (1 in 20) in the experimental group.

The average area of ulceration (in mm), respectively 2,38 and 0.4 mm

On the basis of the conducted research it can be concluded that the claimed product has a protective effect against the mucous membrane of the stomach and duodenum.

Clinical study funds was conducted on a group of patients-volunteers suffering from peptic ulcer disease duodenal ulcer associated with Helicobacter pylori (HP). The contingent of volunteers in kolichestve 40 people was divided into 2 groups of 20 people in each group. The first group received medication "Vikair, the second - stated means, according to the same scheme: 1-2 tablets 3 times a day after meals, dissolving tablets in 1/3 Cup water, the treatment was 40 days.

therapeutic effect was evaluated by scarring ulcers, the degree of contamination HP in the dynamics, the severity of side effects. Examination methods: rapid urease test and morphological painting at the Institute.

Survey data presented in table 2.

As can be seen from table 2, the possible scarring ulcers bet treating drug "Vikair amounted to, on average, 35 days for funds analogion the th indicator - 27 days; severe degree of contamination of Helicobacter pylori detected before treatment in both groups at 100% of the patients decreased after 7 days of treatment in both groups, after 15 days of treatment was achieved full erradicate HP in 95% of cases in the group treated with the claimed means, whereas in the group treated "Vikair, weak degree of contamination after 15 days of treatment were preserved in 50% of cases, i.e. in 10 patients. Side effect when treating prepartum "Vikair noted in the form of complaints of irritation of the digestive tract (8), pain in the gut (4 people) and more frequent stools (3 people). Complaints in the treatment claimed by the tool is not marked.

Thus, the Arsenal of modern medicine is filled with product, which has a pronounced antacid and antiulcer effect, which can be recommended to patients of acid diseases of the gastrointestinal tract.

Included with the tablet herbal extracts possess antiseptic, astringent, absorbent, laxative, choleretic action, improve appetite and digestion. All this allows you to use the claimed remedy for gastric ulcer and duodenal ulcer, hyperacid gastritis, nervous dyspepsia, spasms.

Table 1

Study of the anti-Christ. yazvennogo action funds
Groups of animalsQty animalsNumber of animals with ulcersThe number of ulcersThe total area of ulceration, mmThe average area of ulceration, mm
Control1091945,22,38
Experience20120,80,4

Table 2

The study of therapeutic effect of the claimed funds in a comparative perspective with prototype
Study toolThe number of sickPossible scarring ulcers (days)The degree of dissemination HP % of casesSide effects
before the start of the courseafter 7 daysafter 15 days
"Vikair2035+++

100%
+++

80%
+

50%
Complaints of irritation of the gastrointestinal tract, pain in the intestines, more frequent stools
Declared2027+++++fullno complaints
tool 100%eradication 95%marked
70%

A means of having antiulcer and anti-acid action, including bismuth nitrate basic, magnesium basic carbonate, sodium bicarbonate, buckthorn bark and rhizome of calamus, characterized in that it contains buckthorn bark in the form of water-soluble extract and further includes a water-soluble extracts of licorice root and birch leaves, in the following ratio of components 1 tablet weighing 1.0 g, g:

Bismuth nitrate basic0,350
Magnesium carbonate basic0,400
Sodium bicarbonate0,200
The extract of the bark of buckthorn water soluble0,011
The licorice root extract water soluble0,003
The birch leaves extract water soluble0,011
Acorus calamus rhizome0,025



 

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