Composition for nasal application, based therapeutic agent and method for using same

FIELD: medicine.

SUBSTANCE: composition for nasal application, containing active and additive ingredients, wherein the active ingredients are presented by sea salt and α-glutamyl-tryptophan in the following ratio of the active ingredients (wt %): sea salt 95.00-98.00; alpha-glutamyl-tryptophan 2.00-5.00. The group of inventions also refers to a therapeutic agent, a method, using and a medical device for preventing or treating upper airway diseases.

EFFECT: group of inventions promotes slime evacuation, reduces infected nasal discharge and relieves swollen mucosa, softens and removes crusts and enhances body defences, as well as normalises the barrier function of nasal mucosa epithelium, improves nasal breathing and causes moistening and anti-inflammatory action.

18 cl, 3 tbl, 1 ex

 

Group of inventions relates to the creation of nasal medicines and its application in the prevention of diseases of the upper respiratory tract, in the adjuvant therapy in early signs of flu and colds, as an aid for recurrent infections ways, in the treatment of allergic diseases.

Environmental degradation in the world, the increase in the prevalence of upper respiratory tract diseases, including allergic disorders, and epidemics of viral diseases that affect the respiratory system, dictates the need to develop prevention and treatment of these diseases as in the initial stages, and already far advanced the process.

The main cause is a disruption of the functions of nasal breathing.

These functions include: purification of inhaled air from inorganic (dust) and organic (bacteria, viruses, fungi, protozoa) impurities, its humidifying and warming, disinfection, filtration, and the nasal cavity performs olfactory cavity and facial features. The implementation of the cleansing function due to the presence in the nose of the appropriate architectonics, creating turbulent air flow on the breath, a hair ahead of the nasal cavity and the working mechanisms of bessara is the air traffic management. A very important feature air disinfection is carried out by means of the production of the mucous membrane of the nasal cavity of the factors of nonspecific and specific immune protection and work mucociliary clearance. Long-term effect of pathological constituents of atmospheric air leads to organic disorders.

One of the preventive and therapeutic measures is the cleansing of the nasal cavity with the help of her washing through various medicines. Preventive and curative effect of such funds depends on the ability of funds to be removed from the nasal cavity aggressive organic and inorganic factors breathe atmospheric air and to normalize non-specific immunological protection and work mucociliary clearance.

Therefore, the development of new effective tools and methods for the treatment and prevention based on them - the actual problem of modern pharmacology and clinical medicine, as it will allow to increase the level of social activity and quality of life of patients and reduce the costs associated with the loss of labor time.

Known nasal drug containing the active and auxiliary substances, made in the form of an isotonic sterile solution having osmollnosti from 220 to 350 mm is l/ kg of water and the pH from 6.0 to 9.5, contains natural minerals and trace elements, in which the active substances used natural sea salt, as excipients water for injections, in the following ratio wt./vol.%:

sea salt 0,3-3,0

water for injection - the rest,

in addition, isotonic sterile solution contains ions:

sodium 0,01-1,0;

magnesium 0,001-0,72;

calcium 0,00002-0,00027;

potassium 0,0036-0,0036;

hydrocarbonates 0,002-0,003.

(RF patent 2369397 published 10.10.2009)

Also the patent describes the method of use of a medicinal product, including its purpose for therapeutic purposes, children under 1 year - 2 times a day 2 drops in each nostril; children from 1 year to 7 years - 3 times a day 2 drops in each nostril; children from 7 to 16 years old - 4 times a day 2 drops in each nostril; adult - 4-6 times a day 2 drops in each nostril. Treatment is 2-4 weeks. It is recommended to repeat the treatment after a month.

However, this drug, despite the fact that it effectively removes from the nasal cavity aggressive organic and inorganic factors breathe atmospheric air, not able to normalize non-specific immunological protection in the nose, because it includes no immunologically active components.

Currently BP is me there are data placebo-controlled studies, proved the effectiveness of the intranasal use of immunomodulatory drugs for the prevention of diseases of the upper respiratory tract.

A promising direction for such prophylaxis is the use of tools to enhance the nonspecific resistance of the organism. To this end, in the Russian clinical practice widely used inducers of endogenous interferon - Tilaran, Arbidol, Cold.

From literature is known dipeptide - α-glutamyl-tryptophan in the form of sodium salt (patent RF 2107691 from 1998). The peptide is used as an immunomodulating means of influencing the reaction of cellular, humoral immunity and nonspecific resistance of the organism. Stimulates regeneration processes in the case of depression, improves over the processes of cellular metabolism. Enhances the differentiation of lymphoid cells, has the ability to stimulate colony-forming activity of bone marrow cells, induces the expression of differencirovannyh receptors on lymphocytes, normalizes the number of T-helpers, T-suppressors and their ratio in patients with various immunodeficiency States.

However, our analysis of the prior art showed that this dipeptide was never used for nasal lavage and was not included in the remaining funds contain sea salt.

Thus the aim of the present work was the development of nasal medicines, is able to remove from the nasal cavity aggressive organic and inorganic factors breathe atmospheric air and to normalize non-specific immunological protection and work mucociliary clearance.

Given the fact that the peptides are unstable in the environment, which is a sea water, it was also necessary to find the ratio of components, which would allow to maintain the stability of the dipeptide in the tool.

This object is achieved by a group of the invention aimed at solving one problem and achieve the same result.

The technical result of the claimed group of inventions is to provide a composition, medicinal products and medical devices it is the basis, the use of which is capable of removing from the nasal cavity aggressive organic and inorganic factors breathe atmospheric air and to normalize non-specific immunological protection and work mucociliary clearance with the achievement of synergistic effects from the joint application of the active ingredients.

In addition, an additional technical result t is aetsa obtaining a stable composition, contain sea salt and dipeptide.

The proposed composition for nasal application containing the active and auxiliary substances, in which the active substances used sea salt and α-glutamyl-tryptophan in the following ratio of active substances (wt..%):

- sea salt 95,00-for 98.00;

- alpha-glutamyl-tryptophan 2,00-5,00.

As auxiliary substances is water, optionally in combination with preservatives (nipagin and others).

The composition may be made in the form of drops or spray, or aerosol.

Also proposed drug on the basis of the above compositions for the prevention and/or treatment of upper respiratory tract diseases, in particular acute respiratory viral infections (ARVI) (e.g., influenza), and the manner of its application.

In addition, the proposed medical devices on the basis of the above compositions for the prevention and/or treatment of upper respiratory tract diseases, in particular acute respiratory viral infections (ARVI) (e.g., influenza)

The present group of inventions is illustrated by a detailed description, examples of preparation and use.

The composition and the means at its base was prepared as follows.

For the preparation of nasal medicines in 50 l of water for injection is dissolved p and stirring 1,08 kg sea salt, which use natural sea salt. Then add 25 grams of the dipeptide. Then the solution volume was adjusted with water for injection to 100 HP and then the resulting solution was subjected to sterilizing filtration, followed by filling into prepared for therapeutic application container.

The content of ions per 100 ml of solution:

sodium is not less than 2.5 mg/ml;

magnesium is not less than 0.35 mg/ml;

calcium is not less than 0.008 mg/ml;

potassium is not less than 0.10 mg/ml;

the hydrocarbons is not less than 0.03 mg/ml

Also in the preparation of medicaments can optionally add a preservative in 50 l of water for injection is dissolved with stirring 1,049 kg sea salt, which use natural sea salt. Then add 55,25 grams of the dipeptide and 40 Gy nipagina. Then the solution volume was adjusted with water for injection to 100 HP and then the resulting solution was subjected to sterilizing filtration, followed by filling into prepared for therapeutic application container.

The content of ions per 100 ml of solution:

sodium is not less than 2.5 mg/ml;

magnesium is not less than 0.35 mg/ml;

calcium is not less than 0.008 mg/ml;

potassium is not less than 0.10 mg/ml;

the hydrocarbons is not less than 0.03 mg/ml

The medical devices may represent, for example, spray, stood the which includes a bottle of polymer or glass, the nozzle cap nozzle-rapidities, sterile solution of the claimed composition.

The spray can be produced in bottles with a nominal volume of 5, 10, 20, 50, 100 ml.

The pressing force required for actuation of the spray should be from 6 to 9 N.

The spray should provide at a distance of 10 mm from the edge of the outlet nozzles of the spray dispersion composition of the spray solution in the range from 5 to 180 μm.

The spray should ensure that the dose output of the solution at each working press from 130 to 150 mg.

The spray should be watertight, resistant to climatic factors with the upper limit temperature of 25°C and disinfection.

Conducted a Toxicological study of the composition and tools based on it showed that:

- in the acute experience in outbred mice (males) by intraperitoneal injection at a dose of 50 ml/kg of body weight was not observed mortality;

- animals have revealed no clinical signs of intoxication: the General condition, behaviour, condition of coat, eating poop in the experimental group did not differ from control;

on autopsy tissue at the injection site, regional lymph nodes, internal organs of animals exposed to the drug, had no signs of pathology;

- weights HV the internal organs (liver, kidney, spleen) in the experimental mice within physiological norms and similar indicators of control;

in vitro experiments with isolated and washed rabbit erythrocytes is not marked hemolytic effect of extracts;

in experiments on rats and rabbits shows no local irritating action of the drug on the skin and mucous membranes;

- sample tests for sterility is the result: - the sample is sterile during the entire shelf life;

- sample tests on progenote - the result: - sample aerogenes during the entire shelf life;

- the value of the index of toxicity accounted for 70.9% of the permissible value of from 70 to 120%;

- studied drug samples meet the requirements for medical devices in contact with the tissues of the body: in the experiment, the materials of the products showed sufficient chemical stability, extracts of them had no adverse effects on biological objects.

Next, the group of inventions is illustrated by the following examples of practical use, showing the effectiveness of the developed drugs for the treatment and/or prevention of diseases of the upper respiratory tract.

We recommend the following regimens medication.

Fo the IU drops

For therapeutic purposes nasal drug is prescribed: children under 1 year - 2 times a day 2 drops in each nostril; children from 1 year to 7 years - 3 times a day 2 drops in each nostril; children from 7 to 16 years old - 4 times a day 2 drops in each nostril; adult - 4-6 times a day 2 drops in each nostril. Treatment is 2-4 weeks. It is recommended to repeat the treatment after a month.

With the preventive purpose

For the softening and removal of secretions from the nose - drops instilled in each nostril in the required amount, removing the remainder of the fluid flowing out of the nose, handkerchief or with the help of cotton wool.

The procedure can be repeated multiple times up until the selection accumulated in the nasal passage will not be softened and removed.

In children under 1 year is recommended toilet mucous membrane of the nasal cavity for the safety of its physiological characteristics in dripping drops 2-3 times daily 1-2 drops in each nostril.

For the softening and removal of contaminating clusters and nasal secretions drug use as needed.

In the form of a spray or aerosol

A child from 1 year to 2 years is the supine position, head turned to the side. Nasal drug injected into the nostril above.

Seated child to clean his nose.

<> Then similarly repeat the procedure with the other nostril.

Adults and children over 2 years with the use of nasal medicines tilt your head to the side. With the assistance or self-administered nasal drug in the form of a spray or aerosol nostril above. After 2-3 minutes, you need to clean the nose by bismarkian. Then similarly repeat the procedure with the other nostril.

The recommended single dose of the drug (number of pumps in each nostril) and the rate of application per day is given in table 1.

Clinical examples of the use of medicines nasal application in diseases of the upper respiratory tract

The drug was prepared in accordance with the approved formulation: 100 ml contain 1,08 g sea salt, 25 mg of alpha-glutamyl-tryptophan. The effectiveness of the present compositions (K) and placebo (P) was tested on a pilot group of 15 people and a control group of 15 people in 1 year. As a composition, or placebo was administered 4 times per day. The results of the study are presented in table 2.

The total number of diseases cold was 42 cases (i.e. on average 1.4 disease per year per person), and a group of volunteers receiving placebo, have 76,19%, which is 3.2 times the pre is oshodi number of diseases in a group of volunteers, the host composition. Here the "cold" was defined symptomatically (increased body temperature, signs of flu, colds, rhinitis and so on).

Additionally, we have investigated cytokines in order to confirm the effect of improving immunity using the composition. To this end we measured the cytokines in the blood, responsible for the development of inflammatory reactions and characterizing the intensity of the immune system of the patient, namely IL-2, INF-γ, IL-4, IL-10 and IL-12. The study was carried out by ELISA analysis. Each of the samples were taken from those who took placebo and composition containing sea salt and alpha-glutamyl-tryptophan.

Studies have shown that patients who use the tool according to the invention, increased levels of IL-2, INF-γ, IL-12, with a slight increase in levels of IL-4, IL-10, in contrast to the control group, demonstrating the prevention of infection without signs of further generalization.

Additionally, the invention is illustrated in the following clinical example.

Example. Patient, 23 years. Treated for chronic vasomotor rhinitis, frequent colds and acute respiratory infections. Complaints to the constant difficulty of nasal breathing, chronic runny nose. Took composition 4-6 times a day for two weeks. After 2-3 days there was an improvement in status. After treatment, the symptoms disappeared rhinitis, n the financial allocation has decreased significantly, I have a free nasal breathing.

Thus, the proposed new treatment is effective and can be widely recommended for treatment and prevention purposes.

Also to confirm the stability we have conducted a study of the stability of the tool during its storage.

The stability properties of the drug during storage was determined by the method of "accelerated aging", based on the increase in the rate of chemical processes at elevated temperatures, in excess of the maximum allowable storage means under normal conditions.

To this end 3 of a series of experimental samples in a volume of 300 cm3was placed in a thermostat with a temperature of 50°C. the quality of the series was estimated by the change of the mass fraction of clathrate ammonium compounds with urea, density, and refractive index in accordance with one HUNDRED 719544720-0003-2008.

The experiment lasted 12 months. Every 2 months, samples were taken and determine the mass fraction of active substances by the method of two-phase titration using anion standard solution (sodium dodecyl sulphate) in alkaline medium in the presence of the indicator bromophenol blue, density - using hydrometer, the refractive index - refractometric method.

The results of the study are presented in table 3. Studies have shown the stability of the Reparata when it is stored.

Thus, the proposed nasal medication contains all the active ingredients and minerals from natural sea water and provides active lavage of the nasal cavity: helps to remove mucus, decrease of infected secretions and swelling of nasal mucosa, to soften and remove crusts and increases the body's defenses. The drug normalizes the protective function of the ciliated epithelium of the nasal mucosa and improves nasal breathing. Provides moisturizing and anti-inflammatory effect.

After washing means increases therapeutic efficacy of drugs applied to the nasal mucosa, and reduced the duration of respiratory diseases. The drug reduces the risk of spreading the infection in the sinuses and the ear cavity (maxillary sinusitis, frontal sinusitis, otitis, etc). Reduces the risk of local complications and speeds up the healing process after surgery (removal of the adenoids, polyps, septoplasty and others) in the nasal cavity. Relieves irritation of nasal mucosa in persons, the mucous membrane of the upper respiratory tract which is constantly exposed to harmful influences (smokers, drivers, people living and working in rooms with air conditioning and/or Central heating, running hot and dusty shops, as well as being in the region is under severe climatic conditions).

Table 1
Patient ageThe application for therapeutic purposesUse with hygienic purpose
Children aged 1 to 2 years1 injection in each nostril 2 times/day1 injection in each nostril 1 times/day
Children aged from 2 years to 7 years2 injection in each nostril 2 times/day1-2 injection in each nostril 1-2 times/day
Children and adolescents aged from 7 years to 16 years2 injection in each nostril 4 times/day2 injection in each nostril 2 times/day
Adults and adolescents older than 16 years2 injection in each nostril 4-6 times/day2 injection in each nostril 4-6 times/day

Table 2
no patient recordage FloorThe frequency of colds
0145To24Husband0
0146To26Husband0
0147P19Wives0
0148P32Husband3
0149To33Wives1
0150P21Wives2
0151P22Wives2
0152To45Husband1
0153P41Wives4
0154P26Wives3
0155To27Husband1
0156To43Wives2
0157P39Wives3
0158To38Wives0
0159P32Husband3
0160To25Wives1
0161P22Husband 2
0162P23Wives3
0163P27Wives2
0164To49Wives1
0165P51Husband1
0166To25Wives1
0167P23Wives1
0168To45Wives0
0169To42Wives1
0170To20 Wives0
0171P41Husband1
0172P38Wives2
0173To37Husband2
0174To26wives1

Table 3
The duration of storage, the monthCorresponding to the storage time of the yearMass fraction of active substance %Density, g/cm3Refractive indexHUNDREDStability properties
21101,055of 1.353ACC. The camera.
42101,055of 1.353ACC.The camera.
63101,055of 1.353ACC.The camera.
84101,055of 1.353ACC.The camera.
105101,055of 1.353ACC.The camera.
126101,055of 1.353ACC.The camera.

1. Composition for nasal application containing the active and auxiliary substances, in which the active substances used sea salt and α-glutamyl-tryptophan in the following ratio asset is s substances (wt.%):
- sea salt 95,00-for 98.00
- alpha-glutamyl-tryptophan 2,00-5,00

2. The composition according to p. 1, characterized in that the auxiliary substances used water, optionally in combination with a preservative.

3. The composition according to p. 2, characterized in that the preservative is used nipagin.

4. The composition according to p. 1, characterized in that it is made in the form of drops, spray or aerosol.

5. Drug for prevention or treatment of diseases of the upper respiratory tract, including composition on PP.1-4.

6. Drug under item 5, characterized in that it is made in the form of drops, spray or aerosol.

7. Drug under item 5, characterized in that the upper respiratory tract diseases are acute respiratory viral infections (ARVI).

8. Drug under item 7, characterized in that the flu is the flu.

9. The method of prevention or treatment of diseases of the upper respiratory tract, including the introduction into the nasal cavity means on p. 5 in an effective amount.

10. Use sea salt and α-glutamyl-tryptophan for the manufacture of nasal medicines.

11. Application under item 10, characterized in that the drugs are made in the form of drops, spray or aerosol.

12. Application under item 10 or 11, characterized in that lekarstvennogo is intended for the prevention or treatment of diseases of the upper respiratory tract.

13. Application under item 12, characterized in that the upper respiratory tract diseases are acute respiratory viral infections (ARVI).

14. Application under item 13, wherein ARI is the flu.

15. Medical devices for the prevention or treatment of diseases of the upper respiratory tract, including composition on PP.1-4.

16. The product under item 15, characterized in that it is made in the form of a spray or aerosol.

17. The product under item 15, wherein the upper respiratory tract diseases are acute respiratory viral infections (ARVI).

18. The product under item 17, characterized in that the flu is the flu.



 

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9 cl, 10 tbl

FIELD: medicine.

SUBSTANCE: group of inventions refers to agents for preventing and treating arthropathies containing a mixture of peptides H-Ala-Glu-Asp-OH, Lys-Glu-Asp and H-Lys-Glu-OH and a mixture of chondroitin and/or its salts, and/or glucosamines and/or its salts; methods for using them. The group of inventions provides a positive variation of clinical-biochemical dynamics. What is also provided is normalising the morphological structure of joint tissues, including a cytoarchitectonic characteristic of cartilaginous tissue with decreasing apoptotic chondrocyte count, especially at the final stages.

EFFECT: provided favourable effect on the metabolic processes in chondrocytes, activated synthetic processes and normalised biopolymer composition of the cartilage matrix An evident analgesic effect is manifested.

20 cl, 5 ex, 5 tbl

FIELD: medicine.

SUBSTANCE: invention represents a drug preparation for treating diseases caused by type 1 herpes simplex and cytomegalovirus, containing recombinant human interferon 2α, lisocyme, Licopid, carnitine 20%, vitamin E and a fatty base.

EFFECT: higher clinical effectiveness and reduced length of treatment, prolonged intercurrent periods, lower recurrent rate by prophylactic administration, reduced manifestation of neurotoxic effects of herpes viruses, lower administration of antibiotics for preventing bacterial complications in infectious-inflammatory diseases caused by herpes simplex virus and cytomegalovirus in children.

2 cl, 3 tbl

FIELD: medicine.

SUBSTANCE: there are presented: a method for preventing or treating diseases caused by (+)RNA containing viruses of the genus Enterovirus or Flavivirus (the virus of the genus Enterovirus is specified in a group consisting of rhinoviruses and enterovirus type 71; the virus of the genus Flavivirus is specified in a group consisting of West Nile virus, dengue virus, tick-borne encephalitis virus, Saint Louis encephalitis virus, Murray Valley encephalitis virus and yellow fever virus) providing the use of an effective amount of glutaryl histamine or its pharmaceutically acceptable salt. There are also presented: a pharmaceutical composition for the above application and formulation, and a kit, the use of glutaryl histamine or its pharmaceutically acceptable salt for preparing the pharmaceutical composition for preventing or treating the diseases caused by (+)RNA containing viruses of the genus Enterovirus or Flavivirus. It has been shown that glutaryl histamine inhibited the dengue virus replication, provided the 40% death protection of the mice infected by tick-borne encephalitis virus (protective activity of ribavirin made 15%).

EFFECT: improved properties of the agent.

22 cl, 8 tbl

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to pharmacology and medicine and concerns using a dipeptide of a general formula Tyr-Pro-X, where X - OH, NH2, OCH3, OC2H5, as an anti-inflammatory, antibacterial, wound-healing, regenerative, analgesic and burntreating agent for external application, as well as a dosage form for external application containing this dipeptide.

EFFECT: group of inventions provides preparing the effective agent for external applications with no side effects.

3 cl, 1 tbl, 22 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to pharmacology and medicine and concerns an immunostimulating composition, and methods for using it for enhancing the immune response, particularly for treating infections caused by bacterial and viral pathogens, to adjuvant compositions and methods for enhancing the antigen immunogenicity when used as an adjuvant of vaccines. The pharmaceutical composition of pattern-recognising receptor ligands contains muramyl peptide of structural formula N-acetylmuramyl-L-alanyl-D-isoglutamine and lipopolysaccharide or lipid A in the following proportions, wt %: muramyl peptide of structural formula N-acetylmuramyl-L-alanyl-D-isoglutamine 0.00001 to 0.01, lipopolysaccharide or lipid A 0.00001 to 0.01, a solvent - the rest.

EFFECT: group of inventions provides high immunostimulating activity and prolonged action of the composition.

7 cl, 5 ex, 1 tbl, 9 dwg

FIELD: veterinary medicine.

SUBSTANCE: method comprises administering a mixture of medicinal solution of formaldehyde and isotonic solution of sodium chloride at a ratio by weight of (2-6):(994-998). The mixture is administered intramuscularly at a dose of 5-6 ml 6 times. The second injection is administered on the day 7-8 after the first injection, the third - on the day 7-8 after the second injection, the fourth - 12 hours after the third, the fifth - 12 hours after the fourth, the sixth - 7-8 days after the fifth injection.

EFFECT: method is highly effective in treatment of brucellosis of cattle.

3 tbl, 3 ex

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