WO2019039964A1 - Antibacterial composition to deliver gramicidin c to a site of local inflammation, method of producing an antibacterial composition to deliver gramicidin c to a site of local inflammation, and method of delivering gramicidin c to a site of local inflammation - Google Patents

Abstract

The claimed technical solution relates to the field of medicine and hygiene, and may be used to suppress the growth of pathogenic microflora at a site of local inflammation in the human body in order to increase the effectiveness of therapy of infectious inflammatory diseases of the mouth and throat, specifically acute tonsillitis (sore throat), pharyngitis, periodontal disease, gingivitis, and stomatitis. The aims of the claimed technical solution are to develop an antibacterial composition that would deliver Gramicidin C to a site of local inflammation and would be sprayable, and that would be capable of most precisely delivering Gramicidin C to the site of local inflammation, covering each section of the site, and that would have minimal side effects on the human body; to develop a simple method for producing it; and to develop a method for arranging the delivery of the antibacterial composition to a site of local inflammation that would enable treatment of the entire surface of the site of local inflammation while minimally affecting adjacent tissues. The set of claims contains 3 independent claims and 19 dependent claims.

Description

 Antibacterial composition for delivery

 Gramicidin C to local inflammation, method of preparing antibacterial composition for Gramicidin C delivery to local inflammation, Gramicidin C delivery method to local inflammation

The claimed technical solution relates to the field of medicine and hygiene, can be used to suppress the growth of pathogenic microflora in the focus of local inflammation of the human body, to increase the effectiveness of therapy for insrektsionno-inflammatory diseases of the oral cavity and throat, namely: acute tonsillitis (angina); pharyngitis; periodontal disease; gingivitis; stomatitis

Terms used:

Gramicidin C - Gramicidin C hydrochloride or dihydrochloride, the original domestic antibiotic, first received by I.F. Gause and M.G. Brazhnikova in 1942 Gramicidin C hydrochloride is a colorless needle-like crystals. Gramicidin C exhibits increased antimicrobial activity, is intended solely for local use, has no analogues for systemic use. The drug has a pronounced bactericidal action against pathogenic Gram-positive and Gram-negative bacteria, which in most cases either directly cause diseases of the throat and oral cavity, or reattach themselves during the initial viral infection of Streptococcus spp., Staphylococcus spp., Streptococcus pneumoniae, neyseria, anaerobes, etc. (A. Khokhlov, M. Shemyakin. M. Chemistry of antibiotic substances. - 1949. - 455).

Solution — in medicine — a liquid dosage form — a homogeneous, transparent mixture of a drug (solid or liquid) and some kind of liquid (solvent). (Great Encyclopedic Dictionary. 2000 / http://dic.academic.ru/)

Dispersion - lat. dispersus - scattered, scattered - 1) scattering; 2) chemical, physical. fragmentation of a substance into very small particles. (Dictionary of foreign words. - Komlev NG, 2006. URL: / http://dic.academic.ru/) Substance - lat. substantia - essence; that — which lies at the base — is relatively stable; that which exists by itself does not depend on anything else. (Big Encyclopedic Dictionary. 2000. URL: http://dic.academic.ru/) Active pharmaceutical substance; APS (active pharmaceutical ingredient; API): Any substance or mixture of substances intended for the manufacture of medicinal products, which during the manufacture of a medicinal product become the active ingredient of this medicinal product. Such substances are intended to manifest pharmacological activity or other direct effect in the diagnosis, treatment, alleviation of symptoms or prevention of the disease or to affect the structure or function of the body. (GOST R 52249-2009: Rules for the production and quality control of medicines).

 Medical adj - relate to the noun treatment associated with it. Treating Glecheny 1], characteristic of him. Intended for the treatment of Glecheniy 1] (Efremova Explanatory Dictionary. T.F. Efremova. 2000. / URL: http://dic.academic.ru/dic.nsf/efremova)

Organize (fr. Organizer, from the Latin. Organum organ). - Combine different objects or forces of nature to achieve any specific goal; arrange, animate. (Dictionary of foreign words of Russian language Chudinov // URL: URL: http://dic.academic.ru//

An organization (the French Organization, from late Lat. Organize — I give a slender appearance, I arrange it) is a set of processes or actions leading to the formation and improvement of interrelations between parts of a whole. / Big Encyclopedic Dictionary // URL: http://dic.academic.ru//

Spray - m. The device for the directed spraying of liquid. (Efremova Explanatory Dictionary. T.F. Efremova. 2000 / Modern Efremova Russian Explanatory Dictionary. URL: http://dic.academic.ru/dic.nsf/efremova/)

Spray [eng. spray - mist, spray] - 1) spray, spray; 2) cosmetics, dyes, aerosol chemicals. Dictionary of foreign words. / Komlev NG, 2006. URL: /http://dic.academic.ru/. Stabilizer - substance, composition, which delays the process of changing something (for example, the oxidation process) / New dictionary of foreign words. 2009 URL: http://slovari.ru/search. aspx? s = 0 & p = 3068 & di = vsem2 & wi = 4063);

Co-solvent is an individual chemical compound or mixture capable of dissolving various substances, i.e. form homogeneous systems of variable composition, consisting of two or more components.

Known technical solutions, in which the active pharmaceutical substance Gramicidin C, is in a solid state of aggregation, the drugs are produced in the form of lozenges. (Patent RU 2213558 C1, IPC A61 K9 / 20, A61 K38 / 08, priority 30.09.2002, published on 10.10.2003; Patent RU 2160088 C1, IPC А61К7 / 16, А61К9 / 06, priority 02.11.1999, published 10.12.2000 ; Patent RU 2590980 С2, IPC А61 Р31 / 00, А61 К31 / 155, А61 К31 / 7004, А61 К31 / 194, А61 К31 / 375, А61 КЗЗ / 30, priority 24.14.2009, published 10.07.2016).

The disadvantages of the known technical solutions is the low bioavailability of Gramicidin C in the local inflammation. When ingested into the oral cavity, Gramicidin C solid particles are not able to firmly contact the surface of the site of infection and are washed out from this surface, which reduces the therapeutic effect of known antibacterial compositions. In addition, they contain, as an auxiliary, substances that may cause side effects, for example, allergic reactions.

Known technical solutions, in which the active pharmaceutical substance Gramicidin C, is in a liquid state of aggregation, representing an alcoholic solution from light yellow to yellow with a characteristic odor, containing 2% Gramicidin C hydrochloride, which has a specific taste and smell. (Gramicidin C - official instructions for use, URL: https://medi.ru/instrukciya/gramitsidin-s_12289/).

A disadvantage of the known technical solution is that due to the dilution of a 2% alcoholic solution of Gramicidin C in the preparation of a drug, an opalescence of the solution is observed, followed by sedimentation, which leads to a loss of therapeutic properties. In the factory, an aqueous solution of Gramicidin C based on an alcoholic 2% solution is unprofitable and impossible to do due to the short duration of preservation of the aggregative stability of Gramicidin C particles in aqueous solutions not exceeding 3 days. Preparation of a medicinal product based on a 2% alcoholic solution at home is also impossible due to the lack of the ability to accurately dispense components. These facts exclude the possibility of retail sale of a 2% alcohol solution of Gramicidin C. It is also known that the method of applying the obtained aqueous solution of Gramicidin C (rinsing) is not effective enough, because the active substance is not fully distributed in the focus of infection, but partially beyond its limits, which does not allow for the exact dosing of the active substance.

In this regard, it is considered more effective to create a liquid dosage form containing Gramicidin C in the form of a spray, which allows to achieve a higher concentration of the active substance in the area of the source of infection and ensure its accurate dosing.

Known technical solution that describes an antibacterial composition based on pharmaceutical substance, including Gramicidin C and ethanol, for the treatment of topical inflammatory diseases, its preparation and use (Patent RU 2604576 C1, IPC A61 K31 / 216, A61 K31 / 44, A61 K38 / 12, A61 K9 / 12, A61 K2121 / 00, priority 12/01/2015, published 10/12/2016). The composition contains Gramicidin C, hydroxybuprocaine hydrochloride and cetylpyridinium chloride, ethanol 96%, as excipients - sucralose, glycerol, citric acid monohydrate, sodium citrate, polysorbate 80, methylparaben, propylparaben, mint flavoring, purified water.

Known technical solution that describes the antibacterial composition based on pharmaceutical substance, including Gramicidin C and ethanol, for the treatment of infectious and inflammatory diseases of local use, made in the form of a solution, with the ability to save in a state of solution until use, and including Gramicidin C dihydrochloride, ethanol 96%, purified water, stabilizer in the form of polysorbate 80, antiseptic cetylpyridinium chloride and excipients - sucralose, glycerol, citric acid monohydrate, sodium citrate, methylparaben, propylparaben, flavoring mint, the composition of the composition of the preparation to the focus of local inflammation, which is taken as a prototype (Patent RU 2604575 C1, IPC A61 K31 / 216, A61 K31 / 44, A61 K38 / 12, A61 K9 / 12, A61 K2121 / 00 priority 01.12.2015, published 10.12.2016 ).

A disadvantage of the known technical solutions is the high probability of manifestation of allergic reactions and side effects during use. The occurrence of these effects may be due to the presence in the composition of known technical solutions such substances as: oxybuprocaine hydrochloride, cetylpyridinium chloride, citric acid monohydrate, sodium citrate, methylparaben and propylparaben.

It is known that oxybuprocaine hydrochloride with prolonged use can cause a temporary burning sensation of the mucous membranes. Also, in the presence of increased sensitivity of the body, the component may cause adverse reactions of the cardiovascular system, anaphylactic shock, temporary or short-term loss of consciousness.

Cetylpyridinium chloride with prolonged use causes local irritation. In some cases, contributes to the development of gastrointestinal disorders, noted mainly in excess of the recommended doses.

Citric acid monohydrate and sodium citrate also cause local irritation of the mucous membrane.

Methylparaben and propylparaben, due to their surface-active properties, are able to penetrate deep into the tissues of the body to accumulate (especially when renal dysfunction) and initiate the development of breast cancer, male fertility. Additionally, parabens can cause damage to the mucous membrane and cause allergic reactions in the form of skin rashes and itching. The negative effect of the use of these substances is exacerbated when the tissues of the oral cavity and throat are damaged.

In addition, the known technical solutions due to the presence in the composition of excipients glycerol have a high viscosity, which complicates the dosing of the therapeutic solution through the dosing device. When dosing, a part of the solution is retained in the dosing device until the next use, which may cause additional microbial contamination of the composition.

In addition, the method of preparation of known antibacterial compositions is quite complicated and consists of two stages.

The objective of the proposed technical solution is the development of an antibacterial composition for the delivery of Gramicidin C to the local inflammation site, which would allow disperse spraying, while being able to deliver Gramicidin C most precisely to the local inflammation site, covering every part of it, and having minimal side effects on the human body, the simplicity of its method of manufacture and the method of organizing the delivery of the antibacterial composition to the nidus of local inflammation, which It would completely treat the surface of local inflammation, while at the same time grabbing adjacent tissues, besides, it would allow to pack into bottles, without presenting strength requirements, to use sprays intended for disperse spraying and not accumulating sprays in themselves after use.

 The problem is solved by the fact that the antibacterial composition for delivery of Gramicidin C to the local inflammation, made in the form of a therapeutic solution, with the ability to save in a state of therapeutic solution until the moment of use and including a pharmaceutical substance containing Gramicidin C and ethanol, purified water, auxiliary substances containing a stabilizer in the form of a polysorbate, additionally the excipients contain a co-solvent in the form of propylene glycol, while the therapeutic solution is made with Stew

b dispersed spray, and the ratio of components in the treatment solution in May. % is:

Gramicidin C 0.32 - 0.8

 ethyl alcohol 16.0 - 40.0

 propylene glycol 10.0 - 12.0

 polysorbate 0.9 - 1, 1

 purified water else

At the same time, the pharmaceutical substance, including Gramicidin C and ethanol, can be made either as a finished mixture, or by diluting Gramicidin C powder in ethyl alcohol, or flavors, or flavors of taste, or both can be added to the excipients. In addition, the treatment solution is designed to disperse the dose through a metering device, including in the form of a spray. The antibacterial composition is designed to be used as water of purified water for injection, with the possibility of using as polysorbate either polysorbate 80 or polysorbate 20, with the possibility of packaging in a sealed bottle, made with the use of a dosing device, including spray, with the possibility of dispersed spray when pressing the metering device on a sealed vial dose equivalent to the effective therapeutic dose of a pharmaceutical substance containing Gramicidin C in firmly th phase from 1, 35 to 1, 65 mg., as well as with the ability to store at room temperature.

In the method of preparing the antibacterial composition for delivery of Gramicidin C to the local inflammatory focus, including the manufacture of the latter in the form of a therapeutic solution, which is carried out with stirring the pharmaceutical substance, including G ramicidin C and ethanol, purified water, auxiliary substances, including a stabilizer in the form of a polysorbate, filtering the therapeutic solution, and the implementation of a therapeutic solution with the ability to maintain in an unchanged state until the moment of use, is additionally introduced into auxiliary ve co-solvent is in the form of propylene glycol, while the treatment solution is additionally adapted to disperse spraying, and the content of components in the treatment solution in May. % choose:

Gramicidin C 0.32 - 0.8

 ethyl alcohol 16.0 - 40.0

 propylene glycol 10.0 - 12.0

 polysorbate 0.9 - 1, 1

 purified water else

As a pharmaceutical substance, including Gramicidin C and ethanol, you can either use the finished mixture, or get the mixture by diluting Gramicidin C powder in ethyl alcohol. At the same time, as flavoring agents, either flavoring agents or flavor flavors, or both can be additionally used. Water for injections can be used as purified water, or polysorbate 80 or polysorbate 20 can be used as a polysorbate. The therapeutic solution is packaged in an airtight vial, which can be used with a metering device, including a spray. In addition, with the possibility of dispersed dosing, when pressing the dosing device on a sealed vial, the dose equivalent to the effective therapeutic dose of the pharmaceutical substance containing Gramicidin C in the solid phase is from 1, 35 to 1, 65 mg.

And in the method of delivery of Gramicidin C to the center of local inflammation, including the use of a sealed vial equipped with a dosing device, an antibacterial composition in the form of a therapeutic solution, which is performed with the ability to remain intact until the moment of use and includes a pharmaceutical substance containing Gramicidin C and ethanol; purified water; excipients containing a polysorbate stabilizer; dosing by pressing the dosing device on a sealed vial doses of a therapeutic solution to a local inflammatory focus, a therapeutic solution is used in which co-solvent is additionally introduced into auxiliary substances in the form of propylene glycol, while the therapeutic solution is additionally performed with the possibility of its dispersion, and the ratio of components to medical solution in May. % choose: Gramicidin C 0.32 - 0.8

 ethyl alcohol 16.0 - 40.0

 propylene glycol 10.0 - 12.0

 polysorbate 0.9 - 1, 1

 purified water else

As a pharmaceutical substance, including Gramicidin C and ethanol, either use the finished mixture, or get it by diluting Gramicidin C powder in ethanol.

 As auxiliary substances, either flavoring agents or flavoring agents may be used, or both. As purified water, water for injection can be used. Either polysorbate 80 or polysorbate 20 is used as the polysorbate. The therapeutic solution is packaged in a hermetically sealed bottle, which is carried out with a supplied dosing device, including as a spray. As well as with the possibility of pressing a dosing device on a sealed vial of dispersed spraying of a dose of a medicinal solution equivalent to the effective therapeutic dose of a pharmaceutical substance containing Gramicidin C in the solid phase from 1, 35 to 1, 65 mg.

The technical effect achieved by the claimed technical solution consists in the possibility of disperse spraying of a therapeutic solution exclusively on the local inflammation focus, the effect of Gramicidin C only on the local inflammation focus, covering its entire surface, in reducing the impact on the tissues adjacent to the local inflammation focus, in reducing the occurrence adverse reactions of the human body, including allergic, in simplifying the manufacturing process, in expanding the arsenal of tools for this purpose.

The essence of the proposed technical solutions is explained as follows.

As is well known, the unique therapeutic properties of the Gramicidin C molecule are associated with an increase in the permeability of the cytoplasmic membrane of the microbial cell, which violates its stability and causes cell death. Particularly active molecule of gramicidin C against gram-positive bacteria, which allows the use of this compound as an active the pharmaceutical substance of drugs in the treatment of infectious and inflammatory diseases of the oral cavity and throat, such as: acute tonsillitis (tonsillitis), pharyngitis; periodontal disease, gingivitis; stomatitis. In the manufacture of the active pharmaceutical substance Gramicidin C, the quality of the Gramicidin C molecule is used to be extracted with ethyl alcohol from the bacterial biomass of the strain You. brevis and form a precipitate of Gramicidin C hydrochloride when an acidified solution of sodium chloride is added to the alcoholic extract of Gramicidin C. The precipitate formed is dried. Due to its combination with alcohol, the bioavailability of gramicidin C molecules increases, as a result of which gramicidin C molecules easily integrate into the wall of the microbial cell and increase its permeability. According to the principle of pharmacological action, the drug is unique in that the resistance to gramicidin C in most bacteria is not produced, the drug is not absorbed in the gastrointestinal tract, thus avoiding undesirable side effects. Therefore, the use of a solution of an antibacterial composition has the stated therapeutic effect with repeated use and does not cause dysbacteriosis, which is especially important in modern conditions of supersaturation of the pharmaceutical market with antibiotics.

An additional advantage is provided by the introduction of the antibacterial composition for the delivery of Gramicidin C to the site of local inflammation of propylene glycol as a co-solvent. This excipient does not cause side effects or allergic reactions from the human body. In addition, the use of propylene glycol slightly changes the viscosity of the therapeutic solution, unlike glycerol in the prototype, which allows for more accurate dosing of the therapeutic solution, as well as a more complete extraction of the therapeutic solution from the metering device, which reduces the risk of microbial contamination of the therapeutic solution.

 The preparation of an antibacterial composition for delivering G ramicidin C to the site of local inflammation is as follows:

- Pharmaceutical substance, including Gramicidin C and ethyl alcohol, is mixed with purified water; Yu - Into the resulting solution, propylene glycol and polysorbate are introduced, using either polysorbate 80 or polysorbate 20;

- Filter the treatment solution through a cascade of filters;

- Place the antibacterial composition for delivering G ramicidin C to the local inflammation in a hermetically sealed vial.

The obtained antibacterial composition for delivery of Gramicidin C to the local inflammatory focus is performed with the possibility of packaging in a sealed bottle, which is performed with the possibility of using a dosing device that provides dispersed spraying by pressing it.

The dosing device is in the form of a spray that provides dosing with one press of a dose equivalent to the effective therapeutic dose of the pharmaceutical substance containing Gramicidin C in the solid phase from 1, 35 to 1, 65 mg

 The study of the activity of the antibacterial composition for the delivery of Gramicidin C to the local inflammation site was conducted at the Federal State Institution “Research Institute of Epidemiology and Microbiology named after honorary academician N.F. Gamalei "of the Ministry of Health of the Russian Federation.

Research methods: microbiological studies in accordance with the “Guidelines for conducting preclinical studies of drugs”, Chapter 316, paragraph 1.2 and MUK 4.2.1890-04 - by the method of serial dilutions in a liquid nutrient medium - Muller-Hinton broth.

Bactericidal concentration is determined by seeding on Muller-Hinton agar, chocolate and blood agar.

The determination of the activity of the antibacterial composition for the organization of delivery of Gramicidin C to the local inflammation site is carried out by seeding from dilutions of 10 ³ , 10 ⁴ , 10 ⁵ , 10 ⁶ , 10 ⁷ CFU / ml of cultures of the strains with the addition of a solution of the composition, incubated at 37 ° C for 18-24 hours. The results of the study are shown in table 1.

Based on the research conducted, it was established:

- solution investigated the antibacterial composition for delivery Gramicidin S to the site of local inflammation has bactericidal effect on all clinical strains were included in the study: Streptococcus pyogenes, Streptococcus faecalis, Staphylococcus aureus, Porphyromonas gingivalis, Candida albicans, Arcanobacterium haemolyticum, the quantitative content of said exciters ¹⁰ March , 10 ⁴ , 10 ^s , 10 ⁶ , 10 ⁷ CFU / ml;

- indicators of the minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBC) of the antibacterial composition under study for delivery of Gramicidin C to the local inflammation site with respect to microorganisms were obtained: Streptococcus pyogenes, Streptococcus faecalis, Staphylococcus aureus, Porphyromonas gingivalis, omega, chromoshylacine faecalis, Porphylococcus aureus, Porphyromonas gingivalis, osexia, Oralis, Porphyrominas gingivalis, osexia, Antibiotic

The advantages of the proposed technical solutions are as follows:

The obtained antibacterial composition for delivery of Gramicidin C to the local inflammation has a high specific biological activity, destroys pathogenic microflora, causing infectious and inflammatory diseases of the oral cavity and throat, with minimal risk of adverse reactions, including allergic ones.

 The antibacterial composition for the delivery of Gramicidin C to the local inflammation is packed in a sealed vial that preserves the consumer properties of the therapeutic solution for the shelf life declared by the manufacturer at room temperature, without requiring special storage conditions. The stability of the obtained therapeutic solution is ensured by a combination of purified water or water for injection, propylene glycol and either polysorbate 80 or polysorbate 20.

The amount of Gramicidin C, providing a therapeutic effect, is 1, 5 mg. This amount is confirmed by preclinical and clinical trials. The invention is characterized by the following examples, which are given in the form of tables 2, 3, 4 and 5, which reflect the influence of the content in the composition of gramicidin C, ethyl alcohol, propylene glycol or polysorbate, respectively, in amounts different from those stated.

 As follows from the above examples, the most optimal from the point of view of therapeutic properties (therapeutic effect, side effects), ease of dosing and technical characteristics of the antibacterial composition for the delivery of Gramicidin C to the local inflammation (viscosity, uniformity of dosage, stability, technical process) content of components in% May:

Gramicidin C 0.32 - 0.8

 ethyl alcohol 16.0 - 40.0

 propylene glycol 10.0 - 12.0

 polysorbate 0.9 - 1, 1

 purified water else

The advantages of using this antibacterial composition for the delivery of Gramicidin C to the local inflammation are as follows:

 - an optimal therapeutic effect is achieved, with minimal side effects;

 - it is possible to use any kind of dosing device, for example in the form of a spray;

 - dispersed dosing is provided, while pressing the dosing device on the vial, the dose of the therapeutic solution is sprayed equivalent to the effective therapeutic dose of the pharmaceutical substance containing Gramicidin C in the solid phase from 1, 35 to 1, 65 mg.

- the ability to use a sealed vial of any material capable of maintaining the properties of a therapeutic solution in an unchanged condition for a given shelf life. Tabli a 2

Table 3

Table 4

Table 5

Claims

Claim  1. An antibacterial composition for delivering G ramicidin C to a local inflammation site, made in the form of a therapeutic solution, with the possibility of being kept in a state of a therapeutic solution until it is used and including a pharmaceutical substance containing Gramicidin C and ethanol; purified water; Excipients; containing a stabilizer in the form of a polysorbate, characterized in that the excipients additionally contain a co-solvent in the form of propylene glycol, while the treatment solution is made with the possibility of dispersed spraying, and the ratio of components in the treatment solution in May. % is: G ramicidin C 0.32 - 0.8  ethyl alcohol 16.0 - 40.0  propylene glycol 10.0 - 12.0  polysorbate 0.9 - 1, 1  purified water else 2. Antibacterial composition according to claim 1, characterized in that the pharmaceutical substance, including Gramicidin C and ethanol, can be made either as a finished mixture, or obtained by diluting Gramicidin C powder in ethanol.  3. The antibacterial composition according to claim 1, wherein the excipients may contain either flavoring agents, or flavoring agents of taste, or both.  4. The antibacterial composition according to claim 1, characterized in that it is made with the possibility of using purified water as water for injection.  5. Antibacterial composition according to claim 1, characterized in that either polysorbate 80 or polysorbate 20 is used as a polysorbale. 6. The antibacterial composition according to claim 1, characterized in that it is made with the possibility of packaging in a sealed bottle, made with the possibility of using a metering device, including spray.  7. Antibacterial composition according to claim 1, characterized in that it is made with the possibility of dispersed spraying, when pressing the metering device on the vial, the dose of therapeutic solution is equivalent to the effective therapeutic dose of the pharmaceutical substance containing Gramicidin C in the solid phase from 1, 35 to 1, 65 mg.  8. The antibacterial composition according to claim 1, characterized in that it is adapted to be stored at room temperature.  9. The method of preparation of the antibacterial composition for delivery of Gramicidin C to local inflammation, including the manufacture of the latter in the form of a therapeutic solution, which is carried out with stirring the pharmaceutical substance, including Gramicidin C and ethanol, purified water, auxiliary substances, including a stabilizer in the form of a polysorbate, filtration, therapeutic solution, and the implementation of a therapeutic solution with the ability to maintain in an unchanged condition until the moment of use, characterized in that it is additionally introduced into adjuvants co-solvent is a glycol, wherein the medical solution further is configured to disperse spray, and the content of components in the treatment solution in May. % choose: Gramicidin C 0.32 - 0.8  ethyl alcohol 16.0 - 40.0  propylene glycol 10.0 - 12.0  polysorbate 0.9 - 1, 1  purified water else 10. The method of claim 8, wherein the pharmaceutical substance, including Gramicidin C and ethanol, is carried out either as a ready-mixed mixture, or by diluting Gramicidin C powder in ethanol. 11. The method according to p. 8, characterized in that the composition of auxiliary substances can be used either flavors or flavors of taste, or both.  12. The method according to claim 8, characterized in that water for injection is used as purified water.  13. The method according to claim 8, characterized in that either polysorbate 80 or polysorbate 20 is used as a polysorbate.  14. The method according to p. 8, characterized in that the therapeutic solution is performed with the possibility of packaging in a sealed bottle, made with the possibility of using a dosing device, including spray.  15. The method according to any one of claims 1 or 8, characterized in that the treatment solution is made with the possibility of dispersed spraying when the dosage device is pressed, a dose equivalent to the effective therapeutic dose of the pharmaceutical substance containing Gramicidin C solid phase from 1, 35 to 1, 65 mg.  16. The method of delivery of Gramicidin C to the center of local inflammation, including the use of a sealed vial equipped with a dosing device, an antibacterial composition, in the form of a therapeutic solution, which is performed with the ability to remain intact until the moment of use, and includes a pharmaceutical substance containing Gramicidin C and ethanol ; purified water; excipients containing a polysorbate stabilizer; dosing a dosage of a therapeutic solution by pressing a dosing device onto a local inflammation focus, characterized in that a therapeutic solution is used in which a co-solvent in the form of propylene glycol is additionally introduced into the excipients, while the therapeutic solution is additionally performed with the possibility of its dispersion spraying, the ratio of components in the treatment solution in May. % choose: Gramicidin C 0.32 - 0.8  ethyl alcohol 16.0 - 40.0 propylene glycol 10.0 - 12.0 polysorbate 0.9 - 1, 1  purified water else 17. The method according to p. 14, characterized in that the pharmaceutical substance, including Gramicidin C and ethanol, can be either used as a mixture, or obtained by diluting Gramicidin C powder in ethanol.  18. The method according to p. 14, characterized in that in the excipients can be entered or flavors, or flavors of taste, or both.  19. The method according to p. 14, characterized in that the antibacterial composition is made with the possibility of using purified water as water for injection.  20. The method according to p. 14, characterized in that the antibacterial composition is made with the possibility of use as a Polysorbate or Polysorbate 80, or Polysorbate 20.  21. The method according to p. 14, characterized in that the treatment solution is made with the possibility of packaging in a sealed bottle, made with the possibility of using a dosing device, including a spray.  22. The method according to any of paragraphs.14 or 18, characterized in that the therapeutic solution is made with the possibility of dispersed dosing, when pressing the metering device on the bottle, the dose equivalent to the effective therapeutic dose of the pharmaceutical substance containing Gramicidin C in the solid phase, from 1, 35 to 1, 65 mg.