RU2404745C2 - Hydrophilic pharmaceutical composition for treatment of burns (versions) - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to hydrophilic pharmaceutical compositions for treatment of burn wounds. According to the first version of invention, pharmaceutical composition contains 1-β-oxyethyl)-4,6-dimethyl-1,2-dihydro-2-oxopyrimidine (xymedone) in amount of 1-10 wt %, chloramphenicol sodium succinate in amount of 0.1-5 wt % and gel base. According to the second version of invention, pharmaceutical composition contains xymedone in amount of 1-10 wt %, chloramphenicol sodium succinate in amount of 0.1-5 wt %, tri-(oxymethyl)-aminomethane (trisamine) in amount of 0.5-1.5 wt %, anesthesin in amount of 0-1 wt % and gel base.

EFFECT: compositions of invention are efficient for treatment of infected burn wounds, possess reparative, anti-inflammatory and antimicrobial effect as a result of synergetic and prolonged effect of xymedone and chloramphenicol sodium succinate.

8 cl, 2 tbl, 10 ex

Description

 The invention relates to medicine, namely to medicines in the form of a gel for topical application, and can be used to treat burns of all degrees and of various origins (thermal, solar, chemical, electric shock, radiation) in humans and animals.

The search for effective agents for treating wounds caused by burns is an urgent problem of modern medicine and pharmacology. Burns of varying severity are accompanied by a violation of acid-base balance and protein synthesis, a combination of enzymatic reactions of the decomposition of complex macromolecular and bioorganic compounds, which leads to tissue necrosis, exudative reactions, the formation of granulation tissue, bacterial contamination of the burn surface.

Known drugs for the treatment of burns, made in the form of gels, characterized in the use of various active substances and gelling components.

So, for example, there is known a composition for treating burns in children (see RF patent No. 2209074, publ. 2003), including the biologically active component of the drug Actovegin in the form of a solution for injection and Tizol gel in the following ratio, wt.%: Solution Actovegin for injection in terms of the content of the active component 0.2-0.3, Tizol - up to 100.

The composition is used to treat burns in children as follows. After the primary toilet of the burn wound, which includes covering and emptying the epidermal blisters, removing the remnants of the affected epidermis, cleaning the wound with sterile gauze swabs moistened with an antiseptic, the application of the proposed composition is performed - thisol with Actovegin. The lack of composition is the occurrence of allergic reactions in some patients (urticaria, sensation of fever, fever, shock), which is especially important when treating children.

A wound healing agent is also known (see RF patent No. 2259816, publ. 2005), comprising the active substance mexidol (2-ethyl 6-methyl 3-hydroxypyridine succinate), a gel and distilled water in the following ratio, wt.%: Gel 0.5-5.0, stabilizer 0.01-0.8, preservative 0.01-1.0, mexidol 0.01-10.0, distilled deionized water - the rest. Known tool is highly effective. It has a pronounced wound healing effect in the 1st, 2nd and 3rd phases of the wound healing process. It quickly eliminates inflammatory processes, reduces soreness, swelling, significantly improves the condition of affected tissues, accelerates reparative-degenerative processes and the timing of epithelization, has a wide spectrum of action.

A disadvantage of the known wound healing agent is that mexidol, being an antioxidant, exhibits a therapeutic effect only in the initial period of application of the drug to the wound surface. The more intense the inflammatory processes, the more intensively the products of lipid peroxidation accumulate and, accordingly, mexidol is consumed faster, while the bulk of the active substance is inactivated in the aqueous phase due to atmospheric oxygen. These processes are enhanced by the fact that a monomolecular film is formed on the surface of the skin, which in fact is a membrane and enhances the inactivation of mexidol. In addition, Mexidol is unstable under aseptic conditions, i.e. after violation of the integrity of industrial packaging, the active substance is rapidly inactivated. Based on the foregoing, Mexidol is an ambulance: its effect is very effective, but it is short-lived, which is not rational in the treatment of burns.

Also known anti-burn agent "Xymedon" - 1- (β-hydroxyethyl) -4,6-dimethyldihydropyrimedone-2, pyrimidine derivative of the 3rd generation, which has high regenerative activity (see AS No. 1685454, publ. 1991) . Xymedon is an effective treatment for burns due to its high anti-inflammatory and regenerative activity. The therapeutic effect is expressed in the quickest healing of the wound surface, scab falling off at an earlier date, in improving the morphological and purely chemical picture of skin lesions and restoring biochemical parameters indicating the normalization of metabolic processes. Based on this tool, a number of drugs have been created.

Closest to the invention is a pharmaceutical composition for the treatment of burns (see RF patent No. 2317811, publ. 2008). The pharmaceutical composition contains the active substance N- (β-hydroxyethyl) -4,6-dimethyldihydropyrimedone-2 (xymedon) and a gel base. An embodiment of the invention further includes a preparation from the group of chloramphenicol and succinic acid, and the gel base contains a gelling agent, which is sodium salts of biopolymers, a water-retaining agent glycerin in an amount of at least 20 wt.%, A stabilizer, a preservative and distilled water. As the gelling agent, sodium carboxymethyl cellulose is preferably used.

As a preparation from the chloramphenicol group, the composition contains an antibiotic chloramphenicol, sparingly soluble in water. To ensure hydrophilicity and homogeneity of the pharmaceutical composition, it is necessary to transfer chloramphenicol to a soluble state. For this purpose, succinic acid is introduced into the pharmaceutical composition - prototype, which acts not only as a medicinal substance, but also as a complexing agent, as well as alcohol, for example glycerin.

Succinic acid in an amount of 2.0-10.0 wt.% Causes skin irritation (“burning” effect), which is unfavorable for the use of the gel in the treatment of burns in children or in persons with increased skin sensitivity. Another drawback of the composition is that colonies of microorganisms develop well in a solution of the sodium salt of carboxymethyl cellulose and other cellulose derivatives, as a result of which a large number of preservatives and stabilizers must be introduced into the pharmaceutical composition. In addition, in burns and other wounds, acidosis may develop, which the known composition is unable to eliminate.

The problem to which the invention is directed, is to create a highly effective tool for the treatment of infected burn wounds, made in the form of a gel with reparative, anti-inflammatory and antimicrobial effects.

To solve this problem, a group of inventions is proposed that combines variants of a pharmaceutical composition for the treatment of burns based on the active substance xymedon.

The hydrophilic pharmaceutical composition for treating burn wounds according to the first embodiment of the invention contains 1- (β-hydroxyethyl) -4,6-dimethyl-1,2-dihydro-2-oxopyrimidine (xymedon), a preparation from the group of chloramphenicol and a gel base in which according to the invention as a drug from the group of chloramphenicol it contains chloramphenicol sodium succinate in the following ratio, wt.%:

Ximedon 1-10 Chloramphenicol sodium succinate 0.1-5 Gel base the rest is up to 100

Also according to the invention, the gel base contains a gelling agent, non-aqueous hydrophilic solvents, purified water, a preservative and a neutralizing agent. Rare crosslinked copolymers based on acrylic or (meth) acrylic acid are used as a gelling agent, and a mixture of polyethylene oxide with a molecular weight of 400-6000 Da with propylene glycol is used as non-aqueous hydrophilic solvents.

The hydrophilic pharmaceutical composition for treating burn wounds according to the second embodiment of the invention contains 1- (β-hydroxyethyl) -4,6-dimethyl-1,2-dihydro-2-oxopyrimidine (xymedon), a preparation from the group of chloramphenicol and a gel base in which according to According to the invention, as a preparation from the chloramphenicol group, it contains chloramphenicol sodium succinate, additionally contains tri- (oxymethyl) -aminomethane (trisamine) and optionally anestezin in the following ratio, wt.%:

Ximedon 1-10 Chloramphenicol sodium succinate 0.1-5 Tri- (hydroxymethyl) -aminomethane (trisamine) 0.5-1.5 Anestezin 0-1.0 Gel base the rest is up to 100

Also, according to the invention, the gel base contains a gelling agent, non-aqueous hydrophilic solvents, purified water, a preservative, and optionally a stabilizer. Rare cross-linked copolymers based on acrylic or (meth) acrylic acid are used as a gelling agent; a mixture of polyethylene oxide with a molecular weight of 400-6000 Da with propylene glycol is used as non-aqueous hydrophilic solvents.

The essence of the proposed invention lies in the fact that as a drug from the group of chloramphenicol, the composition contains chloramphenicol sodium succinate - an antibiotic that is very soluble in water. Chloramphenicol sodium succinate has an antimicrobial, antibacterial (bacteriostatic) effect. It is effective against many gram-positive and gram-negative bacteria. The use of this drug made it possible to abandon the introduction of succinic acid into the composition and, thereby, create an effective hydrophilic and homogeneous pharmaceutical composition for its use in the treatment of burns in children or in persons with increased skin sensitivity.

The technical result in this invention is achieved not only by using the main active substances - xymedon and chloramphenicol sodium succinate, but also by synergism and prolonged action of its components.

According to the invention, the gel base contains a gelling agent, non-aqueous hydrophilic solvents, purified water, a preservative and a neutralizing agent. Rare crosslinked copolymers based on acrylic or (meth) acrylic acids, the elementary link of which is extremely small, are used as a gelling agent. Polymers of this class (Karbopol U-10, Karbopol 934P, Karbopol 940, Karbopol 974P, Karbopol 980) have a higher permeability to the skin due to the smaller size of the globules. Their aqueous solutions do not undergo microbial contamination. For the same reasons, carbopol-based gels require significantly less preservatives and stabilizers, compared, for example, with Na-CMC and other gelling agents. The interaction of xymedon with polyacrylic acid (PAA) occurs according to a complex mechanism, not only due to electrostatic, van der Waals forces and hydrophobic binding, but also due to the formation of polymer-colloidal complexes of -COOH and -COONa units in PAA with xymedon at a nitrogen atom having main character. Therefore, PAA solutions with Xymedon simultaneously and quickly penetrate the skin barrier, and also form a dense surface film of PAA complexes with Xymedon, causing a prolonged action. This allows us to recommend the resulting composition for pediatric practice. The use of rare crosslinked copolymers based on acrylic or (meth) acrylic acid dictates the use of traditionally used mixtures of polyethylene oxides with a molecular weight of 400-6000 Da with propylene glycols as non-aqueous hydrophilic solvents. In liquid polyethylene oxides, in particular, in PEO-400, drugs that are hardly soluble in water dissolve well.

A second embodiment of the pharmaceutical composition further comprises the active substances tri- (oxymethyl) -aminomethane (trisamine) and optionally anestezin. Trisamine is a white crystalline powder readily soluble in water with a faint smell of amines. Trisamine is a systemic antacid, has buffering properties and inhibits acidosis in a burn wound or wound of any other etiology, as it can penetrate cell membranes [Mashkovsky M. D. Medicinal product. - 15th edition - M: RIA "New Wave" publisher Umerenkov, 2008, p.686]. In addition, since trisamine belongs to the group of drugs used to correct the acid-base state and ionic balance in the body, it exhibits the properties of a thickener and promotes gelation of the pharmaceutical composition.

Anestezin is an odorless white crystalline powder. Soluble in alcohol, in particular propylene glycol. The introduction of anestezin in the composition allows for local anesthetic action.

The active substances - xymedon, chloramphenicol sodium succinate, trisamine and anestezin are present in pharmaceutical compositions in an effective amount. An amount less than the specified does not give an effect, an amount greater than the specified is not appropriate, since an increase in the effect does not occur.

The agents used as a neutralizing agent, preservative and stabilizer are traditional in pharmacopeia practice and are used for their intended purpose. Their number is determined experimentally and depends on both the active substances used and other components of the composition.

Table 1 presents examples of formulations of the claimed variants of pharmaceutical compositions for the treatment of burns. The amount of ingredients is given per 100 wt.% Of the composition.

A method of obtaining a composition.

A measured amount of carbopol is moistened with an aqueous solution of polyethylene oxide (PEO-400, PEG-1500, PEG-6000). With vigorous stirring, aqueous and non-aqueous solvents are sequentially introduced in the amounts indicated in table 1 for each example. The hydrophilic base is brought to complete homogenization. Sodium chloramphenicol succinate and, if necessary, a neutralizing agent (sodium hydroxide), anestezin, stabilizer (Tween 80) and preservative (nipagin) are introduced into the resulting turbid homogeneous colloidal solution with vigorous stirring. The gel becomes clear and thick. Then, Ximedon is introduced into the resulting gel. Bring the resulting gel with water to 100 g.

Example 1. A method of obtaining a composition is as follows.

1.0 g of carbopol 980 powder is placed in the reactor, which is wetted with 5 g of a 20% aqueous solution of polyethylene oxide, with vigorous stirring, purified water is added in an amount of 50-70% of its total mass. Then, 2.0 g of chloramphenicol sodium succinate are introduced into the resulting turbid homogeneous solution with vigorous stirring and the pH of the solution is adjusted to 6-7 with sodium hydroxide solution. Then, 0.2 g of nipagin preservative dissolved in 30.0 g of propylene glycol are added to the solution. Then, with vigorous stirring, xymedon in the amount of 6.0 g is added to the resulting mass and the resulting gel is brought with water to 100 g.

The resulting composition has the following composition, wt.%:

Xymedon - 6.0; chloramphenicol sodium succinate - 2.0; carbopol 980 - 1.0; PEO-400 - 1.0; propylene glycol - 30.0; preservative (nipagin) - 0.2; a neutralizing agent is a solution of sodium hydroxide to pH 7.0; purified water - the rest is up to 100.

Example 2. A method of obtaining a composition is as follows.

0.5 g of carbopol U-10 powder is placed in the reactor, which is wetted with 6 g of a 25% aqueous solution of polyethylene oxide, with vigorous stirring, purified water is added in an amount of 50-70% of its total mass. Then, 3.0 g of chloramphenicol sodium succinate are introduced into the resulting turbid homogeneous solution with vigorous stirring, and 4.5 g of a 33.4% aqueous trisamine solution are added. Then, with vigorous stirring, 0.5 g of anestezin dissolved in a mixture of 1.0 g of Tween-80 stabilizer, 0.1 g of nipagin preservative and 10.0 g of propylene glycol are introduced into the solution. Then, with vigorous stirring, xymedon in the amount of 10.0 g is added to the resulting mass and the resulting gel is brought with water to 100 g.

The resulting composition has the following composition, wt.%:

Xymedon - 10.0; chloramphenicol sodium succinate - 3.0; carbopol U-10 - 0.5; PEO-400 - 1.5; propylene glycol - 10.0; Trisamine - 1.5 g; anestezin 0.5 g; stabilizer (twin-80) - 1.0; preservative (nipagin) - 0.1; purified water - the rest is up to 100.

Examples 3-4 are carried out in accordance with the method described in example 2. The composition of the compositions, see table 1.

Example 5. A method of obtaining a composition is as follows. 1 g of carbopol 934P powder is placed in the reactor, which is wetted with 5 g of a 20% aqueous solution of polyethylene oxide 400, and purified water is added with vigorous stirring in an amount of 50-70% of its total mass. Then, 2.0 g of chloramphenicol sodium succinate are introduced into the resulting turbid homogeneous solution with vigorous stirring and 3.0 g of a 33.4% aqueous trisamine solution are added. Then, with vigorous stirring, 0.2 g of nipagin preservative dissolved in 30.0 g of propylene glycol are added to the solution. Then, with vigorous stirring, xymedon in the amount of 8.0 g is added to the resulting mass and the resulting gel is adjusted with water to 100 g.

The resulting composition has the following composition, wt.%:

Xymedon - 8.0; chloramphenicol sodium succinate - 2.0; carbopol 934P - 1; PEO-400 - 1.0; propylene glycol - 30.0; Trisamine - 1.0 g; preservative (nipagin) - 0.2; purified water - the rest is up to 100.

Example 6 is carried out in accordance with the method described in example 2. The composition of the compositions, see table 1.

Example 7 is carried out in accordance with the method described in example 5. The composition of the compositions, see table 1.

Examples 8-10 are carried out in accordance with the method described in example 2. The composition of the compositions, see table 1.

To confirm effectiveness, preclinical studies were conducted, the results of which are illustrated by the following examples.

The results of preclinical trials of drugs for the presence of antimicrobial activity in in vitro experiments.

The studies were performed in the problematic scientific laboratory of microbiology of the Research Institute of PFM GOU VPO "NizhGMA Roszdrava". Tests of the gels proposed according to the invention were carried out in comparison with traditionally used for the treatment of burns in everyday life and inpatient conditions topical preparations “Methyluracil” (ointment, manufacturer Nizhpharm OJSC, Russia), “D-Panthenol” (cream, manufacturer JSC “Yadran” , Croatia), Actovegin (gel, manufacturer Nycomed, Austria), Solcoseryl (gel, manufacturer ICN, Switzerland), Levosin (ointment, manufacturer Nizhpharm, Russia), " Levomikol "(ointment, manufacturer of Nizhpharm OJSC, Russia).

The determination of antimicrobial activity was carried out according to the standard methodology approved by the Ministry of Health of the State Pharmacopoeia, M., "Medicine", 1990, issue 2, in the section "Methods of microbiological control of drugs." Tests were conducted in relation to: S.aureus - museum strain number 906, obtained from the GISK named after Tarasevich; E.coli M-17 - museum strain number B-8208, obtained from the GISK named after Tarasevich; Ps.aeruginosae is an isolate isolated from a patient.

The data of the in-vitro test results of the compositions of the invention reflecting the antimicrobial effect on the test cultures of S. aureus, E. coli, Ps. Aeruginosae are summarized in table 2.

As can be seen from table 2, proposed according to the invention, the compositions have antimicrobial activity in relation to all tested test cultures. This is important in the effective treatment of burns and other skin lesions, when during treatment there is an increase in microbial infection, attachment (or intensification) of an existing secondary infection.

The results of a study of the clinical effectiveness of the external use of the composition according to the invention.

The studies were carried out in the Russian burn center of the Federal State Institution NNIITO of Rosmedtehnologii. Nizhny Novgorod.

The effectiveness of the use of the gels with xymedon according to the invention was studied in comparison with traditional agents in the local treatment of burn wounds. Method of use - after a thorough toilet, the wound surface was covered with a thin layer of gel, after which gauze dressings were applied up to 3-5 layers thick (including fixing bandages). Change of dressings - every other day or as soon as wound is fouled, but not more often than 3 times a week. Control methods: monitoring the course of the wound process was carried out on the basis of visual observation, assessing the number and nature of the wound discharge, wound bleeding, the timing of the transition to another phase of the wound healing process, the timing of the onset of epithelization. The pain response directly during ligation was subjectively evaluated by patients according to the intensity of pain. Comparison was made with neighboring sections of burn wounds, similar in depth to the lesion, and with averaged indices of patients in the burn department who treated wounds traditionally with the use of Levomekol ointment.

The first group - 4 patients with burns of the II-IIIA degree of various etiologies with an area of 2% -5% of the body surface. The following patients were included in this group:

Patient K., 1.1 g. - burn with boiling water of the left shoulder at S = 5% bp;

Patient B., 1 year - burn with boiling water of the left lower leg on S = 2% of the body surface;

Patient Yu., 1.1 g. - burn with a flame of a volt arc of the right hand at S = 1% of the body surface;

Patient G., 10 months - thermal back burn on S = 3% of the body surface. Patients of this group were treated using drug No. 1 (Table 1).

Treatment of patients with the drug started in the period from 1 to 2 days from the moment of injury. Before treatment, burn wounds after removal of the exfoliated epidermis were moist pink surfaces in separate areas of a whitish color.

After taking the seeding and thorough toilet of the wounds, dressings with the preparation were applied. In 1 person from this group, the dressings were not removed until the wounds were completely healed. During treatment, skin hyperemia and edema of tissues surrounding the wound were significantly reduced, dressings were easily removed without injuring the granulating, epithelizing surface. In all patients, the wounds healed without complications, with the formation of a soft, elastic, non-constricting scar. The terms of epithelization were 6-8 days.

The second group - 3 people with burns of the II-IIIA degree from 3% to 12% of the body surface. Patients of this group were treated using drug No. 4. This group of patients was composed of the following patients:

Patient M., 3 g., - thermal chest burn on S = 3% of the body surface;

Patient L., 2.5 g., Burn with boiling water of the right hand on S = 2% of the body surface;

Patient I., 1.2 g., Thermal burn of the body, right thigh at S = 12% p.t.

Treatment of patients of the second group (drug No. 4) was started in the period from 1 to 2 days from the moment of injury. After taking the seeding and thorough toilet of the wounds, dressings with the preparation were applied. After the second and subsequent dressings, which took place painlessly, without significant bleeding, it was possible to ascertain: the disappearance of puffiness, rapid epithelization from the edges of the wound, a sharp decrease in discharge. During treatment, in the experimental areas, perifocal inflammation subsided 3-5 days earlier, the wounds were brighter and more even than in the control areas. The terms of epithelization were 6–8 days, whereas in the control plots it was 11–13 days.

The third group consisted of 4 people with burns of the II-IIIA degree of various etiologies with an area of 2% to 9% of the body surface. Patients of this group were treated using drug No. 5. This group included the following patients:

Patient K., 16 years old, - thermal burn of the body, right leg on S = 9% of the body surface;

Patient P., 17 L., - granulating wounds of the legal forearm on S = 2% of the body surface;

Patient L., 11 l., - mosaic wounds of the trunk at S = 2% of the body surface;

Patient E., 11 l., - granulating wounds of the left hand at S = 3% bp

Treatment of patients of the third group with drug No. 5 with superficial burns of various etiologies from 2 to 9% was started at different times. After taking the seeding and thorough toilet of the wounds, dressings with the preparation were applied. St.aureus, Ps.aeruginosa was sown from the wound discharge. Under the action of gel No. 5, Pseudomonas aeruginosa strains ceased to stand out on the 7th day from the start of therapy, and on the 12-14th day in patients with cultures of the wound separated from the wound, there was no clinically significant increase in Pseudomonas microflora. The change of dressings in the experimental areas was painless compared to dressings with levomikol and wet-drying dressings. Epithelization of burn wounds of the IIIA degree in the third group in the experimental plots began on the 5-7th day after the start of treatment, the epithelization was completed on average for 12 days, in the control sections of the wounds on the 16th day. On average, wound healing under the influence of gel No. 5 occurred 4.3 days earlier than with conventional treatment; in some cases, the difference in healing time reached 7 days.

As an additional study, 3 patients were monitored for the effect of drug No. 5 on the healing of donor wounds. As a result, no significant differences were found in the healing time, however, the quality of the regenerate was slightly different from the control site - the regenerates on wounds treated with gel No. 5 were more durable, clean, even, less painful.

So, the average duration of epithelization was 6-8 days. The average duration of treatment in groups was 12-14 days, which is lower than the average duration of treatment over the past 5 years. Use in the treatment of the composition according to the invention makes it possible to reduce pain in patients with dressing, to reduce the number of dressings and the healing time of wounds. In some cases, 1-2 dressings were enough for complete wound healing. Gels have a pronounced bactericidal and bacteriostatic effect. The use of these drugs was well tolerated by patients; no irritating effect or allergic reactions were noted.

Thus, the hydrophilic pharmaceutical composition proposed by the invention is an effective therapeutic agent, it is recommended for burns of various degrees in the form of dressings or open treatment. Dressings with the drug are easily removed without giving painful sensations and without injuring the granulating, epithelizing surface.

The wounds on the background of the treatment with the proposed gels heal with the subsequent formation of a soft, elastic, non-constricting scar. The use of the composition is not accompanied by side effects in the patient’s body, which makes it possible to use it for extensive burns.

table 2 Preparations S.aureus E. Coli Ps. Aeruginosae Example No. 1 strong strong strong Example No. 4 strong strong strong Example No. 5 strong strong strong Methyluracil Ointment does not possess does not possess does not possess D-Panthenol Cream does not possess does not possess does not possess Actovegin gel does not possess does not possess does not possess Solcoserin gel does not possess does not possess weak Levosin Ointment pronounced weak pronounced Levomekol ointment strong strong strong

Claims (8)

1. Hydrophilic pharmaceutical composition for the treatment of burn wounds containing 1- (β-hydroxyethyl) -4,6-dimethyl-1,2-dihydro-2-oxopyrimidine (xymedon), a preparation from the group of chloramphenicol and a gel base, characterized in that as a drug from the group of chloramphenicol it contains chloramphenicol sodium succinate in the following ratio, wt.%:
xymedon 1-10 chloramphenicol sodium succinate 0.1-5 gel base the rest is up to 100 2. The composition according to claim 1, characterized in that the gel base contains a gelling agent, non-aqueous hydrophilic solvents, purified water, a preservative and a neutralizing agent. 3. The composition according to claim 2, characterized in that the rarely used crosslinked copolymers based on acrylic or (meth) acrylic acid are used as a gelling agent. 4. A composition according to any one of claims 2 and 3, characterized in that a mixture of polyethylene oxide with a molecular weight of 400-6000 Da with propylene glycol is used as non-aqueous hydrophilic solvents. 5. A hydrophilic pharmaceutical composition for treating burn wounds containing 1- (β-hydroxyethyl) -4,6-dimethyl-1,2-dihydro-2-oxopyrimidine (xymedon), a preparation from the group of chloramphenicol and a gel base, characterized in that as a drug from the chloramphenicol group, it contains chloramphenicol sodium succinate, additionally contains tri- (oxymethyl) -aminomethane (trisamine) and optionally anestezin in the following ratio, wt.%:
Ximedon 1-10 chloramphenicol sodium succinate 0.1-5 tri- (hydroxymethyl) -aminomethane (trisamine) 0.5-1.5 anestezin 0-1.0 gel base the rest is up to 100 6. The composition according to claim 5, characterized in that the gel base contains a gelling agent, non-aqueous hydrophilic solvents, purified water, a preservative and optionally a stabilizer. 7. The composition according to claim 6, characterized in that rarely crosslinked copolymers based on acrylic or (meth) acrylic acid are used as a gelling agent. 8. A composition according to any one of claims 6 and 7, characterized in that a mixture of polyethylene oxide with a molecular weight of 400-6000 Da with propylene glycol is used as non-aqueous hydrophilic solvents.