RU2274456C2 - Wound-healing agent - Google Patents

Abstract

FIELD: medicine, pharmacy.

SUBSTANCE: invention relates to the development of ointment consisting of 10.0 ml of 1% aqueous solution of humic acids (pH = 7.4), low-mineralized peloids and aerosil-glycerol base for preparing ointment with mass 100.0 g. Invention provides the development of a medicinal agent possessing the wound-healing effect and used in injuries of different etiology, free of ecotoxic agents of different nature and possessing high biological availability.

EFFECT: valuable medicinal properties of agent.

1 tbl

Description

The invention relates to medicine, namely to pharmacology, and can be used as a means to stimulate wound healing of various etiologies.

Known drugs based on antibiotics (levomekol, levosin), which give positive results as wound healing agents.

A significant drawback of these drugs is toxicity to natural microflora [1].

Also known means "Dexpanthenol" [1], which is a synthetic derivative of pantothenic acid.

The disadvantages of "dexpanthenol" include that this drug can cause allergic reactions.

As a wound healing agent, it was proposed to use the Peat preparation in the form of an ointment containing peat distillation from certain deposits [2].

The disadvantage of this drug is the difficulty of standardizing the active substance and the likelihood of contamination by anthropogenic products.

Known organizational products "Actovegin" (Norway) and "Solcoseryl" (Poland). Actovegin contains deproteinized hemoderivative from calf blood serum with low molecular weight peptides, amino acids, nucleosides and other organic substances and trace elements.

The disadvantage of the drug is its high cost and hypeallergenicity.

Solcoseryl contains a standardized deproteinized hemodialysate from the blood of dairy calves.

The disadvantage of solcoseryl is the high allergenic ability in the form of a skin rash. The source of this drug cannot be recognized as optimal. This drug is the closest to the invention in essence, achieved therapeutic effect and is selected as a prototype.

The objective of the invention is the creation of a new drug that has a wound healing effect on lesions of various etiologies, containing humic acids of low mineralized silt sulfide mud, purified from ecotoxicants of various nature, with high bioavailability, low cost, unlimited sources of production.

Humic acids are a natural component of therapeutic mud, harmless to the body, do not cause side effects, allergic reactions. The study of acute toxicity of humic acids was carried out on sexually mature Wistar rats weighing 180-200 g. Observation of the animals was carried out for 14 days. The introduction of "per os" from 0.5 g / kg to 15 g / kg did not cause a toxic effect. Intramuscular administration from 1 mg / kg to 20 mg / kg also did not cause death of animals. The introduction of a larger amount of the active substance cannot be carried out practically and is unreasonable.

Aerosil is an inorganic polymer of synthetic origin - a colloidal form of silicon oxide (IV). This is a very light white powder, which in a thin layer seems transparent, bluish. It forms turbid mixtures with water and alcohol, has good sorption and bactericidal properties, and does not irritate the skin.

Glycerin is a colorless syrup-like hygroscopic liquid, odorless, sweet taste, neutral reaction. It mixes with water and alcohol in all proportions. It has a softening and at the same time astringent effect on the fabric. When applied to the skin, it activates metabolic processes.

The problem is solved in that the proposed tool contains biologically active humic acids, according to the invention is made in the form of an ointment and further comprises a base in the following ratio of components in grams per 100.0 grams of ointment:

- 1.0% solution of humic acids (pH 7.4) - 10.0 ml.

- ointment base up to 100.0.

In this case, an aerosil-glycerin base containing aerosil: glycerin: water in a ratio of 7:60:30 is used as a base.

The preparation of the ointment consists of the following operations: weighed and placed in a mortar 90.0 g of ointment base, measured, added with stirring in parts of 10.0 ml of a 1% aqueous solution of humic acids (pH 7.4), mixed until a homogeneous mass is formed . The resulting dosage form is packaged and issued for vacation.

The proposed ratio of therapeutic substance and ointment base is optimal and provides the therapeutic effect of the drug. The dose of the drug is established experimentally. The content of the therapeutic substance less than 0.1 g per 100.0 g of ointment does not provide the required therapeutic effect.

The effectiveness of the ointment, made according to the specified recipe, was studied in the Central Research Laboratory of Samara State Medical University on white male rats of the Wistar line.

The invention is illustrated by the following examples. Male Wistar rats weighing 200-250.0 g are kept on a normal diet under vivarium conditions one at a time in a cage. Animals are anesthetized with ether. Before causing damage, the hairline is removed by plucking from an area of 400.0 mm ² . After this, full-layer circular wounds in the interscapular region are applied. The rate of epithelialization is recorded by a decrease in area, superimposing a millimeter grid. To compare the wound healing effect of humisil, solcoseryl ointment was used. Aseptic wounds and wounds treated with ointment base served as control. The ointment with the studied drugs was applied to the wounds daily, once. There were 7 animals in each study group. The results of the study are presented in the table.

Table
The dynamics of changes in wound surfaces (mm ² ) Day 2 four 6 8 10 12 fourteen 16 eighteen twenty A drug Solcoseryl 400.3 ± 4.3 375.2 ± 2.5 310.5 ± 9.3 256.4 ± 1.3 145.1 ± 1.2 105.1 ± 0.8 40.4 ± 1.6 16.3 ± 1.2 0,0 Gumisil 402.3 ± 3.9 362.6 ± 2.6 304.6 ± 3.2 205.7 ± 4.1 131.2 ± 4.6 98.5 ± 1.2 35.6 ± 1.3 9.2 ± 0.8 0,0 Ointment base 400.4 ± 2.7 371.9 ± 2.9 330.8 ± 1.5 267.9 ± 3.6 206.3 ± 2.3 186.5 ± 3.2 52.2 ± 1.9 35.2 ± 1.1 10.1 ± 0.9 0,0 Asept. wound 402.6 ± 4.8 391.5 ± 2.7 309.7 ± 3.5 268.6 ± 7.1 210.7 ± 6.8 93.2 ± 4.7 43.2 ± 3.8 25.2 ± 2.9 15.6 ± 2.5 0,0 Before treatment 400.5 ± 2.4

The inventive therapeutic agent expands the arsenal of wound healing agents. Compared with well-known therapeutic agents, it has a high therapeutic effect, the absence of allergic reactions, lower cost, which has socio-economic significance.

Information sources

1. The register of medicines of Russia. 7th ed. Redesigned and supplemented. / Ch. ed. Yu.F. Krylov - M.: Radar - 2000, - 2000. - 1520 s.

2. Melikyants A.G., Kutkova O.N. Wound healing agent. Bull. No. 43-44 dated 11/30/1993. - 4 p.

Claims (1)

A wound healing agent containing an ointment base and an active substance, characterized in that an aerosil-glycerin composition consisting of aerosil, glycerin, water in a ratio of 7:60:30 is used as an ointment base, and 1% aqueous as a medicinal substance humic acid solution of low mineralized silt sulphide mud (pH 7.4) with the following ratio of components: 1.0% humic acid solution (pH 7.4) - 10.0 ml, ointment base up to 100.0 g of ointment.