RU2396972C2 - Wound healing agent - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to chemical-pharmaceutical industry, namely to creation of a wound healing agent. The wound healing agent contains a dry extract of Sphagnum fuscum peat dust, polyethylene glycol of molecular weights 400 and 1500, Dimexid, purified water.

EFFECT: agents extends the range of herbal wound healing products, exhibits wound healing action for treating infected wounds.

1 tbl

Description

The invention relates to the field of medicine, pharmacy, pharmacognosy, to drugs with a pronounced wound healing effect.

One of the most serious problems in the treatment of wound pathologies is their infection with pathogenic bacteria and fungi, which leads to various complications and a significant increase in the time of complete recovery. Rational therapy of wound lesions includes the mandatory antimicrobial component. Today, clinical medicine has a large assortment of antibacterial and antifungal agents (methyluracil ointment, nystatin, sanguirytrin, etc.), however, many of them have side effects in the form of dispersions, hepato-, nephrotoxic and teratogenic effects, allergic reactions, dysbacterioses, immunopathies. One of the ways to solve this problem is to use antimicrobial preparations of plant origin, which have significant advantages over various synthetic and semi-synthetic antimicrobial agents: low toxicity, the absence of side effects, the effect on multiresistant strains of gram-positive and gram-negative bacteria, a beneficial effect on nonspecific resistance of the body (2). The presence of bactericidal and wound healing properties of sphagnum moss is widely known; they provided this plant with universal recognition during the First and Second World Wars. It is important that over the entire time of its use, not a single case of contraindications was recorded (1).

Known funds based on sphagnum mosses. Mostly sphagnum was used as a dressing material, in addition, I.P. Vinogradov prepared sphagnum ointment from the leaves of papillose sphagnum (S.papillosum) and petroleum jelly taken in a 1: 1 ratio, which contributed to the healing of purulent wounds (4 prototype). However, the antimicrobial activity of Sphagnum fuscum is higher and the supply of raw materials is much larger than that of S. papillosum (3).

A new technical task is to expand the range of products based on plant materials that have a wound healing effect for the treatment of infected wounds.

To solve the problem in a wound healing agent, based on the raw material of sphagnum moss, sphagnum extract Sphagnum fuscum is used, additionally containing purified water, polyethylene glycol with mol.m. 400 and 1500 and dimexide in the following ratio of components,%:

sphagnum extract 3 purified water 5 polyethylene glycol with mol.mass. 400 65 polyethylene glycol with mol.mass. 1500 25 dimexide 2

The ratio of extract and excipients was selected during experimental studies with animals.

The technological process for obtaining a 3% ointment extract includes the following stages:

1. In a tank 1 in a water bath, polyethylene glycol (PEG-1500) is melted (70-80 ° C) and mixed with polyethylene glycol (PEG-400) using a tissue micro-chopper for 2 minutes.

2. A sphagnum extract (Sphagnum fuscum) is placed in a container 2 (porcelain mortar) and purified water is added in portions, preheated to 20 ° C, with thorough stirring until the extract is completely dissolved, after which dimexide is introduced.

3. The resulting concentrated aqueous solution of the extract is introduced into the molten base and homogenized using a tissue micro-grinder for 3 minutes.

4. Conduct standardization on the following indicators:

organoleptic

physico-chemical

microbiological (SanPiN 2.3.2.1078-01, index 1.10.5.1),

on the content of toxic elements, pesticides and radionuclides (SanPiN 2.3.2.1078-01, index 1.10.5. every 5 batch).

5. Packed in containers of 50.0 g, packaged.

The product is an ointment of a uniform consistency, from light brown to brown. The presence of extraneous mechanical impurities is not allowed. The smell is weak or absent.

The introduction of water-soluble polyethylene glycols with molecular weights of 400 and 1500 into the composition of the proposed medicinal product within the proposed limits promotes the maximum penetration of the active substance of sphagnum moss extract through cell membranes, since this base has an osmotic activity that provides dehydration effect on tissues in the focus of inflammation. Dimexide is a component that also contributes to the delivery of biologically active substances to the pathological zone. The ratio of the components is selected empirically and ensures the presence of the necessary organoleptic and therapeutic properties of the composition.

A study of the wound healing activity of the proposed drug was carried out on models of “aseptically cut wounds” in rats (5). Pharmacopeia wound healing agents: 10% methyluracil ointment and sea buckthorn oil (Biolit LLC, Tomsk) were used as comparison preparations. The wound healing activity of the studied drugs was judged by the timing of complete wound healing and morphological indicators of the state of the tissues in the area of the cut wound.

In the control group of animals (treated with an ointment base: PEG 400-PEG 1500 (1: 4)) after applying an “aseptic wound” in the back, by removing the fascial-skin fascial flap with a diameter of 20 mm, the healing of the skin defect occurred within 18.60 ± 1 , 40 days (see the table in which the data on the effect of applications of 3% ointment 20% water-ethanol extract from S. fuscum, 10% methyluracil ointment and sea buckthorn oil on the healing time of the “aseptically cut wound” in rats, where - * The differences with the control are significant, (p≤0.05), ** The stomach was taken for the control group ny processed ointment base).

During the first 5-7 days, a purulent-inflammatory reaction of the soft tissues surrounding the wound defect was observed, accompanied by abundant exudation and the formation of a purulent-necrotic crust. When the latter was removed on the 7th day, a discharge of abundant purulent discharge, accumulated between the granulation tissue of the wound bottom and the removed crust, was noted. Marked maceration of the skin surrounding the wound.

The morphological picture, indicating the severity of the inflammatory process in animals of the control group, was confirmed by histological examination. Microscopy of the preparations of the wound defect site showed the presence of purulent-necrotic crust and superficial hematoma. The epidermis was well defined with preserved differentiation of the layers, but on the surface there was necrotic detritus with severe leukocyte infiltration with the presence of purulent bodies, between the purulent-necrotic crust and the surface of the wound defect, a destroyed erythrocyte thrombus was determined.

When treating a wound with a 3% ointment extract, complete epithelization of the defect was observed within 12.20 ± 1.4 days. The acceleration of wound healing in relation to the control group was 34.4%, see table, which presents data on the effect of applications of 3% ointment 20% ethanol water extract from S. fuscum, 10% methyluracil ointment and sea buckthorn oil on the healing time "Aseptically cut wounds" in rats.

The wound treatment with the proposed wound healing agent helped to eliminate the purulent-exudative inflammatory reaction, as evidenced by the absence of pus accumulation under the removed crust on the 7th day after the wound was applied.

Microscopy of the surface of the wound defect surface showed an epidermis with the presence of acanthotic strands, granulation tissue with a transition to the maturing, in the papillary layer of the dermis focal hyperkeratosis in different phases of maturation. Horn scales in the state of focal desquamation were determined along the surface.

It should be noted that 10% methyluracil ointment and sea buckthorn oil under similar experimental conditions had less pronounced wound healing effects - complete epithelialization of the wound was observed at 13.40 ± 1.20 and 15.60 ± 1.60 days 28.0%, respectively. In addition, in the group of animals that received the application of sea buckthorn oil, as well as in the control group, during the first 5-7 days, a purulent-inflammatory reaction of soft tissues surrounding the wound defect was observed, accompanied by profuse exudation and the formation of a purulent-necrotic crust.

Thus, the proposed tool allows you to expand the range of effective wound healing products based on plant materials.

Table Observation group The terms of wound healing (days, M ± m) Acceleration of wound healing in relation to the control group ** (%) Ointment base (n = 10) 18.60 ± 1.40 - 10% methyluracil ointment (n = 10) 13.40 ± 1.20 * 28.0 Sea buckthorn oil (n = 10) 15.60 ± 1.60 * 16,2 3% ointment 20% water-ethanol extract from S. fuscum (n = 10) 12.20 ± 1.40 * 34,4

Sources of information taken into account

1. Savich-Lyubitskaya S.I. The use of sphagnum (peat) moss in medicine / S.I. Savich-Lyubitskaya // Nature. - 1943. - N4. - S.41-50.

2. Dmitruk S.E. Antifungal properties of biologically active substances of some representatives of the Siberian flora. - Abstract. doc farm. sciences. - Kharkov, 1991.45 s.

3. Babeshina L.G. Sphagnum mosses of the Tomsk region and the prospects for their use in medicine. - Abstract. Cand. biol. sciences. - Tomsk, 2002.19 p.

4. Savich-Lyubitskaya L.I. Flora of spore plants of the USSR. - M .: AN USSR, 1952 - S.97-109.

5. Guidance on the experimental (preclinical) study of new pharmacological substances / Ed. Corresponding Member RAMS prof. R.U. Khabrieva. - 2nd ed., Revised. and add. - M .: OJSC "Publishing House" Medicine ", 2005. - 832 p.: Ill.

Claims (1)

A wound healing agent containing a component of plant origin, polyethylene glycol with molecular weights of 400 and 1500, dimexide and purified water, characterized in that as a component of plant origin includes dry extract of sphagnum moss Sphagnum fuscum in the following ratio, wt.%:
Dry sphagnum moss extract Sphagnum fuscum 3 Polyethylene glycol with a molecular weight of 400 65 Polyethylene glycol with a molecular weight of 1,500 25 Dimexide 2 Purified water 5