RU2462270C2 - Method for making hydrocolloid bactericidal dressing - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a method for making a hydrocolloid bactericidal dressing with wound-healing and antimicrobial properties. The dressing represents a structure of a number of layers fastened to each other. The layer adjoining the wound represents a perforated polyethylene film; it is coated with a hydrocolloid plate of acryl compounds with added glycerol covered with a non-woven layer with deposited dialdehydecellulose microfibers with the immobilised enzyme lysoamidase. An upper protective layer represents a perforated polyethylene film.

EFFECT: dressing reduces length of wound healing, easily removed from the surface of purified wound causing no injuries and pain sensations in a patient.

6 cl, 2 tbl, 4 ex

Description

The invention relates to medicine, specifically to surgery.

State of the art

A dressing is known, which is medical gauze, oxidized to DAC dialdehyde cellulose with an oxidation state of 0.5-1.5%, containing the immobilized enzyme lysoamidase at a mass ratio of DAC - lysoamidase 1000: 10-28.8, i.e. 1-2.88 mg of lysoamidase per 1 g of DAC (see, for example, RF patent 2127609 - prototype).

The proteolytic activity of the known material is from 0.3 to 0.7 PE (proteolytic units) per 1 g of carrier, bacteriolytic activity is 5.9-10.2 units. per 1 g of carrier.

The average time for wound cleansing (necrolysis) is from 3.0 ± 0.5 to 4.0 ± 0.3 days.

When using material containing only immobilized trypsin with an activity of 0.25 PE / g, the average time for wound cleansing was 5.8 ± 0.4 days.

Known dressings have significant disadvantages. The terms of cleansing wounds from detritus are large, which leads to a slowdown in the terms of complete healing of wounds. The force of separation of the known material from the wound surface during dressings is 202 g, which leads to pain in patients and secondary bleeding. For this reason, many patients, especially children, refuse treatment with such materials.

A known method of obtaining dressings "Filatov-Ryltsev wipes" (RF Patent No. 2142818 - analogue). At the DAC with an oxidation state of 0.04-0.03 mEq. per 1 g of carrier are co-immobilized, 0.33 mg of trypsin and 0.33 mg of lysozyme per 1 g of carrier. The terms of cleansing wounds from detritus were 2.2-2.3 days. A disadvantage of the known napkins is their high invasiveness, the same as in the prototype. The aim of the present invention is to remedy these disadvantages.

SUMMARY OF THE INVENTION

The present invention provides a new method for producing a hydrocolloid bactericidal dressing having a wound healing and antimicrobial effect.

The first aspect of the present invention is a method for producing a highly oxidized dialdehyde cellulose-based material with an enzyme complex of microbial origin lysoamidase immobilized on it, providing accelerated cleansing of wounds from purulent-necrotic masses, prevention of secondary infection and, as a result, reduction of wound healing time.

The enzyme complex of lysoamidase consists of several enzymatic fractions with different substrate specificity - proteolytic and bacteriolytic, which is most pronounced in this complex. Proteolytic fractions lyse purulent-necrotic masses and thus cleanse the wound, and bacteriolytic fractions act on certain structures of the bacterial cell wall, which leads to the death of microorganisms.

The second aspect of the present invention is a method for producing a hydrocolloid plate based on acrylic polymers with the addition of glycerol, which gives the plate elasticity and allows you to simulate the wound surface. The presence of a hydrocolloid component containing at least 6% moisture ensures atraumaticity of the dressing and performs a sorption function, having a high absorbency, and, most importantly, keeps a moist environment on the wound.

A third aspect of the present invention is that the medicament chemically bound to the carrier, dialdehyde cellulose, is in the form of microfibres with a particle size of 40-80 microns.

A fourth aspect of the present invention is the presence of atraumatic absorbent layers in the form of a double-sided perforated film based on a modified polyethylene with viscose filler inside. These layers perform a complex function - they absorb detachable wounds, the inner film is a layer adjacent to the wound, the outer film is a protective layer. Dialdehyde cellulose microfibre with an immobilized enzyme complex lysoamidase is deposited on the inner surface of the viscose layer, a hydrocolloid plate is placed between the inner film and the viscose filler with microfiber included in its structure.

All layers are connected by sewing.

Thus, the present invention provides a new method for producing a hydrocolloid bactericidal dressing for wound healing of various etiologies having various types of biological activity. A dressing can reduce wound healing time. The dressing is easily removed from the surface of the cleaned wound, without injuring it and without causing pain in the patient. No adhesion. This explains the mechanism of high non-invasiveness of the proposed material.

DETAILED DESCRIPTION OF THE INVENTION

The invention is further described by examples of its implementation.

Example 1

Upon receipt of textile material for wound healing use medical gauze. 3.3 l of distilled water are poured into the reactor, a stirrer is included, and 121.875 g of iodic acid are added. 3.3 L of distilled water are poured into another reactor, the stirrer is turned on, and 20.31 g of sodium hydroxide are added. Both solutions are mixed until the acid and alkali are completely dissolved for 5-15 minutes. Then, the alkali solution is poured with stirring into the acid solution for 3-6 minutes. In the resulting sodium periodate solution, 1 kg of medical cotton gauze is placed in the form of a web and kept at room temperature in the dark for 14 hours. After activation, the canvas is squeezed, washed 4 times with distilled water of 10 l each, squeezed again and dried in air in the dark to a residual moisture content of not more than 10% at room temperature.

The gauze oxidation state was 6.0 ± 0.33 for a sample of 25 experiments.

Example 2

The oxidized cellulosic material (oxidation state of 6.5%) in the form of medical gauze weighing 100 g is treated with a solution of lysoamidase in water with a concentration of 0.4%, module 6. After 2 hours, the material is squeezed on rollers to a weight gain of 120% and dried in air. The content of lysoamidase is 4.8 mg per g. The proteolytic activity of the material is 0.8 PE / g, the bacteriolytic activity is 10.2 U / g. The material is ground to a particle size of 40-80 microns.

Example 3

24 g of Temposcrin are dissolved in 1 liter of distilled water at a temperature of 80 °. Cool to room temperature and add 12 ml of 85% glycerol with stirring. 20 g of the resulting mass is poured into a 10 × 10 cm mold. Dried in air. The weight of the dry plate is 1 g.

Example 4

Microfiber is sprayed onto the non-woven base of the atraumatic material LN-0040, coated with a hydrogel plate and a perforated plastic film, rolled and all layers are joined by sewing.

The advantage of the invention

The tool can be used to treat purulent-necrotic wounds of any origin, including long-term non-healing wounds, such as wounds and ulcers against trophic disorders.

The terms of wound healing coincide with the analogue. The proposed material has a multifunctional effect, which allows us to recommend it for closing wounds in emergency situations - natural and man-made disasters, accompanied by mass destruction of people, and in the field.

The oxidation state of DAC is 6.0 ± 0.33%, and the amount of immobilized lysoamidase is 4.8 mg per 1 g of carrier. After immobilization, lysoamidases are crushed to particles with a size of 40-80 microns. The dressing design includes a hydrocolloid plate based on polyacrylamide compounds and glycerol, which ensures constant dressing moisture. Microfiber is sprayed onto the non-woven base of the atraumatic material LN-0040, coated with a hydrocolloid plate and a perforated film, rolled and all layers are joined by sewing.

The surface of microfibers of the indicated sizes is hundreds of times higher than the initial ones. Therefore, the hydrolytic destruction of microfibers is sharply accelerated with the release of soluble DAC-lysoamidase oligomers into the wound, which are the main active principle of the process, providing accelerated cleansing of wounds from detritus.

The hydrocolloid plate actively absorbs wound and is constantly in a wet state, providing a high non-invasive dressing.

An experimental study of dressings showed their high healing properties, obviously associated with the synergistic action of the hydrocolloid and microfiber components (see Table 1).

Table 1 Duration of wound cleansing using various materials Material Activity The average time for cleansing wounds, day Proteolytic, PE / g Bacteriolytic, Unit / g According to the patent of the Russian Federation No. 2127609 DAC-
Lizoamidase 0.3 5.9 4.0 ± 0.3 DAC-Lizoamidase 0.8 10,2 3.1 ± 0.4 DAC-Lizoamidase 0.7 9.0 3.0 ± 0.5 DAC-Trypsin 0.25 - 5.8 ± 0.4 According to the patent of the Russian Federation No. 2142818 - - 2.3 ± 0.5 According to the proposed method 1.6 ± 0.2

The average time for wound cleansing according to the invention is on average 2 times lower than in the treatment of DAC-lysoamidase.

The hydrocolloid plate provides almost complete atraumaticity of the dressing (see table 2).

table 2 Comparative atraumatism of various materials Type of material The separation force, g Medical gauze 398 DAC-lysozyme-trypsin 202 DAC-lisoamidase 200 According to the invention twenty

Claims (6)

1. A method of producing a hydrocolloid bactericidal dressing in which the treatment layer is dialdehyde cellulose (DAC) in the form of microfibre with the enzyme lysoamidase immobilized on it, characterized in that, in addition to the treatment layer, the dressing contains a hydrocolloid plate from Temposcrin (based on derivatives of acrylic acids), this microfiber is sprayed onto a non-woven layer of atraumatic material LN-0040, cover the material from above and below with a perforated film and fasten the bandage in a single design by sewing. 2. The method according to claim 1, characterized in that the oxidation state of the DAC is 6.0 ± 0.33%. 3. The method according to claim 1, characterized in that the content of lysoamidase is 4.8 mg per 1 g of carrier. 4. The method according to claim 1, characterized in that to give elasticity to the hydrocolloid plate per 24 g of Temposcrin, 12 ml (10.2 g) of an 85% glycerol solution are added. 5. The method according to claim 1, characterized in that the moisture content in the hydrocolloid plate is at least 6%. 6. The method according to claim 1, characterized in that the particle size of the microfiber is 40-80 microns.