RU2131268C1 - Method of manufacturing dressing materials with therapeutic properties - Google Patents

Abstract

FIELD: medical materials. SUBSTANCE: invention relates to dressing materials for treating purulent and infected wounds, trophic wounds, and for preventing suppuration of infected wounds. Method enables reducing utilization of reagents, i.e. simplifies manufacturing dressing material with immobilized trypsin and insulin by way of activation of textile substrate followed by immobilization trypsin and insulin from 0.02 wt % trypsin solution in phosphate buffer with pH 4.9-5.5 and from insulin solution with activity 3.6-4.0 unit/ml and treatment modulus 2.5 for 1.5 h. EFFECT: simplified procedure. 1 tbl, 3 ex

Description

 The invention relates to medicine, specifically to a method for producing dressings for the treatment of purulent and infected wounds, trophic ulcers and for the prevention of suppuration of infected wounds.

 The prior art.

 A known method of producing a dressing, consisting in the fact that medical gauze is pre-oxidized with a sodium periodate solution to dialdehyde cellulose, then treated with a trypsin solution, washed and dried. The resulting material is impregnated with a 0.02% solution of furatsilina in distilled water (a. S. USSR N 1474917, class F 61 K 31/25, 1984). The resulting material has the following properties: accelerates the cleansing of the wound from pus; stimulates tissue granulation; leads to a reduction in treatment time.

 A disadvantage of the known material is the need for its use only under the supervision of a doctor, because in some patients, when using this material, allergic reactions were observed. In addition, the material is not effective enough in the treatment of patients with diabetes mellitus and does not have drainage properties.

 There is also known a method for producing a dressing material, consisting in the fact that a textile matrix — a fabric of poly-laproamide filaments — is activated with glutaraldehyde and treated with a solution of a proteolytic enzyme, for example, trypsin, with a mass ratio of the enzyme and substrate of 0.04 - 0.2: 99.96 - 98.8 (A.S. USSR N 1448441, class A 61 K 31/00, 1981).

 The use of the material can improve the treatment of purulent wounds, but not effective enough. In addition, the material is also not effective enough in the treatment of wounds in patients with diabetes mellitus, debilitated patients, in the treatment of trophic ulcers, and also does not have drainage properties.

 Known closest to the claimed method for producing dressings, including activation of a textile carrier, followed by treatment with a 0.05% solution of trypsin in phosphate buffer at pH 6.5 - 7.5 for 2 hours at module 5 - 6. The resulting material is squeezed , dried in air and subjected to treatment with an aqueous insulin solution with an activity of 4.0 - 4.4 u / ml (RF Patent N 2062113, CL A 61 L 15/38, publ. 06/20/96.).

 The resulting dressing material not only has prolonged necrolytic, anti-inflammatory, anti-toxic and draining properties, but also accelerates the elimination of wound infections, activates anabolic and regenerative processes in wounds, is traumatic, has a long shelf life and sterility and is convenient for mass use. However, the method of obtaining the material is time-consuming and requires a rather high consumption of expensive reagents - trypsin and insulin.

 The invention solves the problem of reducing the consumption of reagents, i.e. improving the efficiency of the method and simplifying the method of obtaining dressings with immobilized trypsin and insulin with high efficiency of the material in the treatment of purulent and infected wounds and trophic ulcers.

 Disclosure of the invention.

 The solution to this problem is achieved due to the fact that in a method for producing dressings with medicinal properties, including activation of a textile carrier with subsequent immobilization of trypsin and insulin, a trypsin solution with a concentration of 0.02 wt.% At pH 4.9-5 is prepared before immobilization 5 and an aqueous insulin solution with an activity of 3.6 - 4.0 u / ml, and immobilization is carried out with a module of 2.5 and an equal volume ratio of solutions for 1.5 hours.

The method is as follows:
First, the textile matrix is activated. If medical gauze is used as a matrix, activation is carried out by oxidizing gauze with an aqueous solution of sodium periodate at a concentration of 0.022 mol / L at room temperature in the dark for 18 hours to an oxidation state of 2%.

 If a polycaproamide knitted fabric is used as a matrix, activation is carried out by hydrolysis of a 2 N fabric. an aqueous solution of sodium hydroxide at room temperature for 20 hours, followed by washing and treatment with glutaraldehyde in carbonate buffer at pH 9.0 for 20 hours.

 Then a solution of trypsin in phosphate buffer is prepared at a pH of 4.9-5.5 with a concentration of 0.02% and a solution of insulin in water with an activity of 3.6-4.0 u / ml. After preparation, the solutions are mixed in equal volume ratios and a textile carrier is immediately placed in the resulting mixture. Processing is carried out with a module of 2.5 for 1.5 hours. Then the material is squeezed on rollers to a gain of 100%, incubated for 2 hours in ripening air and dried.

 Receive dressings with high therapeutic efficacy while reducing reagent consumption and reducing processing time.

 The best embodiment of the invention.

 The invention is illustrated by examples.

 Example 1

 Upon receipt of the dressing use medical gauze. First, gauze is activated by oxidation with sodium periodate to dialdehyde cellulose (DAC). The oxidation is carried out with a solution of sodium periodate with a concentration of 0.022 mol / L and at pH 5.5 at room temperature in the dark for 18 hours. The oxidized material is washed with distilled water and dried at room temperature. The ratio of the weight of the solution and gauze during oxidation is 5: 1. The oxidation state is 2%.

 Then prepare a solution of trypsin in phosphate buffer at a pH of 4.9 concentration of 0.02 wt. % and a solution of insulin in distilled water with an activity of 3.6 u / ml

 Immediately after preparation, the solutions are mixed in equal volume ratios and the oxidized cellulosic textile material is placed in the resulting mixture with a processing module of 2.5. Processing is carried out for 1.5 hours. Then the material is squeezed on a roll to a weight gain of 100%, incubated for 2 hours in air and dried.

 Data on the therapeutic activity of the obtained material are given in the table.

 Example 2

 Upon receipt of the dressing, an activated polycaproamide knitted fabric is used. Activation is carried out as follows. Polycaproamide knitted fabric is subjected to hydrolysis of 2 N. aqueous sodium hydroxide solution at room temperature for 20 hours. Processing module - 6. After hydrolysis, the material is washed with distilled water, activated with a 3% solution of glutaraldehyde in carbonate buffer at a pH of 9.0 - 11.0 for 20 hours. The activated material is washed from glutaraldehyde with distilled water.

 Further, the processing is carried out as in example 1, but a trypsin solution is prepared at a pH of 5.5, and an insulin solution with an activity of 4.0 u / ml

 Data on the therapeutic activity of the obtained material are given in the table.

 Example 3

 The activation of the textile material and the preparation of a medical dressing is carried out according to Example 2, but a trypsin solution is prepared at a pH of 5.2, and an insulin solution with an activity of 3.8 u / ml.

 Data on the therapeutic activity of the obtained material are given in the table.

 Industrial applicability.

 Medical tests of new dressings obtained in examples 1 to 3 were carried out in the clinic of the Department of General Surgery for 94 patients in the treatment of purulent-necrotic wounds and trophic ulcers.

 The tested napkins were moistened in a physiological solution of sodium chloride or a 0.5% solution of an antiseptic - chlorhexidine bigluconate - and after the toilet they were applied to a purulent wound or purulent cavities were loosely tamped. Dressing was changed after 1 - 2 days.

 Clinical observations and cytological studies have shown that new dressings containing trypsin and insulin contribute to the early subsidence of inflammation in the soft tissues, reduce purulent detectable, its transition to serous, accelerate the completion of phagocyton in wounds, more active proliferation of connective tissue cells - fibroblasts and thus contribute to the purification of purulent wounds and stimulate earlier formation of healthy, juicy granulations, filling the wounds with scar tissue and pitelizatsiyu. This makes it possible to impose early secondary sutures and reduce treatment time.

 The course of the first phase of the wound healing process using a binary textile dressing is reduced by 4-6 days compared with the traditional method of treating gauze moistened with a 10% solution of sodium chloride. So, on the 2nd - 3rd day of treatment with a binary napkin, the wounds cleansed from purulent necrotic masses and ended on the 3rd - 4th day, which made it possible to transfer to ointment dressings or to apply early secondary sutures. In the control group treated by the traditional method, the period of wound cleansing was 10-12 days.

 In the observed group, the appearance of granulations and epithelization accelerated by 1.5 - 2.0 times.

Claims (1)

 A method of producing dressings with medicinal properties, including activation of a textile carrier followed by immobilization of trypsin and insulin, characterized in that before immobilization a solution of trypsin with a concentration of 0.02 wt.% In phosphate buffer at pH 4.9-5.5 and aqueous insulin solution with an activity of 3.6 - 4.0 u / ml, and immobilization is carried out with a module of 2.5 and an equal volume ratio of solutions for 1.5 hours

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