WO2014062080A1 - Medicated wound-healing aid for treating wounds and burns - Google Patents

Abstract

The therapeutically effective, medicated wound-healing aid for wounds and burns relates to medicine and can be used in the production of medicated remedies which stimulate the healing of wounds and burns of diverse etiology. The aid for wounds and burns comprises an absorbent material constituting a nonwoven perforated material impregnated by a medicament which constitutes a gel-like mixture of boric acid, hydroxypropylmethyl cellulose, lidocaine hydrochloride and purified water, with the following ratio of components: 0.001-20.0% by mass of boric acid, 0.001-10.0% by mass of hydroxypropylmethyl cellulose, 0.001-10.0% by mass of lidocaine hydrochloride, with the remainder being purified water. The aid additionally comprises 0.0001-1.0% by mass of betamethasone, or recombinant interferon selected from the group: alpha, beta or gamma recombinant interferon in an amount of 100-1000000 ME, or heparin in an amount of 10-100000 ME. The aid is in the form of medicated wipes, bandages or applied patches applications.

Description

 WELL HEALING MEDICINE FOR

 TREATMENT OF RAS AND BURNS

Application area

 The invention relates to the medical industry, and can be used in the manufacture of medical drugs that stimulate the healing of wounds and burns of various etiologies and consisting of absorbent material impregnated with drugs.

 State of the art

 Currently, various types of absorbent medical devices are known in the form of medical napkins, dressings, application plates containing gel-forming, protective and other layers that are convenient to use and have prophylactic and therapeutic functions.

 The prior art currently known non-woven material used in the form of products designed to collect the secretions of the human body, in particular disposable diapers, treated with a linear polymer biguanide to eliminate bacterial activity. (EP application 0174128, class A 61 L 15/00, publ. 12.03.86).

Antimicrobial dressings Neotulle from Fisons (Germany) and Sofratulle from A. Roussel (Germany) are known, which are sterile wipes on a woven mesh substrate, impregnated with neomycin or framycetin ointment (synonymous with neomycin) based on petrolatum or white solid paraffin in combination with lanolin (Martal the Extra Pharmacopoeia, London, 1978, v. 27, p. 1159). However, these wipes contain the antibiotic neomycin, which has high ototoxicity and nephrotoxicity and is not active against infections caused by resistant gram-negative microorganisms.

 The disadvantage of Neotulle and Sofratulle antimicrobial dressings is that they do not contain a biologically active component that accelerates reparative processes in the wound.

 A three-layer gauze napkin giaplus-containing on a woven mesh basis is known, impregnated with a biologically active component - hyaluronic acid, which stimulates regenerative processes in the wound (TU 9358-004-12466809-96). However, the disadvantage of this dressing is the lack of the necessary therapeutic effect, since the napkin does not contain antimicrobial substances. In addition, the napkin cannot be used on wounds with a large surface, as it is limited by size.

 Known gauze impregnated with sanguiritrin, an antimicrobial substance of plant origin and with a wide spectrum of antimicrobial activity. However, the napkin does not contain biostimulants of regenerative processes in the wound (TU TU 0.009.295.108,

Joint venture "Khoros", Russia-Sweden).

 Known antimicrobial dressing for the treatment of purulent wounds, which is a sterile napkin on a knitted mesh substrate of an open-cell structure, impregnated with 0.1% gentamicin ointment (Abstracts of the 1st All-Union Conference

"Modern approaches to the development of effective dressings and suture materials." M .: AMS, Institute of Surgery. A.V. Vishnevsky,

1989, p. 106-107, article by Kagan EZ, Sinitsyna N.I., Mining SV. and others. "The effectiveness of the treatment of purulent wounds using antimicrobial ointment dressings on a mesh substrate").

Gentamicin sulfate is an aminoglycoside antibiotic of the second generation with a wide spectrum of antibacterial action, active with mixed infection and against Pseudomonas aeruginosa, resistance to it develops slowly.

 However, this form of dressing, even with an antibiotic such as gentamicin sulfate, does not meet the requirements of surgical practice, since there is no biostimulating component, and the hydrophobic base of the ointment reduces the rate of wetting of the dressing with wound exudate, which reduces the drainage properties of the dressing.

 The closest technical solution to the claimed invention is a wound healing preparation and a surgical wound healing wipe (RU JN ° 21 14639 C1, A61L 15/44, 1998). The wound healing preparation contains an antibacterial agent and a biostimulant, glycerin and purified water and is made in the form of a hydrophilic composition containing gentamicin sulfate as an antibacterial agent, a collagen-containing extract as a biostimulator, in the following ratio, wt.%:

 Gentamicin sulfate - 0.5 - 0.7 (in terms of the active substance) Collagen-containing extract - 43 - 58

 Glycerin - 4.5 - 5.3

 Purified water - 36 - 52.

 A wound healing napkin is made on a woven mesh basis, impregnated with a medicinal product, which is a composition comprising components in the above ratio.

 However, this tool is not always effective in the treatment of infected wounds, is not able to relieve pain and does not have a hemostatic effect and insufficient shelf life.

 Disclosure of invention

The objective of the invention is the creation of funds with antimicrobial, analgesic, hemostatic properties and stimulating healing of wounds and burns of various etiologies.

 The technical result of the invention is to increase the therapeutic effectiveness of the treatment of wounds and burns of various etiologies, accelerate the healing of wounds and burns, relieve pain, cleanse the wound surface from pus and create conditions for tissue epithelization.

 To achieve this result, a wound healing medicine for wounds and burns with a therapeutic effect, comprising an absorbent material impregnated with a drug according to the invention, the absorbent material is a non-woven perforated material, and as a medicine it contains a gel-like mixture of boric acid, hydroxypropyl methylcellulose, lidocaine hydrochloride and purified water in the following ratio of components in wt.%:

 boric acid 0.001 - 20.0

 hydroxypropyl methyl cellulose 0.001 - 10.0

 lidocaine hydrochloride 0.001 - 10.0

 purified water the rest.

 In addition, the tool additionally contains betamethasone in an amount of 0.0001 - 1, 0. And also it additionally contains recombinant interferon selected from the group: alpha, beta, gamma recombinant interferon in an amount of 100-100000000 ME.

and heparin in an amount of 10-100000 ME. In this case, the tool can be made in the form of drops, solution, gel, medical napkins, dressings, wafer applications.

 The invention is illustrated by the following examples.

 Example 1

Non-woven perforated material in the form of napkins or dressings, or plate-applications made of cotton fibers, impregnated with a medicinal product containing a gel-mixed mixture of boric acid, hydroxypropyl methylcellulose, lidocaine hydrochloride and purified water. These components are taken in the following ratio in wt.%:

 Options: 1 2 3 4 5 boric acid 0.001 0, 1 2.0 10.0 20.0 hydroxypropyl methylcellulose 10.0 5.0 1.0 0.1 0.001 lidocaine hydrochloride 0.001 0.1 1, 0 5.0 10.0 purified water the rest is up to 100.

Example 2

 Carried out analogously to example 1. Except that in the composition of the medicinal product for the impregnation of cotton non-woven material, betamethasone is additionally added in an amount of 0.0001 - 1.0 wt.%.

 Example 3

 Carried out analogously to example 1. With the exception that the composition of the medicinal product for the impregnation of cotton non-woven material, additionally introduce recombinant interferon selected from the group: alpha, beta, gamma recombinant interferon in an amount of 100-100000000 ME.

 Example 4

Carried out analogously to example 1. Except that in the composition of the medicinal product for the impregnation of cotton non-woven material, heparin is additionally introduced in an amount of 10-100000 ME. Industrial applicability

 The claimed tool actively sorb microbial bodies, chemicals, has a therapeutic effect, the use of the drug is recommended in the treatment of burn wounds, trophic ulcers, fistulas and purulent wounds, where productive processes are predominant, accompanied by profuse purulent discharge and tissue necrosis.

 Due to its high hygroscopicity, the drug adsorbs wound compartments, prevents the absorption of toxic substances into the blood and helps to reduce the treatment time.

 The tool is applied to the wound and worn for 2-12 hours, depending on the amount of wound discharge. The multiplicity of dressings is unlimited, either until the wound is completely cleaned and subsequent plastic surgery or by the application of secondary sutures, or until the wound is completely epithelized.

 Volunteer patients who applied to medical institutions for wounds and burns of various etiologies were proposed to use the claimed wound healing agent. The observation was carried out on 100 patients. Of these, no one had a relapse of the disease, and the recovery time was reduced by 3-4 days compared with the prototype.

 A biomedical study of wound healing wipes was carried out on white outbred rats. Napkins impregnated with the claimed mixture of the drug were applied to standard full-layer wounds with a generalization of the infectious process. Observations of the clinical picture of the development of the lesion and purification of purulent wounds showed that wound healing accelerated by 15-20% in all phases of the wound process, i.e. occurred 4-5 days earlier than when using the prototype dressings.

Microbiological and histological studies showed that when using a wound healing agent, distinct morphological signs appear already on the 3rd day (reduction of signs of inflammation - swelling of tissues, degree of leukocyte infiltration, etc.) of maturation granulation tissue and the appearance of regional, islet epithelization. The amount of wound contraction / day is 7.37% of the initial value of the wound; by the 7th day there is a decrease in microbial contamination of the wound below the "critical". The wound process of the prototype is characterized by a more protracted course and the appearance of squamous cells only by the 11th day.

 Toxicological tests of a wound healing agent and clinical trials for 200 patients of various ages and sexes with various purulent-inflammatory diseases of the skin and soft tissues and with clean postoperative wounds were carried out.

 Clinical observations have shown that when using a wound healing agent, the treatment of wounds and burns is more effective, which ensures positive dynamics of the course of the wound process in all its periods.

 Granulation tissue maturation occurs even in conditions of incomplete cleansing of pathological microflora of the wound. The total effect of the use of known techniques, namely: the use of the claimed means, with a different percentage of components within the prescribed limits, for the treatment of purulent wounds and burns was significantly higher than the expected effect, as evidenced by the results of a clinical study, reducing the number of dressings.

Claims

Claim  1. Wound healing medicine for wounds and burns with a therapeutic effect, including absorbent material impregnated with a medicinal product, characterized in that the absorbent material is a non-woven perforated material, and as a medicine it contains a gel-like mixture of boric acid, hydroxypropyl methylcellulose, lidocaine hydrochloride and purified water in the following ratio of components in wt.%:  boric acid 0.001 - 20.0  hydroxypropyl methyl cellulose 0.001 - 10.0  lidocaine hydrochloride 0.001 - 10.0  purified water the rest.  2. The tool according to claim 1, characterized in that it additionally contains betamethasone in an amount of 0.0001 - 1, 0  3. The tool according to claim 1, characterized in that it further comprises recombinant interferon selected from the group: alpha, beta, gamma recombinant interferon in an amount of 100-100000000 ME.  4. The tool according to claim 1, characterized in that it further comprises heparin in an amount of 10-100000 ME.  5. The tool according to claim 1, characterized in that it is made in the form of drops, solution, gel, medical napkins, dressings, wafers.