BG60950B1 - Medicamentous form for wounds and skin impairments - Google Patents

Abstract

The medicamentous form is used in human medicine for the treatment or large skin impairments as a result of burns and for the treatment of atrophic inflammatory processes of different etiology. The medicamentous form contains, in wt.%: mixture of sodium salt of transport RNA of bread yeasts with molecular weight from 4 to 5 Svedberg units and sodium salt of DNA of bovine thymus having molecular weight from 18 to 20 Svedberg units in ratio from 1.5:1 to 2.5:1. The medicametous form can be 0.2-0.3% solution or gel based on hydrophiline vehiculum.

Description

The invention relates to the manufacture of topical agents for the treatment and treatment of wounds, in particular for the topical application of extensive skin damage from burns, as well as for the treatment of atrophic inflammatory processes of different etiology.

BACKGROUND OF THE INVENTION

It is known that difficult to heal wounds of different etiology are a big problem in all areas of surgery. Generally, delayed regenerative processes are due to poor trophy for both primary causes and complications in the course of the disease, for example due to prolonged exposure to radiation, extensive burns and injuries.

Over the last two to three decades, a number of preparations have been developed and applied in clinical medicine that, to varying degrees, affect the healing of the wound from necrosis and the leukocyte necrotic layer. Such preparations are the various antiseptic agents, for example the hypertonic solution of sodium chloride and the hypertonic solutions of other chemicals (1). These preparations are also used for irrigation and irrigation dressings and cannot be retained on the treated surface of the body on its own for a long period of time. Another well-known preparation used for burns, trophic ulcers and slow healing wounds is the preparation Vinisol in aerosol form containing vinyl, linetol, citral and propellant (1).

An enzymatic treatment is applied to prepare wounds for skin plastic recovery. One of the good preparations for this purpose used in practice (1) is the Fibrolan preparation containing deoxyribonuclease. This preparation cleanses the wound and in most cases promotes healing.

Balsam liniment is known, the so-called Vishnevsky ointment containing birch tar, due to its antimicrobial, keratilitic and keratoplastic action / 1 /.

These and other known preparations have a surface effect on the wound substrate and have a predominantly cleansing effect. Good wound cleaning, necrosis removal, and antiseptic assurance are prerequisites for the epithelialization and granulation process, but it is also necessary to administer preparations that can last effectively for a long time on the surface and stimulate epithelialization and granulation. In this direction are attempts to administer nucleic acids for the treatment of wounds of different nature. Extremely experimental data show that RNA and DNA affect the regenerative processes of many organs and tissues.

A DNA-based preparation (2) is known, comprising native DNA 2000 / ml from 12.5 to 50 g and a hydrophilic vehicle up to 100 g, which has been tested mainly in radiodermatitis, in which it shows an epithelialization-stimulating effect as compared to other epithelialization preparations occur 15-20 days earlier.

SUMMARY OF THE INVENTION

The problems to be solved by the invention relate to the creation, under slow healing wounds and extensive burns, of conditions for epithelialization to cover superficial lesions and for the formation of a granulation shaft for deeper tissue and subcutaneous tissue destruction. Another problem is the creation of a form of topical administration of the drug that solves the clinical problem, which form provides effective long-term retention on the area of the body and easy and atraumatic removal after the impact, while stable, without undesirable side effects.

According to the invention, a dosage form is prepared which comprises a mixture of sodium RNA (ribonucleic acid) transport salt of bread yeast with a molecular weight of 4 to 5 Sberberg units and sodium salt of DNA (deoxyribonucleic k2 selenium) of calf thymus with a molecular weight of 18 up to 20 sweden units, with components ranging from 1.5: 1 to 2.5: 1. The dosage form of the invention may be 0.2 to 0.3% solution of the mixture in 0.9% sodium chloride solution. The dosage form of the invention may be a hydrophilic vehicle based gel form comprising a 0.2 to 0.3% solution of the active ingredient mixture.

The dosage forms are prepared by dissolving the active ingredients individually in saline-0.9% sodium chloride solution, and the two solutions are mixed. To obtain the gel form, the resulting solution is mixed with a pharmaceutically acceptable hydrophilic gel carrier, and the resulting forms are sterilized.

The dosage form of the invention has a high therapeutic effect in the treatment of post-radiation injury, thermal burn injuries, in the treatment of atrophic inflammatory processes such as gingivitis, stomatitis, in the treatment of acute and chronic pharyngitis and atrophic rhinitis. This effect is mainly due to the basic property of accelerating the growth and maturation of granulation tissue and stimulating the proliferation of the epidermis. The agent is non-toxic, virtually no adverse side effects, allergic reactions, and others.

It has been found that a higher epithelialization and granulation shortening effect occurs at ratios between the active ingredients in which the RNA is in greater quantity and the effect is optimally high at the proposed ratios according to the invention, compared to the effect of the active ingredients taken alone or in a 1: 1 ratio.

Examples of carrying out the invention

EXAMPLE FOR PREPARATION

The RNA used in the agent according to the invention is 4 _s of bread yeast RNA in the form of a sodium salt with a molecular weight of about 31,000 daltons (5sberg units).

The DNA used in the agent of the invention is 20 _s of calf thymus DNA in the form of a sodium salt with a molecular weight of 18-20 Sberberg units.

1. Preparation of solution. The calculated amounts of the active ingredients are dissolved in 0.9% saline, the mixture is cooled to about 4C and sterilized.

2. Gel preparation. A stylized hydrophilic gel-forming agent was added to the solution.

Experimental data on the effect of the agent were obtained from experiments with rabbits. Healing of slit wounds is accelerated after administration of the agent of the invention compared to control (untreated) animals for 5 to 8 days. The effect was also tested on a model of dry skin burn (P-W grade). The agent accelerates the growth and maturation of granulation tissue and stimulates the proliferation of the epidermis.

Toxicological studies have shown that the agent is non-toxic and has no teratogenic or mutagenic effect on warm-blooded animals.

No allergic reactions are observed. With prolonged local use on the mucous membranes (for more than a month without interruption), mucous membrane drying is sometimes observed.

The agent has been clinically tested on 73 patients with wounds of different etiology.

The test results prove that the proposed remedy has broad indications of wounds in which regenerative processes are delayed or missing, with wounds requiring maximum skin graft coverage as quickly as possible. It significantly shortens the preoperative local preparation, and in radiation burns it is possible for the local treatment with the proposed agent to be taken as a routine method of treatment.

Claims (3)

Claims A wound and skin lesion formulation comprising a mixture of sodium salt of bread yeast transport RNA with a molecular weight of 4 to 5 Sberberg units and a sodium thymus DNA salt of a molecular weight of 18 to 20 Sberberg units, the components being in the ratio of 1.5: 1 to 2.5: 1. A dosage form according to claim 1, characterized in that it represents a 0.2 - 0.3% solution of the mixture in 0.9% sodium chloride solution. A dosage form according to claim 1, characterized in that it is a gel form based on a hydrophilic vehicle comprising a 0.2-0.3% solution of the mixture of active ingredients.