RU2414909C2 - Medication "regenerin" for local treatment of purulent diseases of soft tissues and method of its obtaining - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to field of medicine, namely to chemical-pharmaceutical industry and, can be applied for treatment of local purulent diseases of soft tissues. In accordance with invention, as active substance, it contains mixture of calcium lactogluconate, calcium carbonate, sodium bicarbonate, benzocaine and saccharose with following component ratio, wt %: Calcium lactogluconate 16.0-65.0; Calcium carbonate 2.0-13.0; Sodium bicarbonate 1.0-3.0; Benzocaine 0.1-13.0; saccharose to 100.0. Method of clamed substance obtaining, consists in preliminary milling and grinding of upper said components and after that, mixing of milled components in proper upper said proportions until homogeneous powder is obtained.

EFFECT: medicine ensures high anti-microbial activity of components in wound, quick action and, as a result, 2-3 time increase of treatment efficiency in general.

2 cl, 2 ex

Description

The invention relates to medicine, namely to the pharmaceutical industry, and relates to a treatment for purulent wounds.

Purulent soft tissue diseases are common diseases in surgical departments, the treatment of which requires an integrated approach and high economic costs.

The closest drug to the prototype of the claimed method includes the tool "curiosin" in the form of a solution for external use ("GEDEON RICHTER", Hungary) [VIDAL HANDBOOK. Medicines in Russia: A Handbook. M .: AstraPharmService, 2004.1488 s; S: B-543]. The drug "curiosin" includes two active components: hyaluronic acid and zinc salt. Hyaluronic acid and zinc are naturally active substances that make up the body. Hyaluronic acid binds to water and protein molecules, thereby achieving the integrity of tissues, blood vessels, as well as elasticity and skin tone. Locally applied hyaluronic acid creates a microenvironment on the affected surface with optimal conditions for the physiological healing of the wound, while creating a matrix of hyaluronic acid - fibrin, which stimulates the activity of granulocytes; macrophages, fibroblast migration, the formation of microvessels and the process of wound epithelization. Zinc has its own therapeutic effect, which is enhanced by hyaluronic acid. Due to the bacteriostatic activity of zinc, the number of bacterial superinfection in the damage zone is reduced.

Despite the significant advantages of the prototype drug, it has several disadvantages, first of all, the antimicrobial activity of the drug is insufficient, in addition, the drug is easily washed off and does not fix well on the affected surface. Treatment with the drug lasts too long, on average 28 days, in connection with which the length of hospital days and the cost of treatment increase. Based on the foregoing, the prototype drug is characterized by insufficient activity against microbes and, in general, insufficient treatment effectiveness.

The objective of the present invention is to provide a means for the treatment of purulent diseases of soft tissues by selecting components, each of which has its own therapeutic effect and at the same time increases the influence of others, thereby increasing the effectiveness of treatment and shortening its duration.

The problem is solved in that the agent for the treatment of purulent diseases of soft tissues "regenerator" includes active substances based on three metal salts, local anesthetic and sucrose, according to the invention. The active substances of "regenerator" are a mixture of calcium lactogluconate, calcium carbonate, sodium bicarbonate, benzocaine and sucrose in the following ratio, wt.%:

calcium lactogluconate -16.0-65.0;

calcium carbonate -2.0-13.0;

sodium bicarbonate - 1.0-3.0;

benzocaine - 0.1-13.0;

sucrose - up to 100.0.

A method of obtaining the specified funds, which consists in pre-grinding and grinding the above components and then mixing the crushed components in the appropriate proportions of the above to obtain a homogeneous powder. The authors found that the component that determines the activity of the drug is calcium lactogluconate, which, by enhancing phagocytosis, contributes to a more complete cleansing of the wound and enhances the course of the protective process. Calcium carbonate is designed to maximize the neutralization of the acidic environment that occurs with a purulent wound or trophic ulcer, in other words, the introduction of carbonate enhances the action of the main active component. Sodium bicarbonate additionally adjusts the pH of the medium, which ensures the maximum effect of the above components. Benzocaine is a local anesthetic, thereby relieving pain. And, in the end, sucrose absorbs moisture from the wound, improves the energy of cells, which provides a favorable background for the overall effect on the processes that occur in the wound. In addition, sucrose is a filler for the active substances "regenerator" and thus regulates their concentration in the medical powder.

The quantitative content of each of the starting components of the “regenerin” agent, which is claimed, is determined by the fact that with a lower concentration the effectiveness of the therapeutic effect decreases, and with a higher concentration the effectiveness practically does not increase, but adverse reactions, in particular allergic and pain ones, can occur.

Since the amount of agent needed for treatment depends on the plane of the infected surface and the degree of infection, in each case, it is possible to create the optimal concentration of active ingredients, which is achieved by the selected quantitative interval for sucrose and other components.

The preparation of the “regenerated” product, which is claimed, consists in thoroughly rubbing each of the ingredients that make up its composition, and only after that thoroughly mixing these ingredients.

The invention is explained by an example of a specific implementation.

Example 1

Calcium lactogluconate in an amount of 6 g was mixed with 1 g of calcium carbonate, after which 0.3 g of sodium bicarbonate, 0.3 g of benzocaine and 0.7 g of sucrose were added with stirring. The resulting mixture was thoroughly mixed until a homogeneous powder. It should be noted that ingredients that were previously crushed and ground separately are used, i.e. homomorphic powders, which only after that are mixed in the appropriate quantitative proportions.

Example 2

The proposed tool "regeneration" is convenient to use, since the powder is well fixed on the wound. To identify the therapeutic effect of "regenerator" conducted an experimental study on animals with a model of purulent wounds. The experiments were conducted on 40 rats of the Wistar line, weight 180-220 g, males. Animals are divided into 4 groups, 10 in each. The first group: animals with a model of purulent wounds (untreated animals). The second group: animals with a model of purulent wounds + placebo (physiological saline). The third group: animals with a purulent wound model + prototype drug “curiosin” in the form of a solution for external use (“GEDEON RICHTER”, Hungary). The fourth group: animals with a model of purulent wounds + "regeneration". All work with animals was carried out in compliance with the ethical standards and rules for the treatment of animals [Guide for the Care and Use of Laboratory Animals, National Academy Press, Washington, D.C .: National Academy of Press, 1996. - 140 p.]. Purulent wound modeling was carried out according to standard and generally accepted methods. Animal operations were performed under ether anesthesia. The hair of the right sacral-femoral region was carefully cut, the skin was treated with ethanol and iodine. A sterile fascial skin flap with a diameter of 11 mm was excised with sterile instruments. A culture of Staphylococcus aureus strain 201189 at a dose of 1.5 109 cells in 0.5 ml of 0.85% sodium chloride solution was introduced into the muscles of the wound floor. Wound treatment was started on the sixth day, which corresponded to the maximum manifestation of the inflammatory process: the wounds were covered with a crust of the primary scab, during the removal of which in most cases a small amount of thick fetid pus was secreted, and the bottom of the wound was lined with gray tissue with separate sections of dull granulation tissue. Wound healing continued until complete healing. Powder "regenerated" uniformly thin layer was sprinkled on the wound surface three times a day. The drug "curiosin" was applied to the wound surface drip in an amount that provides uniform hydration, three times a day. In the “regenerated” group, on the 3rd day of treatment, all animals of this group significantly reduced tissue infiltration, while the wound surface cleared of purulent-necrotic masses. In the group of untreated animals, these changes appeared only on day 8-10. In the group of animals treated with “curiosin”, wound cleansing from purulent necrotic masses was observed on the 5-6th day of treatment. The period of complete healing of the wound in the group of animals treated with "regenerator" was about 14-16 days. In the group that received "curiosin" - 19-20 days, and in the group of untreated animals - 24-26 days. In the following terms, the method of contact lifetime microscopy revealed the following: the effect of "regenerator" leads to purification of the wound from purulent necrotic masses, stimulation of the development of granulation tissue, pronounced proliferation of fibroblasts, more active capillary neoplasm compared to the group of "curiosin" and to the group of untreated animals.

Thus, the proposed tool has a high treatment efficiency, which is expressed in the ability to fully clean the wound, enhance the action of the trophic factor, accelerate healing, and increase local immunity.

The tool "regenerator" is convenient to use, since the powder is well fixed on the wound.

Claims (2)

1. An agent for topical treatment of purulent diseases of soft tissues, which includes a complex of active substances based on metal salts, local anesthetic and sucrose, characterized in that the active substance includes a mixture of calcium lactogluconate, calcium carbonate, sodium bicarbonate, and sucrose in the following ratio of components, wt.%:
calcium lactogluconate 16.0-65.0 calcium carbonate 2.0-13.0 bicarbonate of soda 1.0-3.0 benzocaine 0.1-13.0 sucrose Up to 100.0 2. The method of obtaining funds according to claim 1, which consists in pre-grinding and grinding the components specified in claim 1, and then mixing the crushed components in the appropriate proportions indicated in claim 1, until a homogeneous powder is obtained.