RU2242987C1 - Hemostatic preparation - Google Patents

Abstract

FIELD: medicinal pharmacology.

SUBSTANCE: the present innovation deals with organic hemostatics applied for stopping capillary and mixed hemorrhages in case of traumatic skin lesions and those of muscular tissues in surgical practice. Hemostatic preparation consists of calcium alginate and wound-healing and antiseptic additives, such as plant extract of oak bark, dry extracts of plants, e-aminocaproic acid and chlorohexidine.

EFFECT: higher efficiency.

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Description

The invention relates to the field of medical pharmacology, in particular to organic hemostatic agents used to stop capillary and mixed bleeding with traumatic lesions of the skin and muscle tissue in surgical practice.

Analogues of a hemostatic drug are known: hemostatic and gelatin sponges (Guidelines for the use of blood and blood substitutes, Medicine, 1973). Fibrin films (adhesives), pastes, such as fibrin glue according to US Pat. the glue contains fibrin polymer. Also known is the domestic drug Algistab of the Omega company (Prospectus of the Omega company, Russia).

The disadvantages of the above drugs are complex compositions of drugs, expensive composition.

The closest accepted for the prototype is the domestic drug "Zhelplastan" (Copyright certificate of the Russian Federation No. 725289 from 07/31/1975).

The known preparation contains plasma of cattle, gelatin and the antibiotic kanamycin sulfate. It has a hemostatic effect, however, the active substances of the drug components are deactivated during the technological cycle, the blood plasma of cattle, introduced into its composition in the finished dosage form, practically does not affect the hemostatic properties of the drug. The antibacterial component does not work. The hemostatic properties of the drug are mainly determined by gelatin powder, which is structured in a certain way during technological processing, but at the same time becomes practically insoluble, which impairs its adhesive properties (especially at the first moment of use).

The purpose of this invention is the improvement of hemostatic, wound healing effect and the achievement of antiseptic action. A preparation is proposed, an organic hemostatic in powder form based on plant and synthetic components, which completely dissolves in the tissues of the body without harmful effects, is hypoallergenic, it does not contain viruses of pathogens of infections dangerous to humans, because the preparation uses only raw materials of plant origin and synthetic components. The hemostatic agent contains calcium alginate, dry phytoextracts: oak bark, yarrow grass, St. John's wort, horsetail grass, nettle leaves, epsilon-aminocaproic acid, chlorhexidine with a ratio of components, wt.%:

Calcium Alginate 68.4-73.4

Dry Oak Extract 16.5-21.5

Yarrow extract dry 1

Hypericum extract dry 1

Dry horsetail extract 1

Nettle dry extract 1

Epsilon-aminocaproic acid 6

Chlorhexidine 0.1

Calcium alginate is used as the basis of the drug and acts as a matrix for thrombosis. To increase the hemostatic properties, the extract of oak bark is added to the preparation, and to extract the wound healing, anti-inflammatory, antiseptic properties - extracts of herbs.

When the drug comes in contact with bleeding calcium alginate particles close the wound surface, taking its shape, without causing trauma to the surrounding tissues. They enhance normal thrombus formation, playing the role of a matrix around which blood clots form and platelets are captured. Calcium ions of the polysaccharide base activate the process of thrombosis. Due to the tannins that cover the base particles, there is an additional increase in thrombus formation and their adhesion to the wound surface, as well as between themselves. Having a large surface area and good sorption properties, the base powder is quickly impregnated with bleeding blood. In this case, the concentration of thrombogenic substances on their surface increases. Partial immobilization of the components of the drug with the polysaccharide base of the active substances reduces its toxicity and allergy, and also ensures their prolonged action.

Thus, oak bark extract causes direct coagulation of plasma proteins, which ensures rapid thrombogenesis and good adhesion of the base particles. It causes compaction of the surface layer of tissue of the wound surface with a decrease in its permeability due to non-specific physico-chemical changes in cell colloids and extracellular fluid. At the same time, a dense protective film is formed that protects the tissues from the effects of irritating substances, reducing pain, which contributes to the narrowing of the capillaries and the compaction of the vessel walls.

Epsilon-aminocaproic acid, being an inhibitor of fibrinolysis, ensures the stability of the thrombus formed, preventing its premature destruction by plasmin, and stabilizes the fibrin clot for a long period.

Chlorhexidine, being one of the most active local antiseptic agents, has a quick and strong bactericidal effect on the causative agents of major wound infections. It is stable after treating it with a wound and remains in it, continuing to have a bactericidal effect. Chlorhexidine remains active in the presence of blood. The introduction of an antiseptic component into the drug has become urgent, as it makes it possible to use the drug without prior antiseptic treatment of wounds, which is important in extreme and field conditions.

Extracts of yarrow, St. John's wort, horsetail and nettle activate reparative processes in the wound.

After applying the drug to the surface of the wound, its active components begin to dissolve in the bleeding blood and provide a hemostatic and wound healing effect.

The proposed drug is prepared as follows. Take calcium alginate powder in an amount of 68.4 g, add 6 g of aminocaproic acid diluted in 200 ml of chlorhexidine, a suspension of 21.5 g of dry extract of oak bark and 200 ml of ethyl alcohol 95%. From the resulting mixture on a rotary evaporator at a temperature of 105 ° C and with a residual pressure of up to 5 mm Hg the water-alcohol mixture is distilled off. The drying process should not exceed 4 hours. Dry extracts are mixed with the obtained semi-finished product: yarrow, St. John's wort, horsetail, nettle. The resulting brown powder is packaged in sealed bags of moisture-proof and light-tight material.

A number of works have been carried out (selection of a new drug base, selection of components, development of the technological process), which can significantly increase the hemostatic effect. When conducting a series of tests to determine the hemostatic activity of the drug, the time of hemostasis (s) was reduced by at least 30% compared with the norm (see table).

Thus, the proposed object allows to achieve a higher hemostatic and wound healing effect. All components of the hemostatic agent are available and manufactured in Russia. The technology for producing this hemostatic is simple, does not require the use of toxic substances, is implemented on small areas and uses few pieces of equipment, which significantly reduces the cost of the drug compared to domestic and foreign counterparts.

Claims (1)

Hemostatic agent containing wound healing and antiseptic additives and a base, characterized in that it contains calcium alginate as a base, dry extracts of oak bark, yarrow, St. John's wort, horsetail, nettle and optionally epsilon-aminocaproic acid and chlorhexidine in the following ratio components, wt.%: Calcium Alginate 68.4-73.4 Dry oak bark extract 16.5-21.5 Yarrow extract dry 1 Hypericum extract dry 1 Dry horsetail extract 1 Nettle dry extract 1 Epsilon-aminocaproic acid 6 Chlorhexidine 0.1