Haemostatic agent

FIELD: medicine.

SUBSTANCE: invention relates to medicine and veterinary and is intended for the acceleration of stopping bleeding in case of injury to blood vessels in traumas and wounds. A haemostatic agent contains 3-20 wt % of a polysaccharide, where the polysaccharide is represented by chitosan and/or starch, 0.1-2 wt % of calcium chloride and a 0.5-5% water solution of succinic or hydrochloric acid - the remaining part.

EFFECT: accelerating the initiation of the thrombus-forming process and enhancement of the regenerative ability of tissues in the area of wounds of different aetiology.

1 tbl, 14 ex

 

The present invention relates to the field of medicine and veterinary medicine and can be used for rapid hemostatic effect in the provision of emergency medical care and self-help in emergency situations (armed conflicts, catastrophes, natural disasters), industrial, household trauma, etc.

Known hemostatic drug for the treatment of wounds of warm-blooded mammals (patent US No. 4822349, IPC A61F 13/02, A61L 15/18, publ. 18.04.1989 G.), in which the zeolite is prepared in the binder - clay, and is applied directly to the wound. But there is a strong exothermic effect, resulting in strong thermal burn tissues.

Also known hemostatic material (application US No. 20050074505, IPC 7 AC 33/06, publ. 07.04.2005). It is a composition consisting of binders based on clay and zeolite placed in a binder, wherein the zeolite has adjusted the calcium content is from 75% by weight. up to 83% by weight., which is produced by adding a calcium compound to the source zeolite, wherein calculaterate compound selected from the group consisting of calcium oxide, calcium sulphates and chlorides of calcium. This material has the following disadvantages: very high calcium concentration, significantly exceeding the best - 0,8-1,75 mmol/l (D. M. Tooth�the moat. Biochemistry of blood coagulation. - M.: Medicine. - 1978), which reduces the clotting. This solid composition, and if it enters an open wound of the oxides and chlorides of calcium possible chemical burns to tissues. The hardened mass traumatize the wound edges when removing it from the wound, and when the position of the injured area.

Also known selected as a prototype hemostatic drug (application 2007114557/15, publ. 17.04.2007) on the basis of zeolite, comprising a compound of calcium, according to the proposed solution contains as compounds of calcium ground calcium carbonate and boehmite nanoparticles and the polysaccharide and/or lignin in the following ratio of components, wt.%:

Nanoparticles of boehmite20-40
Ground calcium carbonate5-10
The polysaccharide and/or lignin10-20
Zeoliteelse

This drug has the following disadvantages: there is no antiseptic effect when applied into the wound, the drug is time-consuming to manufacture, solid composition partially in contact with wound surface, there is a thermal eff�CT when applied to the wound, ground calcium carbonate (PR=3.8·10-9) is practically insoluble in water.

The technical task of the invention is the creation of the drug, quickly stopping the blood, ensuring full contact with the wound or enveloping her without causing pain. The drug must be possible the introduction of antiseptic and antinociceptive components to extend its medical action.

The challenge is the fact that in hemostatic drug containing polysaccharide, inputs of one or more water-soluble hemostatic agents (eg, calcium chloride), organic or inorganic acid, distilled water, with the following ratio of components, wt.%:

Polysaccharide0,5-20%
Hemostatic additive0.01 to 2%
Organic or inorganic acid0.5 to 6%
Distilled waterelse

When creating the drug was analyzed available literature data on the mechanism of thrombosis in the body. The process swertia�I blood is a cascade of enzymatic reactions, in which proenzymes (predecessors), transitioning to the active state, is able to activate other coagulation factors (human Physiology / ed Pokrovsky V. M., Korotko G. F. - M.: Medicine - 1997 - T1 - 448 p.). In the basis of blood coagulation is the conversion of the soluble plasma protein fibrinogen into the insoluble protein fibrin. Among the agents of the process are calcium ions and prothrombin. This plasma protein is produced in the liver, and its formation requires vitamin K. the Process cannot begin without another component - thromboplastin - protein-phospholipid fragment of the membranes of platelets, cells of the vascular wall, collapsing in bleeding. In the presence of calcium ions and thromboplastin and prothrombinase prothrombin is converted to thrombin, which converts the soluble protein fibrinogen into insoluble fibrin. Important role in the mechanism of cessation of bleeding platelets play. Until the vessels are damaged, platelets adhere to vessel walls, but in violation of their integrity or the appearance of abnormal roughness they settle on damaged surfaces, stick together with each other and release substances that stimulate blood clotting. This forms a blood clot, which is when growth turns into a clot.

It is necessary to clarify the ro�ü calcium ions.

1. Calcium ions are necessary for giving the native conformation of coagulation factors, after which the latter are able to participate in enzymatic reactions of hemostasis.

2. Calcium ions act as bridges between the protein components and cell membranes. These calcium bridges there is an initial orientation of coagulation factors on phospholipid matrix, and as a result the conformation of protein molecules open active centers.

In this hemostatic product feature matrix - a kind of analogue of the lipid bilayer membrane of blood cells and their fragments thromboplastin - performs chitosan. Chitosan is non-toxic biocompatible component, is able to dissolve in the biological environment. It acts as energy and plastic material during epithelization of the wound. During application of the drug after stop bleeding on a wound film is formed, enveloping the wound. It is breathable and transmits ultraviolet (additional disinfecting effect), does not require removal and replacement, promotes the flow of exudate from the wound.

The experiments in vitro and in vivo, during which the maximum effectiveness of the drug when the content of calcium ions from 0.01-1 wt. % and the polysaccharide is 0.5-20 wt. %. The content of organic�tion or inorganic acid should not exceed 5 wt. % to ensure the pH of the drug close to the pH value of the skin.

The ability to perform hemostatic drug in the form of films, gels, sponges or foam of different densities is achieved by introducing an additional crosslinking agent and foaming agent.

You can enhance the hemostatic properties of the drug by the introduction of antiseptic and antinociceptive dobavkok, providing additional bactericidal and analgesic effect.

The production of this drug is not harmful to the environment, production costs are low (simple non-energy-intensive technology, a large number of raw materials). This drug has no side effects, does not cause allergies and has healing and antiseptic effect.

The proposed hemostatic drug has the following effects:

1. Stimulates the regeneration of tissue in the wound area.

2. Calcium ions during their adsorption on polysaccharide accelerate the start of the process of thrombosis. Blood clots within 20-40 C.

3. The polysaccharide chitosan provides anti-inflammatory, antiviral effect and easy analgesic effect.

4. The drug provides a tight contact with the wound and gently wraps the wound.

5. For drugs having good adhesion to the tissues and congruence with wound surface

6. The drug does not cause allergic reactions.

7. The drug does not cause painful sensations.

8. No exothermic effect in contact with the wound.

9. Perhaps the introduction of antiseptic components for additional bactericidal effect.

10. Perhaps the introduction antinociceptive components for additional analgesic effect.

11. The drug is not toxic.

The technical result from the use of the invention is to accelerate the start of the process of clot formation and strengthening of regenerative capacity of tissues in the field of various etiologies due to the introduction in the drug-containing polysaccharide, water-soluble hemostatic products.

Below are examples of specific tests.

The test samples obtained hemostatic drug was conducted in the laboratory on experimental animals.

For experience took 10 nonlinear rats, 5 of them intact (normal) and 5 experienced. All animals were dissected skin flap left thigh about the size of 2×2 cm, exposing the femoral vein, and made a neat incision, after which the wounds of experimental animals was applied hemostatic drug composition No. 1-14. In intact rats the blood clot within 90-120 seconds, while subjects under the influence of the drug within 40 CE�und. Caused product film formed on the wounds. Further observation of the experimental animals showed that wounds treated with the drug, formation of epithelial cover was twice as fast and without infection.

The hemostatic compositions of the preparation:

Hemostatic drug containing 3-20 wt%. polysaccharide, where the polysaccharide represented by the chitosan and/or starch, 0.1 to 2 wt%. calcium chloride and 0.5-5% aqueous solution of succinic acid or hydrochloric acid - the rest.



 

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