RU2519026C2 - Topical combined hemostatic preparation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention represents a hemostatic preparation containing a complex of aminocaproic acid and ferric iron stabilised with sodium chloride in the isotonic concentration. The invention aims at wound healing, small hemostasis at administering the first medical aid at the pre-hospital emergency evacuation.

EFFECT: what is provided is preparing the preparation very soluble in water and possessing high hemostatic activity, low costs and extended storage period.

Description

The invention relates to the chemical and pharmaceutical industry and relates to the field of medicine for disasters and emergency pharmacy, is a hemostatic agent and is intended for treating wounds and stopping minor bleeding during first-aid medical care at the prehospital stage of evacuation of victims in an emergency. The specified drug can also find application in surgery, including military field, everyday life, etc.

It is known that hemostatic sponge is currently used to stop bleeding (patent RU 2198684 C1). It is a dry porous mass of yellow color with a slight smell of acetic acid, a soft elastic consistency, a good absorbent liquid, slightly swelling at the same time. The use of such a hemostatic sponge is effective, however, it requires fixing on the skin, which is not always relevant for minor bleeding, and in an emergency it requires additional time and labor.

A known drug for stopping bleeding using the synthetic polymer Feracryl (Annenkova VZ et al. New hemostatic polymer Feracryl and its interaction with plasma proteins. // Pharmaceutical Chemistry Journal. - 1982, No. 3, p. 66-69) .

Also known is a means having hemostatic and antiseptic properties, based on the iron-containing salt of polyacrylic acid with 1,4-di-N-oxide 2,3-bis- (oxymethyl) quinoxaline (RF patent No. 2132678). A common drawback of these drugs is that they are relatively expensive, and therefore their use in emergency situations when there is a massive flow of victims with minor bleeding is not economically viable.

The closest set of essential features to the claimed hemostatic agent is caprofer, a carbonyl complex of ferric iron and ε-aminocaproic acid, developed by the Institute of Fine Organic Chemistry in Armenia and produced by the Scientific Research Institute of Experimental Cardiology and Pharmacology (Samson, St. Petersburg). The medicine is available in dark glass bottles of 10 and 30 ml and requires storage in a dry, dark place. This form of release in glass materials is inconvenient when providing first aid, when deploying field hospitals to work in an emergency, since glass containers are highly fragile.

The technical result to which the claimed invention is directed is to increase hemostatic properties, ensure a low cost of treatment, increase the shelf life of the drug. An increase in the hemostatic properties of the drug based on a complex of aminocaproic acid and ferric iron is achieved by introducing sodium chloride into its composition, which increases the osmotic activity and the rate of penetration into the cell. Ensuring low cost, increasing shelf life is due to the creation of a new tablet form of the drug for the preparation of a solution for external use.

The specified technical result was achieved using ε-aminocaproic acid, iron chloride and sodium chloride in its composition in the following ratio of components:

Aminocaproic acid 1.5 g

Iron trichloride 0.6 g

Sodium chloride 0.27 g

When creating this combined hemostatic drug for external use, it was taken into account that aminocaproic acid is an inhibitor of fibrinolysis and is available as an injection solution, 1 ml of which contains 50 mg of aminocaproic acid.

Indications for its use are bleeding during surgical interventions on organs rich in fibrinolysis activators (lungs, thyroid gland, stomach, cervix, prostate gland).

Iron is contained in the hemoglobin of the blood, participates in hematopoiesis, its introduction into this drug leads to hemostatic properties and prevents anemia.

Sodium chloride creates an isotonic environment of the drug and improves penetration into blood cells, thereby improving hemostasis.

The finished dosage form of the drug is a tablet with an average weight of 2.4 g ± 5%. Apply topically, externally, in the form of an aqueous solution (1 tablet per 30 ml of water). Irrigate wounds and apply gauze dressings.

Indications for use are capillary bleeding with damage to the skin, bedsores, otitis media, nasal, from the sinuses of the dura mater, during dental interventions.

Obtaining hemostatic drug "Stopblad" local action for external use is as follows.

Powders of aminocaproic acid (per 100 tablets) 150 g, iron chloride 60 g, sodium chloride 27 g are loaded into the mixer, the mixture is thoroughly mixed in a blade type mixer until they are evenly distributed over the total weight. The resulting powder has optimal technological characteristics (flowability, compressibility, humidity, etc.), therefore, to obtain a tablet form (2.4 g each), the direct compression method under a pressure of 90-100 Pa was used.

To determine the quantitative content of the ingredients in the mixture, titrimetric methods were used. The quantitative content of the substances met the requirements of the State Pharmacopoeia of the Russian Federation XI edition.

Claims (1)

A hemostatic preparation for external use based on aminocaproic acid and iron trichloride, characterized in that sodium chloride is introduced into its composition, while the preparation has a tablet form for preparing a solution for external use in the following ratio of components:
Aminocaproic acid 1.5 g
Iron trichloride 0.6 g
Sodium chloride 0.27 g