SU700129A1 - Method of obtaining hemostatic diseases - Google Patents

Description

one

The invention relates to the field of medicine, in particular to methods for the preparation of hemostatic preparations from donor blood.

A known method of obtaining a hemostatic sponge by coagulating native donor plasma, foaming the mixture, freeze-drying and sterilization 1.

However, the raw material base, necessary for the implementation of this method, is limited, and the resulting sponge has low activity.

The aim of the invention is to expand the raw material base and increase the activity of the sponge.

This goal is achieved by using the III fraction of plasma proteins, which is mixed with cooled pyrogen-free water, to suspend the mixture, adjust the pH to 6.9 + 0.05 and add a solution of calcium chloride and aminocaproic acid.

The method for preparing the hemostatic sponge is as follows.

One part of sediment A of fraction III (prothrombin) and 3 parts of sediment 5 (α-globulins and other proteins) of fraction III are combined and suspended in pyrogen-cooled water at 0 ° C at a ratio of 1: 3. The pH is adjusted to 6.9 + 0.05. Next, the suspension is poured into 10 ml vials. A ratvor containing 0.05 g of calcium chloride and 0.2 g of aminocaproic acid in 1 ml of pyrogen-free Voy is prepared. 1 ml solution of calcium chloride with aminocaproic acid is added to the suspension vials. After clotting, the vials are placed in carbon dioxide for 2 hours or in a refrigerated cabinet at -50 ° C for 5 hours. The products are freeze dried, sterilized, and the product is packaged.

Claims (2)

Example 1. The precipitate of fraction III of donor plasma proteins, separated in the process of total alcohol fractionation into prothrombin (precipitate A) and -globulins and other proteins (precipitate B), is combined in a 1: 3 ratio and suspended in pyrogen-free water at a ratio of 1: 3 . 140 g of sediment N ° 1 + 420 g of sediment No. 2 are suspended in 1 l of 680 ml of water, the pH is adjusted to 1 n. NaOH up to 6.9 + 0.05; the mixture is heated to (-Y8) - (+ 20) ° C and poured into 10 ml vials with a capacity of 50 ml. To each vial is added 1 ml of a previously prepared solution containing 0.05 g of calcium chloride and 0.2 g of aminocaproic acid dissolved in 1 ml of apyroheic water. The mixture is agitated by shaking the vials, sealed with the vials and allowed to stand at room temperature until a clot forms. Then the vials with the product is frozen and freeze dried. After drying, the bottles are sealed, rolled up with metal caps and sterilized in a drying cabinet for 1 hour at + 120 ° C. Cooled vials are poured with Unna paste or metallex, labeled and subjected to all types of control according to FS 42-434-72. The properties of the resulting hemostatic sponge are as follows: coagulation activity of 19 s; antifibrinolytic activity 150 min; compressed moisture 0.7%. Example 2. Sediment of P1 fraction of donor plasma proteins, isolated in the process of total alcohol fractionation, upon receipt of antistaphylococcal gammaglobulin as prothrombin (precipitate A) and p-globulins and other proteins (precipitate B), in a ratio of 1: 3 are combined and suspended in apyrohepic water at the rate of 1: 3. 200 g of sediment No. 1 -f 600 g of sediment No. 2 -f 2400 ml of water. The rest of the process is carried out as in Example 1. The properties of the obtained hemostatic sponge: coagulation activity 18 s; antifibrinolytic activity 150 min; residual moisture 0.7%; The titer of a-antistaphyllolysins 65 ME. Thus, the advantage of the inventive method is an increase in the hemostatic activity of the target product due to coagulation of suspension P1 of plasma protein fraction with calcium chloride with aminocaproic acid, which is a powerful inhibitor of fibrinolysis, and due to use of 1P fraction remaining during the preparation of antistaphylococcal gamma globulin, which greatly expands the range of application of the target product. The results of studies of 10 series of hemostatic sponge obtained by the proposed method are as follows: Coagulation activity, from 18-29 Anti-friyolysis activity, min 90-150 Residual moisture,% 0,25-0,75 Titer a-antistaphylyolysins (depending on the titer in the original plasma), ME 50-70 The coagulation activity of a sponge obtained in a known manner is 40-95 s, antifibrinolytic activity is 30- 45 minutes. In the course of 18 months of storage at room temperature, the sponge obtained by the inventive method retains its activity. The absence of a hemostatic sponge in the technological process of the proposed method of thromboplastin makes it possible to consider the target product harmless in relation to allergic reactions with repeated use of large doses. The invention of the method of obtaining a hemostatic sponge by coagulating the positive donor plasma, foaming the mixture, lyophilization, sterilization, characterized in that, in order to expand the raw material base and increase the activity of the sponge, a fraction of plasma proteins that is mixed with cooled pyrogen-free water is used as a source of raw material The mixture is suspended, the RP is adjusted to 6.9 + 0.05, and a solution of calcium chloride and aminocaproic acid is added. Sources of information taken into account during the examination 1. USSR Author's Certificate No. 83093, cl. A 61 K 35/16, 1949,