A kind of method and application thereof for preparing cryoprecipitate

Abstract

The invention provides a cryoprecipitate preparation method comprising the following steps: (1) healthy human plasma cryopreserved at a temperature of -20 DEG C is fetched; the temperature of the plasma is increased to -15 DEG C to -5 DEG C within 24h; (2) under a circulation water condition with a temperature no higher than 37 DEG C, the plasma is completely molten; (3) the temperature of the plasma is controlled at -2 DEG C to 5 DEG C, and the plasma is allowed to stand for 3-9h; and (4) centrifugation is carried out, such that cryoprecipitate is obtained. As a result of comparative tests, it is proved that human coagulation factor VIII prepared with the cryoprecipitate provided by the invention has a specific activity approximately 4 times as much as that of human coagulation factor VIII with a common cryoprecipitate as a raw material. The specific activity is much higher than a standard of 1IU / mg specified by Chinese Pharmacopoeia. It is known in the art that human coagulation factor VIII is expensive. With the greatly increased specific activity, economic benefit can be greatly improved. The method has good industrial application prospect.

Description

technical field [0001] The invention relates to a preparation process of blood products, in particular to a method for preparing cryoprecipitate with high specific activity and the application of the cryoprecipitate in the production of human blood coagulation factor VIII. Background technique [0002] Cryoprecipitate is a blood component prepared from fresh frozen plasma. It is a white cryoprecipitate that remains after fresh frozen plasma (FFP) melts at 4°C. It mainly contains factor VIII, fibrinogen, and von Willebrand factor (VWF). ), factor XIII, fibronectin and other components are the raw materials for the preparation of human blood coagulation factor VIII preparations. [0003] There are two existing methods for preparing cryoprecipitate from plasma: rapid thaw centrifugation and siphon method. Because the content of human coagulation factor VIII in the cryoprecipitate prepared by the siphon method is low, the industry usually adopts the rapid melting centrifugation...

AI Technical Summary

Problems solved by technology

[0005] The idea of ​​this improvement is to shorten the melting time and centrifuge while melting, but it requires high capacity control. If the amount of crushed ice is too much before centrifugation, the capacity of the cryoprecipitate will be excessive, and if it is too small, it will affect the cryoprecipitate. deposition

In actual industrial production, heat medium is often used for rapid melting of plasma, the temperature control is difficult, and the extraction of cryoprecipitate is not uniform enough

Moreover, the amount of cryoprecipitate produced by the above method is less, usually only 8.9kg cryoprecipitate is obtained per ton of plasma, and the specific activity of human blood coagulation factor VIII in the cryoprecipitate is 39.951IU / g (see battalion chief Yong et al., "Human blood coagulation Factor VIII Separation and Purification Technology Research", Master's Thesis of Shandong University), and the amount of human blood coagulation factor VIII preparation obtained by further separation and purification of cryoprecipitate is also relatively small, resulting in a waste of plasma resources

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