Technology for extracting human blood coagulation factor VIII and human fibrinogen from plasma constituent precipitation

Abstract

The invention provides a technology for extracting human blood coagulation factor VIII and human fibrinogen from plasma constituent precipitation. The preparation technology comprises the following steps: fresh plasma is subjected to primary sedimentation, so that blood coagulation factor VIII and fibrinogen precipitation can be jointly precipitated from the plasma; the primary precipitation is subjected to suspension; the suspension liquid is subjected to centrifugal separation to obtain supernatant; the centrifugally separated supernatant is subjected to virus inactivation and chromatography refining to respectively obtain human blood coagulation factor VIII refined liquid used for preparing human blood coagulation factor VIII products and chromatography effluent used for preparing human fibrinogen products. According to the invention, the human blood coagulation factor VIII and the human fibrinogen are precipitated through the one-step plasma constituent precipitation, and an ion-exchange column chromatography technology is adopted to perform purification preparation of the human blood coagulation factor VIII and the human fibrinogen, so that the deficiency that the human fibrinogen cannot be normally produced as the human blood coagulation factor VIII is prepared through cryoprecipitation is overcome.

Description

【Technical field】 [0001] The invention relates to the field of biopharmaceuticals, in particular to a process for extracting human coagulation factor VIII and human fibrinogen from plasma component precipitation. 【Background technique】 [0002] As a substitute for blood, blood products have a broad market prospect. The shelf life of fresh blood is 21 days, while the shelf life of blood products is as short as 2 years and as long as 5 years. In the case of identified diseases, blood products are generally used clinically instead of fresh blood in developed countries. Compared with other medicines, the price of blood products is generally higher. In addition to blood coagulation factor products, the consumption of albumin and cetyl alcohol in my country is also far lower than that in developed countries. In the future, with the development of the economy and the improvement of people's living standards, the continuous improvement of the medical security system, the gradual ...

AI Technical Summary

Problems solved by technology

[0011] 1. Ethanol reaction can easily lead to protein denaturation and poor protein stability;

[0012] 2. The content of coagulable protein is reduced, and the purity of fibrinogen is reduced, usually only about 80% (the relevant standard of the third part of "Chinese Pharmacopoeia" is greater than 70%);

[0013] 3. The reconstitution time of freeze-dried products is longer, generally more than 20 minutes

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