A process for extracting human blood coagulation factor ⅷ from plasma

Abstract

The invention discloses an economical and simple method for improving the separation efficiency, activity, specific activity and recovery rate of coagulation factor VIII. In this method, the cryoprecipitate is firstly washed with heparin sodium twice, and then passed through ion exchange chromatography once, and the eluent is eluted to obtain relatively pure blood coagulation factor VIII. Compared with the traditional method, the invention has the advantages of simple and convenient operation and low cost, meanwhile, the separation efficiency, activity, specific activity and recovery rate are also improved.

Description

technical field [0001] The invention relates to a preparation process of human blood coagulation factor VIII, which belongs to the field of biopharmaceuticals. Background technique [0002] Blood coagulation factor Ⅷ is the only specific drug for the treatment of hemophilia A, which has great clinical application value. Due to the defect of blood coagulation mechanism, the patient often bleeds incessantly when encountering trauma, so a sufficient amount of blood coagulation factor Ⅷ preparation needs to be injected, plus blood coagulation The half-life of factor VIII in the human body is only 8 to 12 hours. Although the effect is remarkable, it cannot last long. Once you get sick, you will need this drug for life. Although the number of such people is small, the demand is high, so the supply exceeds demand in the world. [0003] Out of safety considerations, my country has no plans to lift the ban on blood imports. The Chinese market is entirely produced by domestic manufac...

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Problems solved by technology

[0004] Up to now, there have been many methods for extracting and purifying factor VIII from blood at home and abroad. Although the existing multi-step ion exchange chromatography has a high purification rate, the steps are cumbersome and require a lot of time; in recent years, the development of monoclonal antibody technology development, immunoaffinity chromatography has been applied, but monoclonal antibodies are expensive and have poor stability, which may cause secondary pollution to plasma and are difficult to apply to industrial production on a large scale; heparin, as another affinity Heparin can use electrostatic and affinity interactions to separate many coagulation factors in plasma. Heparin is cheap, but has poor affinity and specificity

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