Process for extracting human coagulation factor VIII from plasma

Abstract

The invention discloses an economic and simple method for improving the separation efficiency, activity, specific activity and recovery rate of coagulation factor VIII. The method comprises washing cryoprecipitate twice with sodium heparin firstly, then carrying out ion exchange chromatography and eluting with an eluent to obtain higher-purity coagulation factor VIII. Compared with traditional methods, the method has the advantages of simple process and low cost; the separation efficiency, activity, specific activity and recovery rate of the coagulation factor VIII 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, monoclonal antibody technology The development of immunoaffinity chromatography has been applied, but the monoclonal antibody is expensive and has poor stability, which may cause secondary pollution to plasma and is 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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