A kind of preparation method of human coagulation factor VIII

Abstract

The invention discloses a preparation method of a human coagulation factor VIII. The human coagulation factor VIII prepared by the method does not contain human serum albumin or other animal-derived protein, does not contain sugar or sugar alcohol, does not have the risk for transmitting other viruses or pathogene, and is wide in applicable crowd scope, and can be used by diabetic patients; the human coagulation factor VIII prepared by the method is fast to redissolve and good in redissolving effect, and still keeps high titer and high specific activity which are respectively larger than 80 percent and 40 IU / mg; in addition, the preparation method is simple, the cost is low, the human coagulation factor VIII is safe and effective, and has a good industrial application prospect.

Description

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of human blood coagulation factor VIII. Background technique

[0002] Hemophilia is a genetic bleeding disorder in which the level of clotting factors in the human body is reduced or lacked due to mutations in the clotting factor genes, leading to bleeding. Deficiency or insufficiency of clotting factor FVIII leads to hemophilia A, and deficiency or insufficiency of clotting factor IX leads to hemophilia B. Clotting factor replacement therapy is the mainstay of treatment for hemophilia.

[0003] With the development of modern chromatography technology, foreign blood product companies have developed high-purity human coagulation factor products to meet the needs of hemophiliacs. Considering the safety of viruses in my country, the National Drug Administration has not yet approved the import of coagulation factors derived from human blood. Domes...