Preparation method of human thrombinogen compound

Abstract

The invention belongs to the technical fields of bio-pharmaceuticals and blood products, and particularly relates to a preparation method of a human thrombinogen compound. According to the human thrombinogen compound prepared by the method, an excellent production process is obtained by improving and researching adsorbing balance liquid, subsequent washing liquid and eluent and a freeze-drying process, four blood coagulation factors that the PCC product contain have high active ratio, the yield of each component is high, the IX specific activity is up to 3.13 IU/mg, the specific activity is higher than that of the pharmacopeia standard, the thrombosis probability is effectively reduced and activation of the blood coagulation factors is reduced.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals and blood products, and in particular relates to a preparation method of human prothrombin complex. Background technique [0002] Human prothrombin complex concentrates (PCC) is a plasma protein preparation containing four vitamin K-dependent coagulation factors, coagulation factors II, VII, IX, and X, which can promote blood coagulation. Clinically, PCC is mainly used to treat hemophilia B and liver disease, as well as bleeding symptoms caused by low coagulation factor levels caused by vitamin K deficiency. In addition, it has also been affirmed in the treatment of bleeding symptoms caused by FVIII inhibitors in hemophilia A patients who have been infused with FVIII for a long time. In foreign countries, PCC is also widely used to treat bleeding symptoms caused by overdose of vitamin K antagonists as anticoagulant drugs. In recent years, with the recognition of clinicians, the demand...

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Problems solved by technology

[0007] CN201710118663.7, the invention discloses a method for preparing human prothrombin complex from plasma, using DEAEA-50 gel to directly adsorb human prothrombin complex from plasma, and absorbing A-50 gel Packed in a fixed-bed chromatography column, the packed chromatography column uses a peristaltic pump to pump in the eluent for online washing and elution, the eluent is deactivated by S / D, and the fixed-bed chromatography column is purified by secondary chromatography , so that the gel loss in the production process can be reduced by more than 20%, but the specific activity of the coagulation factor obtained is low, and the product quality is not good

[0008] The preparation of the human prothrombin complex mentioned above was improved from a single aspect, and the entire production process was not optimized, and the obtained human prothrombin complex only improved a certain factor of the human prothrombin complex. Yield and specific activity, there is no balanced improvement of the yield and specific activity of the four factors, yet human prothrombin complex (prothrombin complex concetrate, PCC) is prepared from the separation and preparation of mixed plasma of healthy people, and the raw material plasma for production is scarce, so It is necessary to improve each step of its production, hoping to obtain an efficient and safe preparation method

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