A method for preparing human prothrombin complex from plasma

Abstract

The invention discloses a method for preparing a human prothrombin complex from plasma. The method comprises: directly adsorbing the human prothrombin complex from the plasma by using DEAE A-50 gel, filling the adsorbed A-50 gel into a chromatographic column of a fixed bed, pumping eluant into the filled chromatographic column by using a peristaltic pump for online washing and elution, performing S / D inactivation on the eluant, and performing secondary chromatographic purification by using the chromatographic column of the fixed bed to obtain a high-purity human prothrombin complex product. According to the method, elution flow and speed can be accurately controlled by online elution after filling the gel into the column, the problems of contamination, cross contamination, gel leakage and the like caused by an open operation are reduced, an obtained product is high in purity, an IX factor titer can exceed 27IU / ml, and the IX factor specific activity exceeds 0.8IU / mg protein. Meanwhile, a self-flushing type filter with a pressure difference controller and an automatic solid matter stripping system is adopted, so the pressure difference in the whole filtering process is stable and controllable, gel particles can be well protected, broken colloidal particles flowing into a plasma tank in the filtering process are remarkably reduced, and gel losses in a production process can be reduced by above 20%.

Description

Technical field [0001] The invention belongs to the technical field of biopharmaceuticals and blood products, and specifically relates to a method for preparing human prothrombin complex from plasma in the preparation of blood products. Background technique [0002] Prothrombin complex concentrate (PCC) is derived from healthy human plasma. It is a traditional plasma protein product. In addition to treating hemophilia B, it can also be used to treat vitamin K deficiency or liver disease. With the gradual recognition of clinicians, the use of PCC is also increasing year by year. At present, there are not many manufacturers of PCC in my country, and the shortage of raw material plasma has caused a serious shortage of PCC. Therefore, its production and preparation have attracted attention from all aspects. [0003] The current classic process for preparing human prothrombin complex is the batch adsorption process proposed by the Dutch Red Cross Blood Center: using a weak anion exchan...

AI Technical Summary

Problems solved by technology

The batch adsorption process is an open operation, the operation is cumbersome, and it is easy to cause pollution, cross-contamination, gel leakage and other problems

Domestic human prothrombin complexes are also reported to be prepared using component III of the cohn method as the starting material, but this method is prone to prothrombin activation, causing blood coagulation reactions in drug users, and there are great safety hazards

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