A method for preparing human prothrombin complex from plasma
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A technology of human prothrombin and complexes, which is applied in the field of preparation of human prothrombin complexes, can solve the problems of prothrombin activation, cumbersome operation, blood coagulation reaction, etc., to reduce the mixing of foreign proteins and control the process , the effect of reducing pollution
Active Publication Date: 2020-01-10
广东双林生物制药有限公司
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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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Embodiment 1
[0027] Removal of plasma cryoprecipitate: using fresh frozen human plasma as a raw material, the cryoprecipitate in the plasma is removed by melting, mixing, and continuous centrifugation to obtain 2kg of plasma centrifugal supernatant without cryoprecipitation;
[0028] Gel batch adsorption: The plasma temperature is controlled at 10°C, and the equilibrium DEAE A-50 gel is added to the cryoprecipitated plasma according to 1.0g dry gel / L plasma, and the stirring is turned off after 45 minutes of stirring and adsorption. The plasma after gel adsorption is filtered with a self-washing filter, the adsorbed A-50 gel is collected, and the plasma filtrate is incorporated into the plasma tank;
[0029] Packing and elution: Pack the adsorbed A-50 gel in a fixed-bed chromatography column, and use a peristaltic pump to pump the washing liquid into the packed chromatography column for online washing. The washing liquid flow rate is 35 cm / h, and the washing time 60min. The washed A-50 gel use...
Embodiment 2
[0034] Removal of plasma cryoprecipitate: using fresh frozen human plasma as a raw material, the cryoprecipitate in the plasma is removed by melting, mixing, and continuous centrifugation to obtain 2kg of plasma centrifugal supernatant without cryoprecipitation;
[0035] Gel batch adsorption: the plasma temperature is controlled at 15℃, according to 1.5g dry gel / L plasma, add the balanced DEAE A-50 gel to the cryoprecipitated plasma, stir and absorb for 45 minutes, then turn off the stirring, and let stand for 45 minutes. . The plasma after gel adsorption is filtered with a self-washing filter, the adsorbed A-50 gel is collected, and the plasma filtrate is incorporated into the plasma tank;
[0036] Packing and elution: Pack the adsorbed A-50 gel in a fixed-bed chromatography column, and use a peristaltic pump to pump the washing liquid into the packed chromatography column for online washing. The washing liquid flow rate is 40 cm / h, and the washing time is 70min. The washed A-50...
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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...
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