Production method of freeze dried human prothrombin compound

A human prothrombin and production method technology, applied in the production field of freeze-dried human prothrombin complex, can solve the problems of low specific activity, virus transmission, incomplete inactivation, etc.

Inactive Publication Date: 2004-02-18
HUALAN BIOLOGICAL ENG INC
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Problems solved by technology

[0002] The existing production methods of freeze-dried human prothrombin complexes all use cryoprecipitated supernatant plasma or FIII precipitation as raw materials, remove impurity proteins through polyethylene glycol separation, and adsorb through anion exchange gel DEAE-SephadexA-50 Human prothrombin complex (PCC) produced by inactivation processes such as S / D or dry heat, because the inactivation method is a single inactivation process, so its inactivation is not complete, and there is still the possibility of virus transmission Sex, and the content of factor IX in the product per unit volume is less, and its specific activity is also lower, so the clinical use effect is poor

Method used

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Embodiment Construction

[0004] The production method of freeze-dried human prothrombin complex comprises the following steps: (1) Take 2 kg of FIII, dissolve it with 10 liters of dissolving solution, and dissolve it with a volume of 12 liters, and add 1 kg of 40% PEG at a temperature of 25°C solution, with NaHCO 3 , adjust the pH value to 6.8 with about 450 ml, (2) lower the above solution to 5°C and separate it in a centrifuge, filter the supernatant with a filter plate to obtain a volume of 14 liters, (3) add DEAE-SephadexA-50 to wet condensation Adsorb 200 grams of gel for 60 minutes, (4) wash the gel for 3 volumes with washing liquid, then wash the gel twice with eluent, collect 600 ml of eluent, (5) filter and ultrafilter the above eluent Dialysis, the concentrated volume was 0.4 liters, (6) S / D inactivated virus, added 40 ml of S / D mother solution, and slowly stirred at 24-26 ° C for 6 hours to obtain a volume of 450 ml, (7) Add 120 grams of DEAE-Sephadex A-50 wet gel and carry out adsorption ...

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Abstract

A process for preparing freeze dried human thrombinogen compound includes dissolving FIII deposit, low-temp centrifugal separation, filtering, gel adsorption, washing, eluting gel, superfiltering, concentrating, S/D deactivation of virus, secondary gel adsorption, washing, eluting gel, superfiltering, dialysis, removing bacteria by miniporous membrane, filtering and freeze drying. It features that said compound is deactivated in boiling water bath at 98-100 deg.C for 30 min. It has high content (2010/ml) of factor IX and high specific activity of factor IC (>0.610/ag).

Description

(1) Technical field: [0001] The invention belongs to a production method of medical materials, in particular to a production method of freeze-dried human prothrombin complex. (two) background technology: [0002] The existing production methods of freeze-dried human prothrombin complexes all use cryoprecipitated supernatant plasma or FIII precipitation as raw materials, remove impurity proteins through polyethylene glycol separation, and adsorb through anion exchange gel DEAE-SephadexA-50 Human prothrombin complex (PCC) produced by inactivation processes such as S / D or dry heat, because the inactivation method is a single inactivation process, so its inactivation is not complete, and there is still the possibility of virus transmission Sex, and the IX factor content in the unit volume product is less, and its specific activity is also lower, thereby clinical use effect is poorer. (3) Contents of the invention: [0003] The technical problem to be solved by the present inv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N9/48
Inventor 安康潘若文马小伟张宝献范蓓郭建伟杨保平
Owner HUALAN BIOLOGICAL ENG INC
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