Production method of freeze dried human prothrombin compound

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...

AI Technical Summary

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