Process for the preparation of a sterile plasma protein solution containing fibrinogen and coagulation factor XIII

摘要

The procedures hitherto used to obtain fibrinogen and coagulation factor XIII from blood plasma either give products which are not hepatitis-safe or require excessively complicated sterilisation. The present procedure is intended to prepare a sterile and stable plasma protein solution which contains both components in elevated concentration. …??A citrate-stabilised blood plasma is sterilised by treatment with beta -propiolactone and irradiation with UV light before removal of coagulation factors II, VII, IX and X with the aid of an anion exchanger. Fibrinogen and coagulation factor XIII are obtained in concentrated form by fractional precipitation with ethanol after removal of the concomitant proteins. …??The sterile and stable plasma protein solution is particularly suitable as fibrinogen adhesive component.