Process Research And Process Scale-up Of Human Prothrombin Complex

Human Prothrombin Complex belongs to biological products blood products.With the aid of the plasma from health humans,it was isolated by a method of Cohn low temperature ethanol,using DEAE Sephadex A-50 hydrogel to adsorb Fr ? supernatant and then went through with a series of processes of desorption,S/D viral inactivation,ultrafiltration,constant volume(metered volume),aseptic filling and lyophilization,and finally came out with a sterile free dried injection.The major components are human coagulation factor ?,?,?,?,which are mainly used to treat the congenital and acquired coagulation factor deficiency of factor ?,?,?,?.Based on the optimization of previous experiments,this paper has identified the optimal extraction and separation condition.As the exploration in the actual production goes deeper,it is possible to produce the human prothrombin complex products which conforms to the quality standards steadily.The study is in clinical trials now.