Effect of Lyophilized Protective Agent Content on Product Quality and Stability of Human Coagulation Factor Ⅷ
Objective:To investigate the effect of lyophilized protective agent(glycine)content of human coagulation factor Ⅷ on product quality and stability.Methods:The glycine content is adjusted to 2 to 20 g/L,and the appearance,potency,specific activity and other indexes of the products are compared with the relevant standards,and the appropriate lyophilized protective agent addition is screened.Long-term stability test(2 to 8℃,3 years)is carried out for human coagulation factor Ⅷ produced according to the preferred prescription,and the stability of the product is tested according to relevant standards.Results:The lyophilized protective agent(glycine)content of lyophilized human coagulation factor Ⅷ is determined to be 12 g/L,and after long-term stability test,the product met the quality standards after 3 years(appearance,visible foreign body,vacuum,moisture content,pH value,human coagulation factor Ⅷ potency,specific activity,etc.),and the product is stable.Conclusion:Under the confirmed lyophilized formulation,the product quality is good,and the stability of human coagulation factor Ⅷ is good,which can be used for mass production.
human coagulation factor Ⅷlyophilized protective agentstability
NETL
NSTL
万方数据
维普
