摘要
目的:研究一种冻干型人凝血因子Ⅷ(Human Coagulation FactorⅧ,FⅧ)的制备方法。方法:采用聚乙二醇(PEG)沉淀结合离子交换层析技术从人血浆冷沉淀中分离纯化FⅧ,连续制备3批次的FⅧ制品,计算洗脱、除菌过滤、冻干和干热病毒灭活后各级回收率,并根据《中华人民共和国药典(2020版)》三部要求对FⅧ成品进行物理检查和化学检定。结果:从上样液开始计算,FⅧ各级平均回收率分别为75.66%、66.73%、62.98%和60.45%,成品比活性均值为70.17 IU/mg,RSD为10.08%。成品的物理检查和化学检定结果均符合药典要求。结论:该技术能够有效提高FVⅢ制品的质量且稳定可靠,适用于FⅧ的商业规模化生产。
Objective:To study a preparation method of human coagulation factorⅧ(FⅧ).Methods:FⅧis separated and purified from human plasma cryoprecipitate by polyethylene glycol(PEG)precipitation combined with ion-exchange chromatography.Three batches of FⅧproducts are prepared consecutively.The recovery rates after elution,sterilization and filtration,lyophilization and dry heat inactivation of virus are calculated.Physical inspection and chemical verification of FⅧproducts are carried out according to the Pharmacopoeia of the People’s Republic of China(2020Edition)PartⅢ.Results:The average recoveries of FⅧat all levels are 75.66%,66.73%,62.98%and 60.45%,and the average specific activities of FⅧproducts is 70.17 IU/mg,RSD is 10.08%.The results of physical inspection and chemical verification of FⅧproducts are in accordance with the requirements of pharmacopoeia.Conclusion:The technology can effectively improve the quality of FⅧproducts and is stable and reliable,which is more suitable for commercial scale production of FⅧ.
作者
刘环
陈红霞
李勇
邹越
孙振宇
LIU Huan;CHEN Hongxia;LI Yong;ZOU Yue;SUN Zhenyu(Sinopharm Shanghai Plasma-derived Biotherapies Co.,Ltd.,Shanghai 200051,China;Yunnan Branch of Sinopharm Shanghai Plasma-derived Biotherapies Co.,Ltd.,Kunming 650000,China)
出处
《生物化工》
2022年第6期75-77,共3页
Biological Chemical Engineering
关键词
人凝血因子Ⅷ
离子交换层析
血浆冷沉淀
分离纯化
human coagulation factorⅧ
ion-exchange chromatography
plasma cryoprecipitate
separation and purification
