人用马免疫血清制品质量控制  

Quality control of equine-derived immunosera products for human use

作　　者：张华捷[1] 曹琰[2] 马霄[1] ZHANG Huajie;CAO Yan;MA Xiao(National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药典委员会,北京100061

出　　处：《中国药品标准》2022年第3期263-266,共4页Drug Standards of China

基　　金：国家药品标准提高课题2018S007抗毒素抗血清制品总论建立。

摘　　要：本文介绍了2020年版《中国药典》第三部中人用马免疫血清制品总论的制定情况,并从生产工艺和产品检定两方面对人用马免疫血清制品质量控制的要点进行了阐述,便于使用者对人用马免疫血清制品的质量控制全面、整体的理解和认识。This review introduces the formulation of general introduction of equine-derived immunosera products for human use in the Chinese pharmacopoeia 2020 VolumeⅢ,and presents the key points of the quality control of equine-derived immunosera products for human use from two aspects of manufacturing process and quality tests.Therefore,users can have an overall understanding of the quality control of equine-derived immunosera products for human use.

关 键 词：中国药典 人用马免疫血清制品 质量控制 

分 类 号：R921.2[医药卫生—药学]