《欧洲药典》通则“用于疫苗质量控制的体外方法替代体内方法”的解读和思考  

Interpretation and consideration of“Substitution of in vivo method(s)by in vitro method(s)for the quality control of vaccines”in General Texts of European Pharmacopoeia

作　　者：张旋旋 吴星 毛群颖 徐苗 梁争论 ZHANG Xuan-xuan;WU Xing;MAO Qun-ying;XU Miao;LIANG Zheng-lun(Institute of Biological Products,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院生物制品检定所,北京102629

出　　处：《中国生物制品学杂志》2023年第1期1-4,10,共5页Chinese Journal of Biologicals

基　　金：国家重点研发计划(2020YFC0860500);中国医学科学院医学与健康科技创新工程(2021-12M-5-005)。

摘　　要：效价是控制疫苗有效性和批间一致性的关键指标,依据是否使用实验动物分为体内法和体外法。体内法存在动物需求量大、操作费时及检测结果变异大等缺陷,体外替代方法因操作简便、符合3R原则、变异小等优势一直是人们研究的重点,但因替代实验设计和操作复杂并缺少相应指南进展较慢。近年《欧洲药典》10.0版通则增加了“用于疫苗质量控制的体外方法替代体内方法”章节,明确了开展方法替代的考虑要点。本文在《中国药典》和《欧洲药典》收载的体内外效力检测品种及相关变革基础上,解读《欧洲药典》体外替代章节,提出对我国疫苗效价体外替代方法的思考,以期加速相关研究进程,提升我国疫苗质控和监管能力。Potency is a critical quality attribute for controlling relevant biological properties and batch consistency of vaccines.The methods can be divided into in vivo and in vitro methods according to whether animals are used.The in vivo methods are large consuming of animals and time,as well as have large variant detection results.In contrast,the in vitro alternative methods have been the hotspot of research due to their simple operations,in line with 3Rs principles,and more stable results.However,owing to the complexity of experimental design and the lack of corresponding guidance,the research progress of alternative methods is slow.Recently,“Substitution of in vivo method(s)by in vitro method(s)for the quality control of vaccines”was adopted in the European Pharmacopoeia(10th Edition),which clarifies the critical points of consideration for substitution.This paper interprets the chapter and puts forward some thoughts on that in China,which is expected to speed up the alternative methods research and improve the ability of vaccine quality control and supervision in China.

关 键 词：疫苗 质量控制 效价 体内效力 体外效力 方法替代 

分 类 号：R186[医药卫生—流行病学]