2025年版《中国药典》三部通则0237国家生物标准物质研制解读  

Interpretation for the General Chapter 0237 the preparation and establishment of national biological reference standards in Chinese Pharmacopoeia 2025 Edition VolumeⅢ

作　　者：王一平[1,3] 毛群颖 王晓娟 梁争论[2,3] WANG Yiping;MAO Qunying;WANG Xiaojuan;LIANG Zhenglun(The Center for Reference Material and Standardization,National Institutes for Food and Drug Control,Beijing 102629,China;The Institute for Biological Products Control(IBPC),NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing 102629,China;State Key Laboratory of Drug Regulatory Science,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标准物质和标准化管理中心,北京102629 [2]中国食品药品检定研究院生物制品检定所,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京102629 [3]药品监管科学全国重点实验室,北京102629 [4]国家药典委员会,北京100061

出　　处：《中国药品标准》2025年第1期99-104,共6页Drug Standards of China

基　　金：国家科技重大专项,创新生物技术药评价及标准化关键技术研究(2018ZX09101-001);中国医学科学院医学与健康科技创新工程项目(2021-I2M-5-005);药品监管科学全国重点实验室课题(2023SKLDRS0114);中国食品药品检定研究院中青年发展研究基金(2024C1)。

摘　　要：2025年版《中国药典》即将正式发布。第十二届药典委员会疫苗制品专业委员会在多次开会讨论并广泛征求意见的基础上,修订形成2025年版《中国药典》三部通则0237国家生物标准物质研制。通则0237在整合WHO相关指南文件的前沿理念和国内外生物标准物质实践经验的基础上,修订了通则名称,更新完善了标准物质候选材料、协作标定和定值、以及稳定性研究和监测等技术要求,新提出了应计算生物标准物质的不确定度,并要求关注标准物质的互换性。通则0237的实施,对提升我国生物标准物质的研制和应用水平将发挥指导作用。本文解读通则0237修订内容,为生物标准物质研制人员提供参考。The Chinese Pharmacopoeia 2025 Edition is about to be officially released.Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission,has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volumeⅢ.General chapter 0237,integrating the cutting-edge concepts from WHO′s related guidelines and the practical experience of biological reference standards both domestically,has revised the names of this chapter,updated and improved the technical requirements for candidate reference materials,collaborative calibration and value assignment,as well as stability research and monitoring.It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability.The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China.This article,by interpreting the revised content of general chapter 0237,aims to provide a reference for the researchers of biological reference materials.

关 键 词：国家生物标准物质 研制 协作标定 互换性 稳定性 

分 类 号：R97[医药卫生—药品]