《中华人民共和国药典》（2025年版）注射剂安全性检查法应用指导原则修订解读

doi:10.19803/j.1672-8629.20250648

摘要/Abstract

摘要： 目的解析《中华人民共和国药典》（以下简称《中国药典》）（2025年版）四部收载的9301注射剂安全性检查法应用指导原则,为其使用提供参考。方法对比2020年版与2025年版《中国药典》中9301指导原则的修订内容,结合国内外相关资料对本次修订进行解读。结果本次修订注重国际协调,明确安全性检查法设定原则,对致热物质检查及异常毒性检查等安全检测项目设立做修订,对与药品直接接触的料、辅料、包材联合表述,对具体实验细节进行规范。结论本次修订的指导原则与国际药品标准制修订前沿动态接轨,充分发挥规范性和导向性作用,对提升注射剂质量安全水平有重要意义。

关键词: 注射剂, 安全性检查, 《中国药典》（2025年版）四部, 9301应用指导原则, 单核细胞活化反应, 重组C因子法, 异常毒性检查

Abstract: Objective To interpret the revised guidelines for applications of safety tests for injections in the Chinese Pharmacopoeia 2025 edition (Volume IV) in order to provide a reference for related applications. Methods The revisions in guidelines 9301 between the 2020 and 2025 editions of the Chinese Pharmacopoeia were compared and contrasted before the amendments were interpreted based on relevant literature at home and abroad. Results This revision focused on alignment with international practices. The principles about safety tests were specified, items for safety testing such as pyrogen testing and abnormal toxicity testing were revised, and details on experiments were elaborated. Raw materials, excipients, and packaging materials that came into direct contact with drugs were described together. Conclusion The revised guidelines have been made compatible with the formation of standards for medical products administration in other countries, and can contribute to standardization and guidance, which is of vital importance for quality control of injections.

Key words: Injections, Safety Test, Chinese Pharmacopoeia 2025 Edition (Volume IV), Guideline 9301, Monocyte Activation Test, Recombinant Factor C, Abnormal Toxicity Test

中图分类号:

R927.1

徐琳, 吴彦霖, 裴宇盛, 蔡彤, 华晓东. 《中华人民共和国药典》（2025年版）注射剂安全性检查法应用指导原则修订解读[J]. 中国药物警戒, 2025, 22(11): 1258-1262.

XU Lin, WU Yanlin, PEI Yusheng, CAI Tong, HUA Xiaodong. Interpretations of Amendments to Guidelines for Applications of Safety Tests for Injections in Chinese Pharmacopoeia 2025 Edition[J]. Chinese Journal of Pharmacovigilance, 2025, 22(11): 1258-1262.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I11/1258

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