| 引用本文: | 陈学艳,张敏娟,魏文芝,张耀元,张玉兰,尹常晴,尚悦,张军,代文兵.2025年版《中国药典》注射剂可见异物控制指导原则解读[J].中国现代应用药学,2025,42(20):1-5. |
| chenxueyan,ZHANG Minjuan,WEI Wenzhi,ZHANG Yaoyuan,ZHANG Yulan,YIN Changqing,SHANG Yue,ZHANG Jun,DAI Wenbing.Interpretation of the Chinese Pharmacopoeia 2025 Guidelines for the Control of Visible Particulates in Injections[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(20):1-5. |
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| 2025年版《中国药典》注射剂可见异物控制指导原则解读 |
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陈学艳1, 张敏娟1, 魏文芝1, 张耀元1, 张玉兰2, 尹常晴2, 尚悦3, 张军3, 代文兵4
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1.青海省药品检验检测院;2.国家药典委员会;3.齐鲁制药有限公司;4.北京大学药学院
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| 摘要: |
| 目的 解析2025年版《中国药典》新增的注射剂可见异物控制指导原则（通则9016）核心要义，指导行业准确理解药品全生命周期质量管理理念，优化注射剂可见异物控制体系，推动新标准有效实施。方法 基于指导原则起草背景，系统解读在可见异物来源、检测方法、过程控制和风险分析等方面的相关规定。结果 指导原则系统性归纳了可见异物的两类来源，对比解析现有检查程序及方法，研究提炼出了“预防-控制-监测”三位一体的全生命周期控制理念。结论 指导原则的制定标志着我国注射剂质量控制进入风险管理新阶段，通过系统化的过程控制方法和科学化的风险分析工具，可有效提升可见异物防控水平，为注射剂质量控制提供技术支撑，保障临床用药安全。 |
| 关键词: 2025年版《中国药典》 注射剂 可见异物控制 指导原则 解读 |
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| 基金项目:2023年度国家药品标准制修订研究课题(2023Y24) |
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| Interpretation of the Chinese Pharmacopoeia 2025 Guidelines for the Control of Visible Particulates in Injections |
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chenxueyan1, ZHANG Minjuan1, WEI Wenzhi1, ZHANG Yaoyuan1, ZHANG Yulan2, YIN Changqing2, SHANG Yue3, ZHANG Jun3, DAI Wenbing4
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1.Qinghai Pharmaceutical Inspection and Testing Institute;2.State Pharmacopoeia Commission;3.Qilu Pharmaceutical Co. Ltd;4.School of Pharmacy of Peking University
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| Abstract: |
| OBJECTIVE Analyse the core meaning of the new guidelines for the Control of visible particulates in injections (General Chapter 9016) added to the 2025 edition of the Chinese Pharmacopoeia, guide the industry to accurately understand the concept of quality management of the whole life cycle of medicines, optimize the system of controlling visible particulates in injections, and promote the effective implementation of the new standard. METHODS Based on the background of the drafting of the guiding principles, systematically interpret the relevant provisions on the sources of visible foreign bodies, detection methods, process control and risk analysis. RESULTS The guidelines systematically summarize the two types of sources of visible particulates, compare and analyze existing inspection procedures and methods, and study and refine the concept of “prevention-control-monitoring” as a trinity of the whole life cycle control.CONCLUSION The formulation of the guiding principles marks a new stage of risk management for the quality control of injection in China, which can effectively improve the level of prevention and control of visible foreign bodies through systematic process control methods and scientific risk analysis tools, provide technical support for the quality control of injection, and safeguard the safety of clinical use of drugs. |
| Key words: Chinese Pharmacopoeia 2025 injection visible foreign body control guiding principles interpretation |
