《中华人民共和国药典》(2025年版)药包材不溶性微粒测定法研究  

Research on Determination Method of Particulate Matter in Drug Packaging Materials Based on the Pharmacopoeia of the People's Republic of China(2025 Edition)

作　　者：王冬伟 李文丽 熊巍 张静 陈蕾[2] 许凯 WANG Dongwei;LI Wenli;XIONG Wei;ZHANG Jing;CHEN Lei;XU Kai(Shandong Institute of Medical Devices and Pharmaceutical Packaging Inspection,NMPA Key Laboratory of Quality Control for Pharmaceutical Packaging,Jinan 250101,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制重点实验室,济南250101 [2]国家药典委员会,北京100061

出　　处：《医药导报》2024年第11期1740-1744,共5页Herald of Medicine

基　　金：2023年度国家药品标准制修订研究课题(2023Y55)。

摘　　要：目的建立《中华人民共和国药典》(2025年版)药包材不溶性微粒测定法,并对方法内容进行详细说明,为标准后期的使用提供进一步指导和支持。方法梳理现行《国家药包材标准》使用过程中存在的问题,结合《中华人民共和国药典》(2025年版)药包材标准体系建设的内容及验证数据结果,建立《中华人民共和国药典》药包材不溶性微粒测定法,对适用范围、测试方法,以及实验参数的确定进行详细研究和说明。结果与现行《国家药包材标准》相比,《中华人民共和国药典》(2025年版)药包材不溶性微粒测定法解决了原标准适用范围不全、实验参数设定不合理的问题。结论《中华人民共和国药典》(2025年版)药包材不溶性微粒测定法内容更具科学性、适用性和可操作性,可为药包材不溶性微粒的测定提供更加规范、科学的评价方法和手段,可为标准体系的建设起到支撑作用,共同促进产业发展。Objective To establish and interpret of the Pharmacopoeia of the People's Republic of China(2025 Edition),to determine particulate matter in pharmaceutical packaging materials,and to provide further guidance and support for the later use of the standard.Methods By reviewing the existing problems in the use of Chinese pharmaceutical packaging materials standards(YBB standards)standards combined with the construction of new standard system for pharmaceutical packaging materials in the Pharmacopoeia of the People's Republic of China,also about the validation data of the pharmaceutical packaging materials,the scope、testing methods、requirements and the experimental parameters of the Pharmacopoeia of the People's Republic of China determination of particulate matter in pharmaceutical packaging materials are studied and interpreted in detail.Results Compared with the current YBB standard,the Pharmacopoeia of the People's Republic of China-determination of particulate matter in pharmaceutical packaging materials has solved the problems of incomplete application scope and unreasonable requirements and parameters in the YBB standard.Conclusion The content of the Pharmacopoeia of the People's Republic of China(2025 Edition)determination of the particulate matter in drug packaging materials method is more scientific、applicable and operable.This method can standardize the determination of a particulate matter in drug packaging materials and can also play a supporting role in the construction of the standard system to promote industrial development.

关 键 词：药包材 不溶性微粒 光阻法 显微计数法 

分 类 号：R921[医药卫生—药学] R917