《中华人民共和国药典》2025年版药品包装用玻璃材料和容器通用检测方法解读  

Standard Interpretation of General Testing Methods for Glass Materials and Containers for Pharmaceutical Use in the 2025 Edition of the Chinese Pharmacopoeia

作　　者：齐艳菲 王颖[1] 韩小旭 李颖 赵霞[1] QI Yanfei;WANG Ying;HAN Xiaoxu;LI Ying;ZHAO Xia(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《医药导报》2025年第4期536-541,共6页Herald of Medicine

基　　金：国家药典委员会国家药品标准提高项目课题-药品包装用玻璃容器配套通用检测方法(2023Y58)。

摘　　要：目的解读《中华人民共和国药典》(简称《中国药典》)2025版药品包装用玻璃材料和容器通用检测方法,为标准的实施提供帮助。方法介绍药品包装用玻璃材料和容器通用检测方法增修订概况,通过比较新版标准和现行标准的不同,总结新版通用检测方法标准的改进之处。结果《中国药典》2025版药品包装用玻璃材料和容器通用检测方法体系架构上更加科学,方法更加合理,更具操作性。结论《中国药典》2025版11个通用检测方法标准用于控制药品包装用玻璃材料和容器的质量,助力我国药品质量与疗效的提升。Objective To introduce the general testing methods for glass materials and containers for pharmaceutical packaging within the packaging material standard system in the 2025 Edition of the Chinese Pharmacopoeia,aiming to provide assistance for the implementation of these standards.Methods Introduce the general situation of the revision of general testing methods for glass materials and containers for pharmaceutical use.The improvement of new general testing method standards is summarized by contrasting the new version of the general testing methods for pharmaceutical glass materials and containers with the current standards.Results The general testing methods for pharmaceutical glass materials and containers in the Chinese Pharmacopoeia 2025 Edition are more scientific in structure,more rational and operational.Conclusion The 11 general testing methods will control the quality of pharmaceutical glass materials and containers,which could contribute to the enhancement of the quality and efficacy of drugs in our country.

关 键 词：中华人民共和国药典 药品包装用玻璃材料和容器 通用检测方法 

分 类 号：R95[医药卫生—药学]