《中华人民共和国药典》有色玻璃容器遮光性标准设定的思考  

Considerations on the Standard Setting of Shading Property for Colored Glass Containers in Chinese Pharmacopeia

作　　者：韩小旭 齐艳菲 赵霞[1] HAN Xiaoxu;QI Yanfei;ZHAO Xia(National Institutes of 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532-535,共4页Herald of Medicine

基　　金：国家药品标准制修订研究课题资助项目(2023Y58-12);中国食品药品检定研究院中青年发展研究基金资助项目(2023C6)。

摘　　要：目的详细解读《中华人民共和国药典》(简称《中国药典》)2025版有色玻璃容器遮光性测定法,为标准的实施提供理论指导和技术支持。方法通过汇总分析国外有色玻璃容器遮光性相关标准,结合实验验证结果,按照《中国药典》药包材体系建设的要求,建立有色玻璃容器遮光性测定法,对仪器装置选择、供试品制备要求及结果表示方式的确定进行说明。结果结合国外标准制定的有色玻璃容器遮光性测定法,依据详实的实验验证数据,提出了科学合理的操作要求,解决了国内遮光性测定无“法”可依的问题。结论有色玻璃容器遮光性测定法的提出,填补了行业空白,完善了药包材标准体系,规范了方法操作,有助于促进产业发展,确保制剂安全。Objective Interpret the method of determining the shading property for colored glass containers in the Chinese Pharmacopoeia(2025 edition)in detail,and provide theoretical guidance and technical support for the implementation of standards.Methods By summarizing and analyzing the related abroad standards for shading property of colored glass containers,combining with the results of experimental verification,the method for determining the shading property of colored glass containers was established in accordance with the requirements of the construction of the pharmaceutical packaging material s ystem in the Chinese Pharmacopoeia.An explanation was provided for the selection of instruments and equipment,the requirements for the preparation of the samples,and the way of expressing the results.Results The method of determining the shading property for colored glass containers,formulated in conjunction with international standards,proposed scientifically reasonable operational requirements based on solid experimental verification data,and solved the problem of having no“method”to follow in the domestic shading property measurement.Conclusion The proposal of the method for determining the shading property of colored glass containers filled the industry gap,improved the pharmaceutical packaging material standard system,standardized the method operation,and was conducive to promoting industrial development and ensuring the safety of formulations.

关 键 词：有色玻璃容器 遮光性 中华人民共和国药典 标准体系 

分 类 号：R921.2[医药卫生—药学]