摘要
目的:介绍国家药包材标准物质的发展历程、现状,探究我国药包材标准物质的发展方向。方法:通过分析比对的方法,总结国家药包材标准物质现存的问题,为药包材标准物质的发展提出合理化建议。结果:国家药包材标准物质发布5年,在控制药包材质量和提升检测机构检验能力方面起到了很大的作用,但在覆盖面和推广度方面有待提高。结论:国家药包材标准物质是《中华人民共和国药典》2020年版和《国家药包材标准》2015年版顺利实施的重要保障,需进一步发挥药包材标准物质在国家标准中起到的“砝码”作用。目前所发行的药包材标准物质涵盖添加剂品种较少,各品类不能全覆盖,在实际检测中有局限性,亟待更多品种的研制与开发。
Objective: To introduce the development history, current situation of national drug packaging material reference standards, and explore the development direction of reference standards for drug packaging materials in China. Methods: Through the analysis and comparison methods, the existing problems of the national drug packaging material reference standards were summarized, and the reasonable suggestions for the development of drug packaging material reference standards were put forward. Results: Since the release of the national drug packaging material reference standards 5 years ago, it has played a great role in controlling the quality of drug packaging materials and improving the inspection capabilities of testing institutions, while it needs to be improved in terms of coverage and promotion. Conclusion: The national drug packaging material reference standards are important guarantees for the smooth implementation of the 2020 edition of the "Chinese Pharmacopoeia" and the 2015 edition of "National Standard for Drug Packaging Materials". It is necessary to further play the role of "weight" in the national standards for the drug packaging material reference standards.The currently issued drug packaging material reference standards cover a small number of additives, and each category could not be fully covered. There are limitations in actual testing, and more varieties of research and development are urgently needed.
作者
韩小旭
赵霞
杨会英
孙会敏
Han Xiaoxu;Zhao Xia;Yang Huiying;Sun Huimin(National Institutes of Food and Drug Control,Beijing 100050,China)
出处
《中国药事》
CAS
2022年第9期990-1001,共12页
Chinese Pharmaceutical Affairs
关键词
国家药品标准物质
药包材
化学对照品
物理对照物质
质量控制
national drug reference standards
drug packaging materials
chemical reference standards
physical reference standards
quality control
