医药导报2025，Vol.44Issue(11)：1745-1751,7.DOI:10.3870/j.issn.1004-0781.2025.11.003
2025年版《中华人民共和国药典》金属药包材标准制订路径和收载逻辑解析
Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
摘要
Abstract
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.关键词
中华人民共和国药典/金属药包材/标准解析Key words
The pharmacopeia of the People's Republic of China/Metallic pharmaceutical packaging/Standard interpretation分类
医药卫生引用本文复制引用
张芳芳,刘元,许凯,常亮,刘言,贾菲菲,李颖,江燕,王丹丹,伍胜利,沈永,蔡荣,徐向炜,吕杨格格,兰婉玲,陈蕾,姚琳,丁豪,陆维怡,周亚菊,张凤兰..2025年版《中华人民共和国药典》金属药包材标准制订路径和收载逻辑解析[J].医药导报,2025,44(11):1745-1751,7.基金项目
2023、2024年度国家药品标准制修订研究课题(2023Y59,2023Y60,2024Y35). （2023Y59,2023Y60,2024Y35）
