医药导报2025，Vol.44Issue(11)：1757-1762,6.DOI:10.3870/j.issn.1004-0781.2025.11.005
2025年版《中华人民共和国药典》药品包装用金属材料和容器质量控制与应用分析
Quality Control and Application Analysis of Metallic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
摘要
Abstract
To promote the understanding of the requirements for metal materials and containers used for drug packaging in the 2025 edition of the Pharmacopoeia of the People's Republic of China for related enterprises.Based on this edition of the Chinese Pharmacopoeia,national standards for drug packaging materials,and relevant international standards such as the United States Pharmacopoeia(USP).The raw material selection,production process,and quality control indicators of metal pharmaceutical packaging materials were systematically sorted out.It was necessary to clarify that for the metal material itself,the base material and coating type should be selected based on the characteristics of the medicine.In terms of the production process,attention should be paid to the impact of the forming process on the material performance.In terms of quality control,it is necessary to combine the material characteristics and the drug requirements,and ensure its protection,safety,and functionality through standardized testing methods.By strengthening the quality control of metal pharmaceutical packaging materials,product quality can be ensured,and the innovative development of the industry can be promoted.关键词
中华人民共和国药典/药品包装材料/金属材料/质量控制/相容性/功能性Key words
The Pharmacopoeia of the People's Republic of China/Pharmaceutical packaging/Matallic materials/Quality control/Compatibility/Functionality分类
医药卫生引用本文复制引用
丁豪,张芳芳,陈蕾..2025年版《中华人民共和国药典》药品包装用金属材料和容器质量控制与应用分析[J].医药导报,2025,44(11):1757-1762,6.基金项目
国家药品标准制修订研究课题(2023Y59,2023Y60,2024Y35). （2023Y59,2023Y60,2024Y35）
