医药导报2025，Vol.44Issue(11)：1751-1756,6.DOI:10.3870/j.issn.1004-0781.2025.11.004
2025年版《中华人民共和国药典》吸入气雾剂用金属罐相关物理性能评价方法要点解析
Key Points Analysis of Physical Performance Evaluation Methods for Metallic MDI Inhalation Canister in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
张凤兰 1张芳芳 1王蓉佳 1姚琳 1陈蕾2
作者信息
- 1. 上海市食品药品包装材料测试所,上海 201203
- 2. 国家药典委员会,北京 100611
- 折叠
摘要
Abstract
The 2025 Edition of the Pharmacopoeia of the People's Republic of China added the physical performance evaluation method of metallic metered dose inhalation(MDI)canister and related standards.The relevant physical performance evaluation methods are of great significance to the quality control of metallic inhalation canister,which is an important basis for the evaluation of drug protection ability,and also fills the blank of the physical performance evaluation method of metallic cans for drug packaging.It can scientifically and effectively guide the drug packaging material production enterprises to carry out standardized and unified quality control of metallic MDI inhalation canister,play a role in the quality control of metallic MDI inhalation canister,and ensure the safety,effectiveness,and accessibility of drugs in the whole life cycle.By comparing the domestic and international standards of metallic canister,this document mainly analyzed the detection principle,method points and its role in drug packaging quality control of pressure resistance performance、internal coating continuity,oxide film thickness,coating surface energy and coating contact angle,to help all parties more effectively and fully understand,master and apply the physical performance evaluation methods of the metallic MDI inhalation canister and relevant standards in the 2025 Edition of the Pharmacopoeia of the People's Republic of China,and provide theoretical guidance and technical support for the implementation of the standard.关键词
中华人民共和国药典/金属罐/耐压性能/内涂层连续性/氧化膜厚度/涂层表面能/涂层接触角Key words
The Pharmacopoeia of the People's Republic of China/Metallic canister/Pressure resistance performance/Internal coating continuity/Oxide film thickness/Coating surface energy/Contact angle performance分类
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张凤兰,张芳芳,王蓉佳,姚琳,陈蕾..2025年版《中华人民共和国药典》吸入气雾剂用金属罐相关物理性能评价方法要点解析[J].医药导报,2025,44(11):1751-1756,6.
