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
10.3870/j.issn.1004-0781.2025.11.004
- VernacularTitle: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
- Author:
Fenglan ZHANG
1
;
Fangfang ZHANG
;
Rongjia WANG
;
Lin YAO
;
Lei CHEN
Author Information
1. 上海市食品药品包装材料测试所,上海 201203
- Publication Type:Journal Article
- Keywords:
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
- From:
Herald of Medicine
2025;44(11):1751-1756
- CountryChina
- Language:Chinese
-
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.
