摘要
定量吸入气雾剂依赖于包装容器系统给药,且药品与包装容器系统发生相互作用的可能性高,故包装容器系统是影响产品质量一个风险较高的因素。在药品申请注册或者上市后发生变更时,研究者应对包装容器系统和药品之间的相互影响进行全面研究,不仅对包装容器系统与制剂的相容性进行研究,还需要结合制剂对包装容器系统的功能性以及其对制剂关键性能的影响进行研究,并且三方面的研究结果应综合考虑,用于评价包装材料对制剂质量、疗效和安全性的影响。目前很多吸入制剂品种申报时对包装容器系统的研究尚不完善,如未对包装容器系统材料进行分析,未进行全面的浸出物研究,未考察在不同温度和湿度情况下阀门系统的密封性以及对产品关键检查项目的影响等。本文结合国内外相关技术法规要求,对定量吸入气雾剂包装容器系统研究评价关注要点进行分析和总结,为吸入制剂包装容器系统相关研究工作提供参考。
Metered dose inhalers (MDI) depend on the packaging container system for drug delivery, and the possibility of interaction between drug and packaging container system is high. Therefore, packaging container system is a high risk factor affecting the quality of inhalation aerosols. Researchers should conduct a comprehensive study on the interaction between packaging container system and drug, not only the compatibility of the packaging container system and the preparation, but also the functions of the packaging container system and its impacts on the key properties of the product. The results of these studies should be considered together to assess whether the packaging material affects the quality, efficacy and safety of the formulation. At present, many studies on the packaging system of inhalations are not perfect. Some packaging container system materials have not been analyzed, comprehensive extract research has not been carried out. Some researchers did not investigate the sealing of valve system in different temperatures and humidities which will impact on key inspection items. Starting from the compositions of the packaging container system for inhalations, combined with the requirements of the relevant technical regulations at home and abroad, this paper analyzes and summarizes the sealing, performance and compatibility studies included in the evaluation of the packaging container system for MDIs, especially in view of different requirements at home and abroad. The related research work of packaging container system can provide references.
作者
张景辰
邵奇
胡玥
吴斌
陈桂良
ZHANG Jingchen;SHAO Qi;HU Yue;WU Bin;CHEN Guiliang(Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203;SPH Sine Pharmaceutical Laboratories Co., Ltd., Shanghai 201206;Shanghai Institute for Food and Drug Control, Shanghai 201203)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2019年第7期722-727,共6页
Chinese Journal of Pharmaceuticals
基金
上海市科委课题(18DZ1910602)
关键词
吸入制剂
定量吸入气雾剂
包装容器系统
inhalation preparation
metered dose inhaler
packaging container system
