吸入气雾剂中水分的摄入及其对产品性能的影响  

Moisture Ingress and Its Influence on Metered Dose Inhalers

作　　者：魏农农[1] 侯曙光 金方[3] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038 [2]3M公司药物递送系统部,美国明尼苏达州圣保罗市55144 [3]中国医药工业研究总院上海医药工业研究院,上海呼吸系统药物工程技术研究中心,上海200437

出　　处：《中国医药工业杂志》2012年第11期949-953,共5页Chinese Journal of Pharmaceuticals

摘　　要：氟利昂(CFC)是定量吸入气雾剂(MDI)中常用的抛射剂,近年来逐渐被氢氟烷烃(HFA)所替代。由于HFA的亲水性比CFC强,因此在生产和贮存过程中HFA-MDI中更易引入水分。然而,水分可能影响MDI产品质量,特别是对于混悬型MDI。本文讨论了MDI中水分的摄入机制并分析了影响水分渗入MDI中的因素。简要介绍了欧美法规对MDI中水分的要求;总结了水分对MDI产品性能的影响及防止MDI水分摄入的措施。The chlorofluorocarbon （CFC） was a commonly used propellant in metered dose inhalers （MDI）, but it has been gradually replaced by hydrofluoroalkane （HFA） in recent years. The hydrophilicity of HFA is stronger than CFC, so that the moisture ingress into HFA-MDI during the preparation and storage process is easier than CFC-MDI. However, the moisture content in MDI, especially in suspension MDI, might affect the product quality. The mechanism of moisture ingress into the MDI is discussed in this paper, and the influence factors on moisture ingress into MDI are analyzed. The European and USA regulatory guidance on moisture in MDI are briefly introduced. The effects of moisture on MDI pharmaceutical performance and the measures to reduce the moisture content in MDI are summarized.

关 键 词：吸入气雾剂 水分 摄入机制 影响因素 产品性能 质量控制 综述 

分 类 号：R944.9[医药卫生—药剂学]