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氟利昂替代后吸入气雾剂(MDIs)的研究要求和进展 Ⅰ.欧美抛射剂替代的MDIs的研发和质量控制 被引量：10

Chlorofluorocarbons Transition of Metered Dose Inhalers (MDIs). Ⅰ. Development and Quality Control of Alternative Propellant MDIs in the USA and Europe
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摘要 分析了欧美国家近20年吸入气雾剂(MDIs)中抛射剂替代的技术、法规、监管的经验和教训;总结了抛射剂替代后MDIs临床前研究的重点考察项目和成品质控的具体要求;介绍了国外MDIs的分类和单个品种与整个类别的淘汰策略。 This paper reviews the technology, quality control and regulations for altemative propellant MDIs in the USA and Europe in the past 20 years and summarizes the main pharmaceutical tests during pre-clinical development and specifications for HFA-MDIs products. The MDIs medication categories, strategies and current status for phase-out of CFC-MDIs abroad are introduced.
作者 金方 侯曙光 魏农农
机构地区 上海医药工业研究院 美国 国家食品药品监督管理局药品审评中心
出处 《中国医药工业杂志》 CAS CSCD 北大核心 2009年第7期543-548,共6页 Chinese Journal of Pharmaceuticals
关键词 吸入气雾剂 抛射剂替代 质控技术 淘汰策略 metered dose inhalers propellant replacement quality control phase-out strategy
分类号 R944.7 [医药卫生—药剂学]
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参考文献4

二级参考文献53

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共引文献16

同被引文献89

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引证文献10

二级引证文献50

中国医药工业杂志
2009年 第7期

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