目的:对国产异丙托溴铵气雾剂装置相关的质量进行考察和评价。方法:按照国家药品标准WS-10001-(HD-1459)-2003、BP2009及中国药典2005年版附录的方法,对国产样品与装置相关的项目如泄漏率、每瓶总揿次、每揿主药含量和雾滴分布进行了考察,并和进口产品质量做对比。结果:国产气雾剂存在室温泄漏率高、喷出揿次不足以及每揿喷出的量少及不均匀等问题,和原研厂的产品质量相比有较大差距。结论:国内气雾剂包材的质量亟待提高,另外建议修订现行国家标准,以使国产样品质量更加可控。 OBJECTIVE: To investigate and evaluate the quality of domestic ipratropium bromide aerosol devices. Methods: According to the methods of national drug standards WS-10001- (HD-1459) -2003, BP2009 and the appendix of Chinese Pharmacopoeia 2005, the domestic sample and device related items such as leakage rate, total bottle times per bottle, Content and droplet distribution were investigated and compared with the quality of imported products. Results: Domestic aerosols had the problems of high room temperature leakage rate, insufficient spurting times, small amount of non-uniform spouting volume and unevenness. Compared with the quality of the original research plant, there was a big gap. Conclusion: The quality of domestic aerosol package materials needs to be improved urgently. In addition, it is suggested to amend the current national standards to make the quality of domestic samples more controllable.