对国产异丙托溴铵气雾剂与装置相关的质量评价

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 evaluate the quality on the devise of ipratropium bromide aerosol Method: According to WS-10001-(HD-1459)-2003,BP2009 and the appendix I L of ChP 2005 Vol Ⅱ,evaluate the leakage test,number of discharges per container,the content of active ingredient delivered by actuation of the valve and deposition of the emitted dose,compare the quality between the homemade drugs and the import drugs. Results: the quality of homemade drugs doesnt meet the requirements,such as:the average leakage rate per year at room temperature(25 ℃) for the 12 containers is more than 3.5% of the net fill weight,the inhalers contain less than the number of discharges stated on the label.the uniformity of the contents of Delivered-Dose is dissatisfactory,the quality is worse than the import drugs. Conclution: the quality of the devise of aerosol should be improved.the national standard should be revised,so that the quality of homemade drugs could be better controlled.