异丙托溴铵气雾剂微生物限度检查方法的建立  

Establishment of Microbial Limit Test of Ipratropium Bromide Aerosol

作　　者：范震洪[1] 

机构地区：[1]首都医科大学附属北京天坛医院药剂科,北京100050

出　　处：《药品评价》2014年第16期34-36,共3页Drug Evaluation

摘　　要：目的:改进异丙托溴铵气雾剂的供试液制备方法。方法:参考中国药典和美国药典32版等文献进行试验,将异丙托溴铵气雾剂的原液进行薄膜过滤后,检查其微生物限度。结果:本方法满足中国药典2010版验证试验的基本要求。结论:用该法进行微生物限度检查能达到检测目的,提高检出率。Objective： To explore the method to prepare Ipratropium Bromide Aerosol. Methods： Membrance filtration was performed and microbial limit of Ipratropium Bromide Aerosol was tested. Validation methods were adopted according to the Chinese pharmacopoeia, American pharmacopoeia and other literatures. Results： The method could pass the validation test of Chinese pharmacopoeia 2010 version. Conclusion：The method of filtration membrane was simple, feasible and accurate. The detection rate was high. The method was capable of microbial limit tests.

关 键 词：微生物限度检查 供试液制备 异丙托溴铵气雾剂 

分 类 号：R943[医药卫生—药剂学]