摘要
目的:改进沙丁胺醇气雾剂的供试液制备方法,提高检出率。方法:参考中国药典和美国药典32版等进行试验,将沙丁胺醇气雾剂的原液进行薄膜过滤后,检查其微生物限度,并对所采用的方法进行方法学验证。结果:本方法满足中国药典2010年版验证试验的基本要求。5株验证菌株的回收率均大于90%。结论:用该法进行微生物限度检查能达到检测目的。对同类局部给药制剂的微生物限度有借鉴作用。
Objective：To explore the method to prepare salbutamol pressurized metered-dose inhalers probational liquid,and impoove the detectable rate.Method：Membrance filtration was provided microbial limit test of salbutamol pressurized metered-dose inhalers and validation methods were adopted according to the Chinese pharmacopoeia,American pharmacopoeia and other literatures.Result：The method could pass the validation test of Chinese pharmacopoeia 2010 version.By filtration membrane,the ratios of five validation strains were 90%.Conclusion：The method of filtration membrane is simple,feasible and accurate.The method may be useful for microbial limit tests of the parallel local administration drugs.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第4期636-638,共3页
Chinese Journal of Pharmaceutical Analysis
关键词
微生物限度检查
供试液制备
沙丁胺醇气雾剂
薄膜过滤法
microbial limit test
examine probational liquid
salbutamol pressurized metered-dose inhalers
film filtration method
