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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 improve the preparation of albuterol aerosol test solution and improve the detection rate. Methods: With reference to the Chinese Pharmacopoeia and the United States Pharmacopoeia 32 edition and other tests, the stock solution of salbutamol aerosol was filtered and examined for its microbial limit, and the method used was verified by methodology. Results: The method meets the basic requirements of the 2010 Chinese Pharmacopoeia validation test. The recoveries of five strains were all over 90%. Conclusion: The method of microbial limit test can achieve the purpose of testing. The same type of topical formulations of microbial limit have reference.