药品评价
藥品評價
약품평개
DRUG REEVALUATION
2014年
16期
34-36
,共3页
微生物限度检查%供试液制备%异丙托溴铵气雾剂
微生物限度檢查%供試液製備%異丙託溴銨氣霧劑
미생물한도검사%공시액제비%이병탁추안기무제
Microbial Limit Test%Examine ProbationalLiquid%Ipratropium Bromide Aerosol
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。
目的：改進異丙託溴銨氣霧劑的供試液製備方法。方法：參攷中國藥典和美國藥典32版等文獻進行試驗，將異丙託溴銨氣霧劑的原液進行薄膜過濾後，檢查其微生物限度。結果：本方法滿足中國藥典2010版驗證試驗的基本要求。結論：用該法進行微生物限度檢查能達到檢測目的，提高檢齣率。
목적：개진이병탁추안기무제적공시액제비방법。방법：삼고중국약전화미국약전32판등문헌진행시험，장이병탁추안기무제적원액진행박막과려후，검사기미생물한도。결과：본방법만족중국약전2010판험증시험적기본요구。결론：용해법진행미생물한도검사능체도검측목적，제고검출솔。
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.
