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口服头孢拉定制剂微生物限度检查法研究试验
引用本文:宋勤 袁林娜 刘应旭. 口服头孢拉定制剂微生物限度检查法研究试验[J]. 药物分析杂志, 2005, 25(6): 689-691
作者姓名:宋勤 袁林娜 刘应旭
作者单位:贵州省药品检验所 550004
摘    要:目的:为头孢拉定制剂建立微生物限度检查方法。方法:以2株细菌、2株真菌对4种口服头孢拉定制剂做了微生物限度检查方法学的比较和验证实验。结果:212批样品的供试液经低速离心和薄膜过滤法2株控制菌均能检出;用常规法检查,2株真菌的平均回收率大于80%。结论:本法简便,准确可靠,为头孢拉定制剂建立微生物限度检查方法提供了科学依据。

关 键 词:头孢拉定  微生物限度检查  细菌数  真菌数  回收率

A Method for Microbial Limit Tests of Cefradine
SONG Qin YUAN Lin-na LIU Ying-xu. A Method for Microbial Limit Tests of Cefradine[J]. Chinese Journal of Pharmaceutical Analysis, 2005, 25(6): 689-691
Authors:SONG Qin YUAN Lin-na LIU Ying-xu
Affiliation:Gui Zhou Provincial Institute for Drug Contro Guiyan 550004
Abstract:Objective:To provide a method of the microbial limit tests of cefradine.Methods:The proposed method of the microbial limit tests of 4 kinds of oral cefradine was compared and verified by 2 strains of bacterium and 2 strains of fungus.Results:After the supply test fluid specimen of 212 batches of samples were centrifuged at a low speed and filtered,all of the 2 strains of fungus was more than 80 percent using routine examination method.Con- clusion:The proposed method was convenient and accurate,which could provide a scientific evidence for establis- hing a method of the microbial limit tests of cefradine.
Keywords:cefradine  microbial limit tests  total bacterial count  total fungus count  recovery rate  
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