阿奇霉素缓释口服干混悬剂微生物限度检测

目的建立阿奇霉素缓释口服干混悬剂微生物限度检查法。方法采用薄膜过滤法进行细菌计数检查和控制菌检查;采用培养基稀释法进行真菌计数检查;选择枯草芽孢杆菌(Bacillus sub-tilis)、大肠埃希菌(Escherichia coli)、白色念珠菌(Candida albicans)为筛选菌株,分别进行薄膜过滤法和培养基稀释法实验条件的筛选。结果采用薄膜过滤法,冲洗量600 mL时,枯草芽孢杆菌回收率为100%;采用培养基稀释法,样品经体积比为1∶200稀释时,白色念珠菌回收率为100%。结论该方法可用做阿奇霉素缓释口服干混悬剂微生物限度检测。

Microbial limit test of azithromycin sustained release oral powder for suspension

Objective To establish a method for microbial limit test of azithromycin sustained release oral powder for suspension.Methods The membrane-filter method was used to count the bacterias and control bacterias,and the medium-dilution method was used to count the fungi.Bacillus subtilis,Escherichia coli and Candida albicans were selected as screening strain to determine the test parameters of membrane-filter and medium-dilution method,respectively.Results For the membrane-filter method,the recovery rate of Bacillus subtilis was 100% when the filter was washed with 600 mL 0.1% peptone solution.For the mediumdilution method,the recovery rate of Candida albicans was 100% when the sample was diluted to 1∶200 with medium.Conclusions The method is suitable for the microbial limit test of azithromycin sustained release oral powder for suspension oral preparation.