Study on Microbial Limit Test Method for Ciclopirox Olamine Vaginal Suppository / 中国药房

ABSTRACT

OBJECTIVE:To establish an optimal method for microbial limit test for ciclopirox olamine vaginal suppository.METHODS:The microbial limit test for antibacterial agents was validated by plating method and membrane filtration method,and the optimal method for the test of bacteria and mold were confirmed based on the recovery rate of artificially sprayed bacteria.RESULTS:By plating method,the recovery rate of artificially sprayed E.coli was more than 70%,whereas that of mould was 0%;however,by membrane filtration method,the recovery rates of bacterial and mould were all higher than 70% when flushing doses of bacteria,mold,and control bacteria were 200 mL,300 mL,and 200 mL,respectively.CONCLUSIONS:The membrane filtration method could be used for the microbial limit test of the preparation the drug quality can be kept under effective control,and the established method is accurate and reliable.