Validation of Microbial Limit Test for Compound Clindamycin Hydrochloride Gel / 中国药房

ABSTRACT

OBJECTIVE:To establish microbial limit test for Compound clindamycin hydrochloride gel and to carry out the validation of three methods.METHODS:According to the appendices volumeⅡof Chinese Pharmacopeia(edition 2005),microbial limit test which contained routine test,medium dilution method and membrane-filter method was adopted to validate Compound clindamycin hydrochloride gel.Recoveries of three methods were compared to make sure the suitable validation method.RESULTS:In routine test,recovery of trial bacteria was lower than 70%and controlled bacteria couldn't be found out.In medium di-lution method,recovery of trial bacteria was higher than 70%and still lower than the recovery of diluents.In membrane-filter method,recovery of trial bacteria was higher than 90%,and controlled bacteria grew well.Membrane-filter method could eliminate inhibition effect of Compound clindamycin hydrochloride gel on bacteria.CONCLUSION:Membrane-filter method is effective and practical for microbial limit test of Compound clindamycin hydrochloride gel.