Validation of Microbial Limit Test for Compound Clindamycin Hydrochloride Gel
- VernacularTitle:复方克林霉素凝胶微生物限度检查法的方法验证研究
- Author:
Jinlei LI
;
Jiayi WANG
;
Danyi CHI
;
Qian ZHU
;
Yi WANG
;
Wenhuan FU
- Publication Type:Journal Article
- Keywords:
Compound clindamycin hydrochloride gel;
Microbial limit test;
Validation;
Membrane-filter method
- From:
China Pharmacy
2007;0(25):-
- CountryChina
- Language:Chinese
-
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.
