Methodological research and comparison of microbial limit test for four antibacterial liquid preparations
OBJECTIVE To control the quality of drugs and establish microbial limit test methods for four antibacterial liquid preparations including diphenhydramine hydrochloride,clobetasol propionate and lincomycin hydrochloride liniment,compound clobetasol propionate liniment,glacial acetic acid paint and concentrated compound benzoic acid paint.METHODS The bacterio-static effect of the tested solution was eliminated by plate method and membrane filtration method,and the recovery tests of the total number of aerobic bacteria,fungi and yeast were carried out.The control bacteria were verified by medium dilution method and membrane filtration method.RESULTS The recoveries of the total aerobic microbial count and the total yeast and mold count for all kinds of testing strains were 0.5-2.0.In the method validations,Pseudomonas aeruginosa and Staphylococcus aureus were detected,and no control bacteria were detected out in the negative control group.CONCLUSION It is proved that the method is scientific and feasible,and the results are accurate and reliable.It is suitable for the quality control of the 4 liquid pharmaceutical preparations,which can objectively reflect the contamination status of microorganisms in drugs.
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