Verification of Microbial Limit Test Methods for Three Kinds of Preparations with Heavy Metals / 中国中医药信息杂志

ABSTRACT

Objective To establish the methods of microbial limit test for three kinds of preparations with heavy metals, such asDingxian Pills,Pizhi Lotion andJiawei Huangqin Ointment.Methods According to Chinese Pharmacopoeia 2010, the recovery rates of bacteria, fungus and yeast treated by three preparations were detected. And the methods of testing control bacteria were also validated.Results Culture medium dilution method was proved to be applicable forDingxian Pills. Culture medium dilution method combined with pre-filtration method was proper for Pizhi Lotion. And the extraction method was adopted forJiawei Huangqin Ointment. The recovery rates of these five validation strains reached 70% by appropriate methods. And the same methods were used for validation of the control bacteria.Conclusion The methods of microbial limit test for these three different preparations were established through this study.