RESUMO
OBJECTIVE: To provide a method for the microbial limit test of Anshenning oral liquid and carry out validation of the mothed. METHODS: The validation on the microbial limit test method was conducted in accordance with the counting method of bacteria, mycetes and yeasts and the control bacteria test method stated in the Appendix of China Pharmacopoeia(2010 edition). Culture dilution method was used in bacterium count and total combined molds and yeasts count; while routine method was used in the control bacteria test. RESULTS: The recoveries of test organisms in the control group 3 preparations by routine method were more than 70%. The recoveries of the test group were more than 70%. In the 3 control bacteria tests the negative control bacterias, was not found in the negative control group, while the control bacteria was found in the test group. CONCLUSION: The established method substances can eliminate the antimicrobial in Anshenning oral liquid is accurate, and comprehensive, and can be used for the microbial limit test of Anshenning oral liquid.