Abstract: OBJECTIVE To establish the method of microbial limit test for Bazhen capsules and Bazhen tablets, analyze the test results and contaminant microbes. METHODS The method validation of Bazhen capsules and Bazhen tablets of microbial limit test of Chinese Pharmacopoeia (2015 Edition) was conducted. Thirty-one batches of Bazhen capsules and Bazhen tablets from 6 manufacturers were tested under the validated method. VITEK 2 Microorganism Identification System was used for bacterial and yeast identification. RESULTS The recoveries of 5 validation strains for the total aerobic microbial count, total yeasts and mold count were more than 0.5. In validation of method tests on Escherichia coli, bile-tolerant gram-negative bacteria and Salmonella enterica subsp., validation strains were detected. The main contaminant microbes were Bacillus spp. and microbe related to the herb material and environment. CONCLUSION The medium dilution method is used for the total aerobic microbial count, routine pour-plate method is used for total yeasts and molds count. The direct inoculation method is used for the detection of Escherichia coli, bile-tolerant gram-negative bacteria and Salmonella enterica subsp. (for the capsule). It is satisfactory that the results of microbial limit tests of 31 batches of samples meet test requirements. The main polluted microbes is Bacillus spp., which are common in the drug material and production environment.