Abstract: OBJECTIVE To establish and validate the microbial limit test for Kangjunxiaoyan capsules. METHODS The microbial limit test for Kangjunxiaoyan capsules was validated using Escherichia coli, Bacillu subtilis, Staphylococcus aureus, Aspergillus niger and Candida albicans according to Chinese Pharmacopoeia 2010. Low speed centrifuge and medium dilution method were used with count of bacterium. Culture medium diluting method was used with counts mold and yeasts. Pathogenic bacteria could be tested when general method were used. RESULTS Kangjunxiaoyan capsules had very strong inhibition on Staphylococcus aureus and Bacillus subtilis, they could make certain inhibition effect on Escherichia coli and Candida albicans. CONCLUSION The method is feasible, effective and can be used for quality control of Kangjunxiaoyan capsules.