Validation of tests for microbial limit count of jianyutangkang tablets

OBJECTIVE To establish a method to determine the effectiveness of microbial limit viable count test of Jianyutangkang tablets.METHODS According to the Chinese Pharmacopoeia 2010 edition,routine method and medium dilution method were respectively performed for microbial limit test validation,two testing methods had different percentage of recovery with 5 control strains.RESULTS Jianyutangkang tablets had crude traditional Chinese medicine(TCM),and had antimicrobial effects.The recovery rate of Bacillus subtilis was 58.2% using conventional method.Medium dilution method could effectively eliminate its bacteriostatic activity.CONCLUSION Both methods confirmed the effectiveness of microbial limit viable count test.