Validation method used for microbial limit test of Baoyuan anticancer oral

OBJECTIVE To establish the method to determine the microbial limit viable count tests for Baoyuan anticancer oral.METHODS According to the Chinese Pharmacopoeia 2010 edition and by the means of routine method and medium dilution method,microbial limit viable count tests for the samples were performed;methodology validation study on the 5 positive control strains in study group,bacilli group,and test control group was performed.RESULTS Baoyuankangai oral had antimicrobial activity,the recovery rate of the routine method was lower than 70.0%,medium dilution method higher than 70.0%,it can effectively eliminate the antibacterial activity.CONCLUSION This method applied for microbial limit test can objectively reflect the status of microbial contamination in drugs so as to meet the destination of examination.