保元抗癌口服液微生物限度检查的方法学验证研究

Validation method used for microbial limit test of Baoyuan anticancer oral

目的建立保元抗癌口服液的微生物限度检验方法。方法按《中国药典》2010年版规定,分别采用常规法、培养基稀释法对样品进行微生物限度检查;根据5株阳性对照菌的试验组、菌液组、供试品对照组的结果进行其方法学验证试验研究。结果保元抗癌口服液具有抑菌活性,常规法回收率<70.0%,培养基稀释法回收率>70.0%,因此有效地去除其抑菌活性。结论用该法进行微生物限度检查,可以客观地反映药物中微生物的污染状况,以达到检测目的。

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.