CAJ | 학술논문

目的：通过对不同厂家同一品种的方法学验证，建立通便灵胶囊微生物限度检查方法。方法按《中国药典》2010版的要求。通过接种代表性的阳性菌株，用常规法及培养基稀释法对五株阳性菌进行回收率测定。结果该品种有抑菌性，采用培养基稀释法对五株阳性菌株回收率均高于70%。结论本样品微生物限度检查中，细菌检查可用培养基稀释法，霉菌酵母菌及控制菌检查可采用常规法。
목적：통과대불동엄가동일품충적방법학험증，건립통편령효낭미생물한도검사방법。방법안《중국약전》2010판적요구。통과접충대표성적양성균주，용상규법급배양기희석법대오주양성균진행회수솔측정。결과해품충유억균성，채용배양기희석법대오주양성균주회수솔균고우70%。결론본양품미생물한도검사중，세균검사가용배양기희석법，매균효모균급공제균검사가채용상규법。
Objective To establish a microbial limit test method of Tongbianling CaPsules through the validation of dif-ferent manufacturers of the same sPecies verification methodology. Methods The recovery Percent of five Positive bacteria was measured by inoculating rePresentative Positive strains using routine method and culture medium dilution method as the requirements of Chinese Pharmacopoeia,2010. Results The studied object had antimicrobial ProPerties and the recovery Percent of the five Positive bacteria are higher than 70% using culture medium dilution method. Conclusion Bacteria detec-tion can be tested by the culture medium dilution method,mold,yeast and control bacteria can be tested by routine method.