CAJ | 학술논문

目的：建立痔瘘洗液的微生物限度检查法，并对方法学进行验证。方法按照《中国药典》2010年版一部附录微生物限度检查法进行验证实验，以回收率对方法有效性进行评价。结果常规法（平皿法）适合于该药品的霉菌及酵母菌菌数的测定；培养基稀释法（1∶10供试液，每皿0．2 mL）适合于该药品的细菌菌数的测定；控制菌采用的常规法能正常检出。结论该方法确立了痔瘘洗液微生物限度检查，为该品种制定微生物限度标准提供了科学依据。
목적：건립치루세액적미생물한도검사법，병대방법학진행험증。방법안조《중국약전》2010년판일부부록미생물한도검사법진행험증실험，이회수솔대방법유효성진행평개。결과상규법（평명법）괄합우해약품적매균급효모균균수적측정；배양기희석법（1∶10공시액，매명0．2 mL）괄합우해약품적세균균수적측정；공제균채용적상규법능정상검출。결론해방법학립료치루세액미생물한도검사，위해품충제정미생물한도표준제공료과학의거。
Objective To inspect and verify the microbial limit test method for hemorrhoid lotion.Methods In accordance with the microbial limit test method in appendix of“Chinese Pharmacopoeia”201 0 edition we carried out the validation experiments to evaluate the effectiveness with the coefficient of recovery.Results The conventional method (plate method)was suitable for the drug mold and yeast cell count determination,medium dilution method (1∶1 0 for the test solution,0.2 mL per dish)for bacterial determination of the drug.The conventional method could be used to detect correctly the controlling bacteria.Conclusions This method can provide a sci-entific basis for developing standards of microbial limits.