CAJ | 학술논문

目的：建立氯达软膏、利唑软膏、硫磺软膏医院软膏剂微生物限度检查方法。方法按《中国药典》2010年版二部微生物限度检查法中对细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证。结果氯达软膏和利唑软膏细菌、霉菌及酵母菌计数检查采用薄膜过滤法，控制菌检查均采用薄膜过滤法；硫磺软膏细菌、霉菌及酵母菌计数检查采用培养基稀释法，控制菌金黄色葡萄球菌检查采用培养基稀释法，铜绿假单胞菌检查采用常规法。结论医院软膏制剂必须通过方法验证试验建立合理的检验方法，以保证检验结果的准确性。
목적：건립록체연고、리서연고、류광연고의원연고제미생물한도검사방법。방법안《중국약전》2010년판이부미생물한도검사법중대세균、매균급효모균계수방법화공제균검사법진행험증。결과록체연고화리서연고세균、매균급효모균계수검사채용박막과려법，공제균검사균채용박막과려법；류광연고세균、매균급효모균계수검사채용배양기희석법，공제균금황색포도구균검사채용배양기희석법，동록가단포균검사채용상규법。결론의원연고제제필수통과방법험증시험건립합리적검험방법，이보증검험결과적준학성。
Objective To establish the methodological validation for microbial limit tests hospital ointment preparations, such as chlorine ointment, azole ointment and sulfur ointment. Methods According to the microbial limit test in 2010 edition of China Pharmacopoeia, this paper setted the methodological validation for the counting methods of bacteria, mold and yeast and the controlling bacteria checking methods. Results Membrane filtration method could be used in the counting test of bacteria mold and yeast for chlorine ointment and azole ointment, and also this method was used in the controlling bacteria checking. For the sulfur ointment, media dilution method could be used in the counting test of bacteria mold and yeast, and also this method was used in the controlling bacteria checking of staphylococcus aureus, and the routine method was used in the pseudomonas aeruginosa checking. Conclusion To ensure the accuracy of test results, it must be established checking methods for the hospital ointment preparations based on the methodological validation.