CAJ | 학술논문

目的：建立5种洗剂类医疗机构制剂微生物限度检查法。方法细菌、真菌和酵母菌计数方法的验证分别采用平皿法、培养基稀释法和薄膜过滤法；控制菌检查法的验证分别采用直接接种法、培养基稀释法和薄膜过滤法。结果1种洗剂的细菌、真菌和酵母菌计数可采用培养基稀释法，控制菌检查可采用直接接种法。另4种洗剂的细菌、真菌和酵母菌计数和控制菌检查均需采用薄膜过滤法。结论5种洗剂类医疗机构制剂微生物限度检查法均通过验证。
목적：건립5충세제류의료궤구제제미생물한도검사법。방법세균、진균화효모균계수방법적험증분별채용평명법、배양기희석법화박막과려법；공제균검사법적험증분별채용직접접충법、배양기희석법화박막과려법。결과1충세제적세균、진균화효모균계수가채용배양기희석법，공제균검사가채용직접접충법。령4충세제적세균、진균화효모균계수화공제균검사균수채용박막과려법。결론5충세제류의료궤구제제미생물한도검사법균통과험증。
OBjective Toestablishamethodofmicrobiallimittestfor5kindsofhospitalpreparationwithlotions. Methods The validation on plate count method,culture medium diluting method and membrane filtration method was con-ducted in accordance with bacterium count,total combined molds and yeasts count. The validation on routine method,culture medium diluting method and membrane filtration method was conducted in accordance with absence of specified microorgan-isms. Results The one kind can be tested with culture medium diluting method on bacterium count,total combined molds and yeasts count,and can be tested with routine method on absence of specified microorganisms. The other 4 kinds can be tested with membrane filtration method on bacterium count,total combined molds and yeasts count,and absence of specified microorganisms. Conclusion The validation results of microbial limit tests of 5 kinds of hospital preparation with lotions met the requirement.