CAJ | 학술논문

目的：建立我市11种医院制剂微生物限度检查方法。方法：按《中国药典》2010年版附录微生物限度检查法及应用指导原则进行方法学验证。结果：11种制剂中，有6种制剂对枯草芽孢杆菌有抑菌作用，细菌计数不能按常规法检查。抑菌作用较弱的3种制剂，细菌计数可按培养基稀释法检查；抑菌作用较强的3种制剂，细菌计数可按薄膜过滤法检查，其他制剂及项目均可按常规法检查。结论：必须进行微生物限度检查方法验证才能确保检验结果准确、可靠。
목적：건립아시11충의원제제미생물한도검사방법。방법：안《중국약전》2010년판부록미생물한도검사법급응용지도원칙진행방법학험증。결과：11충제제중，유6충제제대고초아포간균유억균작용，세균계수불능안상규법검사。억균작용교약적3충제제，세균계수가안배양기희석법검사；억균작용교강적3충제제，세균계수가안박막과려법검사，기타제제급항목균가안상규법검사。결론：필수진행미생물한도검사방법험증재능학보검험결과준학、가고。
Objective:To establish a method for the microbial limit test of 11 hospital preparations. Methods:A validation on the microbial limit test method was conducted in accordance with the counting method of bacteria,mycetes and yeasts,the control bacteria test method and the microbial limit test application guidelines stated in the appendix of china pharmacopoeia (2010 edition). Results:Of 11 varieties,there are six varieties which have antibacterial activity to hay bacillus,and whose bac-teria number can't be inspected according to conventional method. Among the six varieties,the three varieties which have wea-ker bacteriostatic action can breed bacterias whose number can't be inspected according to culture medium dilution method, and the other three varieties which have stronger bacteriostatic action can breed bacterias whose number can't be inspected ac-cording to membrane filtration method. And the other five varieties and items are available according to the onventional meth-od. Conclusion:Hospital preparations should undergo validation with the microbial limit test method to ensure the correctness of test results.