北方药学
北方藥學
북방약학
JOURNAL OF NORTH PHARMACY
2015年
4期
2-3,4
,共3页
孙荣嵘%曹克任%林小晖
孫榮嶸%曹剋任%林小暉
손영영%조극임%림소휘
头孢呋辛酯干混悬剂%离心沉淀联合薄膜过滤法%常规法
頭孢呋辛酯榦混懸劑%離心沉澱聯閤薄膜過濾法%常規法
두포부신지간혼현제%리심침정연합박막과려법%상규법
Cefuroxime axetil for suspension%Centrifugation conbined with membrane filtration method%Routine method
目的：建立头孢呋辛酯干混悬剂微生物限度的检查方法并进行验证。方法：细菌计数、控制菌检查采用离心沉淀联合薄膜过滤法，霉菌及酵母菌计数采用常规法。结果：细菌、霉菌和酵母菌计数验证中各验证菌的回收率均大于70%，控制菌检查验证中可检出验证菌。结论：头孢呋辛酯干混悬剂的微生物限度检查方法可行。
目的：建立頭孢呋辛酯榦混懸劑微生物限度的檢查方法併進行驗證。方法：細菌計數、控製菌檢查採用離心沉澱聯閤薄膜過濾法，黴菌及酵母菌計數採用常規法。結果：細菌、黴菌和酵母菌計數驗證中各驗證菌的迴收率均大于70%，控製菌檢查驗證中可檢齣驗證菌。結論：頭孢呋辛酯榦混懸劑的微生物限度檢查方法可行。
목적：건립두포부신지간혼현제미생물한도적검사방법병진행험증。방법：세균계수、공제균검사채용리심침정연합박막과려법，매균급효모균계수채용상규법。결과：세균、매균화효모균계수험증중각험증균적회수솔균대우70%，공제균검사험증중가검출험증균。결론：두포부신지간혼현제적미생물한도검사방법가행。
Objective:To establish microbial limit test for cefuroxime axetil for suspension and to carry out the validation of methods. Methods:Centrifugation conbined with membrane filtration method was used for bacteria counting and controlled bacteria check, routine method was used for molds combined yeasts counting. Results:The recoveries of validation strains in the bacteria, molds and yeasts counting were both more than 70%. Validation strains were detected in controlled bacteria check. Conclusion:Method established for microbial limit test of cefuroxime axetil for suspension is feasible.
