食品与药品
食品與藥品
식품여약품
FOOD AND DRUG
2015年
1期
40-42,43
,共4页
董芳%王嘉南%于风平%王彦厚
董芳%王嘉南%于風平%王彥厚
동방%왕가남%우풍평%왕언후
盐酸莫西沙星片%微生物限度检查%验证%中和法
鹽痠莫西沙星片%微生物限度檢查%驗證%中和法
염산막서사성편%미생물한도검사%험증%중화법
Moxifloxacin Hydrochloride Tablets%microbial limit test%validation%neutralization method
目的：研究建立盐酸莫西沙星片微生物限度检查方法，并做方法验证。方法用薄膜过滤法结合中和法进行细菌计数、大肠埃希菌的检查；用中和法进行霉菌、酵母菌计数。结果5种试验菌菌数回收率结果均大于70%，符合中国药典2010年版二部微生物限度检查方法验证试验的要求。结论此法可有效消除样品的抑菌活性，可用于该药品的微生物限度检查。
目的：研究建立鹽痠莫西沙星片微生物限度檢查方法，併做方法驗證。方法用薄膜過濾法結閤中和法進行細菌計數、大腸埃希菌的檢查；用中和法進行黴菌、酵母菌計數。結果5種試驗菌菌數迴收率結果均大于70%，符閤中國藥典2010年版二部微生物限度檢查方法驗證試驗的要求。結論此法可有效消除樣品的抑菌活性，可用于該藥品的微生物限度檢查。
목적：연구건립염산막서사성편미생물한도검사방법，병주방법험증。방법용박막과려법결합중화법진행세균계수、대장애희균적검사；용중화법진행매균、효모균계수。결과5충시험균균수회수솔결과균대우70%，부합중국약전2010년판이부미생물한도검사방법험증시험적요구。결론차법가유효소제양품적억균활성，가용우해약품적미생물한도검사。
Objective To study and verify the microbial limit test method for Moxifloxacin Hydrochloride Tablets. Methods The membrane filtration combined with the neutralization method was adopted in the bacterial counting and the Escherichia coli testing. The neutralization method was used in the counting of mold and yeasts. Results The recoveries for bacteria count of five test organisms were more than 70%, meeting the requirement of the guidance of validation test for microbial limit test listed in 2010 version of Chinese Pharmacopoeia. Conclusion The method can effectively eliminate the antimicrobial activity of Moxifloxacin Hydrochloride Tablets and can be used for microbial limit test for this drug.
