中国执业药师
中國執業藥師
중국집업약사
CHINA LICENSED PHARMACIST
2015年
5期
21-23,27
,共4页
颜明%王东兴%王艳美%王宝庆
顏明%王東興%王豔美%王寶慶
안명%왕동흥%왕염미%왕보경
小儿启脾片%微生物限度检查%方法学验证
小兒啟脾片%微生物限度檢查%方法學驗證
소인계비편%미생물한도검사%방법학험증
Pediatric Qipi Tablets%Microbial Limit Test%Methodology Validation
目的：验证小儿启脾片微生物限度检查的方法。方法：采用《中国药典》2010年版一部附录ⅧC微生物限度检查法，对小儿启脾片进行微生物限度检查。通过3次独立的平行试验，分别计算5种验证菌每次试验的回收率。采用在相同环境下培养和观察大肠埃希菌与金黄色葡萄球菌的方法来验证控制菌。结果：5种验证菌的回收率均高于70%；控制菌检查中，试验组均检出验证菌，阴性菌对照组均无生长。结论：可以采用常规方法检查小儿启脾片的微生物限度。
目的：驗證小兒啟脾片微生物限度檢查的方法。方法：採用《中國藥典》2010年版一部附錄ⅧC微生物限度檢查法，對小兒啟脾片進行微生物限度檢查。通過3次獨立的平行試驗，分彆計算5種驗證菌每次試驗的迴收率。採用在相同環境下培養和觀察大腸埃希菌與金黃色葡萄毬菌的方法來驗證控製菌。結果：5種驗證菌的迴收率均高于70%；控製菌檢查中，試驗組均檢齣驗證菌，陰性菌對照組均無生長。結論：可以採用常規方法檢查小兒啟脾片的微生物限度。
목적：험증소인계비편미생물한도검사적방법。방법：채용《중국약전》2010년판일부부록ⅧC미생물한도검사법，대소인계비편진행미생물한도검사。통과3차독립적평행시험，분별계산5충험증균매차시험적회수솔。채용재상동배경하배양화관찰대장애희균여금황색포도구균적방법래험증공제균。결과：5충험증균적회수솔균고우70%；공제균검사중，시험조균검출험증균，음성균대조조균무생장。결론：가이채용상규방법검사소인계비편적미생물한도。
ABSTRACTObjective:To validate the method of microbial limit test for pediatric qipi tablets.Methods:The method of microbial limit test set forth in the appendixⅧC of theChinesePharmacopoeiaof 2010 edition was adopted to determine the microbial limit of pediatric qipi tablets. Through three independent parallel tests, the recov-ery of each test using five kinds of bacteria for validation was calculated respectively. In order to verify the control bacteria,E.coliandStaphylococcusaureuswere cultured and observed at the same environment.Results:The re-covery of five kinds of bacteria was all higher than 70%, and bacteria for validation were detected in the test group, but no growth was observed in the negative control group.Conclusion:The conventional method can be used for the microbial limit test of pediatric qipi tablets.
