中国执业药师
中國執業藥師
중국집업약사
CHINA LICENSED PHARMACIST
2015年
1期
30-33
,共4页
芪参清幽胶囊%微生物限度%方法验证
芪參清幽膠囊%微生物限度%方法驗證
기삼청유효낭%미생물한도%방법험증
Qishenqingyou Capsules%Microbial Limit%Method Validation
目的：建立芪参清幽胶囊微生物限度检查方法。方法：按《中国药典》（2010年版）的规定，进行该品种微生物限度检查方法的验证。结果：常规法试验芪参清幽胶囊对枯草芽孢杆菌、金黄色葡萄球菌均有抗菌作用，回收率小于70%；培养基稀释法可消除本品对上述2种菌株的抗菌作用，回收率大于70%；常规法试验能检出大肠埃希菌。结论：本品可用常规法进行霉菌和酵母菌数测定；可用培养基稀释法进行细菌测定；可用常规法进行控制检验。
目的：建立芪參清幽膠囊微生物限度檢查方法。方法：按《中國藥典》（2010年版）的規定，進行該品種微生物限度檢查方法的驗證。結果：常規法試驗芪參清幽膠囊對枯草芽孢桿菌、金黃色葡萄毬菌均有抗菌作用，迴收率小于70%；培養基稀釋法可消除本品對上述2種菌株的抗菌作用，迴收率大于70%；常規法試驗能檢齣大腸埃希菌。結論：本品可用常規法進行黴菌和酵母菌數測定；可用培養基稀釋法進行細菌測定；可用常規法進行控製檢驗。
목적：건립기삼청유효낭미생물한도검사방법。방법：안《중국약전》（2010년판）적규정，진행해품충미생물한도검사방법적험증。결과：상규법시험기삼청유효낭대고초아포간균、금황색포도구균균유항균작용，회수솔소우70%；배양기희석법가소제본품대상술2충균주적항균작용，회수솔대우70%；상규법시험능검출대장애희균。결론：본품가용상규법진행매균화효모균수측정；가용배양기희석법진행세균측정；가용상규법진행공제검험。
Objective:To establish a method of microbial limit test for qishenqingyou capsules . Methods:Ac-cording to the Chinese Pharmacopoeia of 2010 edition , the method validation of microbial limit test on qishenqingy-ou capsules was conducted . Results: By using the conventional test methods , the antibacterial actions of qishen-qingyou capsules were showed for Bacillus subtilis and Staphylococcus aureus , and the recovery rate was less than 70%. The culture medium dilution method could eliminate the antibacterial activity of the product for the above two strains , and the recovery rate was greater than 70%. The conventional test methods can detect Escherichia coli in the product . Conclusion:For the product , the conventional test methods can be used for the bacterial counting test of mould or yeast and the control tests of bacteria , and the dilution method can be used for determination of bacte-ria .
