CAJ | 학술논문

目的：探讨建立甲磺酸达比加群酯胶囊的微生物限度检查的方法。方法依据《中国药典》2010年版（二部）收载的微生物限度检查法应用指导原则进行方法学验证试验。结果试验表明甲磺酸达比加群酯胶囊对枯草芽孢杆菌和金黄色葡萄球菌具有较强的抑制作用。结论推荐采用薄膜过滤法进行本品的细菌计数；采用常规检验方法进行真菌及酵母菌计数和控制菌检查。
목적：탐토건립갑광산체비가군지효낭적미생물한도검사적방법。방법의거《중국약전》2010년판（이부）수재적미생물한도검사법응용지도원칙진행방법학험증시험。결과시험표명갑광산체비가군지효낭대고초아포간균화금황색포도구균구유교강적억제작용。결론추천채용박막과려법진행본품적세균계수；채용상규검험방법진행진균급효모균계수화공제균검사。
Objective To establish a method of microbial limit test for Dabigatran Etexilate Mesylate Capsules. Meth-ods Validation of microbiological limit tests according to Chinese Pharmacopoeia edition 2010. Results Dabigatran Etex-ilate Mesylate Capsules has strong inhibiting effect on Bacillus subtilis and Staphylococcus aureus in bacterium. Conclusion The membrane filtration method was used in the test of bacterium. The routine method was used in the test of mold and yeasts. The routine method was used in the test of pathogenic bacterium.