CAJ | 학술논문

利用常规法和培养基稀释法对辛伐他汀片微生物限度检查方法进行验证。结果表明，采用培养基稀释法时各试验菌回收率均大于70%；控制菌检测时，采用培养基稀释法，试验组检出控制菌大肠埃希菌，阴性菌对照组未检出阴性对照菌金黄色葡萄球菌。该验证试验表明辛伐他汀片具有微弱的抑菌作用，可采用培养基稀释法进行微生物限度检查。
이용상규법화배양기희석법대신벌타정편미생물한도검사방법진행험증。결과표명，채용배양기희석법시각시험균회수솔균대우70%；공제균검측시，채용배양기희석법，시험조검출공제균대장애희균，음성균대조조미검출음성대조균금황색포도구균。해험증시험표명신벌타정편구유미약적억균작용，가채용배양기희석법진행미생물한도검사。
Using the common method and culture medium dilution method validated the methodological for microbial limit test of simvastatin tablets. Results indicated that the recovery of test bacterium exceed 70%when using the culture medium dilution method. Detection the control strain using the culture medium dilution method. The test group detected the Escherichia coli, and the negative control group didn’t detect the Staphylococcus aureus. This validation method illustrate that the simvastatin tablets have the tenuous bacteriostatic action and could be applied the culture medium dilution method to examine the microbial limit.