中国医药导刊
中國醫藥導刊
중국의약도간
CHINESE JOURNAL OF MEDICAL GUIDE
2013年
7期
1269-1270
,共2页
金莲花颗粒%微生物限度%方法验证
金蓮花顆粒%微生物限度%方法驗證
금연화과립%미생물한도%방법험증
Jinlianhua granule%Microbial limit tests%Verification test
目的：进行金莲花颗粒的微生物限度检查法的验证。方法：按菌落计数法测定金莲花颗粒对5种验证菌株的菌数，计算其回收率，并进行了控制菌的检查。结果：常规法试验时，金黄色葡萄球菌、枯草芽孢杆菌回收率小于70%，大肠埃希菌、白色念珠菌、黑曲霉回收率均高于70%；采用培养基稀释法(0.5ml)则金黄色葡萄球菌、枯草芽孢杆菌回收率亦高于70%。结论：金莲花颗粒可采用培养基稀释法进行微生物限度检查；控制菌可采用常规方法检验。
目的：進行金蓮花顆粒的微生物限度檢查法的驗證。方法：按菌落計數法測定金蓮花顆粒對5種驗證菌株的菌數，計算其迴收率，併進行瞭控製菌的檢查。結果：常規法試驗時，金黃色葡萄毬菌、枯草芽孢桿菌迴收率小于70%，大腸埃希菌、白色唸珠菌、黑麯黴迴收率均高于70%；採用培養基稀釋法(0.5ml)則金黃色葡萄毬菌、枯草芽孢桿菌迴收率亦高于70%。結論：金蓮花顆粒可採用培養基稀釋法進行微生物限度檢查；控製菌可採用常規方法檢驗。
목적：진행금연화과립적미생물한도검사법적험증。방법：안균락계수법측정금연화과립대5충험증균주적균수，계산기회수솔，병진행료공제균적검사。결과：상규법시험시，금황색포도구균、고초아포간균회수솔소우70%，대장애희균、백색념주균、흑곡매회수솔균고우70%；채용배양기희석법(0.5ml)칙금황색포도구균、고초아포간균회수솔역고우70%。결론：금연화과립가채용배양기희석법진행미생물한도검사；공제균가채용상규방법검험。
Objective:To estalish and verify the microbial limit tests for jinlianhua granule.Methods: The recovery rate of 5 tested strains were calculated by the method of plate culture count, the microbial limit tests for the specified microorganisms was validated Results:The recovery rates of Escherichia Coli,Candida albicans,Aspergillus niger had reached over 70%by routine test,except Staphylococcus aureus and Bacillus subtilis . the recovery rates of Staphylococcus aureus and Bacillus subtilis had reached over 70%by medium diluted method(0.5ml).Conclusion:Medium diluted method is available for microbial limit tests for jinlianhua granule;Routine method is suitable for specified microorganisms.
