CAJ | 학술논문

目的：建立安坤种子丸微生物限度检查的方法并进行验证。方法：按2010年版《中华人民共和国药典》，用大肠埃希菌、枯草芽胞杆菌、金黄色葡萄球菌、黑曲霉菌和白色念珠菌对安坤种子丸进行微生物限度检查法的方法学验证试验。结果：安坤种子丸对细菌中的大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌有一定程度的抑制作用，可通过稀释法消除抑菌作用。结论：安坤种子丸对细菌的计数方法采用培养基稀释法(0.2 mL/皿)进行测定，霉菌、酵母菌可采用常规法测定，控制菌检查可采用常规法进行大肠埃希菌和大肠菌群的检验。该方法用于安坤种子丸的质量控制有效可行。
목적：건립안곤충자환미생물한도검사적방법병진행험증。방법：안2010년판《중화인민공화국약전》，용대장애희균、고초아포간균、금황색포도구균、흑곡매균화백색념주균대안곤충자환진행미생물한도검사법적방법학험증시험。결과：안곤충자환대세균중적대장애희균、금황색포도구균、고초아포간균유일정정도적억제작용，가통과희석법소제억균작용。결론：안곤충자환대세균적계수방법채용배양기희석법(0.2 mL/명)진행측정，매균、효모균가채용상규법측정，공제균검사가채용상규법진행대장애희균화대장균군적검험。해방법용우안곤충자환적질량공제유효가행。
Objective: To establish microbial limit test for AnKun ZhongZiWan and validate the method. Method: Escherichia coli, Bacillu Subtilis, Staphy lococcus aureus, Aspergillus niger and Candida albicans were taken as the indexes, microbial limit test for AnKun ZhongZiWan was performed according to Chinese Pharmacopoeia of 2010 version. Result: AnKun ZhongZiWan could inhibit Escherichia coli, Bacillu Subtilis and Staphylococcus aureus to a certain extent, and bacteriostasic activity could be removed by dilution method. Conclusion:Media dilution method (0.2 mL/media) could be used for the tests of bacteria, filamentous fungi and yeasts were detected with routine method, Escherichia coli and coliform could be tested by routine method in bacterial control examination. The method is practicable and could be used for quality control for AnKun ZhongZiWan .