CAJ | 학술논문

目的：建立益肝灵软胶囊的微生物限度检查方法。方法：按《中国药典》2010版一部微生物限度的检查方法，对细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证，通过比较回收率确定适宜的检查方法。结果：益肝灵软胶囊用培养基稀释法（0.5ml/皿）进行细菌计数检查；用平皿法进行霉菌和酵母菌计数检查；按常规法进行控制菌的检查。结论：建立了益肝灵软胶囊微生物限度检查法，方法合理有效，结果可靠。
목적：건립익간령연효낭적미생물한도검사방법。방법：안《중국약전》2010판일부미생물한도적검사방법，대세균、매균급효모균계수방법화공제균검사법진행험증，통과비교회수솔학정괄의적검사방법。결과：익간령연효낭용배양기희석법（0.5ml/명）진행세균계수검사；용평명법진행매균화효모균계수검사；안상규법진행공제균적검사。결론：건립료익간령연효낭미생물한도검사법，방법합리유효，결과가고。
Objietive:To establish the microbial limit test of Yiganling soft capsules and to validate the method. Methods:According to the method for microbial limit test in appendix of Chinese Pharmacopeia (2010 edition),the counting method of bacteria,mucedine and saccharomycetes and controlled bacteria tests were validated. Suitable method was confirmed by comparing recovery. Results:Bacteria test was carried out using medium dilution method, and saccharomycetes and controlled bacteria tests were carried out using conventional method. Conclusions:With the validation, the microbial limit test of Yiganling soft capsules is established. This method is very simple and suitable for practical application.