论文部分内容阅读
目的:建立益心舒微丸微生物限度活菌数测定方法。方法:参考中国药典、国外药典等文献进行试验,以对照菌回收为主要内容,用样本组和对照组之间的回收率对方法有效性进行评价。结果:常规法对照用阳性菌金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌、黑曲霉菌的回收率<70%;稀释法对照用阳性菌金黄色葡萄球菌、枯草芽孢杆菌的回收率<70%;而薄膜过滤法中阳性对照菌的回收率>80%。结论:薄膜过滤法能有效地去除益心舒微丸的抑菌活性,用该法进行微生物限度检查,可行性强,能达到检测目的。
Objective: To establish a method for determining the number of viable microorganisms of Yixinshu Pellets. Methods: The trials were conducted with reference to the Chinese Pharmacopoeia and the Pharmacopoeia of the People’s Republic of China. The recovery of the control bacteria was the main content. The recovery of the samples was used to evaluate the effectiveness of the method. Results: The recovery rate of the positive control Staphylococcus aureus, Bacillus subtilis, Candida albicans, and Aspergillus niger was less than 70%; the recoveries of the positive strains of Staphylococcus aureus and Bacillus subtilis that were used for the dilution method were less than 70. %; and the positive control bacterial recovery in the membrane filtration method was >80%. Conclusion: The membrane filtration method can effectively remove the antibacterial activity of Yixinshu Pellets. The limit of microbiological examination using this method is feasible and can achieve the purpose of detection.