冠心苏合胶囊微生物限度检查方法的验证

目的 确认冠心苏合胶囊微生物限度的检查方法和条件，保证检验方法的科学性、准确性及完整性。方法 采用《中国药典》2010年版（一部）附录“微生物限度检查法”项下相关内容进行方法学验证，通过回收率的比较来确定适宜的检查方法。结果 细菌计数检查采用低速离心-薄膜过滤法；霉菌和酵母菌计数及控制菌检查采用常规法。结论 该方法有效可行，可用于冠心苏合胶囊微生物限度检查。

Validation of determining microbial limit for Guanxin Suhe Capsules

Objective To determine the condition and method in the microbial limit test of Guanxin Suhe Capsules (GSC) in ordor to ensure the scientificity, accuracy, and integrity of the method. Methods The verification test was carried out according to the method of microbial limit test in the appendix of Chinese Pharmacopeia (2010 edition, volume I), suitable method was confirmed by comparing recovery rate. Results Low-speed centrifugal and membrane filtration method was used for the bacterium count; routine method was used for total combined molds and yeasts count, the detection of Escherichia coli, and coliform bacteria. Conclusion The method is effective and feasible. It could be used for the microbial limit test of GSC.