目的 確認冠心蘇合膠囊微生物限度的檢查方法和條件，保證檢驗方法的科學性、準確性及完整性。方法 采用《中國藥典》2010年版（一部）附錄“微生物限度檢查法”項下相關內(nèi)容進行方法學驗證，通過回收率的比較來確定適宜的檢查方法。結果 細菌計數(shù)檢查采用低速離心-薄膜過濾法；霉菌和酵母菌計數(shù)及控制菌檢查采用常規(guī)法。結論 該方法有效可行，可用于冠心蘇合膠囊微生物限度檢查。

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.