清咽喉合剂微生物限度检查方法的验证

摘要

Objective To establish a method to test the microbial limit of Qingyanhou mixture. Methods According to Chinese Pharmacopoeia (2010), the recovery rates of 5 tested strains treated by Qingyanhou mixture were determined by conventional method, and the test method of the control bacteria was verified. Results Using conventional method, the recovery rates of bacteria, mold and yeast were all above 75%, and Escherichia coli can be detected. Conclusion Through the technological validation, the conventional method of the microbial limit test can be used for Qingyanhou mixture.%目的：建立清咽喉合剂微生物限度检查方法。方法按《中国药典》2010年版的规定，采用常规法测定清咽喉合剂对五种验证菌株的回收率和对控制菌检查进行验证。结果采用常规法，细菌、霉菌及酵母菌的回收率均>75%，并可检出大肠埃希菌。结论经方法学验证，可采用常规法进行清咽喉合剂微生物限度检查。