复方九节茶颗粒微生物限度检查方法的建立与验证

Establishment and validation of microbial limit test method for compound Sarcandra granules

目的建立复方九节茶颗粒的微生物限度检查方法。方法需氧菌计数采用平皿法——培养基稀释法、霉菌和酵母菌数计数采用平皿法,大肠埃希菌采用常规法。结果 3个批次的产品进行方法验证,需氧菌、霉菌和酵母菌计数验证中各菌的回收比值均在0.5～2范围内,大肠埃希菌验证中可检出验证菌。结论该方法有效可行,可用于复方九节茶颗粒微生物限度检查。

Objective To establish a method for microbial limit test of compound Sarcandra granules.Methods The count of aerobic bacteria was used by plate method,the culture medium dilution method,the count of mould and yeast count by plate method,and the routine method of Escherichia coli.Results 3 batches of products were validated by methods.Aerobic bacteria,molds and yeasts count for verification.The recovery ratios of all bacteria were in the range of 0.5 to 2.Validation bacteria could be detected in Escherichia coli.Conclusion The method is effective and feasible,and can be used for compound granules of microbial limit test of compound Sarcandra granules.