川贝枇杷糖浆微生物限度检查方法适用性研究

Study on microbial limit suitability test method of Chuanbei Pipa Syrup

目的建立适用于中药液体制剂中微生物限度检查方法。方法采用膜过滤方法等细菌定量培养方法,以某中药糖浆为模型对细菌总数、霉菌酵母菌限度进行检查和评估。结果采用2015年版《中国药典》规定的方法对中药某糖浆中微生物限度进行检查,各试验菌的回收比值均符合规定,且控制菌检查阳性对照组检出大肠埃希菌,阴性对照组未检出大肠埃希菌。结论该方法可用于该川贝枇杷糖浆的微生物限度检查。

Objective To establish a microbial limit test method for a traditional Chinese medicine liquid.Methods Bacterial quantitative culture methods,such as membrane filtration method,were used to detect and evaluate the microbial limit of total aerobic microbial count,total combined yeasts and molds count by taking a traditional Chinese medicine syrup as a model.Results Chp 2015 method was used in the microbial limit test of a traditional Chinese medicine syrup.The recovery ratios of each test bacteria were in line with the provisions of Chp 2015.Escherichia coli was detected in the positive control group,and it was not detected in the negative control group.Conclusion The method is suitable for the microbial limit test of Chuanbei Pipa Syrup.