复方熊胆茵陈颗粒微生物限度检查及控制菌检查方法验证

Microbial Limit Test and Control Bacteria Method Validation of Compound Bear Bile and Capillary Herb Granule

目的建立复方熊胆茵陈颗粒的微生物限度检查方法,保证检验结果的准确可靠。方法按中国药典方法进行菌回收率试验及控制菌检查方法验证。结果 5种试验回收率试验均为70%以上,其中细菌以培养基稀释法进行检查,酵母菌、霉菌以常规法即可。控制菌检查中,大肠埃希菌、大肠菌群、沙门菌3者试验组均可检出试验菌,阴性组均无菌生长,阴性菌对照组亦无菌生长。结论本试验建立的方法可作为复方熊胆茵陈颗粒的微生物限度检查方法学验证的依据。

Objective： To establish a microbial limit test method for Compound Bear Bile and Capillary Herb Granule to ensure accu- rate and reliable test results. Methods ： Bacteria recovery rate tests and control bacteria method validation were conducted according to Chi- nese Pharmacopoeia. Results ： The rate of five recovery tests was more than 70%, wherein the bacteria were checked by culture medium dilution method. Yeasts and molds could go in the conventional method. In the control bacteria check, test organisms could be detected from Escherichia coli, coliform bacteria and Salmonella groups and no bacteria growth was in Gram - negative group. There was also no bacteria growth in the negative control. Conclusion ： The method established in the test may provide a basis for microbial limit test and con- trol bacteria method validation of Compound Bear Bile and Capillary Herb Granule.