柴黄片微生物限度检查法方法验证

Validation method used for microbial limits of Chaihuang tablets

目的:建立柴黄片的微生物限度检查方法。方法:按常规法、培养基稀释法、离心沉淀集菌法、离心稀释法的顺序逐步分析制剂抑菌活性,根据抑菌活性强弱选择适当的检查方法,进行5种菌株的回收率实验,控制菌大肠埃希菌检验方法。结果:供试品5种试验菌回收率均高于70%,控制菌能正常检出。结论:柴黄片细菌计数方法为离心稀释法(0.2ml/皿),霉菌及酵母菌计数方法以及控制菌大肠埃希菌检验为常规法。

Objective： To set up the microbial limit tests ways for Chaihuang tablets. Methods： Using the conventional method ,culture medium dilution method, centrifugal sedimentation method, centrifugal dilution method set bacteria, centrifugal dilution analyzed preparation antibacterial activity by the seguence step, antibacterial activity in accordance with the strength to choose the appropriate method of examination carried out five kinds of strain recovery experiments, the control bacteria Escherichia coli verification test methods. Results： The recovery rate of five tested products were higher than 70%, control bacteria could be normally found. Conclusion： Chaihuang tablets bacteria count method for centrifugal dilution（0.2 ml/Ⅲ）, mold and yeast count method and Escherichia coli test method for the conventional method.