复方三七丸微生物限度检查法的建立

Establishing a Method for Microbial Limit Tests of Compound Prescription Pill Sanqi

[目的]为复方三七丸建立合适的微生物限度检查方法。[方法]用常规法、培养基稀释法、离心沉淀法和薄膜过滤法检测复方三七丸对细菌、酵母菌和霉菌的回收率。[结果]常规检验发现白色念珠菌和黑曲霉的回收率都在70%以上;培养基稀释法检测到金黄色葡萄球菌试验组的回收率在70%以上;离心沉淀法+培养基稀释法检测出大肠埃希氏菌的回收率为84%;离心沉淀法+薄膜过滤法检测出枯草芽孢杆菌的回收率为87%。此外,大肠埃希氏菌、大肠菌群和沙门菌3种控制菌在常规法检测中都表现出专一性。[结论]复方三七丸的微生物限度检查法确立为:酵母菌和霉菌的检测采用常规法;革兰氏阳性菌的检测采用培养基稀释法;革兰氏阴性菌的检测采用离心沉淀法+培养基稀释法;枯草芽孢杆菌检测采用离心沉淀法+薄膜过滤法。控制菌采用常规法即可正确检出。

[Objective]The research was to provide a method of the microbial limit tests of compound prescription pill Sanqi.[Method]The recovery rate of bacteria,yeast and moulds was detected by routine examination methods and those methods with medium dilution,centrifugal sedimentation,centrifugal sedimentation and membrane filtration.[Result]It was validated that it was appropriate for yeast and mould to be detected by routine examination methods,in which the recovery rates of Candida albican and Aspergillus niger were 83% and 8.5%, respectively. It was appropriate for gram-positive bacteria to be detected by the methods with culture medium dilution, in which the recovery rate of Staphylococcus aureus was over 70%. It was appropriate for gram-negative bacteria to be detected by the methods with centrifugal sedimentation and culture medium dilution, in which the recovery rate of Escherichia coli was 84%. And it was appropriate for Bacillus sp. to be detected by the methods with centrifugal sedimentation and membrane filtration, in which the recovery rate was 87%. It was also found that routine examination method was appropriate to be used for the controlled strains, Escherichia coli, coliform and Salmonella.