水调散微生物限度检查的方法验证

目的对水调散微生物限度检查方法进行验证。方法采用平皿计数法,通过5种阳性对照菌回收率实验进行细菌、真菌及酵母菌计数方法的验证;采用相同的实验条件,观察金黄色葡萄球菌、铜绿假单胞菌在实验组、阳性对照组和阴性对照组中的检出情况验证控制菌检查方法。结果用离心沉淀法对细菌、真菌及酵母菌计数时,各实验菌回收率在70%以上;控制菌检查采用离心沉淀法,实验组和阳性对照组检出金黄色葡萄球菌、铜绿假单胞菌,阴性对照组未检出菌株。结论该方法简便可行,结果准确,适合于水调散制剂微生物限度检查。

Validation for determination method of microbacteria limit of Shuitiaosan powder

Objective To validate the determination method of microbacteria limit of Shuitiaosan powder.Methods Plate counting method was used.The method of counting bacteria and mould was validated by the recovery rates with 5 control strains.The method of checking control bacteria was validated by observing cultivation of Staphylococcus aureus and Pseudomonas aeruginosa in the test group,positive control group and negative control group in the same environment.Results The recovery rate of every trail strains was higher than 70% when centrifugal sedimentation methods were used in the counting bacteria and mould.To the examination of control bacteria,Staphylococcus aureus and Pseudomonas aeruginosa were detected by the centrifugal sedimentation methods.The tested strains were observed in the test group and in the positive control group.No strains were observed in the negative control group.Conclusion The methods are simple,feasible,reliable and can be used for the examination of microbacteria limit.