2种剂型甲芬那酸制剂微生物限度与控制菌方法的比较

Verification of microbial limit and control bacteria tests for mefenamic acid in two kinds of dosage forms

目的建立甲芬那酸胶囊与分散片剂微生物限度与控制菌的检查方法。方法采用常规法、培养基稀释法、薄膜过滤与加中和剂法对2种剂型甲芬那酸制剂进行微生物限度方法验证,采用直接接种法进行控制菌方法验证。结果甲芬那酸胶囊与分散剂均采用薄膜过滤与加中和剂法(稀释剂含100mL.L-1吐温80,冲洗量为600mL/膜)测定细菌数;常规法测定霉菌及酵母菌数;直接接种法进行大肠埃希菌检测。结论建立了2种剂型甲芬那酸制剂的微生物限度与控制菌检查方法。

Objective To estabilish mothods of the microbial limit and control bacteria tests for mefenamic acid capsules and dispersible tablets.Methods Routine method,medium diluting method,membrane filter and neutralization agent method were adopted for the verification of microbial methodology,and direct inoculation method for the control bacteria.Results Membrane filter and neutralization agent method were used for the bacterial count of mefenamic acid capsules and dispersible tablets,in which the diluent contained 100 mL·L-1 Twain 80 and the volume of washing fluid for each membrane was 600 mL.Routine method was used for yeast and mold count.The direct inoculation method was used for Escherichia coli.Conclusion The methods of the microbial limit and control bacteria tests for mefenamic acid capsules and dispersible tablets were established.