复方磺胺甲噁唑片微生物限度检查方法验证

Methods validation of microbial limit test of compound sulfamethoxazole tablets

目的建立复方磺胺甲噁唑片的微生物限度检查方法。方法采用5种阳性对照菌对复方磺胺甲噁唑片进行微生物限度检查方法验证,通过回收率试验测定药物的抑菌性。结果采用培养基稀释法检验复方磺胺甲噁唑片,人工加入5种菌液,稀释剂对照组的回收率均高于70%;试验组回收率均高于70%。结论对复方磺胺甲噁唑片进行微生物限度检查,细菌数测定采用培养基稀释法检验,霉菌及酵母菌数测定采用常规法检验,控制菌检查采用薄膜过滤法。

OBJECTIVE To establish the method of microbial limit test for compound sulfamethoxazole tablets.METHODS To determine the antimicrobial effect of compound sulfamethoxazole tablets by recovery with five control strains. RESULTS Dilution method was used for compound sulfamethoxazole tablets, the recovery of the control group and the tested group were higher than 70 96. CONCLUSION The methods of microbial limit test of Compound sulfamethoxazole tablets is recommended as that, dilution method is used for bacilli; the common method is used for fungi and yeast; membrane-filter procedure is used for control of bacilli.