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目的 探讨二甲基亚砜(DMSO)代替N,N-二甲基甲酰胺(DMF)用于制霉菌素效价测定的可行性.方法 制霉菌素分别用DMSO和DMF溶解,采用美国药典中抗生素-微生物测定法检测制霉菌素效价.结果 DMF和DMSO均有较好的准确性、精密度、特异性、线性范围(10.0-40.0 U/mL)、检出限(2.0 U/mL)和稳定性,且DMSO方法的灵敏度、定量下限(LOQ,3.0 U/mL)优于DMF.结论 鉴于DMSO毒性明显低于DMF,且DMSO方法的分析性能特征与DMF法相当甚或更好,故DMSO可代替DMF作为溶剂用于制霉菌素活性测定.“,”Objective To investigate the feasibility of dimethyl sulfoxide (DMSO) instead of N,N-dimethyl formamide (DMF) as a solvent for the nystatin potency assay.Methods Nystatin was dissolved in DMSO or DMF,and its potency was determined using antibiotic microbial assay of the United States Pharmacopeia (USP).Results Both DMF and DMSO methods had satisfied accuracy,precision,specificity,linear range (10.0-40.0 U/mL),limit of detection (2.0 U/mL) and robustness.Meanwhile,DMSO method has higher sensitivity and lower limit of quantitation (LOQ,3.0 U/mL) than DMF method.Conclusion Since DMSO has much less toxicity than DMF,and DMSO method has equivalent or even better analytical performance characteristics than DMF method,DMSO may be a good candidate to replace DMF as the solvent for the determination of nystatin activity.