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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/m L)、检出限(2.0 U/m L)和稳定性,且DMSO方法的灵敏度、定量下限(LOQ,3.0 U/m L)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 using dimethyl sulfoxide (DMSO) instead of N, N-dimethylformamide (DMF) for nystatin titer determination. Methods Nystatin was dissolved in DMSO and DMF, respectively, and the nystatin titer was detected by the antibiotic - microorganism assay in the US Pharmacopoeia. Results Both DMF and DMSO had good accuracy, precision, specificity, linearity (10.0-40.0 U / mL), detection limit (2.0 U / mL) and stability. The sensitivity of the DMSO method, The lower limit of quantification (LOQ, 3.0 U / m L) is better than DMF. Conclusion DMSO was used as a solvent in the nystatin activity assay because DMSO toxicity was significantly lower than that of DMF and the analytical performance characteristics of the DMSO method were comparable to or better than the DMF method.