复方制霉菌素软膏中新霉素微生物检定法研究

Study on Microbiological Potency Measurement of Neomycin in Compound Nystatin Ointment

为了提高复方制霉菌素软膏中新霉素微生物检定法的准确性和可靠性,对其进行了细化和完善。通过试验菌株制备、抗生素浓度范围及双碟制备等方面明确了复方制霉菌素软膏中新霉素微生物检定法各检测指标,并对所得方法进行了验证。结果显示复方制霉菌素软膏中新霉素微生物检定法在4.58~21.84 U/mL范围内线性关系良好,高中低三个浓度的准确度在97.07%~102.63%之间,方法重复性及中间精密度良好(RSD分别为1.5%、1.4%),且方法耐受性和稳定性较优。因此该方法可以作为复方制霉菌素软膏常规质量控制方法。

In order to improve the accuracy and reliability of the microbiological assay for neomycin in compound nystatin ointment,it was refined and improved.Through the preparation of test strains,the range of antibiotic concentration and the preparation of double discs,the detection indexes of the microbial detection method for neomycin in compound nystatin ointment were clarified,and the obtained method was verified.The results showed that the microbial detection method of neomycin in compound nystatin ointment had a good linear relationship in the range of 4.58~21.84 U/mL,and had the high accuracy,medium and low concentrations was between 97.07%~102.63%.The repeatability and intermediate precision of the method were good(RSD was 1.5%and 1.4%,respectively),and the tolerance and stability of the method were better.Therefore,this method can be used as a routine quality control method for compound nystatin ointment.