制霉素搽剂质量控制与稳定性研究

Quality Control and Stability of Nysfungin Liniment

目的建立制霉素搽剂质量控制方法并对稳定性进行考察。方法采用紫外分光光度法测定制霉素搽剂含量,并建立相应质量控制指标,采用经典恒温法和留样试验考察稳定性。结果制霉素在304nm处有最大吸收,浓度线性范围为8.032～16.064μg·mL^(-1)(r=0.9999),平均回收率为98.66%,RSD为0.73%,在冷处保存有效期3个多月。结论制霉素搽剂质量控制方法简便、准确,在冷处保存质量较稳定。

OBJECTIVE To establish the quality control method of Nysfungin Liniment and test its stability. METHODS The content of Nysfungin Liniment was determined by UV-Spectroph otometry and the relative indicators of quality control was established, the stability was tested by classical constant temperature experiment and storage experiment. RESULTS The largest absorbability was at a wavelength of 304nm, The linear range of Nysfungin Liniment was 8. 032-16. 064μg·mL^-1 （ r = 0. 9999）, and its average recovery was 98.66 % （RSD = 0.73 % ）. It was stored for 3 months in refrigeration. CONCLUSION The method of quality control is convenient and accurate, the quaihy is stable comparatively in refrigeration.