制霉素搽剂质量控制与稳定性研究

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8．03216．064μg·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。

Quality Control and Stability of Nysfungin Liniment

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.