乳酸左氧氟沙星乳膏的制备与质量控制

Preparation and quality control of levofloxacin-lactic acid cream

目的:制备左旋氧氟沙星乳膏,建立质量控制方法。方法:以左旋氧氟沙星为主药,10%硬脂酸、4.6%单硬脂酸甘油脂、0.46%对羟基苯甲酸乙酯、1%甘油,2%十八醇、12%凡士林、2%三乙醇胺组成O/W型乳膏,制备左旋氧氟沙星乳膏。用荧光分光光度计在325nm处用共振瑞利散射法测定左旋氧氟沙星的含量,建立质量控制方法。结果:其线性范围为1～15.2mg/L,平均回收率为100.14%,RSD为1.93%。结论:制备方法和质量控制方法简便、快捷、准确。

Objective：To prepare levofloxacin cream and establish its quality control.Methods：Stearic acid 10%, Wikipedia 4.6% ,Ethylparaben 0.46% ,glycerin 1% ,stearyl alcohol 2% ,Vaseline 12% and Triethanolamine 2% were used to prepare levofloxacin cream in the type of O/W.The quality control of levofloxacin cream was established.The content of the ingredient, levofloxacin was determined by Resonance Raleigh Scattering （RRS） at wave length of 325 nm. Results：The line arrange was 1-15.2 mg/L,the average rate of recovery was 100.14% with RSD of 1.93%.Conclusion：The preparation and quality control is simple, quick and accurate.