氧氟沙星凝胶的制备及质量控制

Preparation and Quality Control of Ofloxacin Gel

目的:制备氧氟沙星凝胶,建立其质量控制标准。方法:以0.5%卡波姆940为凝胶基质制备氧氟沙星凝胶剂,采用紫外分光光度法于293 nm处测定制剂中氧氟沙星的含量。结果:氧氟沙星在浓度2～20μg.mL-1范围内与吸收度有良好的线性关系。其平均回收率为99.83%,RSD为0.69%(n=6)。结论:该制剂状态稳定,制备工艺改进科学合理,操作简单,且质量控制方法准确可靠。

OBJECTIVE： To prepare Ofloxacin gel and to establish the standard for its quality control.METHODS： The Ofloxacin gel was prepared using 0.5% Carbopol-940 as the matrix;the content of Ofloxacin in the gel was determined by UV spectrophotometry（with detecting wavelength of 293 nm）.RESULTS： The linear range of Ofloxacin was 2-20 μg·mL-1,with an average recovery rate of 99.83%（RSD=0.69%,n=6）.CONCLUSION： The preparation was stable in quality;the improvement of the preparation technology was scientific,reasonable and simple,and the method for the quality control of the Ofloxacin gel was accurate and reliable.