氟比洛芬凝胶剂的制备与质量控制

Preparation and Quality Control of Flurbiprofen Gel

目的研制氟比洛芬凝胶剂,并建立其质量控制方法。方法选用壳聚糖为凝胶材料制备氟比洛芬凝胶剂,采用紫外分光光度法进行定性鉴别,采用高效液相色谱法测定氟比洛芬含量。结果氟比洛芬质量浓度在10～100μg/mL范围内与峰面积线性关系良好,平均回收率为99.93%,RSD为1.15%。结论该制剂制备工艺合理,质量控制方法可靠。

Objective To prepare flurbiprofen gel and to establish a standard for quality control. Methods To prepare flurbiprofen gel with chitosan as the gel materials. Spectrophotometry was used for qualitative differentiation, and high performance liquid chromatography（HPLC） was used to determine the content of flurbiprofen. Results The linear relationship range of flurbiprofen was 10- 100 μg/mL, while average recovery rate was 99.93%, and RSD was 1.15%. Conclusion The method for preparing is reasonable, the quality control method is reliable.