来氟米特凝胶剂的制备与质量控制

Preparation and Quality Control of Leflunomide Chitosan Gel

目的制备来氟米特凝胶剂,并建立其质量控制方法。方法以壳聚糖为凝胶材料制备来氟米特凝胶剂,采用高效液相色谱法测定来氟米特含量。结果来氟米特质量浓度在10～100μg/mL范围内与峰面积线性关系良好,平均回收率为100.3%,RSD为0.67%(n=6)。结论制备工艺合理、简单,含量测定方法可行,制剂质量稳定。

Objective To study the preparation and quality control method of Leflunomide Chitosan Gel. Methods Chitosan as gel material was used to prepare Leflunomide Chitosan Gel. The content of leflunomide was determined by HPLC. Results The linear range was 10- 100 μg/mL of leflunomide,the average recovery rate was 100. 3% ,and RSD =0, 67% （n = 6）. Conclusion The preparing method is easy, while the assaying method is reliable,the quality of Leflunomide Chitosan Gel is stable.