复方尿囊素乳膏的制备及质量控制

Preparation and Quality Control of Compound Allantoin Cream

目的制备复方尿囊素乳膏,并建立质量控制方法。方法将尿囊素、维生素E等药物和乳膏基质制成复方制剂,并采用高效液相色谱法测定尿囊素的含量。结果尿囊素质量浓度在65.12～520.96μg/mL范围内与峰面积线性关系良好(r=0.9998),平均回收率为100.2%,RSD为0.46%。结论该制剂制备简单,质量控制方法切实可行。

Objective To prepare Compound Allantoin Cream, and to establish the methods of content assay for the quality control. Methods The cream was prepared with allantoin, vitamin E, cream base. The content of allantoin was determined with HPLC. Results The standard curve was linear over the range of 65.12-520.96 μg/mL of allantoin with r =0. 999 8. The average recovery rate and RSD of allantoin were 100. 2% and 0. 46% respectively. Conclusion The preparation method is simple and controllable in quality.