复方维生素E乳膏的制备及质量控制

Preparation and Quality Control of Compound Vitamin E Cream

目的制备复方维生素E乳膏,并建立质量控制方法。方法将维生素E、山莨菪碱等药物与乳膏基质制成复方制剂,并用高效液相色谱法测定维生素E的含量。结果维生素E质量浓度在104.9～839.0μg/mL范围内与峰面积线性关系良好(r=0.9994),平均回收率为97.70%,RSD=0.94%(n=9)。结论该制剂制备工艺简单,质量控制方法切实可行。

Objective To prepare compound vitamin E cream, and to establish the methods of content assay for the quality control. Methods The compound cream was prepared with vitamin E, raceanisodamine, cream base, and the consistency of vitamin E could be determined with HPLC. Results The standard curve was linear over the range of 104. 9 - 839.0 μg/mL of vitamin E with r = 0. 999 4. The average recovery rate and RSD of vitamin E were 97.70%, 0.94% （n = 9） respectively, Conclusion The preparation method was simple and controllable in quality.