维生素E微球凝胶的配制及其包封率测定

Preparation and quality control of vitamin E microsphere gels

目的:制备维生素E微球凝胶(GMS)并建立其质量控制方法.方法:采用四因素三水平的正交设计法筛选GMS的优化处方;采用紫外二阶导数光谱法测定其中维生素E的含量.结果:所制备凝胶性状、鉴别等均符合2005年版《中国药典》相关规定.维生素E在0.1～0.4g/L浓度范围内呈良好的线性关系(r=0.9994),平均回收率为99.2%,RSD=0.75%(n=9).结论:本制剂制备工艺简便可行,质量稳定可控.

AIM： To prepare vitamin E microsphere gels and to establish the quality control method. METHODS： Four factors and three levels of orthogonal design were used to optimize the prescription. Second derivative ultraviolet spectroscopy method was used to determine the vitamin E content. RESULTS： The prepared gels met the descriptions of China Pharmacopeia （2005 edition） in property and identification, etc. The linear range of vitamin E was 0. 1-0.4 g/L （ r = 0. 9994 ） and the average recovery rate was 99.2% （RSD =0.75% , n =9）. CONCLUSION： The established technique of this preparation is simple and feasible, and its quality is stable and controllable.