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

作　　者：黄冬[1] 吴雪梅[1] 李朝晖[1] 钟智[1] 钟震邦[2] 

机构地区：[1]广东医学院附属医院药学部,广东湛江524001 [2]南方医科大学南方医院药学部,广东广州510515

出　　处：《第四军医大学学报》2009年第2期153-155,共3页Journal of the Fourth Military Medical University

摘　　要：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.

关 键 词：维生素E 微球体 凝胶类 药物调剂 质量控制 

分 类 号：R932[医药卫生—生药学]