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
黄冬 1吴雪梅 1李朝晖 1钟智 1钟震邦2
作者信息
- 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
- 折叠
摘要
目的:制备维生索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0.1～0.4 g/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.
Abstract
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Key words
vitamin E/microspheres/gels/drug compounding/quality control引用本文复制引用
出版年
2009
NETL
NSTL
维普
万方数据