李苑新,龚炜,袁旭江,朱盛山
LI Yuan-xin, GONG Wei, YUAN Xu-jiang, ZHU Sheng-shan (Research and Development Institute of Chinese Materia Medica

• 1:广东药学院中药开发研究所
• 2:广东药学院中药开发研究所
• 3:广东药学院中药开发研究所
• 4:广东药学院中药开发研究所 广州510240

摘要(Abstract)：

目的建立罗通定缓释片体外释放度测定方法,评价其体外释药行为。方法用紫外分光光度法和体外释放度试验,考察罗通定缓释片在不同释放介质中和不同释放时间的累积释放度。结果罗通定在281nm处有最大吸收,在5~25μg/ml内与吸收度呈良好的线性关系:Y=0.0143X+0.0378,r=0.9999。罗通定缓释片在人工胃液中的体外释药行为理想符合Higuchi方程:Mt/M∞=0.3933t1/2-0.2274,r=0.9992。结论本法简便、快速,适用于罗通定缓释片的质量控制。
Objective To establish a UV method to determine the release degree of rotundine sustained-release tablets and to evaluate its in-vitro release behavior. Methods Ultraviolet spectrophotometry was applied to determine the release degree of rotundine sustained-release tablets with different release mediums. Results Rotundine had the highest absorptive peak at 281 nm mavelenth and a good linearity in the range of 5～250 μg/ml (Y=0.0143X+0.0378, r=0.9999). Rotundine sustained-release tablets had a good release behavior in gastric juice, which fits the Higuchi Square: M_t/M_∞=0.3933t~ 1/2 -0.2274, r=0.9992. Conclusion This method is simple, rapid, and can be used for the quality control of rotundine sustained-release tablets.

关键词(KeyWords)： 罗通定缓释片;释放度;紫外分光光度法
rotundine sustained-release tablets; release degree; ultraviolet spectrophotometry

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金资助项目(30472198);; 广东省自然科学基金资助项目(04105450)

作者(Author): 李苑新,龚炜,袁旭江,朱盛山
LI Yuan-xin, GONG Wei, YUAN Xu-jiang, ZHU Sheng-shan (Research and Development Institute of Chinese Materia Medica

参考文献(References)：

• [1]赵巧玲,高永良.罗通定双层片的体外释放度研究[J].科学技术与工程,2005,5(9):565.
• [2]国家药典委员会.中国药典(2005年版)二部[S].北京:化学工业出版社,2005:339、附录74、180.