[关键词]
[摘要]
目的: 建立测定槐定碱滴丸中槐定碱溶出度的方法。方法: 选用小杯法,以0. 1mol /L 盐酸为溶出介
质,转速为50 r·min-1 ,用高效液相色谱法测定槐定碱的溶出度,绘制溶出曲线,计算溶出参数T50、Td、m,并用相
似因子法进行评价。结果: 槐定碱的检测浓度在6. 25 ~ 100μg·mL-1( r = 0. 9997) 范围内与其峰面积积分值呈良
好的线性关系; 槐定碱的平均回收率为98. 23% ( RSD = 2. 17%) ,3 批样品溶出度相似。结论: 本方法简便、准
确、可靠,可用于测定槐定碱滴丸中主要组分的溶出度。
[Key word]
[Abstract]
Objective: To determine the dissolution rates of Sophoridine in Sophoridine dropping
pills. Methods: The smal 1 glass cup method was adopted in which 0. 1mol /Lhydrochloric acid was
taken as solvent with a rotating speed of 50 r·min-1 . The dissolution rates of Sophoridine were determined
by RP-HPLC. The dissolution curves were drawn,and the dissolution parameters including T50,
Td,and m were computed and evaluated using similar factors method.Results: The Sophoridine were
linear over the range of 6. 25 ~ 100μg·mL-1( r = 0. 9997) . The average recoveries of the ingredients
were 98. 23%( RSD = 2. 17%) . The three batches samples were proved to be of similar dissolution
rates. Conclusion: The determination method is simple,accurate and reliable,which can be applied to
determine the dissolution rates of Sophoridine in Sophoridine dropping pills simultaneously.
[中图分类号]
R917
[基金项目]
收稿日期: 2014-03-19; 修回日期: 2014-06-08
基金项目: 国家自然科学基金( 81260269) ; 内蒙古自然科学基金( 2012MS1149)
作者简介: 张兰( 1962-) ,男,内蒙古医科大学第一附属医院药剂科副主任药师。
通讯作者: 刘乐乐,教授,硕士研究生导师E-mail: liulele8821@ sina. com 内蒙古医科大学药学院, 010110