槐定碱滴丸体外溶出度测定

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-1盐酸为溶出介质,转速为50r·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98.79%(RSD=2.43%),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。

Determination of Dissolution Rate of Sophoridine Dropping Pills

Objective：To determine the dissolution rates of Sophoridine in Sophoridine dropping pills. Methods： The small glass cup method was adopted in which 0.1mol·L-1 hydrochloric acid was taken as solvent with a rotating speed of 50r·min-1.The dissolution rates of Sophoridine were determined by 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 98.79%（RSD=2.43%）.The three batches samples were proved to be of similar dissolution rates.Conclusions： The determination method is simple, accurate and reliable, which can be applied to determine the dissolution rates of Sophoridine in Sophoridine dropping pills.