目的:建立同时测定天宁滴丸中天麻素和阿魏酸溶出度的方法。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天麻素、阿魏酸的溶出度,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:天麻素、阿魏酸的检测浓度分别在0.0118-0.1180mg·mL^-1(r=0.9992)、0.0048-0.0480mg·mL^-1(r=0.9996)范围内与各自的峰面积积分值呈良好的线性关系;天麻素的平均回收率为97.96%(RSD=2.06%),阿魏酸的平均回收率为98.10%(RSD=2.26%)。3批样品溶出度相似。结论:本方法简便、准确、可靠,能同时测定天宁滴丸中2组分的溶出度。
OBJECTIVE: To determine the dissolution rates of Gastrodin and Ferulic acid in Tianning drop pills simultaneously. METHODS: The small glass cup method was adopted in which 0.1 mol·L^- 1 hydrochloric acid was taken as solvent with a rotating speed of 50 r · min^-1. The dissolution rates of Gastrodin and Ferulic acid 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 Gastrodin and Ferulic acid were linear over the range of 0.011 8-0.118 0 mg · mL^-1 ( r = 0.999 2) and 0.004 8-0.048 0 mg · mL^-1( r = 0.999 6), respectively. The average recoveries of the two ingredients were 97.96% (RSD = 2.06% ) and 98.10% (RSD = 2.26% ), respectively. 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 gastrodin and ferulic acid in Tianning drop pills simultaneously.