依达拉奉滴丸体外溶出度测定

Determination of Dissolution Rate of Edaravone Dropping Pills

目的建立测定依达拉奉滴丸中依达拉奉溶出度的方法。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依达拉奉的溶出度，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。结果依达拉奉的检测浓度在0．1000～1．000mg·mL^-1（r=0．9996）范围内与其峰面积积分值呈良好的线性关系；依达拉奉的平均回收率为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，可用于测定依达拉奉滴丸中主要组分的溶出度。

Objective To determine the dissolution rates of Edaravone in Edaravone dropping 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 Edaravone were determined by HPLC. The dissolution curves were drawn, and the dissolution parameters including T50, Td, and were computed and evaluated using similar factors method. Results The Edaravone were linear over the range of 0.1000～ 1.0000mg·mL^-1 （r=0.9996）. 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 Edaravone in Edaravone dropping pills simultaneously.