元胡止痛分散片中延胡索乙素的体外溶出度研究

A dissolution study of tetrahydropalmatine in Yuanhu analgesia dispersible tablets

目的:探讨元胡止痛分散片中延胡索乙素的体外溶出度及溶出动力学。方法:采用小杯法,考察不同pH的溶液中延胡索乙素的溶出情况,选择合适的溶出介质;以自制普通片为参比制剂,采用HPLC法测定2制剂的累积溶出度,并分别用零级动力学、一级动力学、Highchi方程、Weibull方程进行溶出动力学拟合。结果:分散片中延胡索乙素的溶出受pH影响较大,在pH值1的盐酸溶液中溶出快而完全;与普通片相比,分散片溶出速率快,其溶出过程可用一级动力学或Weibull分布模型较好地拟合。结论:元胡止痛分散片在pH值1介质中的体外溶出动力学符合一级动力学或Weibull分布模型,具有速释作用。

Objective： To analyze the dissolution of tetrahydropalmatine in Yuanhu analgesia dispersible tablets. Methods： A reverse-phase HPLC method was developed to determine the dissolution of tetrahydropalmatine. Dissolution media was optimized by comparing the dissolution of tetrahydropalmatine in different pH solutions. Dissolution behavior of the dispersible tablets was investigated using several dynamic models. Results： The dissolution rate of tetrahydropalmatine was closely dependent on the pH environment. The tetrahydropalmatine showed the fastest and the most complete dissolution at pH 1. The dissolution behavior of the dispersible tablets obeyed one order model or Weibull distributing model. Conclusion： The tetrahydropalmatine in Yuanhu analgesia dispersible tablets featured rapid release.