流化床包衣法制备天麻效应组分缓释微丸的研究

Study on the Preparation of Sustained-release Pellets Containing Active Components from Gastrodia elata by Fluid-bed Coating

目的:在天麻效应组分速释微丸的基础上,采用流化床底喷包衣法制备天麻效应组分缓释微丸。方法:以Eudragit(RS 100为主要包衣材料,用挤出滚圆机制备天麻素效应组分速释微丸,单因素考察法优化包衣液处方,并评价微丸的粉体学性质和体外释放度。结果:微丸粉体学性质良好,体外释放曲线符合H iguch i动力学方程,在12 h内具有缓慢的释药作用。包衣增重和增塑剂的用量是影响微丸释药速率的主要因素,抗粘剂滑石粉对微丸的释药速率影响不大,但可防止微丸的粘结。结论:制备的天麻效应组分缓释微丸具有明显的缓释作用。

Objective： To study the formulation of sustained-release pellets containig active components from Gastrodia elata by coating in the fluid-bed. Methods： The sustained-release pellets were prepared with Eudragit RS 100. The formulation was optimized by the direct comparison. Then their properties were evaluated. Results ： The pellets presented the perfect sphericity and narrow diameter distribution and the curve of their cumulative drug release was in accord with Higuchi equation. Conclusion ： The pellets have sustained-release effect in 12 hours.