盐酸川芎嗪口服定时释药微丸的制备

Preparation of oral timed release pellets of ligustrazine hydrochloride

目的制备盐酸川芎嗪口服定时释药微丸。方法采用挤出滚圆法制备丸芯,底喷式流化床进行包衣,内层包衣选用水溶胀性高分子材料,外层包衣选用惰性高分子材料,考察了溶胀层、控释层及增塑剂的种类和用量等因素对药物释放的影响。结果随着溶胀层厚度的增加,释药时滞有一定程度的缩短;外层膜厚度增加或增塑剂用量增加,可显著延长时滞。结论制备盐酸川芎嗪口服定时释药微丸是可行的。

Objective To prepare oral timed release pellets of ligustrazine hydrochloride. Methods The core pellets were prepared by extrusion-spheronization and then coated on a mini-fluidized bed spray coater with swelling agent as the inner layer and water insoluble material as the outer layer respectively. Then, some factors were investigated, such as the type and amount of the inner and outer layers, and the plasticizer, etc. Resuits The lag time was shortened to some extent with the increase of the thickness of the inner layer, but prolonged with the increase of the outer layer or the amount of the plasticizer. Conclusion The preparation of the ligustrazine hydrochloride timed release pellets is feasible.