左乙拉西坦缓释微丸的研究

Study on Levetiracetam Sustained-release Pellets

摘要: 目的研究左乙拉西坦(levetiracetam，LEV)缓释微丸的制备工艺及其对体外释药的影响。方法采用挤出滚圆法制备LEV含药丸芯，以Surelease? E-7-19010为缓释包衣材料，采用流化床包衣技术制备LEV缓释微丸。结果 LEV缓释微丸的12 h体外释放符合一级释药特征。有无致孔剂、包衣材料的用量、含药丸芯的大小对缓释微丸的体外释药行为有影响，而转篮转速对于缓释微丸的体外释药行为无显著影响。结论自制的缓释微丸工艺简便，具有良好的缓释特征。

Abstract: OBJECTIVE To study the formulation and influence factors of drug release in vitro of the levetiracetam sustained-release pellets. METHODS Levetiracetam sustained-release pellets were prepared by extrusion-spheronisation method, and in a fluidized bed coating system using Surelease? E-7-19010 as coating materials. RESULTS The drug release in vitro of the levetiracetam sustained-release pellets accords with first-order release in 12 h. Porogen, coating weight and pellets size had effect on the drug release rate. While the rotating speed had little effect on it within a certain range. CONCLUSION A simple preparation method of the levetiracetam sustained-release pellets was developed. The pellets can reach the obvious sustained-release characteristics.