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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。
Objective To study the preparation process of levetiracetam (LEV) sustained-release pellets and its effect on drug release in vitro. Methods The LEV pellets were prepared by extrusion spheronization. The sustained-release pellets of LEV were prepared by using Surelease E-7-19010 as the sustained-release coating material and the fluidized bed coating technique. Results The release of LEV sustained release pellets in 12 h was in line with the characteristics of primary release. The presence or absence of porogen and the amount of coating material, the size of drug-containing pellets affected the in vitro release behavior of sustained-release pellets, while the spin-drying speed had no significant effect on sustained-release pellets in vitro release behavior. Conclusion The self-made sustained-release pellets have the advantages of simple process and good sustained-release characteristics.