左乙拉西坦缓释微丸的研究

林丽峰; 曲艳国; 韩晓妮; 潘英; 韩凌

引用本文:	林丽峰,曲艳国,韩晓妮,潘英,韩凌.左乙拉西坦缓释微丸的研究[J].中国现代应用药学,2013,30(5):496-499.
	LIN Lifeng,QU Yanguo,HAN Xiaoni,PAN Ying,HAN Ling.Study on Levetiracetam Sustained-release Pellets[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(5):496-499.

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左乙拉西坦缓释微丸的研究
林丽峰¹, 曲艳国¹, 韩晓妮¹, 潘英², 韩凌¹
1.本溪国家中成药工程技术研究中心有限公司，辽宁本溪 117004;2.辽宁华润本溪三药有限公司，辽宁本溪 117004

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。

关键词: 左乙拉西坦缓释微丸

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Study on Levetiracetam Sustained-release Pellets

LIN Lifeng¹, QU Yanguo¹, HAN Xiaoni¹, PAN Ying², HAN Ling¹

1.National Engineering Research Center for the Pharmaceutics of Traditional Chinese Medicines Co., Ltd.，Benxi 117004, China;2.Liaoning CR Benxi Third Pharmaceutical Co., Ltd., Benxi 117004, China

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.

Key words: levetiracetam sustained-release pellets