胡海洋,宋华先,陈大为,刘丹
HU Hai-yang,SONG Hua-xian,CHEN Da-wei,LIU Dan(School of Pharmacy

• 1:沈阳药科大学药学院
• 2:沈阳药科大学药学院
• 3:沈阳药科大学药学院
• 4:沈阳药科大学药学院 辽宁沈阳110016

摘要(Abstract)：

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.Results 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.

关键词(KeyWords)： 盐酸川芎嗪;定时释药微丸;挤出滚圆法;流化床包衣
ligustrazine hydrochloride;timed release pellets;extrusion-spheronization;fluidized bed spray coater

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 胡海洋,宋华先,陈大为,刘丹
HU Hai-yang,SONG Hua-xian,CHEN Da-wei,LIU Dan(School of Pharmacy

参考文献(References)：

• [1]何绍雄.时间药理学与时间治疗学[M].天津:天津科学技术出版社,1994:114-120.
• [2]张静,平其能.口服择时释药系统[J].药学进展,1999,23(5):265-269.
• [3]邓翠娥.川芎嗪的药理作用及临床应用[J].时珍国医国药,2001,12(7):656-657.
• [4]SCHULTZ P,KLEI NEBUDDE P.Anew multiparticu-late delayed release system.PartⅠ:Dissolution proper-ties and release mechanism[J].J Contr Rel,1997,47:181-189.
• [5]NARISAWA S,NAGATA M,HIRAKAWA Y,et al.An organic acid-induced sigmoidal release systermfor o-ral controlled-release preparations.Ⅲ.Elucidation of theanomalous drug release behavior through osmotic pump-ing mechanism[J].Int J Pharm,1997,148(1):85-91.
• [6]傅崇东,张瑜,徐惠南.增塑剂及热处理对水性包衣美沙拉秦结肠靶向微丸体外释药的影响[J].中国医药工业杂志,2000,31(4):149-151.
• [7]BODMEIER R,PAERATAKUL O.Dry and wet strengthof polymeric films prepared froman aqueous colloidal poly-mer dispersion[J].Int J Pharm,1993,96:129-138.