目的: 制备盐酸地尔硫卓缓释脉冲控释微丸胶囊。方法: 采用丙烯酸树脂Ⅱ号和微晶纤维素
( MCC) 为骨架材料制备盐酸地尔硫卓缓释微丸; 采用低取代羟丙基纤维素( Low Substituted Hydroxypropylcellulose
L － HPC) 为内层溶胀材料，选用乙基纤维素水分散体( Surelease) 为外层控释材料制备脉冲微丸。将两种微
丸混合后制成缓释脉冲微丸胶囊，同时考察体外溶出度的影响因素。结果: 体外释放试验证明，缓释微丸体外
12h 可持续释12h，脉冲微丸体外可达到时滞为4h，滞后1． 5 h，累积释药80%以上的脉冲释药效果。两种微丸
按比例混合后，其释药机制符合一级释药模型，达到良好的混合释放效果。结论:该制剂具有良好的缓释与脉冲
效果。

Objective: To study the preparation of sustained － release and pulsatile pelletsof Diltiazem
Hydrochloride( DIL) ． Methods: To preparation sustained － release solid dispersion of DIL with acrylic
resinⅡand MCC; The cores of pulstile pellets were prepared by extrusion － spheronization and
coated with low － substitued hydroxypropylcellulose( L － HPC) as the inner swelling layer and ethylcellulose
aqueous dispersion( Surelease) as the outer controlled layer． The two kinds of pellets mixed to
preparation Sustained － release and Pulsatile Pellets． Results: The sustained － release pellets can release
to 12h; The pulstile release pellets，with a lag time of 4h and more than 80% released within following
1． 5h under the simulated gastro － intestinal pH conditons． To mixed two kinds of pelltes can
meet the requirements of preparation． Conclusion: The pellets have an ideal sustained － release and
pulsatile release．

R944． 5

 收稿日期: 2013 － 11 － 26; 修回日期: 2014 － 01 － 10
基金项目: 内蒙古自然科学基金( 2009MS 1202)
作者简介: 张晓晖( 1978 － ) ，女，内蒙古医科大学附院主管药师，药学硕士。