pH依赖型苏冰缓释微丸的制备与体外释放度研究
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田晓琳，唐 星
(沈阳药科大学 药学院，辽宁 沈阳 110016)
摘要：目的 制备 3 种pH依赖型苏冰缓释微丸，考察其在模拟胃肠道pH值连续变化的体外环境中的释药行为。方法 分别制备苏合香、冰片的β–环糊精包合物。用MCC为成丸辅料，体积分数为10%的乙醇为润湿剂，挤出滚圆法制备素丸。对素丸分别用 1 种胃溶性包衣材料(RT®包衣剂)和 2 种肠溶性包衣材料(Eudragit® L30D–55，Eudragit® L100与Eudragit® S100的混合物)包衣，制备成 3 种pH依赖型苏冰缓释微丸。将上述 3 种微丸按 2 种比例装填胶囊，制备成 2 种pH依赖型缓释微丸胶囊。结果 以苏合香中的主要成分桂皮酸为指标的体外释放度测定结果表明，两种胶囊的释放曲线均呈现出pH依赖型的梯度脉冲释药特征。结论 体外释放度的测定结果符合本实验设计的目标。
关键词：药剂学；脉冲释药；体外释放；苏合香；冰片；β–环糊精；药物微丸
中图分类号: R94 文献标识码：A
Preparation and in vitro release study of Subing pH-dependent Sustained–release Pellets
TIAN Xiao–lin，TANG Xing
( School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract: Objective To prepare three kinds of Subing pH-dependent sustained release pellets and study their drug release behaviors in the in vitro conditions simulating continuously changing gastrointestinal pH values. Method The b-CD inclusion complexes of styrax and borneol were prepared separately. Uncoated pellets were prepared by an extrusion and spheronization method, using MCC as the excipient and 10% ethanol (V/V) as the wetting agent. The uncoated pellets were coated respectively by a gastro-soluble material (RT® coating solution) and two kinds of enteric materials (Eudragit® L30D-55, the mixture of Eudragit®L100 and Eudragit®S100) to obtain three kinds of Subing pH-dependent sustained release pellets ......
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