泮托拉唑钠肠溶微丸型片剂的制备Preparationof-药学学报.PDFVIP

96 药学学报 Acta Pharmaceutica Sinica 20 11, 46 ( 1) : 96 10 1 泮托拉唑钠肠溶微丸型片剂的制备 1, 2 1 1* 陈眉眉 , 王成润 , 金 一 ( 1. 浙江大学药学院, 浙江 杭州 310058; 2. 延边大学药学院, 吉林 延吉 133000) 摘要: 研究泮托拉唑钠肠溶微丸型片剂制备方法。采用流化床包衣法制备泮托拉唑钠肠溶微丸, 将肠溶微丸 与适合的辅料混合采用直接压片法制备泮托拉唑钠微丸型片剂。用体外释放度法及扫描电镜法观察压片前后药 物的体外累计释放量及微丸形态。结果表明, 优化处方: 衣膜增重 55%, 增塑剂含量 20%, Eudragit L30D-55/ NE30D 为8 ∶2, 肠溶微丸/辅料 (MCC/PPVP/PEG 6000, 2 ∶1 ∶1) 为5 ∶5 时, 肠溶片在0.1 mol L− 1 盐酸中2 h 累 积释放百分数 10%, pH 6.8 磷酸盐缓冲 中1 h 累积释放百分数85% 。制备的泮托拉唑钠肠溶微丸片的释药行 为较好, 有望应用于工业生产。 关键词: 泮托拉唑钠; 肠溶微丸; 微丸压片 中图分类号: R943 文献标识码:A 文章编号: 05 13-4870 (20 11) 01-0096-06 Preparation of pantoprazole sodium enteric-coated pellets-type tablets 1, 2 1 1* CHEN Mei-mei , WANG Cheng-run , JIN Yi (1. College of Pharmaceutical Sciences, Zhej iang University, Hangzhou 310058, China; 2. College of Pharmaceutical Sciences, Yanbian University, Yanj i 133000, China) Abstract: This study is to prepare the pantoprazole sodium enteric-coated tablet which is compacted by pellets. The enteric-coated pantoprazole sodium pellets were prepared by fluid bed coating technology. The pantoprazole sodium enteric-coated tablets were prepared by direct compression of the enteric-coated pellets and suitable excipients. In vitro dissolution method and scanning electron microscope method were used for the observation of the drug release behavior before and after compression of the pellets. The optimized formulation is: the coating level is 55%, the plas