双氯芬酸钠肠溶微丸型片剂的研制  

Preparation of tablets containing enteric-coated diclofenac sodium pellets

作　　者：祁小乐[1] 朱家壁[1] 陈盛君[2] 

机构地区：[1]中国药科大学药剂研究所,江苏南京210038 [2]南京师范大学超分子材料及应用重点实验室,江苏南京210009

出　　处：《药学学报》2008年第1期97-101,共5页Acta Pharmaceutica Sinica

基　　金：国家自然科学基金资助项目(30672549).

摘　　要：本文制备了双氯芬酸钠肠溶微丸型片剂。以丙烯酸树脂Eudragit NE30D和Eudragit L30D-55不同比例的混合物作为衣膜材料,对不同粒径大小的双氯芬酸钠速释丸芯进行不同增重水平的包衣,并与不同压缩特性和用量比例的缓冲微丸混合,压片。所得的双氯芬酸钠肠溶微丸型片剂在人工胃液中2 h内累积释放百分数<10%,在人工肠液中1 h内累积释放百分数为(83±2.42)%。结果表明Eudragit NE30D与Eudragit L30D-55以一定比例混合制备得到适合压片的肠溶微丸,硬脂酸制备的缓冲微丸可用于微丸型片剂的制备。Fluidized-bed manufactured enteric-coated diclofenac sodium pellets were compressed into tablets. The blend of two aqueous acrylic resins dispersion in different ratios, Eudragit NE30D and Eudragit L30D-55, were used to prepare enteric-coated diclofenac sodium pellets of different particle sizes and coating level. The cushioning pellets with different properties and these enteric-coated pellets were compressed into tablets in different proportions. The drug release of the tablets containing these pellets would be lower than 10% in 2 h in simulated gastric fluid, but reach （83±2.42）% in 1 h in simulated enteric fluid. The mixture of Eudragit NE30D and Eudragit L30D-55 could be used to prepare enteric pellets which are suitable for compression. The cushioning pellets which were composed of stearic acid/microcrystalline cellulose （4： 1, w/w） could avoid rupture of the coating of pellets during the compression.

关 键 词：肠溶微丸 微丸压片 释药行为 丙烯酸树脂 

分 类 号：R943.4[医药卫生—药剂学]