祁小乐, 朱家壁, 陈盛君. 双氯芬酸钠肠溶微丸型片剂的研制J. 药学学报, 2008, 43(1): 97-101.
引用本文: 祁小乐, 朱家壁, 陈盛君. 双氯芬酸钠肠溶微丸型片剂的研制J. 药学学报, 2008, 43(1): 97-101.
QI Xiao-le, ZHU Jia-bi CHEN Sheng-jun, . Preparation of tablets containing enteric-coated diclofenac sodium pelletsJ. Acta Pharmaceutica Sinica, 2008, 43(1): 97-101.
Citation: QI Xiao-le, ZHU Jia-bi CHEN Sheng-jun, . Preparation of tablets containing enteric-coated diclofenac sodium pelletsJ. Acta Pharmaceutica Sinica, 2008, 43(1): 97-101.

双氯芬酸钠肠溶微丸型片剂的研制

Preparation of tablets containing enteric-coated diclofenac sodium pellets

  • 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。

     

    Abstract: 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.

     

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