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[含肠溶包衣双氯芬酸钠微丸的片剂的制备]

[Preparation of tablets containing enteric-coated diclofenac sodium pellets].

作者信息

Qi Xiao-Le, Zhu Jia-Bi, Chen Sheng-Jun

机构信息

Pharmaceutical Research Institute, China Pharmaceutical University, Nanjing 210038, China.

出版信息

Yao Xue Xue Bao. 2008 Jan;43(1):97-101.

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.

摘要

将流化床制得的肠溶包衣双氯芬酸钠微丸压制成片剂。使用不同比例的两种水性丙烯酸树脂分散体(尤特奇NE30D和尤特奇L30D-55)的混合物制备不同粒径和包衣水平的肠溶包衣双氯芬酸钠微丸。将具有不同性质的缓冲微丸和这些肠溶包衣微丸按不同比例压制成片剂。含这些微丸的片剂在模拟胃液中2小时内药物释放低于10%,但在模拟肠液中1小时内达到(83±2.42)%。尤特奇NE30D和尤特奇L30D-55的混合物可用于制备适合压制的肠溶微丸。由硬脂酸/微晶纤维素(4:1,w/w)组成的缓冲微丸可避免压制过程中微丸包衣破裂。

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