结肠定位释药双氯芬酸钠包衣片体内外相关性

目的研制时间依赖型口服结肠定位释药双氯芬酸钠包衣片。方法用释放度测定法研究双氯芬酸钠包衣片体外释放行为 ,用HPLC法测定包衣片在家犬体内的血药浓度 ,并计算出相关参数 ,进行体内外相关性考察。结果体外平均延迟释放时间为 4～ 5h时 ,体内平均时滞为 3～ 6h ,达到预期结果。结论本文研制的双氯芬酸钠片有进一步开发的价值

Studies on the coated diclofenac sodium tablets for the colon-specific delivery

Objective To develop a time dependent colon specific delivery system using the diclofenac sodium as a model drug and ethylcellulose (EC) as the coating material. Methods The behaviors of the colon specific delivery coated tablets were evaluated in vitro by the dissolution tests. The pharmacokinetics of the diclofenac sodium tablets with the 10% pore former, 5% coat weight and with the 15% pore former, 7 3% coat weight was studied by HPLC. The correlation between in vitro release and in vivo absorption was evaluated. Results The result indicated that DCF was released at a maximum rate between 3 8 and 6 h in vivo which corresponded to the colonic arrival time as expected. Conclusions This article provided the technology available for the colon specific drug delivery using time as the release trigger.