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通过均匀设计优化了乌拉地尔肠溶膜控片的包衣液处方 ,采用旋转锅包衣技术制备乌拉地尔肠溶膜控片并与德国产缓释胶囊进行了体内药动学比较 .该制剂的体外释放符合零级动力学方程 ,其药物的释放主要受包衣厚度、包衣液中致孔剂和增塑剂的用量的影响 .体内动态过程符合单室模型 ,主要药动学参数为Tmax =3h ,Cmax =6 37 6 7ng·mL-1,T1/ 2Ke =3 5 5h ,AUC =3 5 6 3 9ng·mL-1·h .乌拉地尔肠溶膜控片体内外测定数据具有相关性 .
The formulation of the coating solution of urapidil enteric-coated tablets was optimized by uniform design, and the enalapril enteric-coated tablets were prepared by rotary pan coating and compared with the German-made sustained-release capsules in vivo. The release in vitro was in accordance with the zero-order kinetic equation.The release of the drug was mainly affected by the thickness of the coating and the amount of porogen and plasticizer in the coating solution.The in vivo dynamic process was in accordance with the single-compartment model and the main pharmacokinetic parameters Tmax = 3h, Cmax = 6 37 6 7ng · mL-1, T1 / 2Ke = 35h, AUC = 3563 ng · mL-1 · h. Determination of urapidil enteric-coated tablets in vitro and in vivo Relevant.