羟基红花黄色素A肠溶微丸的研究

Study on hydroxysafflor yellow A enteric pellets

目的制备羟基红花黄色素A(hydroxysafflor yellow A,HSY-A)微丸,对体外释药和体内动力学特性进行考察。方法采用挤出滚圆-流化床包衣技术制备HSY-A微丸,考察粉体学性质,研究影响体外释药的处方因素,通过数学原理和相关模型探讨其释放行为和机制,评价其在体内的口服吸收的药物动力学特征。结果 HSY-A微丸体外释放更符合Ritger-peppas动力学方程,以扩散形式释放药物,体内吸收试验进一步说明其在胃中不释放,具有良好的肠溶特性。结论本研究获得较为满意的HSY-A微丸,达到预期的目的。

Objective To prepare the hydroxysafflor yellow A (HSY-A)enteric coating pellets,and investigate in vitro release and in vivo pharmacokinetic characteristics.Methods HSY-A enteric coating pellets were prepared by extrude-rounding and fluid bed technique.The micromeritic characteristics,the factors affecting the release properties of enteric coating pellets the release mechanism were explored,and the in vivo pharmacokinetic behaviors were also evaluated.Results The in vitro release behavior of HSY-A from enteric coating pellets could be described by Ritger-peppas equation,and fit diffusion mechanism,in vivo pharmacokinetic test confirmed the argument that pellets have good acid residence and enteric properties. Conclusion HSY-A enteric coating pellets have been successfully prepared and the expected release properties is achieved in the study.