组合小片胶囊释放行为的研究及其数学模型嵌合组合小片胶囊释放行为的研究及其数学模型嵌合

目的制备硝苯地平(nifedipine，NP)的速释小片、缓释小片以及不同时滞的脉冲小片和延缓小片，多途径组合实现多次脉冲释药、定位释药、定速释药及快/慢释药系统等。方法采用非线性最小二乘法模型嵌合通用程序求出各小片释药的速率方程，比较4种方案的组合释药理论速率-时间曲线与实测值的差异。结果速率方程较为准确地描述了单片释药行为，速率-时间曲线中各种组合的体外释药实测值与各模拟方程迭加形成的理论曲线较接近，表明组合释药行为是可以理论表征的，因而组合设计可控，组合效应可预估。结论通过加和速率方程可预测由各种小片不同用量、不同组合灌装于胶囊内形成的多种释药行为。

Studies on combined release behaviors of versatile mini-tablets in capsule systems and fittings of their mathematical model

Aim To prepare nifedipine(NP) rapid release mini tablet, sustained release mini tablets, pulsed release mini tablets and delayed onset sustained release mini tablets and develop multiplied pulsed drug delivery system (DDS), site specific DDS, zero order DDS and quick/slow DDS by various ways. Methods Velocity time ( v t ) equation of each mini tablet was deduced by non linear least square model fit. The difference of combinations in v t profiles between theoretical value and test value was compared. Results According to the v t equations, the combined release behaviors were observed directly from v t profiles and the test values coincided with the theoretical profiles. Conclusion The programmed DDS, which consist of a variety of mini tablets with different dosages and combinations in capsules, could be predicted by summing up the v t equation of each tablet.