尼群地平缓释片的制备及体外释放

目的:研究尼群地平(nitrendipine)缓释片的制备,以及考察其缓释片的体外释放行为。方法:制备尼群地平-聚维酮(PVP)固体分散体,将此固体分散体与羟丙甲纤维素(HPMC)制成亲水凝胶骨架缓释片,并对PVP用量、HPMC用量和释放介质等影响体外释药行为的因素进行了考察。结果:HPMC与PVP用量及其释放介质对药物释放行为影响显著,通过调节处方用量比例获得满意的释放效果,其体外释药过程符合零级药动学方程。结论:该法制备的尼群地平缓释片,其体外释药平稳、累积释放率高。

Preparation of Nitrendipine Sustained Release Tablets and Its Release in Vitro

Objective： To study the preparation of nitrendipine sustained-release tablets and to investigate the release behavior in vitro. Methods： The Nitrendipine-PVP solid dispersion was first prepared, and then mixed with HPMC to prepare gel-matrix sustained-release tablets. The influence of HPMC, PVP and release media on the release profiles was studied. Results： The release behavior was affected by the amount of HPMC, PVP and release media obviously. Desired release behavior could be obtained by adjusting the amount of HPMC and PVP. The release kinetics in vitro obeyed zero-order equation. Conclusion： The nitrendipine sustained-release tablets prepared by this method have a stable and complete release in viro.