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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。
OBJECTIVE: To study the preparation of nitrendipine sustained-release tablets and to investigate its in vitro release behavior. Methods: The solid dispersion of nitrendipine-Povidone (PVP) was prepared. The solid dispersion and the hydroxypropyl methylcellulose (HPMC) were made into hydrophilic gel matrix sustained-release tablets. The dosage of PVP, Release of media and other factors that affect in vitro release behavior were investigated. Results: The effect of HPMC and PVP dosage and release medium on drug release was significant. Satisfactory release effect was obtained by adjusting the ratio of prescription dosage. The in vitro release process accorded with the zero-order pharmacokinetic equation. Conclusion: The sustained-release tablets of nitrendipine prepared by this method have stable release in vitro and high cumulative release rate.