伊拉地平缓释胶囊的制备工艺及体外释药研究

发布时间：2018-05-10 05:31

本文选题：伊拉地平 + 缓释胶囊　；参考：《药物分析杂志》2015年03期

【摘要】：目的:研究伊拉地平缓释胶囊制备工艺,并对其体外释药进行考察。方法:采用醇溶上药法(流化床底喷装置)制备伊拉地平微丸,并进行伊拉地平微丸质量评价及粉体学性质研究。用乙基纤维素(EC)和羟丙甲基纤维素(HPMC)为包衣材料,采用流化床进行包衣制备伊拉地平缓释微丸,对缓释微丸体外释放进行评价并考察不同热处理时间以及人工胃液对缓释微丸药物释放的影响,同时对批内和批间释药情况进行比较。结果:制备得到的伊拉地平微丸质量良好,不同热处理时间(1~12 h)对于伊拉地平缓释微丸的释药特性影响不大,在制备过程中可不进行热处理,干燥即可。人工胃液会显著地降低伊拉地平缓释微丸的释药速率,宜将其置于肠溶胶囊中。伊拉地平缓释微丸批间及批内重复性较好,在0.1%十二烷基二甲基氧化胺溶液12 h释放符合零级释药模型动力学过程。结论:制备得到的伊拉地平缓释胶囊缓释效果好,达到了释药要求。
[Abstract]:Objective: to study the preparation process and in vitro release of iladipine sustained-release capsules. Methods: Eladipine pellets were prepared by alcohol solution method (fluidized bed bottom spray device), and the quality evaluation and powder properties of the pellets were studied. Eiladipine sustained-release pellets were prepared by using ethylcellulose (EC) and hydroxypropyl methyl cellulose (HPMC) as coating materials in a fluidized bed. The in vitro release of sustained-release pellets was evaluated and the effects of different heat treatment time and artificial gastric juice on the release of sustained-release pellets were investigated. Results: the quality of the prepared pellets was good, and the effect of different heat treatment time on the release characteristics of the pellets was not significant. The pellets could be dried without heat treatment during the preparation. Artificial gastric juice can significantly reduce the release rate of Eladipine sustained-release pellets, which should be placed in enteric capsules. The inter- and intra-batch reproducibility of iradipine sustained-release pellets was good, and the release in 0.1% dodecyl dimethyl amine solution for 12 h was in accordance with the kinetic process of zero-order release model. Conclusion: the sustained release effect of the prepared sustained release capsules is good and meets the requirements of drug release.
【作者单位】：乐山职业技术学院;重庆康刻尔制药有限公司;
【分类号】：R943

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