本文選題：伊拉地平 + 緩釋膠囊　； 參考：《藥物分析雜志》2015年03期

【摘要】：目的:研究伊拉地平緩釋膠囊制備工藝,并對(duì)其體外釋藥進(jìn)行考察。方法:采用醇溶上藥法(流化床底噴裝置)制備伊拉地平微丸,并進(jìn)行伊拉地平微丸質(zhì)量評(píng)價(jià)及粉體學(xué)性質(zhì)研究。用乙基纖維素(EC)和羥丙甲基纖維素(HPMC)為包衣材料,采用流化床進(jìn)行包衣制備伊拉地平緩釋微丸,對(duì)緩釋微丸體外釋放進(jìn)行評(píng)價(jià)并考察不同熱處理時(shí)間以及人工胃液對(duì)緩釋微丸藥物釋放的影響,同時(shí)對(duì)批內(nèi)和批間釋藥情況進(jìn)行比較。結(jié)果:制備得到的伊拉地平微丸質(zhì)量良好,不同熱處理時(shí)間(1~12 h)對(duì)于伊拉地平緩釋微丸的釋藥特性影響不大,在制備過程中可不進(jìn)行熱處理,干燥即可。人工胃液會(huì)顯著地降低伊拉地平緩釋微丸的釋藥速率,宜將其置于腸溶膠囊中。伊拉地平緩釋微丸批間及批內(nèi)重復(fù)性較好,在0.1%十二烷基二甲基氧化胺溶液12 h釋放符合零級(jí)釋藥模型動(dòng)力學(xué)過程。結(jié)論:制備得到的伊拉地平緩釋膠囊緩釋效果好,達(dá)到了釋藥要求。
[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.
【作者單位】： 樂山職業(yè)技術(shù)學(xué)院;重慶康刻爾制藥有限公司;
【分類號(hào)】：R943

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本文編號(hào)：1867978