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灯盏花素固体分散体缓释片的制备及其体外释药特性考察
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| 篇名： | 灯盏花素固体分散体缓释片的制备及其体外释药特性考察 |
| TITLE： | |
| 摘要： | 目的：制备灯盏花素固体分散体缓释片并考察其体外释药特性。方法：采用热熔挤出法制备固体分散体，以溶出度为指标，采用单因素试验优选载体材料和药载比；通过扫描电镜观察灯盏花素在固体分散体中的状态；以羟丙基纤维素（HPMC）K15M为骨架材料、乳糖为填充剂、硬脂酸镁为润滑剂、微粉硅胶为助流剂，全粉末压片制备灯盏花素缓释片，并与市售灯盏花素片的体外累计溶出度进行比较，并对所制缓释片体外药物释放动力学特征进行拟合。结果：最优载体为聚乙烯吡咯烷酮（PVP）VA64，最优药载比为1 ∶ 5；所制固体分散体1 h时累计溶出度为99.61％，灯盏花素在固体分散体中无明显晶型存在。市售片在1 h内药物体外累计溶出度即达98％以上，而所制缓释片12 h累计溶出度为98％左右；所制缓释片的体外释药行为符合零级药物释放动力学特征。结论：成功制得具有缓释作用的灯盏花素缓释片，且工艺简单可行。 |
| ABSTRACT： | OBJECTIVE： To prepare Breviscapine solid dispersion sustained-release tablet and investigate its drug release property. METHODS： The solid dispersion was prepared by hot melt extrusion method. Using dissolution rate as index， single factor test was used to optimize drug-loading material and drug-loading ratio. The status of breviscapine in solid dispersion were investigated by SEM. Breviscapine sustained-release tablet was prepared by total powder tabletting using HPMC K15M as framework material， lactose as filler， magnesium stearate as lubricant， gum arabic as flow aid. Drug release property in vitro of Breviscapine sustained- release tablet was compared with commercial Breviscapine tablet. The dynamic character of drug release process was fitted. RESULTS： The optimal carrier was PVP VA64， and optimal drug-loading ratio was 1 ∶ 5； accumulative dissolution rate of prepared solid dispersion was 99.61％ within 1 h； breviscapine crystal form hadn’t been found in solid dispersion. Accumulative dissolution rate of commercial tablet reached 98％ above within 1 h， while that of prepared tablet was about 98％ within 12 h. Drug release behavior of prepared tablet fitted to zero-order drug release dynamic characters. CONCLUSIONS： Breviscapine sustained-release tablet is prepared successfully， and the preparation technology is simple and practical. |
| 期刊： | 2016年第27卷第4期 |
| 作者： | 刘柳毅，黄德恩，李庆国 |
| AUTHORS： | LIU Liuyi，HUANG De’en，LI Qingguo |
| 关键字： | 灯盏花素；热熔挤出技术；固体分散体；缓释片 |
| KEYWORDS： | Breviscapine； Hot melt extrusion； Solid dispersion； Sustained-release tablet |
| 阅读数： | 356 次 |
| 本月下载数： | 6 次 |
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