灯盏花素缓释片的制备及体外释放度研究

Preparation and in vitro release of Breviscapine sustained-release tablets

目的以羟丙甲基纤维素为骨架材料制得灯盏花素缓释片,并对释药机制进行探讨。方法进行体外释放度试验,研究体外释放度测定方法,以及辅料和加速稳定性试验对释放度的影响。结果制得的灯盏花素缓释片体外释放度测定结果符合缓释片质量标准中的释放度标准要求,体外释放符合一级释药动力学规律。结论制备灯盏花素缓释片缓释效果明显,方法简单,适于工业化生产。

OBJECTIVE Breviscapine sustained-release tablets （BST） were formulated with hydroxypropyl-methylcellulose as the matrix material and the release mechanism of the tablets was studied. METHODS The effects of determination methods, main excipients and accelerated stability test on the sustained-release character were studied. RESULTS The release results of BST coincided with sustained-release quality standard, and drug release pattern was in accorded with the first order kinetics. CONCLUSION BST has a good sustained-release behavior, while the preparation method is simple, and reasonable in large-scale production.