布洛芬缓释片的制备及其体外释放度考察

目的:研制布洛芬缓释片并建立其体外释放度测定方法。方法:以亲水性凝胶骨架材料羟丙基甲基纤维素制备布洛芬缓释片。采用高效液相色谱法测定其含量,根据《中国药典》2010年版篮法,以磷酸盐缓冲液为溶出介质、转速为150r·min-1测定3批样品的体外释放度,进行批间重现性和同一批样品的均一性(1、3、6、8h)考察。结果:所制3批缓释片在8h内释放基本完成,批间重现性良好;同一批样品在1、3、6、8h各取样时间点,释放度的RSD值分别为0.45%、1.89%、1.88%、1.31%,批间差异小。结论:布洛芬缓释片的制备方法简单、质量稳定,建立的体外释放度测定方法简便、快速,易于操作。

Preparation of Ibuprofen Sustained-release Tablet and Its Release Rate in Vitro

OBJECTIVE： To study and prepare Ibuprofen sustained-release tablets and to establish determination method for release rate of it in vitro. METHODS： Ibuprofen sustained-release tablet was prepared using hydrophilic gel framework material. The content of Ibuprofen sustained release tablets was determined by HPLC. Aceoding to stirring basket method stated in Chinese Phar- macopeia （2010 edition）, phosphate buffer solution was used as solvent at rotating speed of 150 r·min^-1 to determine release rate of 3 batches of samples in vitro. Repeatability of different batches and homogeneity of the same batch of samples （1, 3, 6, 8 h） were investigated. RESULTS ： 3 batches of sustained-release tablet released completely within 8 h with sound repeatability. The RSDs of dissolution rate of the same batch of samples at 1, 3, 6, 8 h were 0.45%, 1.89%, 1.88%, 1.31%. There was small difference among different batches. CONCLUSION： Established preparation method is simple and stable, and the method for in vitro dissolution rate determination is convenient, rapid and easy to do.