罗通定双层片的体外释放度研究

Study on the Drug Release of Rotundine Sustained Released Tablets

建立罗通定双层片释放度测定方法并考察影响释放度的因素。以人工胃液为释放介质,采用紫外分光光度法,检测波长281nm,对其进行常规的方法学研究。本法的平均回收率符合要求,在(6.00-60.00)μg/mL范围内浓度与吸收度线性良好;转速对释放度无显著性影响;硬度对双层片的早期释药行为有显著性影响,对中、后期释药行为无显著性影响。本法适用于该制剂的质量控制;双层片在体外具有良好的速释和缓释特征。

To establish the drug release method of rotundine double-layer tablets(RD) and investigate the factors affecting the dissolubility, simulated gastric fluid was used as solvent,detected wave length was 281 nm. The recoverives accorded with the standard, the line range was (6. 00-60. 00) μg/mL, rotation speed did not affect dissolution speed significantly, hardness of tablets had a significant effect on dissolution only at the beginning of the test. It is suitable for the quatility control of the preparation. RD shows good properties of fast and sustained release.