盐酸曲美他嗪缓释片体外释放度研究

Preparation and in vitro release of trimetazidine dihydrochloride sustained-release tablets

目的以羟丙甲基纤维素为骨架材料制得盐酸曲美他嗪缓释片,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,辅料和加速稳定性试验对释放度的影响。结果制得的盐酸曲美他嗪缓释片具有明显的缓释作用,体外释放符合一级释药动力学规律。结论制备盐酸曲美他嗪缓释片的方法简单,适于工业化生产。

Aim Trimetazidine dihydrochloride sustained-release tablets（TDST）were formulated with hydroxypropyl-methylcellulose as the matrixmateria and the release mechanism of the tablets were determined.Methods The effects of determination methods,main excipients and accelerated stability test on the sustained-release character were studied.Results The results indicated that the TDST had an expected sustained-release quality,and drug release pattern was in accord with the first order kinetics.Conclusion The method is simple for the preparation of TDST,and useful for the large-scale production.