摘要
目的研制氢溴酸加兰他敏缓释片并建立释放度测定方法。方法用正交设计优选处方,以单硬脂酸甘油酯、Eudragit L100-55为主要缓释材料,考察其用量及滑石粉用量对缓释片的影响。用紫外-可见分光光度法测定主药含量,并根据《中国药典》2005年版释放度测定方法,建立了体外释放度测定方法。结果氢溴酸加兰他敏缓释片在24 h内呈现良好的缓释特征,释药行为符合Higuchi方程,制备工艺及释放度测定方法简单易行。结论该氢溴酸加兰他敏缓释片处方设计合理,可进一步研究开发。
AIM To prepare sustained release tablets of galantamine hydrobromide and determine its dissolution profile. METHODS Orthogonal design was utilized to obtain the best formula. Glycerin Monostearate and eudragit L100-55 were used as sustained release material to prepare the sustained-release tablets and impact of their amount and the amount of talcum powder was investigated. The assay of galantamine hydrobromide was determined by UV spectrophotometric analysis and the measure of the drug release in vitro was set up according to the method of Chinese Pharmacopoeia （2005）. RESULTS The sustained release tablets can continuously release for 24 h and the dissolution curves in vitro showed that the drag release could be best described by the H.iguchi equation. The methods of manufacture and determination were simple also. CONCLUSION The formula of the sustained release tablets is reasonable and it is worth doing further research.
出处
《江苏药学与临床研究》
2006年第4期215-217,共3页
Jiangsu Pharmacertical and Clinical Research
关键词
氢溴酸加兰他敏
缓释片
释放度
Galantamine hydrobromide
Sustained release tables
Percentage of release
