盐酸二甲双胍缓释片释药因素考察及处方筛选

目的制备盐酸二甲双胍缓释片并对释药因素进行考察。方法采用HPMC为基本骨架材料制备了盐酸二甲双胍骨架片 ,对影响释药的因素 ,如HPMC规格、粘合剂的种类、润滑剂的用量、制片工艺、制片压力及释放介质 pH等进行了考察 ,并在此基础上进行处方的筛选。结果盐酸二甲双胍缓释骨架片的体外释药行为符合Higuchi方程 ,HPMC规格和制片压力对盐酸二甲双胍骨架片的释药几乎无影响 ,而粘合剂的种类 ,润滑剂的用量 ,制片工艺对药物的释放产生一定的影响 ,介质的pH对药物释放的影响较大。结论采用HPMC作为基本骨架材料 ,结合其他辅料 ,制备了日服 1次的盐酸二甲双胍缓释片

Studies on the factors influencing Metformin Hydrochloride release from matrix tablets and the optimizition of formulation

Objective To prepare the metformin hydrochloride sustained-release tablets(MH-SRT) and study the influencing factors.Methods The metformin hydrochloride sustained-release tablets(MH-SRT) were prepared by HPMC as the matrix material.The effects of the viscosity of HPMC,sort of an adhensive,amount of a lubricant,and the preparation methods on the release of MH from matrix tablets were observed.On the basis of pharmaceutical preformulation studies,the preparation technique and optimized formulation of MH-SRT were determined by the orthogonal design test according to cumulative percent of drug release.Results The release behavior of the tablets follows the Higuchi equation.The viscosity of HPMC,the compression force has no significant effects on the release of MH-SRT,while the sort of an adhensive,amount of a lubricant and the preparation methods influcence the release of MH-SRT to some degree.The pH of the dissolving solution has significant effects.Conclusions Combining with other filers,a sustained release tablet (SRT) of once daily administration is prepared by using hydropropyl methylcellulose as the basic matrix material.