盐酸二甲双胍缓释片的制备工艺及体外释放度研究  

Preparation and in vitro release of metformin hydrochloride sustained release tablets

作　　者：张永春[1] 左立[1] 马毅[1] 刘书庆[1] 李艳[1] 

机构地区：[1]山东轻工业学院化学工程学院,山东济南250100

出　　处：《山东轻工业学院学报（自然科学版）》2006年第1期20-24,共5页Journal of Shandong Polytechnic University

摘　　要：制备盐酸二甲双胍缓释片,并建立测定其释放度的方法。采用羟丙甲纤维素(HPMC)为缓释材料制备盐酸二甲双胍缓释片,用紫外分光光度法测定其释放度。考察了填充剂的种类、粘合剂的种类对本品释放度的影响,并采用正交试验进行处方优化。依据最优处方制备了三批缓释片。与盐酸二甲双胍普通片比较,本品有显著的缓释效果,其体外释放度曲线12g内符合Higuchi方程。The paper discussed how to prepare metfoumin hydrochlofide sustained release tablets（MH - SRT） and establish a detecting method of drug release. The tablets were prepared by using hydrox- ypropymethylcellose（HPMC）as the extended matrix material. The release rate of tablets was measured by UV. The effects of a filler and an adhesive on the release of mefformin hydrochloride 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. Three batch of sustained release tablets were prepared according to the optimized formulation. In vitro releasing properties of the sustained release tablets were compared with normal metformin hydrochloride tablets. The release behavior of the tablets follows the Higuchi equation within 12 hours.

关 键 词：盐酸二甲双胍 缓释片 羟丙纤维素(MPMC) HIGUCHI方程 

分 类 号：R944.9[医药卫生—药剂学]