【作者】 刘波；

【导师】 葛志强； 王春龙；

【作者基本信息】 天津大学 ， 制药工程， 2007， 硕士

【摘要】 为了克服目前市售的格列喹酮普通片剂的不足,将格列喹酮制备成微型缓释片胶囊,本文对微型缓释片胶囊的制备工艺和处方设计进行了优化。取得了以下结果:(1)通过研究在不同pH条件下的溶解度和油水分配系数制定有效的给药途径和给药形式。选择亲水凝胶型骨架、不溶性骨架还有混合型骨架三种骨架作为主要的释放骨架。经过对比三种骨架的释放和其影响因素选择出合适的释放骨架。应用混合设计、正交设计以及效应面设计三种方法对处方设计进行了优化。在制备工艺的研究中,选择单因素试验方法考察了颗粒的粉体学参数以及润滑剂用量,比表面积,微型片硬度等参数对微型缓释片胶囊释放的影响。采用单指数模型、零级动力学方程拟合、Higuchi方程还有Peppas Ritger方程对释放进行拟合寻找出最佳释放模型。并使用分段拟合研究了组合释放规律。(2)选择亲水凝胶型骨架作为微型缓释片胶囊的释放骨架,并使用混合设计对处方进行最终的优化。在对微型片制备工艺进行研究后选择20片/胶囊,微型片硬度为0.5-1.0kg等参数。对其释放机理研究中使用Higuchi方程拟合效果最佳。更多还原

【Abstract】 Gliquidone Sustained Release Minitablets Capsule was prepared through studying prepared technology and exploring formulation optimization in order to overcome the disadvantage of Gliquidone tablets. Following is result:(1)Make effective drug delivery system through studying solubility and oil-water partition. Choose gel matrix, insolvent matrix and mixture matrix as main release matrix. Select proper matrix from these 3 kind release matrixs through the factor experiment. Comparing the mixture design, surface reaction design and orthogonal design in the process of formulation design. In preparation technology research, we used single factor design to study the impaction of particle character, quantity of lubricant, surface area and hardness of minitablets to release of sustained release tablets capsule. The release mechanism is simulated by follow model such as Single Exponent Model, Kinetics Model, Higuchi Model and Ritger Peppas Model.(2)Gel matrix is choosed as final matrix and mixture design is used to optimize the whole process. The parameter of sustained release minitablets capsule is 20 tablets/capsule and hardness of 0.5-1.0 kg. The most proper simulated model is Higuchi Model.更多还原