武汉工程大学学报2018，Vol.40Issue(2)：144-148,155,6.DOI:10.3969/j.issn.1674⁃2869.2018.02.005
苯甲酸阿格列汀片处方工艺的研究及其溶出度评价
Formulation Process Research and Dissolution Evaluation of Alogliptin Benzoate Tablets
摘要
Abstract
To screen the optimal prescription formulation process of the alogliptin benzoate tablets,the ratio of mannitol to microcrystalline cellulose,the amount of 3% HPMC solution,the amount of croscarmellose sodium and its ratio of inside addition to outside addition were optimized with the L9(34)orthogonal test.The friability, hardness,dissolution rate and main component of these self-prepared alogliptin benzoate tablets were also detected. And the dissolution curves of the self-prepared tablets were compared with those of the commercial tablets under the import standard. The optimized formulation of alogliptin benzoate tablet(1 000 pieces)was found to be comprised of 34 g of alogliptin benzoate,50 g of mannitol,50 g of microcrystalline cellulose,62 g of 3% HPMC solution,20 g of microcrystalline cellulose inner-added,10 g of microcrystalline cellulose external-added,1.6 g of magnesium stearate.The friability,hardness,disintegration time and main component of three batches of alogliptin benzoate tablets prepared by optimized prescription were 0.17%-0.21%, 9.9 kgf-10.3 kgf,230 s-240 s and 99.9%,respectively. Similar factors f2of dissolution curves for prepared tables and commercial tablets were above 80 under the import standard. The dissolution behavior of prepared tablets is similar to that of commercial tables.The optimized formulation is rational.关键词
处方工艺/溶出度/相似因子/苯甲酸阿格列汀片剂Key words
formulation process/dissolution/similarity factor/alogliptin benzoate tablets分类
化学化工引用本文复制引用
周博,冯菊红,胡学雷,吴志飞..苯甲酸阿格列汀片处方工艺的研究及其溶出度评价[J].武汉工程大学学报,2018,40(2):144-148,155,6.基金项目
湖北省自然科学基金(2011CDA048) （2011CDA048）
武汉工程大学研究生创新基金(CX2016090) （CX2016090）
