中国药物评价2023,Vol.40Issue(6):489-493,5.
磷酸苯丙哌林多晶型制备、表征及平衡溶解度研究
Preparation,Characterization and Equilibrium Solubility of Benproperine Phosphate Polymorphs
摘要
Abstract
Objective:The polymorphs research of benproperine phosphate provides technical support for improvement of API quality and production process.Methods:Three different crystal forms of benproperine phosphate which were diffrent from API crystal form were obtained by recrystallization in different solvents.Four crystal forms of benproperine phosphate were characterized by powder X-ray diffrac-tometer,scanning electron microscope,differential scanning calorimetry and thermogravimetric analysis,melting point determination and infrared absorption spectrum,and their equilibrium solubility in different pH buffers was determined.Results:Four different crystal forms of benproperine phosphate had different X-ray characteristic peaks,and the appearance and morphology of electron microscope are also ob-viously different.The equilibrium solubility of three new crystal forms in three kinds of buffers was significantly improved.Conclusion:By adjusting the crystallization solvent of benproperine phosphate,the crystal forms with better equilibrium solubility can be obtained.关键词
磷酸苯丙哌林/多晶型/表征/平衡溶解度Key words
Benproperine phosphate/Polymorphs/Characterization/Equilibrium solubility分类
医药卫生引用本文复制引用
徐桂连,董斌,韩春晖,郝爱鱼..磷酸苯丙哌林多晶型制备、表征及平衡溶解度研究[J].中国药物评价,2023,40(6):489-493,5.基金项目
2021年大连市青年科技之星项目(磷酸苯丙哌林(咳快好)生产工艺风险管控关键评价技术研究,课题编号:2021RQ032) (磷酸苯丙哌林(咳快好)