【摘要】 目的:磷酸苯丙哌林多晶型的研究，为磷酸苯丙哌林原料药生产工艺的改进及质量的提升提供技术支持。方法:采用不同溶剂重结晶获得3种不同于原料药晶型的磷酸苯丙哌林。采用粉末X射线衍射仪、电镜扫描、差示扫描量热及热重分析、熔点测定、红外吸收光谱表征了4种磷酸苯丙哌林晶型，并使用高效液相色谱法测定了4种晶型在不同pH缓冲液中的平衡溶解度。结果:重结晶的磷酸苯丙哌林具有不同的X射线特征峰，电镜外观形貌也存在明显差异，且重结晶获得的3种晶型的平衡溶解度均高于原料药晶型。结论:可通过对磷酸苯丙哌林原料药结晶溶剂的调整，获得表观溶解度更好的晶型。更多还原

【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 diffractometer, 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 obviously 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.更多还原