尼达尼布乙磺酸盐固体分散体的制备和性能研究  

Preparation and properties of nintedanib ethanesulfonate salt solid dispersion

作　　者：刘方方 王婷婷 LIU Fangfang;WANG Tingting(Tianjin Cancer Hospital Airport Hospital,Tianjin 300308,China;College of Pharmacy,Nankai University,Tianjin 300350,China)

机构地区：[1]天津市肿瘤医院空港医院,天津300308 [2]南开大学药学院,天津300350

出　　处：《现代药物与临床》2024年第1期88-93,共6页Drugs & Clinic

基　　金：天津市科技计划项目(22JCQNJC01610)。

摘　　要：目的 制备尼达尼布乙磺酸盐固体分散体,并考察其性能。方法 采用溶剂蒸发法制备尼达尼布乙磺酸盐固体分散体,并采用差示扫描量热法、粉末X射线衍射和傅里叶变换红外光谱进行物理表征和高温高湿稳定性考察。结果 尼达尼布乙磺酸盐与Soluplus按质量比1∶9制备固体分散体。尼达尼布乙磺酸盐以无定形存在于分散体中。温度对固体分散体基本无影响,湿度的影响较大。结论 将尼达尼布乙磺酸盐制备固体分散体提高了药物的溶解度和溶出度。Objective To prepare nintedanib ethanesulfonate salt solid dispersion and study its properties.Methods Nintedanib ethanesulfonate salt solid dispersion was prepared by solvent evaporation method,and its physical characterization and stability in high temperature and high humidity were investigated by differential scanning calorimetry(DSC),powder X-ray diffraction(PXRD),and Fourier transform infrared spectroscopy(FR-IR).Results Solid dispersions was prepared with nintedanib ethanesulfonate salt and Soluplus in a mass ratio of 1∶9.Nintedanib ethanesulfonate salt existed in an amorphous form in solid dispersion.Temperature had little effect on solid dispersion,but humidity had a greater impact.Conclusion Preparation of nintedanib ethanesulfonate salt solid dispersion can improve the solubility and dissolution of the drug.

关 键 词：尼达尼布乙磺酸盐固体分散体 尼达尼布乙磺酸盐 差示扫描量热法 粉末X射线衍射 傅里叶变换红外光谱 溶解度 溶出度 

分 类 号：R944[医药卫生—药剂学]