论文部分内容阅读
分别采用热熔挤出法、溶剂挥发和熔融冷却法制备了硝苯地平/Soluplus/Kollidon SR固体分散体(即HMESD、SESD和FCSD),并采用结合FT-IR光谱、拉曼光谱和计算方法 (PCA和HCA)的综合评价方法来考察各固体分散体的光谱特征,以对各样品进行区分。此外,采用DSC、PXRD和SEM分析方法表征各样品,并考察了各样品的溶出曲线和加速条件下的物理稳定性。结果表明,采用不同方法制备的固体分散体在溶出行为和老化趋势上存在明显差异,通过上述综合评价方法可以很容易地区分出用不同方法制备的产品。硝苯地平与聚合物之
The solid dispersions of Nifedipine / Soluplus / Kollidon SR (ie, HMESD, SESD and FCSD) were prepared by hot melt extrusion, solvent evaporation and melt cooling respectively. FT-IR spectra, Raman spectra and calculation methods (PCA and HCA) comprehensive evaluation method to examine the spectral characteristics of each solid dispersion, in order to distinguish between the various samples. In addition, DSC, PXRD and SEM analysis were used to characterize each sample, and the dissolution curves of each sample and the physical stability under accelerated conditions were investigated. The results show that the solid dispersions prepared by different methods have obvious differences in the dissolution behavior and the aging trend. The products prepared by different methods can be easily distinguished by the above comprehensive evaluation methods. Nifedipine and polymers