应用因子分析法评价常用片剂辅料的形变行为

Application of factor analysis to evaluate deformation behaviors of frequently-used tablet excipients

实验考察片剂辅料物理性质和形变行为的相关性,并根据其在压缩过程中的塑性表现进行排名。测定各种辅料的物理性质后,用Korsch XP1进行压片,以Heckle方程、压缩功和模内的弹性松弛为评价形变行为的压缩参数,选择典型相关分析考察物理性质和压缩参数两者的关系,同时用因子分析法对所有辅料的形变行为进行综合评价。典型变量显示,真密度(absolute density,ρa)与塑性系数(plastic coefficient,PL)呈负相关、与屈服应力(yield pressure,YP)呈正相关,压缩度(compression degree,Cp)与PL呈正相关,弹性松弛(fast elastic stretch,FES)和YP呈负相关。结合压缩参数数据,采用因子综合得分能够将辅料分别进行塑性排名分类为高(0.56<F'<0.21)、中(0.16<F'<0.36)、低(0.38<F'<0.84)。排名结果与文献报道一致,表明因子分析可以用于评价药物粉体的形变行为。

The present work is to investigate the correlation between physical properties and deformation behaviors of tablet excipients, and rank them according to their plastic performances during compaction. The excipients selected were compacted using Korsch XP1 after measuring their physical properties where the compression parameters for evaluating deformation behaviors were Heckle equation, compression work and elastic stretch in die. The correlations between compaction descriptors and physical parameters were analyzed by canonical correlation analysis, and factor analysis was simultaneously employed to synthetically assess deformation behaviors for all our samples. The canonical variables show that true density （Pa） correlated negatively with plastic coefficient （PL） and positively with yield pressure （YP）; compression degree （Cp）correlated negatively with fast elastic stretch （FES） as well as YP and positively with PL. When factor scores were used in combination with original data, the plasticity of our samples was sorted and ranked as high （-0.56〈F^1〈0.21）, intermediate （-0.16〈F^1〈0.36）, or low （0.38〈F^1〈0.84）, which are in accord with plasticity rankings previously reported in literature. This study indicates factor analysis can be an approach to evaluate deformation behaviors of pharmaceutical powders.