不同药用辅料流化床制粒的物性质量分析研究

目的研究5种药用辅料制粒后颗粒的物性指标,分析探讨颗粒物性指标的相关性及颗粒物性质量。方法采用Pearson相关性分析法分析颗粒的7项评价指标相关性,采用主成分分析法对颗粒物性指标进行主成分分析和综合评价。结果粒径分布宽度与松密度及振实密度呈极显著正相关,松密度与振实密度呈极显著正相关,振实密度与压缩度呈显著正相关。对第一主成分产生正向影响较大的物性指标是粒径分布宽度和振实密度。乳糖+水制成的颗粒及甘露醇+水制成的颗粒综合评价得分较高,可溶性淀粉+HPMC制成的颗粒综合评价得分最低。结论不同药用辅料制成的颗粒物性质量存在差异,乳糖和甘露醇分别以水为粘合剂制成的颗粒物性质量较好,可溶性淀粉以HPMC为粘合剂制成的颗粒物性质量较差。

Study on the Properties and Quality of Fluid-bed Granulation with Different Pharmaceutical Excipients

Objective To explore the influence of fluid-bed granulation with five different excipients on the properties and quality of the granules.Methods The correlation among the seven evaluation indicators is studied using the Pearson approach.Principal component analysis method is used to analyze and evaluate the particulate.Results The distribution of the particles size is striking positive with the apparent density and tap density of the granules,the correlations between apparent density and tap density,tap density and compressibility are positive,repectively.The particle size distribution width and tap density is found to be the first principal and principal indicators.The comprehensive evaluation scores of lactose+water particles and mannitol+water particles rank first two places.Conclusions Different excipients have different effect on the properties of the granules.The quality of particles made of lactose+water and mannitol+water as binder are better,the quality of particles made of soluble starch+HPMC as binder is worse.