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通过三轴压缩试验对药用粉末湿块进行表征。

Characterization of wet masses of pharmaceutical powders by triaxial compression test.

作者信息

Li J X, Zhou Y, Wu X Y, Odidi I, Odidi A

机构信息

University of Toronto, Toronto, Ontario M5S 2S2, Canada.

出版信息

J Pharm Sci. 2000 Feb;89(2):178-90. doi: 10.1002/(SICI)1520-6017(200002)89:2<178::AID-JPS5>3.0.CO;2-M.

Abstract

The mechanical and rheologic properties of wet masses of pharmaceutical powders determine their processibility and the quality of the product prepared by extrusion/spheronization. In this work, a triaxial compression test was attempted for the first time to characterize material properties of pharmaceutical wet masses of different hydrophilicity and particle sizes. The stress-strain curves and the pore pressure were determined at various cell pressures. The failure criteria of the wet masses were obtained from the stress path on the deviator stress plane. The cohesion (c) and the angle of internal friction (phi) were evaluated from the intercept and the slope of the failure loci. The stress-strain behavior strongly depended on the type of powders and cell pressure. The values of c and phi were similar for wet masses of EC FP, MCC PH101, and SMCC 50, but a very small phi and a very high c value for HPMC. The shear strength and rigidity of the wet masses were in the order of EC FP > SMCC 50 > MCC PH101 > HPMC, whereas the elastic recovery was in the opposite order. These material parameters could be used as references for selection of excipients and formulation for extrusion/spheronization.

摘要

药用粉末湿物料的机械和流变学性质决定了它们的可加工性以及通过挤出/滚圆法制备的产品质量。在这项工作中,首次尝试采用三轴压缩试验来表征不同亲水性和粒径的药用湿物料的材料特性。在不同的围压下测定应力-应变曲线和孔隙压力。湿物料的破坏准则是从偏应力平面上的应力路径获得的。内聚力(c)和内摩擦角(φ)是根据破坏轨迹的截距和斜率来评估的。应力-应变行为强烈依赖于粉末类型和围压。对于乙基纤维素(EC FP)、微晶纤维素(MCC PH101)和交联羧甲基纤维素钠(SMCC 50)的湿物料,c和φ值相似,但羟丙甲纤维素(HPMC)的φ值非常小,c值非常高。湿物料的抗剪强度和刚度顺序为EC FP > SMCC 50 > MCC PH101 > HPMC,而弹性恢复顺序相反。这些材料参数可作为挤出/滚圆法辅料选择和配方设计的参考。

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