中文摘要：

制粒方法和工艺影响中药颗粒的形态和结构,是决定中药固体制剂药剂学性质的主要因素之一。本文通过摇摆制粒、流化床制粒及高速搅拌制粒3种湿法制粒工艺,分别制备健胃消食颗粒并进行颗粒表征;采用同步辐射显微CT对其不规则的立体形态及内部精细结构进行定量研究。三维重构后得到颗粒的三维结构模型,以定量数据更准确地表征颗粒的结构,定量比较相同处方、不同制备工艺的颗粒在结构上的差异,进而分析工艺条件如何影响颗粒的宏观性质。针对颗粒结构的不规则性,采用盒维数方法计算获得3种颗粒的分形维度,结果表明,分形维度比常规的形态定量参数更为敏感,实现对颗粒的特异性区分,可以反映不规则结构颗粒在结构特征上的差异。研究证明,与常规结构参数相比,分形维度定量有效地表征了颗粒不规则结构的特征信息。本研究提出以实体分形维度与表面分形维度的差值（Df,c）表征不规则颗粒的结构,评价制备工艺对颗粒结构的影响,为优化和控制制粒工艺提供一个新的定量指标。

英文摘要：

The shape and structure of granules are controlled by the granulation process, which is one of the main factors to determine the nature of the solid dosage forms. In this article, three kinds of granules of a traditional Chinese medicine for improving appetite and promoting digestion, namely, Jianwei Granules, were prepared using granulation technologies as pendular granulation, high speed stirring granulation, and fluidized bed granulation and the powder properties of them were investigated. Meanwhile, synchrotron radiation X-ray computed micro tomography （SR-μCT） was applied to quantitatively determine the irregular internal structures of the granules. The three-dimensional （3D） structure models were obtained by 3D reconstruction, which were more accurately to characterize the three-dimensional structures of the particles through the quantitative data, The models were also used to quantitatively compare the structural differences of granules prepared by differentgranulation processes with the same formula, so as to characterize how the production process plays a role in the pharmaceutical behaviors of the granules. To focus on the irregularity of the particle structure, the box counting method was used to calculate the fractal dimensions of the granules. The results showed that the fractal dimension is more sensitive to reflect the minor differences in the structure features than the conventional parameters, and capable to specifically distinct granules in structure. It is proved that the fractal dimension could quantitatively characterize the structural information of irregular granules. It is the first time suggested by our research that the fractal dimension difference （Dgc） between two fractal dimension parameters, namely, the volume matrix fractal dimension and the surface matrix fractal dimension, is a new index to characterize granules with irregular structures and evaluate the effects of production processes on the structures of granules as a new indicator for the granulating process contro