中文摘要：

在挤出滚圆法制备微丸中，挤出物的特征物理性质直接影响微丸的成型质量，是微丸处方、工艺研究的核心因素。研究表明，挤出物的表面粗糙度是挤出物特征物理性质之一，与微丸成型质量具有重要的相关性。以蒸馏水为润湿剂，以微晶纤维素、白前提取物为原料制备挤出物，采用显微镜获取挤出物图片，以粒度粒形分析仪的软件进行图片分析，建立并确定了基于等效周长椭圆的表面粗糙度表征方程。方法学考察结果表明，本法具有较高的精密度、准确性、灵敏度。进一步采用本法考察润湿剂不同用量下得到的不同挤出物的表面粗糙度，及表面粗糙度与微丸成型性的关联。结果表明，对于不同的原料，挤出物表面粗糙度对微丸成型性的影响不同。

英文摘要：

The physical properties of extrudates have direct effects on the quality of the final products in the extrusion-spheronization process, which are the key factors for the research of pharmaceutical formulation and process optimization. The previous studies showed that the surface roughness of extrudates was one of the important physical properties, which also had a significant effect on the pellet formation. The extrudates of Baiqian extract and microcrystalline cellulose with different amounts of moistening agent, distilled water, were prepared by extrusion- spheronization process. Their images were made by the microscope and their surface roughness were analyzed by the particle shape and size analyzer. The equation for surface roughness based on the perimeter of ellipse with the equivalent area was established and confirmed in this paper. The results of methodological validation showed that this method had well precision, accuracy and sensitivity. Furthermore, the surface roughness values of the extrudates with different amounts of moistening agent were calculated by this method, and the correlation between the surface roughness and the formation of pellets was also investigated. The results showed that there were different effects of surface roughness of extrudes containing different raw materials on pellet formation.