目的 针对参苓白术散粉体学性质及粉体改性工艺进行研究，为粉体改性技术在中药固体制剂中的适宜性研究奠定基础。方法 借鉴材料学及药学科学领域对粉体的表征和评价方法，通过L₉（3⁴）正交试验对参苓白术散复合粒子制备工艺进行优化，并对复合粒子进行扫描电镜测定（SEM）、红外测定（IR）、X射线衍射分析（XRD）等表面特性的评价。结果 处方饮片粉体学性质研究表明，物料粉碎粒径与粉碎时间具有良好的相关性，以处方比例称取适量人参、山药、莲子、白扁豆、薏苡仁、桔梗粗粉（过3号筛）投入超微粉碎机中，于-10℃粉碎45 min后加入白术、茯苓、砂仁、甘草粗粉继续粉碎4 min，作为复合粒子的最优制备工艺。制备的复合粒子形态良好，制备工艺稳定可行。结论 通过粉体改性技术解决了传统散剂制备过程中易出现的粉体学缺陷，为粉体改性技术用于提升中药固体制剂品质，推动散剂、丸剂等传统剂型的开发与升级提供了实验依据。

Objective To study the powder properties and powder modification technology of Shenling Baizhu Pulvis (SBP), so as to lay a foundation for the study of the suitability of powder modification technology in the solid preparation of traditional Chinese medicine. Methods The characterization and evaluation methods of powder in the field of materials science and pharmaceutical science were used for reference to evaluate the grouping of single medicinal materials in the particle design and the process rationality of composite particles. The preparation process of composite particles of SBP was optimized by L₉(3⁴) orthogonal test, and the surface properties of the composite particles were evaluated by SEM, IR and XRD. Results The study on the powder properties of prescription raw materials showed that there was a good correlation between the grinding time and the particle size. Finally, the best process for composite particles was as following:the pulverization temperature for powders of Ginseng Radix et Rhizoma, Dioscoreag Rhizoma, Nelumbinis Semen, Lablab Semen Album, Coicis Semen and Platycodonis Radix was −10℃ for 45 min, and then pulverization for another 4 min after adding with Atractylodis Macrocephalae Rhizoma, Poria, Amomi Fructus and Glycyrrhizae Radix et Rhizoma. The results showed that the composite particles were well formed and the preparation process was stable and feasible. Conclusion The powder modification technology solves the powder defects in the preparation process of traditional powder, which provides experimental basis for powder modification technology to improve the quality of traditional Chinese medicine solid preparation and promote the development and upgrading of powder, pill and other traditional dosage forms.

R283.6

国家重点研发计划（2018YFC1706904）；陕西省自然科学基础研究项目（2018JM7157）；陕西省中医药管理局中药制药工程重点学科项目（2017）；陕西中医药大学学科创新团队项目（2019-YL11）