目的 采用离散元法模拟中药桂枝茯苓胶囊（Guizhi Fuling Capsules，GFC）制备中的混合过程，以增进对中药固体制剂制备混合过程的理解。方法 以GFC浸膏粉与辅料糊精的混合过程为研究对象，创新提出将2种粉体混合比例置换的方法，以便进行真实物理混合实验与模拟仿真混合实验的对比验证。通过HPLC法定量测定真实混合过程中所取样品内GFC浸膏粉指标性成分芍药苷含量，进而计算样品间芍药苷含量的RSD，以其作为混合均匀度的评价指标，与相应仿真混合实验的混合均匀度进行比较与验证。结果 在相同条件下仿真混合实验结果与真实混合实验结果具有较高的一致性。通过对仿真混合模型的分析，深入探索浸膏粉与辅料的混合机制，并筛选出混合机中易发生偏析的区域网格（3，3，4）作为最佳的在线监控设计位点。结论 验证了使用离散元法深入理解中药固体制剂制备混合过程的可行性，为推动中药固体制剂的智能制造提供新的技术方法。

Objective To improve the understanding of the mixing process in preparing traditional Chinese medicine (TCM) solid dosage forms, the discrete element method was used to simulate the mixing process in preparing Guizhi Fuling Capsules (桂枝茯苓胶囊, GFC) of TCM. Methods Taking the mixing process of GFC extract powder and excipient dextrin as the research object, it is innovatively proposed to exchange the mixing ratio of the two powders to compare and verify real physical mixing experiments and simulation mixing experiments. The content of paeoniflorin, the index component of GFC extract powder, was quantified by HPLC, and the RSD of paeoniflorin content between samples was calculated as an evaluation index of the homogeneity of the mixture. Then, it was compared and validated with the results of the simulated mixing experiments. Results The results of simulated mixing experiments were in high agreement with the results of real mixing experiments under the same conditions. Meanwhile, through the analysis of the simulation mixing model, the mixing mechanism of the extract powder and excipients was explored in depth, and the grid (3, 3, 4) in the mixer prone to segregation was screened out as the optimal online monitoring and control design site. Conclusion This study verifies the feasibility of using the discrete element method to understand the mixing process in preparing TCM solid dosage forms. It provides a new technological approach to promote the intelligent manufacturing of TCM solid dosage forms.

R283.6

国家长三角科技创新共同体联合攻关项目（2023CSJGG1700）;中药制药过程控制与智能制造技术全国重点实验室开放基金课题（SKL2024Z0205）;北京中医药大学基本科研业务（揭榜挂帅）项目（2023-JYB-JBZD-060）