目的 采用離散元法模擬中藥桂枝茯苓膠囊（Guizhi Fuling Capsules，GFC）制備中的混合過程，以增進(jìn)對中藥固體制劑制備混合過程的理解。方法 以GFC浸膏粉與輔料糊精的混合過程為研究對象，創(chuàng)新提出將2種粉體混合比例置換的方法，以便進(jìn)行真實物理混合實驗與模擬仿真混合實驗的對比驗證。通過HPLC法定量測定真實混合過程中所取樣品內(nèi)GFC浸膏粉指標(biāo)性成分芍藥苷含量，進(jìn)而計算樣品間芍藥苷含量的RSD，以其作為混合均勻度的評價指標(biāo)，與相應(yīng)仿真混合實驗的混合均勻度進(jìn)行比較與驗證。結(jié)果 在相同條件下仿真混合實驗結(jié)果與真實混合實驗結(jié)果具有較高的一致性。通過對仿真混合模型的分析，深入探索浸膏粉與輔料的混合機(jī)制，并篩選出混合機(jī)中易發(fā)生偏析的區(qū)域網(wǎng)格（3，3，4）作為最佳的在線監(jiān)控設(shè)計位點。結(jié)論 驗證了使用離散元法深入理解中藥固體制劑制備混合過程的可行性，為推動中藥固體制劑的智能制造提供新的技術(shù)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 (桂枝茯苓膠囊, 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

國家長三角科技創(chuàng)新共同體聯(lián)合攻關(guān)項目（2023CSJGG1700）;中藥制藥過程控制與智能制造技術(shù)全國重點實驗室開放基金課題（SKL2024Z0205）;北京中醫(yī)藥大學(xué)基本科研業(yè)務(wù)（揭榜掛帥）項目（2023-JYB-JBZD-060）