工艺放大是制剂由研发向工业化生产转化的核心环节。干法制粒作为中药固体制剂成型的关键技术，具有工序短、对有效成分影响小、高效节能等优势。但其工艺放大过程面临诸多挑战。综述了中药干法制粒工艺放大的关键技术瓶颈，包括关键工艺参数、送料系统与设备热力学效应，及关键物料属性。从方法论支撑与策略演进2个维度，归纳了放大策略从传统经验放大到数字建模驱动的多尺度智能放大的演进脉络。其中，灰箱混合建模、基于群体平衡模型的全流程集成模拟及过程分析技术驱动的闭环反馈控制，为破解放大过程中的非线性问题提供了新思路。未来，融合物理指纹图谱与数字孪生技术构建跨尺度放大框架，推动工艺研发从“经验驱动”向“模型驱动”转型，助力中药制药实现智能制造的战略升级。

Process scale-up is a critical step in the transition of pharmaceutical preparations from research and development to industrial production. Dry granulation, as a key technology for forming traditional Chinese medicine (TCM) solid dosage forms, offers advantages such as a short process flow, minimal impact on active ingredients, high efficiency, and energy savings. However, its process scale-up faces numerous challenges. This article reviews the key technical bottlenecks in the process scale-up of TCM dry granulation, including critical process parameters, thermodynamic effects of the feeding system and equipment, and critical material attributes. The evolution of scale-up strategies is summarized from perspectives of methodological support and strategic evolution, tracing the progression from traditional empirical scale-up to digital modeling-driven multi-scale intelligent scale-up. Among these, gray-box hybrid modeling, population balance model-based integrated process simulation, and process analytical technology-driven closed-loop feedback control offer new approaches to address nonlinear issues during scale-up. In the future, integrating physical fingerprint with digital twin technology to establish a cross-scale scale-up framework will promote the transformation of process development from “experience-driven” to “model-driven” paradigms, thereby facilitating the strategic upgrade of TCM pharmaceutical manufacturing toward intelligent manufacturing.

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江西省自然科学基金资助项目（20252BAC240049）；全国重点实验室自主部署重点研发计划项目（20243BCC31010）；江西中医药大学科技创新团队项目（CXTD22006）；2025年度江西中医药大学校级研究生创新专项（XJ-S202539）