中草药2026，Vol.57Issue(17)：6985-6997,13.DOI:10.7501/j.issn.0253-2670.2026.17.028
中药干法制粒工艺放大关键技术瓶颈与多尺度数字建模应用研究进展
Key technical bottlenecks in process scale-up of traditional Chinese medicine dry granulation and application of multi-scale digital modeling
摘要
Abstract
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.关键词
干法制粒/工艺放大/物理指纹图谱/数字建模/连续制造/质量源于设计Key words
dry granulation/process scale-up/physical fingerprint/digital modeling/continuous manufacturing/quality by design分类
医药卫生引用本文复制引用
管咏梅,赵子波,刘乐灵,杨明,李糯柔,易秀,臧振中..中药干法制粒工艺放大关键技术瓶颈与多尺度数字建模应用研究进展[J].中草药,2026,57(17):6985-6997,13.基金项目
江西省自然科学基金资助项目(20252BAC240049) （20252BAC240049）
全国重点实验室自主部署重点研发计划项目(20243BCC31010) （20243BCC31010）
江西中医药大学科技创新团队项目(CXTD22006) （CXTD22006）
2025年度江西中医药大学校级研究生创新专项(XJ-S202539) （XJ-S202539）
