中国中药杂志2025，Vol.50Issue(6)：1484-1495,12.DOI:10.19540/j.cnki.cjcmm.20241216.303
湿法制粒与连续制造技术的整合与创新:在线检测、建模及工艺放大的研究进展
Integration and innovation of wet granulation and continuous manufacturing technology:a review of on-line detection,modeling,and process scale-up
摘要
Abstract
Continuous manufacturing,as an innovative pharmaceutical production model,offers advantages such as high production efficiency and ease of control compared to traditional batch production,aligning with the future trend of drug production moving toward greater efficiency and intelligence.However,the development of continuous manufacturing technology in wet granulation has been slow.On one hand,this is closely related to its high technical complexity,substantial equipment investment costs,and stringent process control requirements.On the other hand,the long-term use of the traditional batch production model has created strong path dependence,and the lack of mature standardized processes further increases the difficulty of technological transformation.To promote the deep integration of wet granulation technology with continuous manufacturing,this review systematically outlines the current application of wet granulation in continuous manufacturing.It focuses on the development of key technologies such as online detection,process modeling,and process scale-up,with the aim of providing a reference for process innovation and application in wet granulation.关键词
湿法制粒/连续制造/在线检测/过程建模/工艺放大Key words
wet granulation/continuous manufacturing/on-line detection/process modeling/process scale-up引用本文复制引用
杨广迪,敖歌,陈杨,黄玉芳,陈殊,李东勲,张文锍,王甜甜,张国松..湿法制粒与连续制造技术的整合与创新:在线检测、建模及工艺放大的研究进展[J].中国中药杂志,2025,50(6):1484-1495,12.基金项目
江西中医药大学创新药物研究与开发创新团队项目(CXTD22001) （CXTD22001）
江西中医药大学重点学科建设经费课题(2023jzzdxk018) （2023jzzdxk018）
