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

作　　者：杨广迪 敖歌 陈杨 黄玉芳 陈殊 李东熟 张文锍[2,3] 王甜甜 张国松 YANG Guang-di;AO Ge;CHEN Yang;HUANG Yu-fang;CHEN Shu;LI Dong-xun;ZHANG Wen-liu;WANG Tian-tian;ZHANG Guo-song(Guangxi University of Chinese Medicine,Nanning 530200,China;Jiangxi University of Chinese Medicine,Nanchang 330006,China;National Engineering Research Center of Chinese Medicine Solid Preparation Manufacturing Technology,Nanchang 330006,China;Jiamusi University,Jiamusi 154007,China)

机构地区：[1]广西中医药大学,广西南宁530200 [2]江西中医药大学,江西南昌330006 [3]中药固体制剂制造技术国家工程研究中心,江西南昌330006 [4]佳木斯大学,黑龙江佳木斯154007

出　　处：《中国中药杂志》2025年第6期1484-1495,共12页China Journal of Chinese Materia Medica

基　　金：江西中医药大学创新药物研究与开发创新团队项目(CXTD22001);江西中医药大学重点学科建设经费课题(2023jzzdxk018)。

摘　　要：连续制造作为一种新型的药品生产模式,相较于传统批量生产具有生产效率高和易于控制的优势,契合未来药物生产向高效化、智能化方向发展的趋势。然而在湿法制粒领域中,连续制造技术发展缓慢。一方面,这与其较高的技术复杂性、设备投资成本和严格的过程控制要求密切相关;另一方面,传统批量生产模式的长期应用形成了较强的路径依赖,加之缺乏成熟的标准化流程,进一步增加了技术转型的难度。为推动湿法制粒技术与连续制造的深度融合,该综述系统梳理了湿法制粒在连续制造中的应用现状,着重分析了在线检测、过程建模及工艺放大等关键技术的发展,旨在为湿法制粒的工艺创新和应用提供参考。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 

分 类 号：R94[医药卫生—药剂学]