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热熔挤出技术在制药行业中的应用研究进展

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热熔挤出(HME)技术利用热力学与动力学原理,将药用聚合物与结晶态药物在高温下混合并挤出,能使药物分子镶嵌于高分子聚合物中形成固体分散体。由于其无溶剂性、能够实现一步成型、支持连续化操作等特点,近年来在制药行业获得了极大的关注。该文介绍HME技术的基本原理、发展历程与其上市药品,综述HME技术在改善药物溶解性、掩味、缓控释、定位释放、口腔分散薄膜、植入制剂、半固体制剂及3D打印制剂等方面的研究进展。同时,总结HME技术的优势和发展的局限性,并展望了其发展前景。
Research Progress on the Application of Hot Melt Extrusion Technology in the Pharmaceutical Industry
Hot melt extrusion(HME)technology employs thermodynamic and kinetic principles to mix pharmaceutical polymers with crystalline drugs at high temperatures and extrude them,embedding drug molecules within the polymer matrix to form solid dispersions.Due to its solvent-free nature,capability for one-step processing,and support for continuous operation,HME has garnered significant attention in the pharmaceutical industry in recent years.This article introduced the basic principles and development history of HME technology and its marketed drugs.It reviewed the research progress of HME technology in improving drug solubility,masking taste,controlled release,targeted release,oral dispersible films,implant formulations,semi-solid formulations,and 3D printed formulations.Additionally,the article summarized the advantages and limitations of HME technology and provided an outlook on its future development.

Hot melt extrusionPharmaceuticalsPolymersSolid dispersionsDrug formulation

杨兵、赵朋、帅思祎、洪晓轩、李聪慧、张慧、刘楠、王增明、温嘉、郑爱萍

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河北大学药学院,保定 071002

军事科学院军事医学研究院毒物药物研究所,北京 100850

热熔挤出 制药 聚合物 固体分散体 药物制剂

2025

医药导报
中国药理学会 华中科技大学同济医学院附属同济医院 中国医药商业协会

医药导报

北大核心
影响因子:1.042
ISSN:1004-0781
年,卷(期):2025.44(1)