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热熔挤出技术在制药行业中的应用研究进展

Research Progress on the Application of Hot Melt Extrusion Technology in the Pharmaceutical Industry
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摘要 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。 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.
作者 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 YANG Bing;ZHAO Peng;SHUAI Siyi;HONG Xiaoxuan;LI Conghui;ZHANG Hui;LIU Nan;WANG Zengming;WEN Jia;ZHENG Aiping(School of Pharmacy,Hebei University,Baoding 071002,China;Institute of Pharmacology and Toxicology,Academy of Military Medical Sciences,Beijing 100850,China)
出处 《医药导报》 CAS 北大核心 2025年第1期73-80,共8页 Herald of Medicine
基金 国家重点研发计划(2023YFC2706102)。
关键词 热熔挤出 制药 聚合物 固体分散体 药物制剂 Hot melt extrusion Pharmaceuticals Polymers Solid dispersions Drug formulation
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