过程分析技术在药物3D打印过程中的应用进展

董茹悦, 韩晓璐, 王增明, 万鲲, 洪晓轩, 张慧, 刘楠, 李明媛, 郑爱萍

中国药学杂志 ›› 2025, Vol. 60 ›› Issue (3) : 214-222.

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中国药学杂志
PDF(2214 KB)
中国药学杂志 ›› 2025, Vol. 60 ›› Issue (3) : 214-222. DOI: 10.11669/cpj.2025.03.002
综述

过程分析技术在药物3D打印过程中的应用进展

  • 董茹悦1,2, 韩晓璐1, 王增明1, 万鲲3, 洪晓轩1, 张慧1, 刘楠1, 李明媛2*, 郑爱萍1*
作者信息 +

Progress in the Application of Process Analytical Technology in the Drug 3D Printing Process

  • DONG Ruyue1,2, HAN Xiaolu1, WANG Zengming1, WAN Kun3, HONG Xiaoxuan1, ZHANG Hui1, LIU Nan1, LI Mingyuan2*, ZHENG Aiping1*
Author information +
文章历史 +

摘要

随着科学技术的快速发展,3D打印技术在个性化药物制造的应用日益成熟,为患者和制药行业提供了创新的解决方案。由于3D打印过程的集成化,可调控参数较多,为保证产品质量,需要对打印过程进行分析监控,从而优化打印过程,降低风险。过程分析技术(process analytical technology, PAT)可通过系统控制措施来确保产品质量与预期用途之间的一致性,解决了制药生产批抽样检验带来的局限性、偶然性和滞后性等问题,因此制药工业界已开始引入PAT来共同管理生产过程。基于以上背景,为整合当前研究成果,识别PAT应用中的挑战与机遇,从而为行业的实践和未来研究提供参考,笔者简要介绍了PAT相关法规、模型建立方法,列举了常用的PAT工具,总结了PAT在药物3D打印过程中的应用,并结合PAT的优点和国内外应用现状,评估当前监管环境,分析了目前3D打印药物及PAT面临的挑战。

Abstract

With the rapid development of science and technology, the application of 3D printing technology in personalized drug manufacturing is becoming increasingly mature, providing innovative solutions for patients and the pharmaceutical industry. Due to the integration of the 3D printing process, there are more adjustable parameters, and the printing process needs to be analyzed and monitored so as to optimize the printing process and reduce the risk thus to ensure the quality of the product. Process analytical technology (PAT) can ensure the consistency between product quality and intended use through systematic control measures, solving the limitations, contingencies and lags associated with pharmaceutical batch sampling, so the pharmaceutical industry has begun to introduce PAT technology to co-manage the production process. Based on the above background, this paper aims to integrate current research findings, dentify the challenges and opportunities associated with the application of PAT, and provide references for industry practices and future research. This paper briefly introduces PAT-related regulations, model building methods, lists commonly used PAT tools, and summarizes the application of PAT in the process of drug 3D printing. Combined with the advantages of PAT and the current status of domestic and international applications, we also evaluates the current regulatory environment and analyzes the current challenges faced by 3D printed drugs and PAT.

关键词

3D打印 / 个性化 / 药物制造 / 过程分析技术

Key words

3D printing / personalization / drug manufacturing / process analytical technology

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董茹悦 , 韩晓璐 , 王增明 , 万鲲 , 洪晓轩 , 张慧 , 刘楠 , 李明媛 , 郑爱萍. 过程分析技术在药物3D打印过程中的应用进展[J]. 中国药学杂志, 2025, 60(3): 214-222 https://doi.org/10.11669/cpj.2025.03.002
DONG Ruyue , HAN Xiaolu , WANG Zengming , WAN Kun , HONG Xiaoxuan , ZHANG Hui , LIU Nan , LI Mingyuan , ZHENG Aiping. Progress in the Application of Process Analytical Technology in the Drug 3D Printing Process[J]. Chinese Pharmaceutical Journal, 2025, 60(3): 214-222 https://doi.org/10.11669/cpj.2025.03.002
中图分类号： R944   

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国家重点研发计划资助(2023YFC2706100)
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