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过程分析技术在皮肤递药制剂先进制造中的应用

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过程分析技术(PAT)对于提高皮肤递药制剂制造过程的过程控制和质量保证具有重要意义。本文综述了 PAT技术在皮肤递药制剂先进制造中的应用,介绍了 PAT与化学计量学的基本情况,总结了常用的PAT工具及其在近年的具体应用实例。未来,PAT将在皮肤递药制剂制造过程中发挥更大的作用,但在此方面的研究还非常稀缺。
Application of process analytical technology in advanced manufacturing of dermal drug delivery products
Process analysis technology(PAT)is of great significance to improve the process control and quality as-surance in the manufacture of dermal drug delivery products.This paper reviewed the application of PAT technology in the advanced manufacturing of dermal drug delivery products,introduced the basic situation of PAT and chemo-metrics,and summarized the commonly used PAT tools and their application examples in recent years.In the fu-ture,PAT will play a greater role in the process ofdermal drug delivery products,but the research in this area is still very scarce now.

continuous manufacturingprocess analytical technologycritical quality attributesdermal drug deliv-ery productschemometrics

王一点、罗华菲

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中国医药工业研究总院医药先进制造国家工程研究中心,上海 201203

中国药科大学药学院药剂系,南京 211198

连续制造 过程分析技术 关键质量属性 皮肤递药制剂 化学计量学

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(2)