今日药学

基于QbD-PAT融合的片剂生产全链条智能化质量控制技术进展

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曾上敏 , 秦斯民 , 丁立 , 周代营

今日药学 | 药学进展 2026,36(7): 553-560

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今日药学 |药学进展 2026 , 36 (7) : 553 -560

基于QbD-PAT融合的片剂生产全链条智能化质量控制技术进展

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曾上敏, 秦斯民, 丁立, 周代营

作者信息

广东食品药品职业学院，广东　广州　510520

作者简介:

曾上敏，助理实验师，研究方向：药品生产的工艺开发与质量控制，E-mail：625740365@qq.com

Advances in Intelligent Quality Control Technologies for the Entire Tablet Production Chain Driven by QbD-PAT Integration

Shangmin ZENG, Simin QIN, Li DING, Daiying ZHOU

Affiliations

Guangdong Vocational College of Food and Drug, Guangzhou, Guangdong 510520, China

出版时间: 2026-07-25 doi: 10.12048/j.issn.1674-229X.2026.07.011

文章导航

摘要

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片剂作为口服固体制剂的主要剂型，其质量一致性与生产效率是医药工业4.0时代的核心需求。在仿制药一致性评价持续推进与智能化生产转型的背景下，质量源于设计（QbD）与过程分析技术（PAT）的深度融合，正推动片剂质量控制从传统的终端检测向全链条实时预测控制模式转变。本文系统综述了QbD-PAT融合驱动下片剂生产全链条的关键技术进展，涵盖智能响应型辅料开发与分子模拟辅助处方设计、连续化制粒-干燥集成系统与多尺度在线监控、压片工艺的微观结构调控与人工智能优化、以及纳米包衣材料的智能监测体系。重点分析了各环节关键技术的原理、应用现状与瓶颈问题，指出多模态数据融合、数字孪生模型验证、绿色工艺经济性等挑战，并对区块链溯源、仿生包衣材料、自学习数字孪生及碳中和生产等未来发展方向进行了展望。本文认为，构建片剂设计监控优化闭环智能生产体系，不仅是技术整合，更是一场从检测合规到设计保障的制药理念范式转移。

关键词

片剂生产 / 质量源于设计 / 过程分析技术 / 连续制造 / 智能辅料 / 数字孪生 / 人工智能 / 质量控制

Abstract

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As the dominant oral solid dosage form，tablets are facing core demands for consistent quality and high production efficiency in the era of Pharmaceutical Industry 4.0. Against the backdrop of continuous advancement of generic drug consistency evaluation and transformation toward intelligent manufacturing，the deep integration of Quality by Design (QbD) and Process Analytical Technology (PAT) is promoting a paradigm shift in tablet quality control from traditional end-product testing to full-chain real-time predictive control. This paper systematically reviews key technological advances across the whole tablet production chain driven by the integration of QbD and PAT，including intelligent responsive excipients and molecular simulation-assisted formulation design，continuous granulation-drying integrated systems with multi-scale online monitoring，microstructure regulation and AI-driven optimization of tableting processes，and intelligent monitoring systems for nano-coating materials. The principles，current applications，and bottlenecks of key technologies in each segment are analyzed. Challenges such as multi-modal data fusion，digital twin model verification，and economic viability of green processes are discussed. Future development directions，including blockchain traceability，biomimetic coating materials，self-learning digital twins and carbon-neutral manufacturing，are further prospected. This review holds that constructing a closed-loop intelligent manufacturing system integrating tablet design，monitoring and optimization is not merely technical integration，but a paradigm shift in pharmaceutical philosophy from compliance by testing to.

Key words

tablet production / Quality by Design (QbD) / Process Analytical Technology (PAT) / continuous manufacturing / intelligent excipients / digital twin / artificial intelligence / quality control

引用本文

曾上敏, 秦斯民, 丁立, 周代营. 基于QbD-PAT融合的片剂生产全链条智能化质量控制技术进展. 今日药学, 2026 , 36 (7) : 553 -560 . DOI: 10.12048/j.issn.1674-229X.2026.07.011

Shangmin ZENG, Simin QIN, Li DING, Daiying ZHOU. Advances in Intelligent Quality Control Technologies for the Entire Tablet Production Chain Driven by QbD-PAT Integration[J]. Pharmacy Today, 2026 , 36 (7) : 553 -560 . DOI: 10.12048/j.issn.1674-229X.2026.07.011

基金

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《药物制剂技术》数字资源课程建设(CSDP24LF1G448)
广东省2024年度学习型社会建设（继续教育）质量提升工程项目(JXJYGC2024G358)

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2026年第36卷第7期

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doi: 10.12048/j.issn.1674-229X.2026.07.011

接收时间：2026-01-02
首发时间：2026-10-27
出版时间：2026-07-25

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收稿日期：2026-01-02

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《药物制剂技术》数字资源课程建设(CSDP24LF1G448)

广东省2024年度学习型社会建设（继续教育）质量提升工程项目(JXJYGC2024G358)

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广东食品药品职业学院，广东　广州　510520

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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