中药饮片作为中药产业链的核心载体，其质量直接关联临床用药与大健康产品的安全有效。在“健康中国”战略引领下，其产业规模持续扩大、科技创新深度赋能，已成为大健康产业的重要支柱。当前饮片行业仍面临炮制生产质控瓶颈：数字化识别精度不足、智能化表征技术滞后、质量标准体系缺失及成果转化率低下等问题，亟待技术-标准集成创新与产业化应用突破。通过系统综述饮片质量控制的核心痛点与发展趋势，聚焦数智化质量表征技术的研究进展与产业转型实践，探索炮制质控新范式，提出以“临床价值-药效机制”双核驱动，融合老药工“辨状论质”经验与多模态质控技术（覆盖物理性状、化学成分及生物活性特征），构建“形-味-性-质”多维全息质量表征体系，建立基于“望形色/闻气味/问药性/切品质”的饮片整体性-专属性评价标准及辅料质控规范，为饮片智能制造与全程质控提供科学基础，推动研究成果转化对接国家战略需求，践行“面向人民生命健康、面向世界科技前沿”的双重使命。

As the core carrier of the traditional Chinese medicine (TCM) industrial chain, the quality of Chinese herbal decoction pieces (CHDP) directly determines the safety and efficacy of clinical medications and big health products. Guided by the “Healthy China” strategy, the industry has experienced continuous expansion and deep technological empowerment, emerging as a pivotal pillar of the health industry. However, critical bottlenecks persist in processing quality control, including insufficient digital identification accuracy, lagging intelligent characterization technologies, inadequate quality standards, and low conversion rates of research outcomes. Breakthroughs in integrated technology-standard innovation and industrial application are urgently needed. This review systematically analyzes core challenges and development trends in quality control of CHDP, focusing on advances in digital-intelligent quality characterization technologies and industrial transformation practices. We propose a novel paradigm centered on the “clinical value-pharmacodynamic mechanism” dual-core driver, integrating veteran pharmacists empirical knowledge of “appearance-based quality discrimination” with multimodal quality control technologies (covering physical traits, chemical constituents, and bioactive characteristics). This framework establishes a multidimensional holographic quality characterization system (“shape-flavor-property-quality”) and holistic/specific evaluation standards for CHDP based on “observing shape and color/smelling odor/inquiring property/inspecting quality by touch,” alongside excipient control specifications. Collectively, these provide a scientific foundation for intelligent manufacturing and full-process quality control of CHDP. Ultimately, this facilitates the translation of research outcomes to meet national strategic needs, fulfilling the dual mission of “serving people’s health and advancing global scientific frontiers”.

R28

国家重点研发计划（2023YFC3504200）；2024年南京中医药大学中药学一流学科“引领计划”科学研究专项（ZYXYL2024-006）