中国药物警戒 ›› 2025, Vol. 22 ›› Issue (12): 1340-1344.
DOI: 10.19803/j.1672-8629.20250698

• 心脑血管中药作用机制与安全性评价专栏 • 上一篇    下一篇

基于“矿物-有机”成分互作机制的安宫牛黄丸质量控制与安全性评价研究进展

李雪丽1, 郑恩琪2Δ, 白雪1*   

  1. 1中国中医科学院医学实验中心,北京市中医药防治重大疾病基础研究重点实验室,北京 100700;
    2悉尼大学药学和健康学院,澳大利亚新南威尔士州,悉尼
  • 收稿日期:2025-10-09 发布日期:2025-12-19
  • 通讯作者: *白雪,女,博士,助理研究员,中药防治心脑血管疾病。E-mail: dr.baixue@hotmail.com
  • 作者简介:李雪丽,女,博士,副研究员,中药防治心脑血管疾病。Δ为并列第一作者。
  • 基金资助:
    国家自然科学基金资助项目（82304767、82204670）; 中央级公益性科研院所基本科研业务费专项基金（ZZ15-YQ-055、ZZ13-YQ-081、XTCX2023002）; 中国中医科学院科技创新工程项目（CI2021B017）

Research Progress in Quality Control and Safety Evaluation of Angong Niuhuang Wan Based on “Mineral-Organic” Component Interactions

LI Xueli1, ZHENG Enqi2Δ, BAI Xue1*   

  1. 1Experimental Research Center, China Academy of Chinese Medical Sciences, Beijing Key Laboratory of Traditional Chinese Medicine Basic Research on Prevention and Treatment of Major Disease, Beijing 100700, China;
    2Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia
  • Received:2025-10-09 Published:2025-12-19

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摘要： 目的 针对安宫牛黄丸中矿物药（朱砂、雄黄）的安全性及人工替代品疗效问题, 从“复方微环境下的成分互作”视角讨论其质量与安全评价体系。方法 系统梳理近年来关于安宫牛黄丸中“矿物成分（毒/效）”与“植物/动物成分（解毒/辅助）”相互作用研究, 分析多维减毒机制、形态毒理学及生物等效性评价。结果 现有证据表明, 安宫牛黄丸并非成分的简单混合, 而是一个精密的“毒性调控系统”。植物与动物药成分通过化学螯合（如水牛角肽类）、生理转运调节（如小檗碱上调P-gp外排）及病理抗炎（如麝香酮抗氧化）3个维度, 主动干预重金属的体内过程, 实现“减毒存效”。然而, 现行质控标准尚未涵盖这些关键的“解毒互作”指标, 人工替代品在微量协同成分上的缺失可能削弱这种内源性保护机制。结论 安宫牛黄丸的现代化研究应从“化学成分定量”向“互作机制关联”转型。建议构建基于“重金属形态调控能力”与“生物活性指纹”的综合评价体系, 引入多组学与人工智能技术解析“效毒平衡”物质基础, 为经典名方的精准临床应用提供参考。

关键词: 安宫牛黄丸, 矿物药, 成分互作, 配伍减毒, 重金属形态, 质量标志物

Abstract: Objective To address the safety concerns about mineral drugs (Cinnabar and Realgar) in Angong Niuhuang Wan (AGNHW) and about the uncertain efficacy of artificial substitutes, and to explore its quality and safety evaluation system in terms of “component interactions within the compound micro-environment”. Methods Recent studies on interactions between “mineral components (toxicity/efficacy)” and “plant/animal components (detoxification/assistance)” in AGNHW were reviewed in general and multidimensional detoxification mechanisms, morphological toxicology, and bioequivalence evaluation in particular. Results There was evidence that AGNHW was not merely a simple mixture of ingredients, but instead a precise “toxicity-regulating system”. Plant and animal components proactively intervened in the in vivo processes of heavy metals via chemical chelation (such as peptides from Bubali Cornu), physiological transport regulation (such as upregulation of P-gp efflux by berberine), and pathological anti-inflammation (such as the antioxidant effect of muscone) so that “toxicity was mitigated while efficacy was retained.” However, current quality control standards failed to cover these critical indicators of “detoxification interactions”. The lack of trace synergistic components in artificial substitutes might compromise this endogenous protective mechanism. Conclusion Research on AGNHW should shift from “quantification of chemical components” to “correlations between interactive mechanisms”. It is recommended that an integrated evaluation system based on “the ability of heavy metals to regulate morphology” and “biological activity fingerprints” be established, and that multi-omics and artificial intelligence be used to elucidate the material basis of the “efficacy-toxicity balance” so as to provide a reference for precise clinical applications of classic formulas.

Key words: Angong Niuhuang Wan, Mineral Drugs, Component Interaction, Compatibility for Toxicity Reduction, Morphology of Heavy Metals, Quality Marker

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