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。
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“efficacytoxicity balance”so as to provide a reference for precise clinical applications of classic formulas.
作者
李雪丽
郑恩琪
白雪
LI Xueli;ZHENG Enqi;BAI Xue(Experimental 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;Faculty of Medicine and Health,University of Sydney,Sydney,NSW,Australia)
出处
《中国药物警戒》
2025年第12期1340-1344,1351,共6页
Chinese Journal of Pharmacovigilance
基金
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)。
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
Angong Niuhuang Wan
Mineral Drugs
Component Interaction
Compatibility for Toxicity Reduction
Morphology of Heavy Metals
Quality Marker
