高月,李川,梁爱华,高秀梅,赵艳玲
GAO Yue,LI Chuan,LIANG Ai-hua,GAO Xiu-mei,ZHAO Yan-ling

• 1:军事科学院军事医学研究院辐射医学研究所
• 2:中国科学院上海药物研究所
• 3:中国中医科学院中药研究所
• 4:天津中医药大学

摘要(Abstract)：

中药的减毒配伍是保障中药安全性的有效措施。但中药减毒配伍研究面临诸多难点，涉及因素包括品种基原、炮制方法、配伍模式、用药剂量等，呈现出“毒性物质的不确定性”“毒性发生的隐匿性”“安全剂量的模糊性”“毒-效关系的复杂性”和“个体差异的特殊性”等特征，使得“分子-细胞-器官-整体”系统评价模型的一致性、“多药多物质”的联合暴露、“毒性-功效-配伍-证候”的关联、“量-时-毒-效”转化规律等成为影响中药临床安全研究的关键科学问题。针对上述关键科学问题，应遵循“始于临床、证于基础、终于临床”的模式，通过构建“分子-细胞-器官-整体”多水平毒性确证、多药多物质相互作用和联合暴露、多层面循证、多“量-时-毒-效”转换、基础与临床生物标志物一致性求证等“五多一证”技术体系，系统研究其减毒增(存)效配伍的作用特征、单药和多药体内命运、毒性发生分子机制、“量-时-毒-效”转化规律及病证结合的有毒中药临床特征。通过研究“两类三种机制”赋予中医七情和合配伍理论新内涵，最终提出安全用药策略。
Toxicity-attenuating compatibility is an effective measure to ensure the safety of Chinese medicine. Involving the origin, processing method, compatibility mode, and dosage, it faces multiple challenges, such as the uncertainty of toxic substances, toxicity latency, indefinite safe dose, complex toxicity-efficacy relationship, and individual difference. As a result, research on clinical safety of Chinese medicine is limited by the consistency at "molecular-cellular-organ-overall" levels, unclear interaction of multiple medicinals and multiple substances, the "toxicity-efficacy-compatibility-syndrome" correlation, and the "dosage-time-toxicity-efficacy" conversion law. Therefore, following the principle of "starting from the clinical practice, verifying via the theoretical basis, and finally applying in clinical practice", we verified the toxicity at "molecular-cellular-organ-overall" levels, revealed the interaction of multiple medicinals and substances, collected evidence at multiple levels, clarified the "dosage-time-toxicity-efficacy" relationship, and tested the consistency between basic and clinical biomarkers. On this basis, we studied the toxicity-alleviating and efficacy-enhancing(preserving) compatibility characteristics, the fate of one medicinal and multiple medicinals in vivo, the molecular mechanism of toxicity, the "dosage-time-toxicity-efficacy" conversion law, and the clinical characteristics of toxic traditional Chinese medicine based on disease and syndrome. The three mechanisms of toxicity-attenuating compatibility reflect the seven-reaction theory in Chinese medicine compatibility. Finally, the strategies for safe use of Chinese medicine were proposed.

关键词(KeyWords)： “有毒”中药;临床常用方剂;减毒配伍;策略
toxic traditional Chinese medicine;commonly used prescriptions in clinic;toxicity attenuation with compatibility;strategy

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金重大项目(82192910,82192911)

作者(Author): 高月,李川,梁爱华,高秀梅,赵艳玲
GAO Yue,LI Chuan,LIANG Ai-hua,GAO Xiu-mei,ZHAO Yan-ling

DOI: 10.19540/j.cnki.cjcmm.20220105.401

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