世界中医药

中药毒性研究中因伦理原则不可能在人体进行还原论模式的临床研究,体内外结合、动物与人体临床研究的结合成为研究模式的必然选择。有毒中药药材面临着药材组成成分的定性与定量水平差异、各不同产地药材组成成分巨大变异、毒理机制的万变、体内外模型差异、种属差异、器官组织细胞组成差异、代谢与功能非均一性、评价指标与检测方法多重性等差异的众多挑战与难题。现代毒理学高度重视与强调对人源性毒理学(而非动物毒性或细胞毒性)特征及其本质的研究,但人源性毒性在体内外体系、种属差异、脏器组织特征差异、形态结构学与分子组成差异等众多影响因素的干扰下,常常迷失本质性、机制性或原理性研究方向,理清研究逻辑,选择正确的策略与技术切入点才能避免中药毒性评价与研究误入歧途。

English Summary:

Owning to the ethics concerns,it is impossible to carry out clinical research of reductionism model in human body for the toxicity research of the traditional Chinese medicine,the combination of in vivo and in vitro,animal and human clinical research has become the inevitable choice of research mode.Toxic traditional Chinese medicine(TCM)are faced with many challenges and difficult problems,such as qualitative and quantitative differences in composition,huge variation in composition of medicinal materials from different origin,variation of toxicological mechanism,differences in models in vivo and in vitro,species differences,differences in organ tissue and cell composition,heterogeneity of metabolism and function,multiplicity of evaluation indexes and detection methods.Modern toxicology attaches great importance to and emphasizes the research of the characteristics and nature of the human-derived toxicity rather than animal toxicity or cytotoxicity.However,due to the interference of many influential factors,such as in vivo and in vitro systems,species differences,organ tissue characteristics differences,morphological structure and molecular composition differences,the evaluation of human-derived toxicity often loses its essential,mechanism or theoretical research direction.Only by clarifying the research logic and choosing the right strategy and technical breakthrough point can we avoid the wrong way of toxicity evaluation and research of traditional Chinese medicine.

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