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.