Abstract: Objective To promote the scientific, rational and efficient application of disease-syndrome-based toxicology in the development of new traditional Chinese medicine drugs, the clinical safety evaluation of traditional Chinese medicine (TCM), and the formulation of safe and precise medicine countermeasures, and promote the healthy and sustainable development of TCM. Methods In combination with the application of disease-syndrome-based toxicology in practice, its extension and intension were comprehensively defined. Meanwhile, the new theories, methods and discoveries of TCM safety research based on disease-syndrome-based toxicology were systematically reviewed. Results The toxicity of TCM is mainly divided into two types: intrinsic toxicity and idiosyncratic toxicity. Due to the sporadicity, susceptibility and unpredictability of idiosyncratic toxicity, conventional toxicological models and methods are difficult to evaluate the idiosyncratic toxicity of TCM. Therefore, the author's team inherited and innovated the idea of "You Gu Wu Yun" in TCM theory, and proposed the theory and method of disease-syndrome-based toxicology for the first time in 2016, aiming to break through the limitations of conventional toxicological models and methods, scientifically clarify the influence of factors such as heredity, constitution, disease syndrome, and other factors on the safety of TCM, and solve the problem of evaluating the idiosyncratic toxicity of TCM. In recent years, based on the continuous improvement and optimization of the disease-syndrome-based toxicology theory and methodological system, the author's team used the clinical real-world and the in vivo and in vitro susceptibility model of disease and syndrome as the main evaluation model, and carried out the research on the identification of susceptible population, genetic mechanism analysis and risk prevention and control countermeasures of the idiosyncratic toxicity of TCM such as Polygonum multiflorum, Fructus Psoraleae and Herba Epimedii, which solved the problems of safety evaluation and risk prevention and control of a series of traditional “non-toxic” TCM. Conclusion Disease-syndrome-based toxicology can not only be used for the identification of susceptible populations, mechanism analysis, and risk prevention and control strategies of TCM with idiosyncratic toxicity, but also for the study of the “disease (syndrome)-dose-time-toxicity-effect” relationship and safe therapeutic window of TCM with intrinsic toxicity.

Key words: traditional Chinese medicine, safety, disease-syndrome-based toxicology, toxicity, theoretical system, technological innovation