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Disease-based Toxicology on Safety Assessment Strategy and Application for Herbal and Traditional Medicines

World Journal of Traditional Chinese Medicine 2019年第3期5卷 139-144页

作者： Jia-Bo Wang Zhuo Shi Xiao-He Xiao The Fifth Medical Center China Military Institute of Chinese MedicineGeneral Hospital of PLA Clinical Pharmacokinetics Laboratory School of Basic Medicine and Clinical PharmacyChina Pharmaceutical UniversityNanjingChina Integrative Medical Center The Fifth Medical CenterGeneral Hospitalof PLABeijing

The safety issue on herbal and traditional medicines(H&TM) is one of the most challenging problems and serious concern worldwide. With scientific endeavor and further exploration, we came to realize that there are great differences between H&TM and synthetic drugs in many aspects, such as medical theory, medication experience, compatibility, processing, toxicological characteristics, and safety evaluating requirements. In the current preclinical models for synthetic drugs, the safety assessment results of some conventional deemed 'nontoxic' H&TM were not well consistent with clinical situations, which resulted in major difficulties to understand the mechanisms and guide the safe and rational uses of these H&TM. Thus, based on the traditional Chinese medicine toxicity theory called You Gu Wu Yun, this paper introduces a novel safety assessment strategy for H&TM, named as disease-based toxicology. It aims to cognize the relativity and susceptibility of the toxicity of H&TM, and then to enhance controllability in new drug development and clinical applications. It also provides a theoretical practice for the traditional Chinese medicine toxicity theory and a methodological promotion for the future development of the precision toxicology for H&TM.

关键词： Disease-based toxicology idiosyncratic toxicity safety of herbal and traditional medicines susceptibility syndrome differentiation-based toxicity attenuation

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