Preclinical evaluation of arrhythmogenic risk of traditional Chinese medicines:technical progress and reflections based on international drug safety assessment methods
WANG Xuan-yang
ZHU Ming-jun
LI Bin
YU Rui
WANG Jian-ru
SUN Yu-die
DING Hao
ZHANG Wen-ping
YAN Gan-xin
GAO Yuan
Abstract：Traditional Chinese medicine(TCM)is a treasure of the Chinese nation and has been widely used for thousands of years to treat various diseases.As the application of TCM and compound preparations becomes more and more widespread both domestically and internationally,the reports of TCM-related adverse drug reactions are gradually increasing,and the safety of TCM is facing serious doubts.The potential toxicity and clinical risk of some Chinese medicines such as aconite,toadstool,and shangapi,have become a major problem for Chinese medicine to go global,especially the cardiac safety issues represented by cardiac arrhythmia,which is one of the major reasons leading to the failure of drug research and development and withdrawal of drugs from the market after marketing.Cardiac safety evaluation is an important endpoint that must be considered before a drug enters clinical trials,and the establishment of a preclinical evaluation system for cardiac safety that meets the characteristics of traditional Chinese medicines has become a core topic that needs to be broken through in the field of drug safety evaluation in China.In addition,preclinical analysis plays a crucial role before a drug enters first-in-human(FIH)study.At present,the cardiac safety evaluation and risk assessment system of traditional Chinese medicine in China are not yet perfect.In the face of this problem,scientific,standardized,and feasible preclinical evaluation standards should be established by drawing on international drug safety evaluation standards and related technologies,with a view to developing more scientific and feasible technical specifications for evaluating the risk of cardiac arrhythmia caused by TCM.
Keywords：Chinese medicinearrhythmiapreclinical evaluationinternational drug safetytechnology advances
Publication Date：2026-01-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 154-161 )