Abstract: ObjectiveThe toxicity characteristics, chemical material basis and toxic mechanism of Herba Leonuri were determined and the correlation of its efficacy and toxicity were discussed. The literature evidence and research ideas were provided for making safety standards, and studying its toxicity based on its efficacious substance basis. MethodsLiteratures in latest decades at home and abroad about Herba Leonuri were collated, analyzed and summarized. ResultsAs a commonly used traditional Chinese medicine, Herba Leonuri, which has the efficacy of promoting blood flow for regulating menstruation, diuresis and edema was a traditional Chinese medicine. A number of adverse reactions of Herba Leonuri or Chinese patent drugs containing it were reported. Modern toxicology studies have shown that Herba Leonuri had toxicity, and the dose range, substance basis, site of action and damage mechanism were discussed by toxicology experiment. ConclusionThe Herba Leonuri toxicity and controlling of toxic material basis are studied during the expression of effectiveness and the separation and quality controlling of efficacious material basis, the relationship between the drug efficacy, toxicity and adverse reactions are determined. And we can put forward early-warning scheme and treatment measures of adverse reaction in clinical usage. The safety limitation and standard of content of material basis from Herba Leonuri are established to ensure the safe use of Herba Leonuri as a clinical drug.

Key words: Herba Leonuri, toxicity characteristics, chemical material basis, toxicity mechanism