OBJECTIVE： To investigate acute toxicity and long-term toxicity of Kefang （KF）， and to provide reference for clinical trial and rational drug use. METHODS： 20 ICR mice were randomly divided into KF group （350 g/kg） and normal control group （drinking water）， with 10 mice in each group； they were given relevant medicine intragastrically， twice a day （every 8 h）， for consecutive 14 d； acute toxicity test was conducted. 120 SD rats were randomly divided into normal control group （drinking water）， KF high-dose， medium-dose and low-dose groups [5， 2.5， 1.25 g （crude drug）/ml]， with 30 rats in each group （half male and half female）； treatment groups were given relevant medicine intragastrically twice a day （every 8 h）， for consecutive 12 weeks； long- term toxicity was conducted. RESULTS： The maximum tolerated dose of KF was 350 g/kg， which was equal to 140 times as clinical human dosage. Compared to normal control group， body weight of rats in KF high-dose group increased slowly and food intake decreased （P＜0.05 or P＜0.01）； red blood cell distribution width（RDW）， hemoglobin distribution width （HDW）， mean hemoglobin concentration（MCHC）of male rats were all decreased， while mean platelet volume （MPV） and reticulocyte （RET） were increased （P＜0.05 or P＜0.01）； these indicators were all in normal physiological range of our laboratory. BUN， TBIL， AST and ALT acitivies of KF high-dose groups increased （P＜0.05 or P＜0.01）， and no abnormal change was found during recovery period； 12 weeks after medication， prothrombin time of KF medium-dose and low-dose groups shortened （P＜0.05 or P＜0.01）； mild and middle degeneration and necrosis， denudation of bladder epithelial cells were found in 8 rats of KF high-dose group， no abnormality was found during recovery period. CONCLUSIONS： There was no obvious toxic effect on the mice in the dose of 140 times of the clinical dose. Continuous 12-week administration of KF will influence liver and renal metabolism of rats； KF shows reversibility toxicity to bladder. No deeper lesions or delayed lesions is found in rats during recovery period.