Abstract：Objective To evaluate the toxicological safety of a compound Chinese medicine preparation of gardenia. Methods Eighty healthy SD rats with half males and half females were randomly divided into four groups. The low-,moderate- and high-dose group were given 1.00 g/kgbw,2.00 g/kgbw and 4.00 g/kgbw of the preparation,while the control group was given distilled water,by gavage for 30 days. The changes of diet,weight,hematological parameters and major organs of rats were observed,and the histopathological examination of the main organs was performed. Results The rats in the high-dose group reduced activities and their urine turned dark yellow or green,while the other rats showed no abnormality. No rats died during the experimental period. Compared with the control group,the weight,the total weight gain,the food utilization rate,the fasted weight of the rats in the high-dose group and the hemoglobin content of the female rats in the high-dose group were significantly decreased（P<0.05）;the ratio of liver to body weight,the ratio of kidney to body weight,the serum creatinine levels of the rats in the high-dose group and the serum urea nitrogen levels of the male rats in the high-dose group were significantly higher（P<0.05）. The livers and kidneys of the rats in high-dose group turned different degrees of dark green;the hepatic pigmentation,hepatocyte vacuolar degeneration,bile duct hyperplasia accompanied with inflammatory cell infiltration,renal pigmentation,renal tubular epithelial cellular swelling,and renal interstitial inflammatory cell infiltration were observed. Conclusion This preparation at a dose of 4.0 g/kgbw has hepatotoxicity and nephrotoxicity to rats. A dose of 2.0 g/kgbw has no harmful effect but less than 100 times of the possible human intake,the safety is not guaranteed.