Abstract: OBJECTIVE To evaluate the non-clinical safety of Fuyou granules on SD rats. METHODS For single toxicity experiment, 20 SD rats(6-7 weeks old) were randomly divided into two groups. The rats in the vehicle control group were given deionized water by gavage, and those in the Fuyou group were given Fuyou granules at the dose of 18 g·kg^-1 in a volume of 30 mL·kg^-1 per time, twice in 24 h(in the morning and afternoon), and observation was performed for 14 d after administration. Test items included clinical observation, body mass, gross anatomy, etc. For repeated dose toxicity test, 192 juvenile SD rats(postnatal day 4) were randomly divided into vehicle control group(deionized water) and low, medium and high dose of Fuyou granules groups (1.2, 2.5, 5 g·kg^-1) according to body mass. The rats were orally administered twice daily with vehicle or Fuyou granules for 13 weeks in volume of 10 mL·kg^-1 per time. A recovery period of 4 weeks was followed. Test items included general physiological indexes, ophthalmic examination, development indicators, hematology and biochemical indicators, immunological indicators, hormone indicators, reproductive function and histopathological examinations. RESULTS In the single toxicity experiment, at the dose of 18 g·kg^-1(raw drug: 82 g·kg^-1), Fuyou granules did not show significant acute toxicity in rats. In the repeated dose toxicity test, juvenile SD rats were given Fuyou granules by gavage for 13 weeks, and no significant toxic reaction was observed at the dose level of 2.5 g·kg^-1(raw drug: 11.33 g·kg^-1). The progesterone level of female rats in the high-dose group decreased significantly after recovery period. CONCLUSION Fuyou granules have no obvious single and repeated dose toxicity effects on rats in the clinical dose range．