Objective: To investigate the nephrotoxicity effect and mechanism of gardenoside in rats.Method: Rats were randomly divided into blank group

gardenoside 50 mg·kg-1

gardenoside 100 mg·kg-1

and gardenoside 300 mg·kg-1 groups

n=8 in each group. The rats in gardenoside groups were given with gardenoside for 3 days

once a day. Then their urine samples were collected to analyze kidney injury molecule-1(KIM-1) and neutrophil gelatin-associated lipocalin(NGAL) levels in urine

their blood samples were taken to detect blood urea nitrogen (BUN) and creatinine (CRE) levels

their renal tissues were taken for renal pathology analysis.Result: Rats in gardenoside 300 mg·kg-1 group showed renal toxicity. The renal tubules were slightly swelling with vacuolar degeneration. Gardenoside 50 and 100 mg·kg-1groups showed no obvious pathological changes. There was no significant change in blood BUN and CRE levels in all gardenoside dose groups

but urine KIM-1 level was significantly increased in 5/6 rats and urine NGAL level was significantly increased in 3/6 rats of gardenoside 300 mg·kg-1 group.Conclusion: Higher dose gardenoside (300 mg·kg-1) could cause renal pathological injury in rats after 3 days of oral administration. Under this dose

the addition of urine KIM-1 testing based on routine renal function indexes would probably provide better prediction of nephrotoxicity.