Abstract: Objective To observe the repeat-dose toxicity of Jingfang granule extractum in rats, to as to guide the safe and rational use of Jingfang granules in clinic. Methods Totally 144 SPF rats were randomly divided into 4 groups, namely blank control group (0 g·kg-1·d-1 of water for injection), Jing Fang granule extractum 1, 3, 10 g·kg-1·d-1, with 36 rats in each group and half male and half female. All rats were administered intragastrically once a day for 90 days with 30 days recovery phase. Test indicators included general clinical observation, feeding, weight, ophthalmology and urine examination, hematology, biochemical examination, major organ weighing and organ coefficient, and histopathological examination. Results After 90 days of repeated intragastric administration of Jingfang granule extractum at doses of 1, 3 and 10 g·kg-1·d-1, there were no abnormal changes in general state, food intake, body weight, hematology, blood biochemistry and histopathology. At the dose of 10 g·kg-1·d-1, male rats had lower food intake and slower body weight gain, and histopathological examination showed an increased incidence of early chronic progressive kidney disease, all of which returned to normal after the recovery phase. Conclusion The non-toxic dose (NOAEL) of Jingfang granule extractum is 3 g·kg-1·d-1 and the toxic dose was 10 g·kg-1·d-1. Under this dose, Jingfang granule extractum can cause anorexia and increase the incidence of chronic progressive nephritis (CPN) in animals. Considering that there is no disease corresponding to CPN in human, It is prudent to conclude that at the most severe dose, there is a potential for minor kidney injury. The above effects are recovered after the end of the recovery phase, which indicating that the adverse reactions caused by Jingfang granule extractum are reversible.

Key words: Jingfang granule extractum, rat, intragastric administration, toxicity, kidney