五味子破壁饮片单次和重复给药毒性实验研究OA

Objective:To evaluate the non-clinical safety of Schisandra chinensis wall-broken tablets in SD rats and compare them with Schisandra chinensis to provide reference information for clinical research and application.Meth-ods:Schisandra chinensis wall-broken tablets and Schisandra chinensis were given to SD rats by single gavage at a dose of 8 g/(kg·d)for 2 weeks of continuous observation;Schisandra chinensis wall-broken tablets were given to SD rats by gavage at doses of 1.5 g/(kg·d),3.0 g/(kg·d),6.0 g/(kg·d),and Schisandra chinensis were given to SD rats by gavage at doses of 1.5 g/(kg·d),6.0 g/(kg·d)for 13 weeks and recovery was achieved in 4 weeks.Observe the appearance and signs of the animals and perform various examinations such as body weight,food intake,haematolo-gy,serum biochemistry and pathology.Results:No significant toxic effects were observed in SD rats given Schisandra chinensis wall-broken tablets and Schisandra chinensis(8 g/(kg·d))by single gavage.In the repeated dosing toxicity test,at the middle and end of dosing,the liver of the animals of Schisandra chinensis wall-broken tablets 6.0 g/(kg·d)group showed hepatocellular hypertrophy of the lobule-central type,which was of a slight to mild degree,with a higher prevalence in females,and in the reference preparation.No such pathological changes were seen in the livers of animals in the Schisandra chinensis group.After 4 weeks of drug withdrawal and recovery,the liver lesions in all dose groups of Schisandra chinensis wall-broken tablets had completely recovered,and no other delayed pathological changes were seen.Conclusion:The no-adverse-effect dose level(NOAEL)of Schisandra chinensis wall-broken tablets was 3 g/(kg·d)in the group;the NOAEL of Schisandra chinensis was 6 g/(kg·d)in the group.