南五味子软胶囊对大鼠长期毒性的实验研究

Long-term toxicity study of schisandra sphenanthera softcapsule in rats

目的观察南五味子软胶囊连续灌胃给药13周对大鼠产生的毒性反应。方法南五味子软胶囊分别以1.2、0.438、0.16g.kg-1.d-1灌胃给药,每周给药6 d,试验周期为13周,各试验组剩余的1/2动物观察4周恢复期变化。按中药新药长期毒性试验要求观察动物的一般状况、体重变化、血液细胞学及生化学指征、解剖及组织病理学检查。结果各剂量药组与对照组大鼠比较,白天自发活动减少,高剂量组减少最为明显,但夜间活动无明显差异。血液及生化指标与对照组相比无明显差异,脏器未出现给药相关的病变。结论南五味子软胶囊长期灌胃服用未见毒性反应,长期服用安全。

Objective To observe the toxicity of continuous oral administration of Schisandra sphenanthera softcapsule in rats.Methods Rats were randomly divided into 3 groups,each group was given Schisandra sphenanthera softcapsule intragastrically in dose of 1.2、0.438,0.16 g·kg-1 for 13 weeks.Parameters were examined including general condition,body weight,food intake,blood cell,blood biochemistry,organ index,and pathological changes.Results Each drug group compared with the control had a reduction of spontaneous activity during the day.However,there was no significant difference at night.There were no significant differences in weight,organ coefficient,the indexes of haematology and biochemistry,pathological changes between the two groups.Conclusion Schisandra sphenanthera softcapsule has no significant toxicity for long-term oral administration to rats,which can be used safely.