摘要
目的研究高剂量的健胃消食片长期灌胃对SD大鼠的毒性作用。方法80只SD大鼠根据体重随机分为健胃消食片高剂量组(10g/kg)和空白对照组,每组40只,雌雄各半。每天给药1次,共给药26周,在给药中期和给药末期分别剖杀1/4和1/2的大鼠,剩余1/4大鼠停药观察4周后剖杀。检测一般状况、体重、摄食量、血常规、血生化、凝血功能、脏器湿重、脏器系数和组织病理学变化等指标。结果与对照组相比,高剂量组雌雄大鼠体重增长缓慢(P<0.05或P<0.01),导致多个脏器湿重偏低(P<0.05或P<0.01),脏器系数升高(P<0.05或P<0.01),同时少数大鼠的血常规、血生化(主要是肝功能相关指标)及凝血功能指标出现小幅波动。结论在本实验条件下对SD大鼠以10g/kg的剂量灌胃健胃消食片26周,未产生严重毒性反应,故认为健胃消食片的无毒性反应剂量(no observed adverse effect level,NOAEL)不低于10g/kg,即成人临床使用剂量的100倍。
Objective To study the long-term toxicity reaction of Jianweixiaoshi tablet on SD rats.Methods 80 SD rats were randomly divided into Jianweixiaoshi tablet high-dose group(10g/kg)and blank control group,40 rats in each group,half male and half female.Dosing was given once per day for 26 weeks,1/4 and 2/4 of the rats were sacrificed in the middle and end of the administration.The rest of rats were dissected after 4 weeks of observation.The general condition,body weight,food ration,complete blood count,blood biochemistries,coagulation function,organ wet weight,organ coefficient and histopathological changes were monitored.Results Compared with the control group,the body weight of male and female rats in the high-dose group increased slower(P<0.05 and P<0.01,),resulting in lower wet weight of multiple organs and the increased organ coefficient(P<0.05 and P<0.01).Meanwhile the complete blood count,blood biochemistries(mainly liver function related indexes)and coagulation function indexes of a few experimental animals fluctuated slightly.Conclusion Under the condition of this experiment,there is no serious toxic effect on the SD rats after intragastric administration of Jianweixiaoshi tablet at 10g/kg for 26 weeks,therefore the NOAEL of Jianweixiaoshi tablet is not less than 10g/kg,which is 100 times of the clinical dosage for adults.
作者
万建华
詹扬
杨妮
胡旭
李颖萌
刘文君
Wan Jianhua;Zhan Yang;Yang Ni(R&D Department,Jiangzhong Pharmaceutical Co.,Ltd,Nanchang 330029)
出处
《中国现代医药杂志》
2020年第11期25-29,共5页
Modern Medicine Journal of China
关键词
健胃消食片
毒理学
安全用药
Jianweixiaoshi tablet
Toxicology
Safe medication
