精苓消瘤胶囊对Beagle犬的长期毒性研究

Long-term toxicity study of Jinglingxiaoliu capsule on beagle dogs

观察精苓消瘤胶囊长期给药对Beagle犬产生的毒性反应,确定无毒反应剂量,为临床安全用药的剂量设计提供参考资料.将Beagle犬分为对照组及精苓消瘤胶囊高、中、低(1.50、0.60、0.25g/kg)3个剂量组,每组6只,雌雄各半,每天灌胃给药,每周给药6 d,共给药180 d,并进行恢复期观察.心电图指标中,给药结束时0.60 g/kg组心率、1.50、0.60 g/kg组PR及0.25 g/kg组QRS间期与对照组比较均有降低.血液学检查,给药结束时1.50 g/kg组的WBC与对照组比较有升高.生化学检查,给药90 d时,1.50、0.25 g/kg组的TP与对照组比较有降低,0.60 g/kg组BUN升高,0.60、0.25g/kg组TG降低.给药结束时,1.50 g/kg组ALB降低.恢复期结束时上述指标统计学差异消失.尿常规检查,各组BLO、KET、PRO有一定的阳性结果.在本试验条件下,Beagle犬口服精苓消瘤胶囊180 d给药的未见明显毒性反应剂量为0.60 g/kg.

To evaluate the long term toxicity of Jinglingxiaoliu capsule on beagle dogs,and to provide safety dose range for clinical experiment.A total of 18 beagle dogs are equally assigned to receive Jinglingxiaoliu capsule at high,medium,low doses（1.50,0.60,and 0.25 g/kg）,and 6（blank control group） to receive placebo,the sex ratio of male to female in each group is 1∶1.The beagle dogs are administered intragastrically for 6 consecutive days per week and up to 180 days.All the laboratory indicators are monitored and the recovery of the beagle dogs are observed.During medication,the ECG indicators,0.60 g/kg group decreased heart rate,1.50,0.60 g/kg groups decreased PR and 0.25 g/kg group decreased QRS interval.The hematological indicators,WBC increased are noted in 1.50 g/kg group.The blood biochemical indicators,1.50,0.25 g/kg groups decrease TP,0.60 g/kg groups increase BUN,and 0.60,0.25 g/kg groups decreased TG compare with control group after the beagle dogs are administered 90 days.1.50 g/kg group decreased ALB after the beagle dogs are administered 180 days.During the recovery stage,all of these changes are reversible.The uric biochemical indicators,the dogs in every group is positive in uric biochemical test during the medication and recovery stages,but no evident difference is found compared with history data.The non-toxic dose of Jinglingxiaoliu capsule for beagle dogs is 0.60 g/kg.