银杏内酯B注射液对Beagle犬的长期毒性研究

目的:研究银杏内酯B注射液的长期毒性,为临床试验提供安全性依据。方法:将Beagle犬分为空白对照及银杏内酯B注射液高、中、低剂量(80、20、5mg·kg-1)组,每组6只,♀♂各半,每天静脉滴注给药,每周连续给药6d,共90d,实验时检查各剂量组犬的体重、食量、体温、心电图、血液学、血液生化学、眼科、骨髓、尿常规、病理组织学等,并进行恢复性观察。结果:给药期间,银杏内酯B注射液高剂量组有1只犬出现1次呕吐症状,高、中剂量组犬凝血时间显著延长;恢复期高剂量组有1只犬出现尿蛋白强阳性;各指标显示未见与药物有关的显著毒性反应。结论:银杏内酯B注射液对Beagle犬的无毒反应剂量为20mg·kg-1。

Long Term Toxicity of Ginkgolide B Injection on Beagle Dogs

OBJECTIVE： To evaluate the long- term toxicity of Ginkgolide B injection on Beagle dogs, and to provide safety evidences for clinical experiment .METHODS： A total of 24 Beagle dogs were equally assigned to receive placebo （control group, n = 6） or Ginkgolide B injection at high, medium, and low doses （80, 20, and 5 mg ·kg^ -1） by iv gtt for 6 consecutive days per week for up to 90 days.There were 6 Beagle dogs （male： female = 1 ： 1） in each group. All the laboratory indicators were monitored and the recovery of the Beagle dogs was observed. RESULTS： During medication, vomiting was noted in one dog in high dose group, and the clotting time in high and medium dose groups was prolonged obviously. During the recovery stage, one dog in high dose group was strong positive in urinary protein test. No significant drugassociated toxic reactions were noted judging from Beagle dogs＇ body weight, appetite, temperature, ECG, hematology, blood biochemical analysis, ophthalmology test, marrow test, urine routine test, histopathologic examination etc. CONCLUSION： The non - toxic dose of Ginkgolide B injection for Beagle dogs was 20 mg ·kg^ -1 .