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 drug-associated 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.