摘要
目的评价抗EB病毒口服液的长期毒性作用,为临床实验提供安全性依据。方法将Beagle犬分为抗EB病毒口服液76.41、25.47、8.49g生药/kg3个剂量组及空白对照组,每组6只,♀♂各半,每天灌胃给药1次,每周连续给药6d,共26wk,检查各指标并进行恢复性观察。结果给药期间高剂量组犬出现明显呕吐症状,中剂量组犬也出现相同胃肠道刺激症状,但反应较轻。恢复期高剂量组1只犬出现尿蛋白强阳性,中剂量组1只犬出现尿潜血强阳性。各剂量组犬的体重、体温、食量和心电图、血液学、血液生化学、眼科、骨髓、尿常规、病理组织学检查等均未见与药物有关的明显毒性反应。结论抗EB病毒口服液对Beagle犬的无毒反应剂量为8.49g生药/kg。
OBJECTIVE： To evaluate the long - term toxicity of Anti - EB- virus oral liquid on beagle dogs, and to provide safety evidences for clinical experiment. METHODS： Of the total beagle dogs, three groups totaled 18 were assigned to receive Anti-EB-virus oral liquid at high （76.41 g/kg）, medium （25.47 g/kg） and low dosage （8.49 g/kg）, and 6 （blank control group） to receive placebo. The ratio of male to female in each group was 1 ： 1. The beagle dogs were administered intragastrically with drugs qd, 6 days in a week for up to 26 weeks. All the indicators were monitored and the recovery of the beagle dogs was observed. RESULTS： Dogs in high dose group vomited obviously. Gastrointestinal irritation was also noted in medium dose subgroup, but was less severe than the high dose subgroup. During the recovery stage, one dog in high dose group was strong positive in urinary protein test and one in medium dose group was strong positive in urinary occult blood test. No significant drug associated toxic reactions were noted from beagle dogs＇ body weight, temperature, appetite, ECG, hematology test, blood biochemical analysis, ophthalmology test, marrow test, routine urianlysis, histopathologic examination, etc. CONCLUSION： The non- toxic dose of Anti- EB-Virus Liquid on beagle dogs was 8.49 g/kg in crude drug.
出处
《中国药房》
CAS
CSCD
北大核心
2006年第14期1054-1056,共3页
China Pharmacy
基金
国家"十五"科技攻关计划重大基金项目(2001BA701A07-10)
