›› 2012, Vol. 24 ›› Issue (5): 365-368.doi: 10.3969/j.issn.1004-616x.2012.05.011

• 论著 • 上一篇    下一篇

氟比洛芬酯注射液犬静脉给药急性毒性试验研究

唐晓荞;樊柏林;孙凡中;刘春霞;刘瑶;杨文祥;黄岭   

  1. ( 1. 湖北省疾病预防控制中心,湖北 武汉 430079; 2. 武汉大安制药有限公司,湖北 武汉 430000 )
  • 收稿日期:2011-10-01 修回日期:2012-03-26 出版日期:2012-09-30 发布日期:2012-09-30
  • 通讯作者: 樊柏林

Acute toxicity of intravenous flurbiprofen axetil lipid microspheres in dogs

TANG Xiao-qiao;FAN Bo-lin;SUN Fan-zhong;LIU Chun-xia;LIU Yao;YANG Wen-xiang;HUANG Ling   

  1. ( 1. Hubei Academy of Preventive Medicine, Wuhan 430079; 2. Wuhan Da’an Pharmaceutical CO., LTD, Wuhan 430000, Hubei, China)
  • Received:2011-10-01 Revised:2012-03-26 Online:2012-09-30 Published:2012-09-30
  • Contact: FAN Bo-lin

摘要: 目的:采用近似致死量法,考察氟比洛芬酯注射液对Beagle犬单次静脉给药可能产生的急性中毒症状和毒性靶器官,评价其安全性。方法:按照50%递增法设计剂量序列,给药顺序为96、216、324和486 mg/kg,每个剂量1只动物,单次给药,观察14 d。主要观察指标包括动物一般状况、体质量、摄食量、体温、心电图分析、眼科检查、血液细胞学、血液生化学和凝血功能,对死亡或濒死动物及实验结束时处死的动物进行尸检和病理组织学检查。结果:所有动物给药时均出现轻重不等的毒性症状。给药剂量为96和216 mg/kg的动物给药后逐渐恢复正常,病检仅显示消化道黏膜充血、出血。给药剂量为324 mg/kg的动物给药后第4天突然加重,出现柏油样大便,第9天死亡。给药剂量为486 mg/kg的动物给药后极度衰弱,并出现严重上消化道出血,于第9天死亡。结论:氟比洛芬酯注射液犬单次静脉给药近似致死量范围为216~324 mg/kg,按体表面积计算约为人拟临床用等效剂量的63.2~94.8倍。该药品主要的靶器官为胃、肠、肝、胆、肾。

关键词: 氟比洛芬酯, 脂微球, 急性毒性

Abstract: OBJECTIVE: To evaluate the safety of flurbiprofen axetil 1ipid microspheres given as injection. METHODS:Acute toxicological test was conducted in dogs. Four dogs were given the tested drug at doses of 96,216,324 and 486 mg/kg intravenously and observed for 14 days. RESULTS:All animals suffered from various degrees of upper gastrointestinal bleeding. The animals given the dose of 96 and 216 mg/kg survived but the others died. CONCLUSION: The acute toxicity test showed that the approximate lethal dose of flurbiprofen axetil 1ipid microspheres for injection was 216-324 mg/kg in dogs.

Key words: flurbiprofen axetil, lipid microspheres, acute toxicity