中国药物警戒 ›› 2013, Vol. 10 ›› Issue (10): 580-582.

• 基础及临床研究 •    下一篇

注射用克拉霉素对Beagle犬4周重复给药毒性实验研究

马玉奎,戴晓莉,戴学栋   

  1. 山东省医药工业研究所安评中心,山东济南 250033
  • 收稿日期:2013-06-04 修回日期:2016-03-09 出版日期:2013-10-08 发布日期:2016-03-09
  • 作者简介:马玉奎,男,硕士,副主任药师,药物临床前安全性研究。

Four Weeks Intravenous Repeated Dose Toxicity of Clarithromycin for Injection in Beagle Dogs

MA Yu -kui DAI Xiao -li DAI Xue –dong   

  1. Shandong Institute of Pharmaceutical Industry, Shandong Jinan 250033, China
  • Received:2013-06-04 Revised:2016-03-09 Online:2013-10-08 Published:2016-03-09

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摘要： 目的 研究连续静脉注射给予注射用克拉霉素对Beagle犬的毒性作用。方法 以正常Beagle犬为研究对象,连续静脉注射给药4周,以其体重、血液生化学、血液学、脏器相对重量、组织病理学检查为指标,全面评价其对Beagle犬的毒性作用。结果 注射用克拉霉素80mg·kg-1剂量可引起Beagle 犬肝功能（AST、ALT）和肾功能（BUN）指标异常,组织病理学检查可见肝细胞呈条索状排列,窦周隙增宽,部分肝细胞变性、坏死或出现核固缩以及肾脏毛细血管扩张充血,部分肾小管上皮细胞变性、坏死或发生固缩,停药2周后上述异常指标及病理学改变恢复正常。结论 大剂量注射用克拉霉素重复给药可影响Beagle犬肝肾功能,导致可逆性的肝、肾生化指标异常及病理改变。

关键词: 注射用克拉霉素, Beagle犬, 重复给药毒性

Abstract: Objective To investigate the repeated dose toxicity of clarithromycin for injection in dogs. Methods The normal dogs were administered with clarithromycin for injection by intravenous injection for four weeks. The body weight,blood biochemistry, hematology, viscera relative weight and histopathology were measured for the overall toxicity assessment. Results The normal dogs administered with clarithromycin for injection( 80mg·kg-1) showed abnormal escalation of the levels of aspartic transaminase(AST), alanine aminotransferase(ALT), urea nitrogen(BUN). Histopathological examination indicated that the liver cells were cord -like arranged and perisinusoidal space was broadened,some liver cells degenerated, necrosed or appeared karyopyknosis. Renal capillary dilatation and congestion, epithelial cell degeneration, necrosis or pyknosis of partial renal tubular were also found by histopathological examination. Conclusion Repeated administration of clarithromycin at high dose could lead to abnormal biochemical index and pathological lesions of liver and kidney in dogs.

Key words: clarithromycin for injection, dog, repeated dose toxicity

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