药物安全性评价中豚鼠全身过敏试验方法的研究
作者:
作者简介:

翁谢川(1976-),男,助理研究员,研究方向:神经药理学与新药的安全性评价。E-mail:wengxc2002@yahoo.com.cn。

基金项目:

国家自然科学基金资助项目(No.30500620);重大新药创新专题(2008Zx09305|003);北京市自然科学基金资助项目(7092079)。


Research on the Methods of Active Systemic Anaphylaxis on Guinea Pig in Drug Safety Evaluation
Author:
  • 摘要
  • | |
  • 访问统计
  • |
  • 参考文献
  • |
  • 相似文献
  • |
  • 引证文献
  • | |
  • 文章评论
    摘要:

    目的在新药临床前安全性评价中对药物致敏性的研究日益受到重视。本实验基于我国新药评价指导原则,分析探讨SFDA颁布的指导原则中豚鼠全身过敏实验方案中可能影响实验结果的问题和因素。方法在GLP条件下,以体重为300~400克的豚鼠为实验对象,以牛血清白蛋白、生理盐水等受试物为对照,研究不同致敏剂量、激发剂量、激发时间、激发途径和激发次数等条件下,豚鼠全身过敏的发生情况。结果在一定剂量范围内,豚鼠全身过敏反应的发生率与致敏剂量、激发剂量和激发途径无关,但症状发生的严重程度与致敏剂量、激发剂量和激发途径有关。结论新药过敏性评价研究应参照指导原则,注意试验的剂量设计和给药途径。

    Abstract:

    Objective To analyze some potential factors which might affect the active systemic anaphylaxis (ASA) test on guinea pig. Methods In GLP conditions, guinea pigs from 300 to 400 grams were used as experimental subjects. By using the materials including bovine serum albumin and saline which are recommended for the control subjects by the guidelines, some experimental design factors such as sensitizing dose, challenge dose, challenge interval and challenge injection route, and the frequency of challenge were studied during the systemic anaphylaxis in guinea pigs. ResultsIn a certain dose range, the incidence of allergic reactions in guinea pigs was not related with systemic sensitizing dose, challenge dose and challenge injection approach, but the severity of anaphylaxis symptoms has an obvious relationship with sensitizing dose, challenge dose and challenge injection route. Conclusion Study on the drug-induced anaphylaxis should refer to the guidelines and pay more attention to experimental design dose and the route of administration.

    参考文献
    相似文献
    引证文献
引用本文

翁谢川,樊星,王青秀,施畅,李磊宁,欧阳兆和,孔琦,王全军,关勇彪,丁日高.药物安全性评价中豚鼠全身过敏试验方法的研究[J].中国比较医学杂志,2012,(5):51~55.

复制
分享
文章指标
  • 点击次数:4327
  • 下载次数: 3949
  • HTML阅读次数: 0
  • 引用次数: 0
历史
防诈骗提示!请勿点击不明链接或添加个人微信。编辑部所有邮箱后缀均为@cnilas.org
关闭