实验动物科学

• 研究简报 • 上一篇    下一篇

刍议药包材的异常毒性检查和实验动物福利

  

  1. 河北省医疗器械与药品包装材料检验研究院
  • 出版日期:2020-10-28 发布日期:2021-02-25

Study on Building Mouse Asthma Model with Self-designed Experimental Animal Atomization Box

  • Online:2020-10-28 Published:2021-02-25

摘要: 摘要:目的 研究2015版国家药包材标准(简称 YBB标准)中异常毒性试验的变化,旨在关注实验动物福利。方法 比较新旧YBB标准。结果 发现2015版YBB标准除了滴眼剂瓶和聚乙烯/铝/聚乙烯复合药用软膏管外,其他塑料瓶和复合膜类均新增加了空白对照,而药用铝箔和硬片类、药用低密度聚乙烯膜、袋均未增加空白对照。结论 药包材的异常毒性检查应按非生物制品试验,认为不需要设立空白对照。建议在相关的药包材标准修订时考虑舍去异常毒性试验的空白对照。

Abstract: Abstract: Objective To design an experimental animal atomization box with a household medical atomizer and facilitate airway disease research in experimental animals. Method A household atomizer and a separate ventilating squirrel cage were combined and used to transform into an experimental animal atomization box. We built a mouse asthma model with the self-designed atomization box and ovalbumin. Result The atomization box could produce enough fog for 1 - 20 mice experiment rapidly. We successfully built the mouse asthma model with the atomization box. Conclusion We applied the atomization box to build the mouse allergic asthma model and observed significant lung tissue inflammation. This method provides operational guide for experimental animal inhalation experiment with convenience and low cost.