Based on a comparative analysis of the quality requirements for experimental animals in the Chinese Pharmacopoeia (2020 edition, three parts) and national standards, this paper elaborates on the differences and limitations between the two.With the aim of improving drug testing capabilities, it explores the problems and solutions in the diversity of laboratory animals genetic resources, the application of gene modified animals, as well as animal experimental ethics and biosafety. The purpose is to provide reference for promoting the development of drug testing technology, and for ensuring drug quality and ensuring medication safety for the people.

laboratory animals, Chinese pharmacopoeia, national standard;animal experimental ethics;biological safety

基于对《中国药典》 (2020 年版,三部)和国家标准中实验动物质量要求的对比分析,阐述两者存在的差异性和局限性,并以提升药品检验能力为导向,探讨实验动物基因资源多样性、基因修饰动物的应用,以及动物实验伦理和生物安全等方面存在的问题和解决路径,为助力药品检验技术发展、保证药品质量和人民用药安全提供参考。

实验动物, 中国药典, 国家标准, 动物实验伦理, 生物安全