中日肌肉刺激性试验的比较研究及探讨

肌肉刺激性试验是以肌内注射类药物为主的新药开发研制和新药申报中重要的安全性评价检查项目之一。我国已有一些试验方法被广泛使用,但内容多属于指导性原则,较简约;日本厚生省于1984年推出了更加详实、完善的注射用药的局部刺激性试验的试验方法的修改案。多年来,随着药物临床前试验的发展,安全评价理念的深入以及动物实验研究的进展,有一些值得参考借鉴之处。结合多年动物实验和病理学研究的心得,本文在全面比较中日在肌肉刺激性试验的异同的基础上,全面遵循局部刺激性试验的指导原则,做了进一步探讨并提出建议性的试验方法,仅供参考。

Comparison and discussion of muscular irritation test methods between China and Japan

Muscular irritation test is one of the important safety evaluation items of new drug research and development and new drug applications.Some experimental methods of muscle stimulation test are widely used in China,but there is no detailed instruction manual.Japanese Ministry of Health and Welfare launched a detailed and complete amendment of local irritation test method of injection drugs in 1984.With the development of pre-clinical studies,acceptance of safety evaluation concept and advances of animal experiments,some points in the Japanese amendment are worth of reference.The authors compared the similarity and difference of the muscular irritation test methods between China and Japan,and then brought forward some suggestions for the experimental method of muscular irritation test according to the guideline for local irritation test with years of experience in animal experiments and pathological study.