统一肌肉刺激性试验实验方法的建议  

Comparison and discussion of muscular stimulation test methods in China and Japan

作　　者：金毅[1,2] 徐峰[2] 鲁艺[1] 王晓炜[1] 王平[1] 钟敏[1] 赵承兵[1] 

机构地区：[1]深圳市药品检验所,深圳518057 [2]沈阳药科大学,沈阳110016

出　　处：《中国新药杂志》2013年第8期878-880,共3页Chinese Journal of New Drugs

摘　　要：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。我国已有一些实验方法被广泛使用,但内容较简约;日本厚生省于1984年推出较详实的注射用药的局部刺激性试验的实验方法的修改案,也存在不足。结合动物实验和病理学研究的心得,提出统一实验方法的规范化建议,主张以组织病理学诊断作为结果判定的主要依据。Muscular irritation study is one of the important safety evaluation examination items in new drug research and development and new drug applications. Some experimental methods of muscle stimulation test are widely used in China, but no detailed instruction manuals. Japanese Ministry of Health and Welfare launched an accurate amendment of local irritation test method of injections in 1984, but also with some shortage. Standardiza- tion of muscular irritation study and mainly based on histopathological diagnosis for safety evaluation have been pro- vided, combined with experience of animal experiments and pathological study.

关 键 词：肌肉刺激性试验 实验方法 组织病理学 

分 类 号：R95[医药卫生—药学]