统一血管刺激性试验实验方法的建议  

Suggestion on unifying the experimental method of vascular stimulation test of drug safety evaluation

作　　者：金毅[1,2] 徐峰[2] 王晓炜[1] 鲁艺[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11期1244-1245,共2页Chinese Journal of New Drugs

摘　　要：血管刺激性试验在静脉注射用药的新药申报的安全性评价、药物研发的剂型改进以及完善药物说明书等方面具有重要作用。我国已有一些指导性文献,但尚缺乏统一、可操作性的实验方法。本文结合中日两国的动物实验和病理学诊断,参考比较国内外的实验方法,提出统一实验方法的建议,主张以组织病理学诊断作为结果判定的主要依据。Vascular stimulation test for drug safety evaluation plays an important role in new drug application, clinical medication safety, drug type advantage in research and improvement of drug instructions of intravenous drugs. There are some guiding principles in China, but no unified and maneuverability experimental method. Unifying the experimental method of vascular irritation and histopathological diagnosis as the major basis for safety evaluation have been suggested, combined with comparison among countries, experience of animal experiments and pathological study.

关 键 词：血管刺激性试验 实验方法 组织病理学 

分 类 号：R95[医药卫生—药学]