摘要
脏器质量及系数的分析是药物、生物制剂、食品添加剂和医疗器械等毒性试验评价中不可或缺的部分,可能是体现某些受试物毒性的最敏感指标。然而,脏器的选择以及称质量条件、计算方法等均可能对试验结果的分析产生影响,以致最终影响对受试物毒性的判断。综合分析影响脏器质量及系数的因素,以期用科学严谨的方法进行脏器质量的评价和解释,为毒性试验结果的评价提供一个比较准确的参考指标。
The analysis of organ weight and coefficient in toxicology experiments is an indispensable part of the evaluation of drugs,chemicals, biological agents, food additives and medical devices, because it may be the most sensitive indicators of the toxicity of test substances.However, weighing conditions(such as exsanguination or no exsanguination, weighing fresh or after fixed organs),statistical methods of weight data, and preferred organs for weighing may all have effects on the evaluation of test substances or organ weight.This article comprehensively analyzed the factors of affecting organ weights and coefficient, with a view to scientifically rigorous methods for organ weight evaluation and interpretation, in order to provide a more accurate reference index for the evaluation of results of toxicology experiments.
作者
倪家敏
周飞
黄暨生
郭秋平
NI Jiamin;ZHOU Fei;HUANG Jisheng;GUO Qiupin(Drug Non-clinical Evaluation Center of Guangzhou Institute of Pharmaceutical Industry,Guangzhou General Pharmaceutical Research Institute,Guangzhou Guangdong,510240,China)
出处
《药物评价研究》
CAS
2020年第10期2143-2146,共4页
Drug Evaluation Research
基金
国家科技重大专项重大新药创制(2018ZX09721004-001-003)。
关键词
脏器质量
脏体系数
脏脑系数
毒性试验
安全性评价
organ weight
organ/body weight ratio
organ/brain weight ratio
toxicology experiments
safety evaluation
