儿童用药非临床安全性评价的常见问题  

Common problems of non-clinical safety assessment research on pediatrics medication

作　　者：刘永武[1] 彭金红 朴成玉[1] 房城[1] 刘树民[1] 

机构地区：[1]黑龙江中医药大学药物安全性评价中心,黑龙江哈尔滨150040 [2]中国石油集团石油职业卫生技术服务中心,河北廊坊065000

出　　处：《中国新药与临床杂志》2016年第8期551-554,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：随着儿童用药的安全性日渐引起人们的重视,我国国家食品药品监督管理总局提倡用幼年大鼠评价儿童药物非临床研究,更能充分暴露儿童用药毒性表现。实验过程中幼年大鼠分组容易混乱,应引起注意。在相同剂量下,应尽量减少给药体积,且使用塑料材质灌胃针。应选择发育阶段尽量与拟用年龄段相对应的幼年大鼠,建议采血至少在幼年大鼠出生后38 d。China Food and Drug Administration encourages consulting research data obtained from infant rats toxicity test for non-clinical research on pediatrics medication, especially when safety for children medication trigger more public concern. Grouping should be paid attention for infant rats are very likely to be mistaken. Less volume is preferred when the same dose is given and plastic material made lavage needle is recommended to use. Older rats that correspond, in terms of development stage, with medicine target users should be the first-option testes. Blood is collected from at least 38 day old infant rat.

关 键 词：儿童 毒理学 动物使用替代 儿童用药 非临床安全性评价 

分 类 号：R965.3[医药卫生—药理学]