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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。
With the safety of children’s medication getting more and more attention, China’s State Food and Drug Administration advocated the use of non-clinical evaluation of children’s medicines in young rats, more fully exposed children’s drug toxicity. During the experiment, the young rats were easy to be grouped and should pay attention. In the same dose, should minimize drug delivery volume, and the use of plastic material gavage needle. Should choose the developmental stages as much as possible with the intended age group of young rats, recommended blood sampling at least 38 days after birth in young rats.