文档介绍：: .
中国药物警戒 只，分为给药高( g•kg-1)、中( g•kg-1)、低( g•kg-1) 剂量组，连续给药 90 天，恢复 28 天，主
要检查指标有体质量、摄食量、血液学、血液生化、生理发育、内分泌、神经行为学、病理等。结
果：急性毒性试验幼龄 SD 大鼠灌胃薏芽健脾凝胶最大耐受剂量大于 g•kg-1，且未见明显的毒副
反应。长期毒性试验高剂量组（•kg-1）部分指标出现一过性改变，未见与药物相关的毒性病理改
变。结论：在本试验条件下，薏芽健脾凝胶对受试动物未见明显毒性反应，支持 2 岁儿童临床用量
（ g•kg-1）， 安全范围大，长期使用安全。
关键词 急性毒性试验；长期毒性试验；幼龄动物；薏芽健脾凝胶；非临床安全性评价
中图分类号: 文献标识码: A
DOI:
The general toxicological studies of YIYAJIANPI NINGJIAO on Juvenile
animal
LIU Huan, YUAN Hui, YIN Jing-jing, LIU Meng-ya; QIN Xiu-jun, LI Jian-guo*
Drug Safety Evaluation Center in China Institute for Radiation Protection ,Shanxi Key Laboratory of
Drug Toxicology and Drug for Radiation Injury , Key Laboratory of Radiological Toxicology and
Radiological Drugs Preclinical Evaluation in China National Nuclear Corporation, Taiyuan 030006,
China
Abstract Objective: The aim of this study is to evaluate the safety and effects on growth by the acute
toxicity and long-term toxicity test in Juvenile SD rats of YIYAJIANPI NINGJIAO. Methods: Acute
toxicity test was conducted by the maximum tolerable dose(MTD) method. The maximum dose was
g•kg-1, twice a day, and the total dose was g•kg-1. After administration, the toxic reactions of rats were
closely observed. The repeated toxicity test was conducted that 200 Juvenileest SD rats were divided into
three group which were high dose group ( g•kg-1), medium dose group ( g•kg-1) and low dose (