中国药物警戒 ›› 2017, Vol. 14 ›› Issue (11): 653-656.

• 儿童用药非临床安全性评价专栏 • 上一篇    下一篇

传统药物抗感颗粒幼年大鼠急性毒性及重复给药毒性试验研究

林小琪1, 郭新苗1, 张迎雪1, 魏金锋1,2, 靳洪涛1,2*   

  1. 1 北京协和建昊医药技术开发有限责任公司,北京 100176;
    2 中国医学科学院药物研究所新药安全评价研究中心,北京 100050
  • 收稿日期:2017-12-26 修回日期:2017-12-26 出版日期:2017-11-20 发布日期:2017-12-26
  • 通讯作者: *靳洪涛,男,博士,副研究员·硕导,毒理研究与药物安全性评价。E-mail：jinhongtao@ugcro.com
  • 作者简介:林小琪,女,硕士,助理研究员,一般毒理研究。
  • 基金资助:
    重大新药创制专项支持基金（2013ZX09302302）：医科院国际标准药物安全性评价技术平台建设; （2012ZX09301002-001-009）：药物安全性评价

Experimental Study on Acute and Repeated Dose Toxicity of Traditional Chinese Medicine Kangguan Granule on Juvenile Rats

LIN Xiao-qi1, GUO Xin-miao1, ZHANG Ying-xue1, WEI Jin-feng1,2, JIN Hong-tao1,2,*   

  1. 1 Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., Beijing 100176, China;
    2 New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences, Beijing 100050, China
  • Received:2017-12-26 Revised:2017-12-26 Online:2017-11-20 Published:2017-12-26

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摘要： 目的 通过幼年SD大鼠急性毒性及重复给药毒性试验,评价传统民族药物抗感颗粒的安全性。方法 急性毒性试验采用最大给药量法（36 g·kg-1）,观察给药后大鼠毒性反应。重复给药毒性试验分为1、3、9 g·kg-1 3个给药组和溶剂对照组,对幼年大鼠连续灌胃30天,恢复期4周,检测指标包括一般状况、血液学、凝血、生化、尿指标、激素指标、病理组织学、神经行为指标等。结果 急性毒性试验雌性大鼠36 g·kg-1剂量下体重增长缓慢。重复给药毒性试验在9 g·kg-1剂量下可见红系指标出现变化,主要表现在红细胞数、血红蛋白、红细胞比容轻度降低,网织红细胞轻度增加,恢复期4周后可逆。结论 传统药物抗感颗粒对幼年大鼠无急性毒性作用,重复给药毒性试验未见明显毒性反应剂量为3 g·kg-1。

关键词: 抗感颗粒, 幼年大鼠, 急性毒性, 重复给药毒性

Abstract: Objective To observe the acute and repeated dose toxicity of Kanggan granule on juvenile rats． Methods The acute toxicity study was conducted with the maximum dose method by oral dose of 36 g·kg-1． For the repeated dose toxicity study, Kanggan granule suspended in 0.5% methylcellulose vehicle was administered via oral gavage, once daily, at doses of 1, 3, 9 g·kg-1 for 30 days and with 4 weeks recovery period．Parameters included daily clinical signs, periodic hematology, clinical chemistry and urinalysis determinations, hormone, histopathology and neurobehavioral examination． Results In acute toxicity study, body weight of female rat increased slowly at the dose of 36 g·kg-1. In repeated dose toxicity study, slightly decreased RBC, HGB and HCV, mild increased reticulocytes were observed at the dose of 9 g·kg-1, while reversible at the end of recovery period． Conclusion In acute toxicity study, the maximum tolerance dose was greater than 36 g·kg-1, for repeated toxicity, the NOEAL was 3 g·kg-1 of Kanggan granule on juvenile rats．

Key words: Kanggan granule, juvenile rat, acute toxicity, repeated dose toxicity

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