中国药物警戒 ›› 2022, Vol. 19 ›› Issue (12): 1321-1324.
DOI: 10.19803/j.1672-8629.20210621

• 基础与临床研究 • 上一篇    下一篇

蒙药沙棘糖浆对14日龄SD大鼠的急毒与长毒实验研究

高琴琴1, 梁国栋1, 周泽璇1, 盛惟1, 徐晓双2, 刘卫东1,*, 娜黑芽3,#   

  1. 1内蒙古盛唐国际蒙医药研究院有限公司,内蒙古自治区蒙药新药研发企业重点实验室,内蒙古 呼和浩特 010010;
    2中国药科大学新药安全评价研究中心,江苏 南京 211198;
    3内蒙古农业大学,内蒙古 呼和浩特 010018
  • 收稿日期:2021-06-19 出版日期:2022-12-15 发布日期:2022-12-21
  • 通讯作者: *刘卫东,男,硕士,高级工程师,新药开发。E-mail：1527530016@qq.com; #为共同通信作者。
  • 作者简介:高琴琴,女,硕士,中药和蒙药的新药研究开发。
  • 基金资助:
    内蒙古自治区科技重大专项“基于基因组学的道地蒙药材开发利用与规范化种植标准体系的建立”项目; 内蒙古农业大学高层次人才引进科研启动项目（NDYB2017-14）

Acute toxicity and long toxicity of Mongolian medicine sea-buckthorn syrup on 14-day-old SD rats

GAO Qinqin1, LIANG Guodong1, ZHOU Zexuan1, SHENG Wei1, XU Xiaoshuang2, LIU Weidong1,*, NA Heiya3,#   

  1. 1Inner Mongolia Sheng Tang Mongolian Medicine Research Institute Co., Ltd., Inner Mongolia Enterprise Key Laboratory of Innovative Mongolian Medicine Research, Hohhot Inner Mongolia 010010, China;
    2New Drug Safety Evaluation Research Center, China Pharmaceutical University, Nanjing Jiangsu 211198, China;
    3Inner Mongolia Agricultural University, Hohhot Inner Mongolia, 010018, China
  • Received:2021-06-19 Online:2022-12-15 Published:2022-12-21

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摘要： 目的 观察出生后14日龄SD大鼠经口给予不同剂量的沙棘糖浆后机体可能出现的急性毒性、长期毒性,为增加沙棘糖浆儿童适应人群提供安全评价资料。方法 急性毒性试验：14日龄SD大鼠分别经口单次给予30、90、180 g·kg-1·d-1沙棘糖浆,观察给药2周内大鼠出现的急性毒性反应。长期毒性试验：14日龄SD大鼠分别经口给予15（低剂量）、45（中剂量）、90g·kg-1·d-1（高剂量）沙棘糖浆13周,恢复4周,观察并检测一般临床症状、体重、摄食量、生理发育指标、功能观察组合试验指标、学习记忆能力指标、脏器重量及脏器系数、血液学、凝血、血生化、尿液指标、组织病理学检查等。结果 急性毒性试验中,沙棘糖浆单次给药最大耐受剂量（MTD）>180 g·kg-1。长期毒性试验中,沙棘糖浆临床未观察到不良反应的剂量（NOAEL）水平为90 g·kg-1。结论 幼鼠体重、摄食量降低与沙棘糖浆给药剂量呈正相关,其他各指标与剂量无明显相关性,临床避免大剂量（>180 g·kg-1）使用。

关键词: 沙棘糖浆, 急性毒性试验, 长期毒性试验, 最大耐受剂量

Abstract: Objective To observe the acute toxicity and long-term toxicity that may occur in the body of 14-day-old SD rats after oral administration of different doses of sea-buckthorn syrup, and provide data on safety for a larger population that is eligible for sea-buckthorn syrup. Methods On the acute toxicity test, 14-day-old SD rats were given 30, 90, and 180 g·kg-1·d-1 sea-buckthorn syrup at a single oral dose, and the acute toxicity within 2 weeks of administration was observed. On the long-term toxicity test, 14-day-old SD rats were given 15 (low dose), 45 (medium dose), 90 (high dose)g·kg-1·d-1 sea-buckthorn syrup orally for 13 weeks before being allowed to recover for 4 weeks. The clinical symptoms, body weight, food intake, indicators of physiological development, indicators of FOB, learning and memory ability, organ weights and coefficients, hematology, coagulation, blood biochemistry, urine indicators, results of histopathological examinations were observed. Results On the acute toxicity test, the MTD of sea-buckthorn syrup for a single administration exceeded 180 g·kg-1. On the long-term toxicity test, the NOAEL level of sea-buckthorn syrup was 90 g·kg-1. Conclusion The decrease in weight and food intake of young rats is positively correlated with the dose of sea-buckthorn syrup, and large doses ( >180 g·kg-1) should be avoided in clinical use.

Key words: sea-buckthorn syrup, acute toxicity test, long-term toxicity test, maximal tolerance dose（MTD）

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