中国药物警戒 ›› 2012, Vol. 9 ›› Issue (6): 330-332.

• 基于“功效”的有毒中药毒性综合评价 • 上一篇    下一篇

艾叶不同组分发挥镇痛作用的安全范围研究

迟雪洁1，2，王会3，黄伟2，鲍志烨3，孙蓉2，*   

  1. 1 天津中医药大学，天津 300193；
    2 山东省中医药研究院，山东 济南 250014；
    3 山东中医药大学，山东 济南 250355
  • 收稿日期:2012-05-11 出版日期:2012-06-10 发布日期:2015-08-10
  • 通讯作者: 孙蓉,女,研究员,博导,博士,中药药理与毒理。E-mail：sunrong107@163.com
  • 作者简介:迟雪洁，女，硕士研究生，中药分析与毒代研究。
  • 基金资助:
    国家973计划中医基础理论专项资助项目（2009CB522802）,山东省科技平台建设项目课题（2008GG2NS02021）

The Analgesic Effect Study on Margin of Safety on Different Components from Folium Artemisiae Argyi

CHI Xue-jie1, 2, WANG Hui3, HUANG Wei2, BAO Zhi-ye3, SUN Rong2, *   

  1. 1 Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;
    2 Shandong Research Academy of TCM, Shandong Jinan 250014, China;
    3 Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China
  • Received:2012-05-11 Online:2012-06-10 Published:2015-08-10

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摘要： 目的明确艾叶发挥镇痛作用的物质基础和剂量范围，确定相应的安全范围，为临床用药提供依据。方法采用热板法进行艾叶水提组分和挥发油小鼠镇痛作用考察，采用经典的急性毒性方法进行小鼠毒性数据考察，并通过Bliss法计算相关指标。结果艾叶水提组分和挥发油发挥镇痛作用的的半数有效量（ED50）分别为2.0978 g·kg-1·d-1、0.302 mL·kg-1·d-1（折合生药量为39.7 g·kg-1·d-1）ED5095%可信区间为（1.5555~2.7917）g·kg-1·d-1、（0.213~0.429）mL·kg-1·d-1折合生药量为（28.0~56.4）g·kg-1·d-1。艾叶水提组分小鼠镇痛作用的治疗指数（TI）为38.2、安全系数（SF）为10.9，其ED95和LD5分别相当于药典规定的人日用量的46.40和505.60倍。艾叶挥发油的TI为5.53、SF为1.06，其ED95和LD5分别相当于药典规定的人日用量的1086.70和1151.60倍。结论艾叶水提组分和挥发油均是其镇痛物质基础，发挥镇痛作用的剂量范围分别为（1.5555~2.7917）g·kg-1·d-1、（28.0~56.5）g·kg-1·d-1，明确了水提组分较挥发油对小鼠热刺激的反应更灵敏，治疗效果更佳，挥发油较水提组分安全范围较窄、安全性低。

关键词: 艾叶, 镇痛, 安全范围, 治疗指数, 半数有效量

Abstract: Objective To determine the material basis of analgesic effect and the effective dose range of Folium Artemisia Argyi, to clear the appropriate therapeutic index and safety margin, in order to provide the basis for the clinical safety. MethodsAnalgesic effect of the volatile oil and water extracts from Folium Artemisia Argyi were investigated by hot plate test and the toxicity in mice were investigated by the Bliss method to calculate the relevant indicators. ResultsThe ED50 and 95% confidence limit of water extraction components and volatile oil in Artemisia Argyi are respectively 2.0978 g·kg-1·d-1(1.5555~2.7917)g·kg-1·d-1, 0.302 mL·kg-1·d-1(0.213~0.429)mL·kg-1·d-1. TI and SF of water extraction components are respectively 38.2,10.9. TI and SF of volatile oil volatile oil in Artemisia Argyi are respectively 5.53, 1.06. ED95 and LD5 are respectively 1 086.70 and 1 151.60 amounts equivalent to the pharmacopoeia. ConclusionThe material basis of Folium Artemisia Argyi are water extraction components and volatile oil, the effective dose range are respectively(1.5555~2.7917)g·kg-1·d-1, (28.0~56.5)g ·kg-1·d-1. This study cleared water extraction components were more sensitive than volatile oil on the response to thermal stimulation in mice. The volatile oil has narrower margin of safety and low security than water extraction components.

Key words: Folium Artemisia Argyi, analgesic, margin of safety, therapeutic index, ED50