中国药物警戒 ›› 2016, Vol. 13 ›› Issue (7): 417-421.

• 安全性评价与合理用药 • 上一篇    下一篇

基于文献资料的槟榔安全性分析

侯文珍1, 马长华1*, 杨乐2, 郭晓昕2, 任经天2, 宋海波2, 逄瑜2   

  1. 1 北京中医药大学中药学院,北京100102;
    2 国家食品药品监督管理总局药品评价中心,北京 100045
  • 收稿日期:2016-05-30 修回日期:2018-07-17 出版日期:2016-07-20 发布日期:2018-07-17
  • 通讯作者: 马长华,男,教授,硕士生导师,药品质量控制研究。E-mail: machanghua60@sina.com
  • 作者简介:侯文珍,女,在读硕士,中药检验与分析。
  • 基金资助:
    国家“重大新药创制”科技重大专项(2015ZX09501004-001);中医药行业科研专项(201507004)。

Safety and Risk Factor Analysis on Arecae Semen Based on Literatures

HOU Wen-zhen1, MA Chang-hua1*, YANG Le2, GUO Xiao-xin2, REN Jing-tian2, SONG Hai-bo2, PANG Yu2   

  1. 1 School of Chinese Pharmacy, Beijing University of Chinese Medicine, Beijing 100102, China;
    2 Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2016-05-30 Revised:2018-07-17 Online:2016-07-20 Published:2018-07-17

摘要: 目的 为槟榔的使用注意事项提供依据。方法 通过中国知网知识资源总库(CNKI)系统检索单味槟榔、槟榔制剂临床不良反应报告,探索槟榔不良反应事件的关联性。结果 槟榔及其提取物有致癌致突变作用、生殖系统毒性、神经系统毒性等。在槟榔加工过程及食用中存在产生毒副作用的可能,应当加以规范。食用槟榔及药材槟榔在加工工艺、使用方法、用量等方面均有不同,应区别对待。结论 目前缺乏槟榔药用致癌的直接证据,但不排除其致癌的可能性,临床应用需提高警惕。

关键词: 槟榔, 安全性, 文献研究

Abstract: Objective To provide basis for the precautions of Arecae Semen. Methods The adverse event reports of Arecae Semen and Arecae Semen preparations were collected in the China national knowledge infrastructure(CNKI), the relationships were explored. Results Aqueous extract of Arecae Semen has carcinogenicity, mutagenicity reproduction toxicity and neurotoxicity. There has possibility of side effects during processing and eating, which should be regulated. And the processing technology, usage, dosage, etc between Arecae Semen for eating and medicinal are different, which should be treated different. Conclution There was no direct evidence for Arecae Semen can cause cancer, but it can not rule out the possibility.Great care should be required in clinical application of Arecae Semen.

Key words: Arecae semen, safety, literature study

中图分类号: