中国药物警戒 ›› 2012, Vol. 9 ›› Issue (2): 89-91.

• 管理及工作研究 • 上一篇    下一篇

中药注射剂安全性问题探讨

毕凤兰，张力   

  1. 国家食品药品监督管理局药品评价中心，北京 100045
  • 收稿日期:2011-11-28 出版日期:2012-02-10 发布日期:2015-08-10
  • 作者简介:毕凤兰，女，主任药师，药品上市后监测与评价。

Discussion on the Safety of Traditional Chinese Medicine Injection

BI Feng-lan, ZHANG Li   

  1. Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2011-11-28 Online:2012-02-10 Published:2015-08-10

PDF (PC)

616

摘要： 中药注射剂是我国目前临床应用广泛的一类药品，随着我国药品监管机制和药品不良反应监测与评价制度的不断完善，中药注射剂的不良反应报告也日益增多。本文通过分析中药注射剂的特点及发展现状， 从中药注射剂安全性评价角度提出相关风险因素和控制措施，从而为提高中药注射剂安全性提供技术支持。

关键词: 中药注射剂, 药物不良反应, 安全性评价, 风险管理

Abstract: Traditional Chinese Medicine Injection(TCMI) is widely used in China at present. With the improvement of the drug supervision and administration and the adverse drug reaction surveillance system in China, the number of ADR reports is increasing steadily. The author put forward to related risk factors and risk control measurements after analyzing the characteristics of the traditional Chinese medicine injection and current status of the development, to offer information on the technical supports for improvement of the safety of TCMI.

Key words: traditional Chinese medicine injection, adverse drug reaction, safety evaluation, risk management