中国药物警戒 ›› 2010, Vol. 7 ›› Issue (12): 730-732.

• 管理及工作研究 • 上一篇    下一篇

中药非临床安全性评价对上市后安全性再评价作用之思考

宋军1,赵军宁1,吴承云2,周亚莉2   

  1. 1. 四川省中医药科学院,四川成都610041；
    2.四川省食品药品安全监测及评审认证中心,四川成都610017
  • 收稿日期:2010-05-18 修回日期:2016-03-09 出版日期:2010-12-08 发布日期:2016-03-09
  • 通讯作者: 周亚莉,女,食品药品安全监测。Ｅ-mail：zhouyali@scfda.gov.cn
  • 作者简介:宋军,男,博士,副研究员,中药药理毒理。
  • 基金资助:
    四川省科技厅课题“中药安全性监测规范研究”（2008SZ0138）

Non-Clinical Safety Study's Role on Safety Reassessment of Post-Marketing Traditional Chinese Medicine

SONG Jun1, ZHAO Jun-ning1 ,WU Cheng-yun2 ,ZHOU Ya-li2   

  1. 1.Sichuan Academy of Chinese Medicine Science, Sichuan Chengdu 610041, China;
    2.Sichuan Food and Drug Safety Monitoring and Evaluation Certification Center, Sichuan Chengdu 610017, China
  • Received:2010-05-18 Revised:2016-03-09 Online:2010-12-08 Published:2016-03-09

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摘要： 从中药毒性的内涵、中药非临床安全性评价目的及作用等方面,探讨了中药非临床安全性评价在已上市中药安全性再评价中所起的作用。经验和事实证明,中药非临床安全性评价能为临床安全用药提供参考性试验数据；能够提示药物风险,权衡药物的风险和效益；弥补临床安全性评价的不足；能逐步深化、丰富上市中药的安全性评价内容,为中成药上市后新发现的不良反应提供基础性研究支撑。因而非临床安全性评价在已上市中药安全性再评价中具有重要的意义并可发挥不可或缺的作用。

关键词: 中药, 非临床安全性评价, 上市后安全性再评价, 药品不良反应

Abstract: It was discussed that non-clinical safety study's role on safety reassessment of post -marketing Traditional Chinese Medicine(TCM) from aspects of toxic connotation, aim and effect of non-clinical safety study. It was proved by experience and fact that non-clinical safety study could provided referential testing data for clinical use, prompted the risk, weighed the advantage and disadvantage of drug and remedied the deficiency of clinical safety study, non-clinical safety study could gradually deepened and enriched safety evaluation and provided basic study support for new ADRs of post-marketing TCM as well. So it was strongly recommended that non-clinical safety study could played an considerable and indispensable role.

Key words: Traditional Chinese Medicine(TCM), non-clinical safety study, safety reassessment of post-marketing drug, adverse drug reaction(ADR)

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