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中药注射剂安全性问题探讨
引用本文:毕凤兰,张力.中药注射剂安全性问题探讨[J].中国药物警戒,2012,9(2):89-92.
作者姓名:毕凤兰  张力
作者单位:国家食品药品监督管理局药品评价中心,北京,100045
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

Discussion on the Safety of Traditional Chinese Medicine Injection
BI Feng-lan , ZHANG Li.Discussion on the Safety of Traditional Chinese Medicine Injection[J].Chinese JOurnal of Pharmacovigilance,2012,9(2):89-92.
Authors:BI Feng-lan  ZHANG Li
Affiliation:BI Feng-lan ZHANG Li (Center for Drug Reevaluation, SFDA, Beijing 100045, China)
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.
Keywords:traditional Chinese medicine injection  adverse drug reaction  safety evaluation  risk management
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