| 中药注射剂临床安全性评价研究进展 |
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| 引用本文： | 李双虎,秦侃,范鲁雁.中药注射剂临床安全性评价研究进展[J].安徽医药,2014,18(2):221-224. |
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| 作者姓名： | 李双虎 秦侃 范鲁雁 |
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| 作者单位： | 安徽中医药大学药学院,安徽,合肥,230031;安徽医科大学第三附属医院药学部,安徽,合肥,230061 |
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| 基金项目： | 国家科技部重大新药创制科技重大专项(项目编号：2009ZX0,9502-030) |
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| 摘 要： | 由于中药上市前研究目的比较单纯、实验人群范围比较窄、用药时间较短等原因,很难得出药品全面的安全性数据,这不利于药品上市后的合理安全的应用。安全性再评价是中药上市后再评价的首要环节,该文通过查阅文献资料,对参麦注射液、丹红注射液、参芪扶正注射液等中药注射剂目前的安全性研究作一综述,为临床合理用药提供参考。
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| 关 键 词： | 中药注射剂 安全性 研究进展 |
Research progress of clinical safety evaluation of traditional Chinese medicine injection |
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| LI Shuang-hu,QIN Kan,FAN Lu-yan.Research progress of clinical safety evaluation of traditional Chinese medicine injection[J].Anhui Medical and Pharmaceutical Journal,2014,18(2):221-224. |
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| Authors: | LI Shuang-hu QIN Kan FAN Lu-yan |
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| Institution: | 1. School of Pharmacy,Anhui University of Chinese Medicine, Hefei ,Anhui 230031, China ; 2. Department of Pharmacy, Hefei First People＇ s Hospital, Hefei ,Anhui 230061, China) |
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| Abstract: | Because of relatively simple purposes,narrow population range,small samples,stringent controlled conditions for using medicine,and short time of clinical trials,the researches for listing approval of Chinese medicine can not draw to comprehensive conclusions on safety and effectivenes,which is not conductive to the reasonable and safe application of postmarketing Chinese medicine. Safety reevaluation is the most important issue of the postmarketing re-evaluation of Chinese medicine. Through searching and summing up the literatures about this issue,review was conducted of the safety of Shenmai injection,Danhong injection,Shenqi FuZheng injection and other traditional Chinese medicine injection,in order to provide information for clinical reasonable medication. |
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| Keywords: | traditional Chinese medicine injection safety research progress |
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