中国中药杂志

2013, v.38(18) 2933-2936

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中药上市后人群免疫毒理学评价检测方案及流程专家共识(征求意见稿)
Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations(draft version for comments)

谢雁鸣;赵玉斌;姜俊杰;常艳鹏;张雯;申浩;卢鹏飞;
XIE Yan-ming;ZHAO Yu-bin;JIANG Jun-jie;CHANG Yan-peng;ZHANG Wen;SHEN Hao;LU Peng-fei;Institute of Basic Clinical Medicine,China Academy of Chinese Medical Sciences;Traditional Chinese Medicine Hospital of Shijiazhuang Affiliated to Hebei Medical University;

摘要(Abstract):

建立中药上市后人群免疫毒理学评价检测方案及流程,以评价上市中药的免疫毒性以及上市中药对人体免疫系统的影响。对血样本采集、储存、运输血清样本的方法及流程进行了规定。该文适用于已上市中药(包括中药注射剂及其他用药途径的制剂)的人群免疫毒理学评价的科学研究。
Through consensus,establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population,as well as its beneficial influences on the immune system.Provide regulations on the collection,storage and transportation of serum samples.This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered,and for other ways of taking Chinese medicine.

关键词(KeyWords): 上市后中药;人群免疫毒理学;检测方法及流程;专家共识
post-marketing evaluation of Chinese medicine;human immunotoxicity;clinical evaluation scheme;expert con sensus

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基金项目(Foundation): 国家“重大新药创制”科技重大专项(2009ZX09502-030)

作者(Author): 谢雁鸣;赵玉斌;姜俊杰;常艳鹏;张雯;申浩;卢鹏飞;
XIE Yan-ming;ZHAO Yu-bin;JIANG Jun-jie;CHANG Yan-peng;ZHANG Wen;SHEN Hao;LU Peng-fei;Institute of Basic Clinical Medicine,China Academy of Chinese Medical Sciences;Traditional Chinese Medicine Hospital of Shijiazhuang Affiliated to Hebei Medical University;

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