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)

作　　者：谢雁鸣[1] 赵玉斌[1,2] 姜俊杰[1] 常艳鹏[1] 张雯[1] 申浩[1] 卢鹏飞[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]河北医科大学附属石家庄市中医院,河北石家庄050051

出　　处：《中国中药杂志》2013年第18期2933-2936,共4页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030)

摘　　要：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 paten- termly administered, and for other ways of taking Chinese medicine.

关 键 词：上市后中药 人群免疫毒理学 检测方法及流程 专家共识 

分 类 号：R285[医药卫生—中药学]