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)

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.