儿童中药饮片临床运用及儿童药物研发中安全性问题研究  

Safety of Children’s Traditional Chinese Medicine Decoction Pieces in Clinical Application and Children’s Drug Development

作　　者：贾志超 胡思源[1] 李瑞本 许雅倩 JIA Zhichao;HU Siyuan;LI Ruiben;XU Yaqian(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China)

机构地区：[1]天津中医药大学第一附属医院,国家中医针灸临床医学研究中心,天津300381

出　　处：《中国药物警戒》2025年第3期324-328,共5页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项重大新药创制(2020ZX09201-008)。

摘　　要：目的基于《中华人民共和国药典》(2020年版)一部(简称“《中国药典》”)中药饮片涉及儿童用药品种情况,为儿童中药饮片临床运用和药物研发提出参考建议。方法整理《中国药典》涉及儿童内容的饮片情况,分析存在的安全性问题。结果《中国药典》共收载中药饮片616种,明确涉及儿童人群的共26种。其中,有儿童主治且有儿童用法用量1种;有儿童主治但无儿童用法用量23种;无儿童主治但有儿童用法用量1种;儿童禁用1种。在有儿童主治的24种饮片中,涉及最多的主治为小儿疳病,标注为“有毒”的共3种,“有小毒”的共2种。结论建议加强对涉及儿童主治和儿童常用中药饮片的药学、毒理学等基础研究工作;重视临床中儿童药品不良反应的上报;进一步完善儿童用药相关标准,更好指导儿童中药饮片安全合理使用及儿童药物研发。Objective To give tips about the clinical application and development of traditional Chinese medicine decoction pieces for children based on the 2020 edition of the Pharmacopoeia of the People's Republic of China(ChP 2020).Methods The children’s decoction pieces specified in the ChP 2020 were categorized before safety risks were analyzed.Results The ChP 2020 covered a total of 616 types of traditional Chinese medicine decoction pieces,26 of which were specifically related to children.Among them,one type had both indications and dosage for children,23 had indications for children only,one had only dosage for children,and one was prohibited for children.Among the 24 herbal medicines with indications for children,the most commonly used indication was infantile malnutrition,and a total of 3 drugs were labeled as“toxic”and 2 as“slightly toxic”.Conclusion It is recommended that basic research on pharmacy and toxicology related to indications and TCM decoction pieces,adverse drug reactions in children be reported,and related standards be improved so as to facilitate safe medication and drug development.

关 键 词：儿童 中药饮片 安全性 《中华人民共和国药典》 药物研发 

分 类 号：R985[医药卫生—药品] R994.11[医药卫生—药学]