药品说明书中儿童用法用量药学信息的撰写与思考  

Consideration of Pharmaceutical Information Writing in Posology and Method of Administration of Pediatric Information of Labeling

作　　者：马骏威 任连杰 MA Junwei;REN Lianjie(Center for Drug Evaluation,National Medical products Administration,Beijing 100022)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国医药工业杂志》2022年第11期1583-1587,共5页Chinese Journal of Pharmaceuticals

摘　　要：药品说明书中往往缺失儿童用药的用法用量信息,且对用法用量的表述也存在不全面、不准确的问题,亟需出台相关要求予以规范指导。该研究介绍了儿童用药说明书中用法用量存在的主要问题,从整体考虑、药品预处理、调制方式和用药指导等4个方面讨论了用法用量的药学信息内容及撰写要点,提出开展相应药学研究的建议,同时对我国儿童用药的研发和监管进行思考,并提出了建议。The labelings of medicines lack information and have problems of incomplete and inaccurate descriptions on posology and method of administration for pediatrics.There is an urgent need to issue relevant requirements to provide standardized guidance for posology and method of administration for pediatrics.This paper introduces the main problems of posology and method of administration in the labelings of pediatric medicines,discusses the writing requirement from general consideration,medicine pretreatment,preparation method,and medicine usage instruction,and proposes recommendations for relevant pharmaceutical research.Considerations and suggestions were put forward on the research,development,and supervision of pediatric medicine in China.

关 键 词：说明书 儿童 用法用量 药学信息 

分 类 号：R985[医药卫生—药品]