《国家基本药物目录（2018年版）》中儿科专用药仅22个品种，其中化学药品5个品种，中成药17个品种（13种组方）。临床常使用中成药治疗儿科疾病，中成药的组方多来源于古代经典方剂，以中医辨证论治理论为基础。中成药说明书作为指导药品正确使用的文书，其规范性、完整性直接影响药物是否被安全、有效地使用。对《国家基本药物目录（2018年版）》中儿科使用的中成药说明书进行研究，并对比美国、日本说明书的相关要求，分析儿科中成药毒性、禁忌，概括儿科中成药说明书存在的问题，提出完善建议。结果显示儿科专用中成药品种较少，儿科中成药说明书普遍存在成分含量未标示，功能主治不规范，用法用量、禁忌、注意事项不明确等问题，为进一步完善中成药说明书提供依据，有助于促进儿童安全合理用药。

There are only 22 varieties of pediatric drugs in National Essential Drug Catalogue (2018 Edition), including five chemicals and 17 Chinese patent medicines (13 prescriptions). Chinese patent medicines are widely used to treat pediatric diseases. The formulations of Chinese patent medicines are mostly derived from ancient classic prescriptions, based on the theory of syndrome differentiation and treatment of traditional Chinese medicine. The instruction of Chinese patent medicine as a document to guide the use of medicines, the specification and integrity of it directly affects whether Chinese patent medicine is used safely and effectively. This paper investigates the instructions of pediatric Chinese patent medicines in National Essential Drug Catalogue (2018 Edition) comparing with the relevant requirements of the United States and Japan, analyzes the toxicity and contraindication of Chinese patent medicines for pediatrics, summarizes the problems existing in these instructions, and puts forward some suggestions. The result shows that there are few kinds of proprietary Chinese patent medicines for pediatrics. There exist common shortcomings in the instructions of Chinese patent medicines for pediatrics, such as unlabeled contents, unnormalized indications, unclear usage and dosage, unknown contraindications and unclear precautions. This study provides a basis for further perfecting the instructions of Chinese patent medicines, and it is helpful to promote the safe and rational use of medicines for children.

国家自然科学基金资助项目（21177098）；温州市基础性科研项目（2018Y0209）；浙江省自然科学基金项目（LY16B070006）