2025版《中国药典》收载儿科中成药的系统分析

doi:10.20274/j.cnki.issn.1674-3865.2026.01.012

摘要/Abstract

摘要：

目的调查分析2025版《中国药典（一部）》中收录的儿科中成药情况，为临床合理使用儿童中成药提供参考。方法系统分析2025 版《中国药典（一部）》儿科用中成药的品种、剂型、功效主治、用法用量及安全信息等现状，并挖掘高频用药组方规律。结果 2025版共收载中成药1 616种，其中收录药名含“儿童”“小儿”的儿童专用中成药100种，占比6.19%，2020版儿童专用中成药53种，较2020版增加了47种。儿童可用中成药642种，慎用或禁用中成药61种；儿童中成药主要功效以化痰止咳平喘类最多（21%),主要剂型以颗粒剂最多（24%），有具体年龄划分用法的占多数（65%），但明确标注不良反应的较少，仅占儿童专用药的26%，并采用SPSS Statistics 21.0和SPSS Modeler 18.0软件对高频药物(频数>10)进行系统聚类分析和关联规则分析。得到4个聚类处方,C1：麦芽、神曲、山楂、槟榔、茯苓、陈皮、白术、麦冬，C2：葛根、水牛角、连翘、板蓝根、金银花、黄芩、柴胡、大黄、栀子，C3：牛黄、冰片、麝香、黄连、朱砂、薄荷，C4：苦杏仁、石膏、桔梗、玄参、知母、贝母、甘草。结论我国儿童中成药的发展存在专用品种匮乏、用法用量不明确、功能主治不规范等问题。应鼓励研发创新、完善药品标准、加强临床研究、加强合理用药指导以及建立监测体系等多方面的措施，可以有效改善儿科用中成药的用药现状，提高其安全性和有效性，为儿童健康提供更好的保障。

关键词: 中成药, 中国药典(2025版), 用药安全, 研发趋势, 儿童

Abstract:

Objective To investigate and analyze the status of pediatric Chinese patent medicines and simple preparations included in the 2025 edition of Chinese Pharmacopoeia (Volume I), in order to provide reference for the rational use of pediatric Chinese patent medicines and simple preparations in clinical practice. Methods Based on the contents contained in the 2025 edition of Chinese Pharmacopoeia (Volume I), the current status of pediatric Chinese patent medicines and simple preparations was systematically analyzed in terms of varieties, dosage forms, efficacy and indications, usage and dosage, and safety information, and the prescription rules of high-frequency drugs were explored. Results The 2025 edition contains 1 616 kinds of traditional Chinese patent medicines and simple preparations, including 100 kinds of traditional Chinese patent medicines and simple preparations for children whose names include "child" and "pediatric", accounting for 6.19%, while in the 2020 edition, there are 53 kinds of Chinese patent medicines and simple preparations for children, so the 2025 edition contains 47 more than the 2020 edition. There are 642 kinds of traditional Chinese patent medicines and simple preparations that can be used for children, and 61 kinds of traditional Chinese patent medicines and simple preparations that should be used with caution or must be prohibited. The main efficacy of traditional Chinese patent medicines and simple preparations for children is cough-relieving and asthma-relieving (21%), and the main dosage form is granules (24%). A majority of the medicines (65%) has usage based on specific age classification, but not many with adverse reactions clarified, accounting for only 26% of specific drugs for children. SPSS Statistics 21.0 and SPSS Modeler 18.0 software were used to conduct systematic cluster analysis and association rule analysis on high-frequency drugs (frequency>10). Four cluster prescriptions were obtained, C1: malt, Shenqu, hawthorn, betel nut, Poria cocos, tangerine peel, Atractylodes macrocephala, Ophiopogon japonicus; C2: Pueraria lobata, buffalo horn, Forsythia suspensa, Isatis root, honeysuckle, Scutellaria baicalensis, Bupleurum chinense, Rheum palmatum, Gardenia jasminoides; C3: bezoar, borneol, musk, Coptis chinensis, cinnabar, peppermint; C4: bitter almond, gypsum, Platycodon grandiflorum, Scrophularia suspensa, Anemarrhena chinensis, Bulbus fritillaria, licorice. Conclusion The development of traditional Chinese patent medicines and simple preparations for children in China has some problems, such as lack of specific varieties, unclear usage and dosage, and non-standard functions and indications. We should encourage R&D and innovation, improve drug standards, strengthen clinical research, strengthen rational drug use guidance and establish a monitoring system and adopt other measures, which can effectively improve the current situation of the use of traditional Chinese patent medicines and simple preparations for pediatric use, improve its safety and effectiveness, and better safeguard children's health.

Key words: Traditional Chinese patent medicines and simple preparations, Chinese Pharmacopoeia (2025 edition), Medication safety, Research and development trends, Child

中图分类号:

万慕湲, 易鹏飞, 徐清怡, 颜劲松, 张甜, 刘丽琴, 陈梦琦, 李青青. 2025版《中国药典》收载儿科中成药的系统分析[J]. 中国中西医结合儿科学, 2026, 18(1): 60-66.

Muyuan WAN, Pengfei YI, Qingyi XU, Jinsong YAN, Tian ZHANG, Liqin LIU, Mengqi CHEN, Qingqing LI. Systematic analysis of pediatric Chinese patent medicines and simple preparations included in the 2025 edition of the Chinese Pharmacopoeia[J]. Chinese Pediatrics of Integrated Traditional and Western Medicine, 2026, 18(1): 60-66.

图/表 9

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儿童中成药具体品种表"

功效主治	药品
化痰止咳平喘剂	儿童清肺丸、九味石灰华散、小儿止咳糖浆、小儿止嗽糖浆、小儿百部止咳糖浆、小儿金丹片、小儿肺咳颗粒、小儿肺热平胶囊、小儿肺热咳喘口服液、小儿咳喘灵口服液、小儿咳喘颗粒、小儿消积止咳口服液、小儿清肺止咳片、小儿清肺化痰口服液、小儿清热止咳合剂、贝羚胶囊、百咳静糖浆、金振口服液、清肺消炎丸、清宣止咳颗粒、解肌宁嗽丸
解表剂	儿感退热宁口服液、小儿百寿丸、小儿至宝丸、小儿宝泰康颗粒、小儿退热合剂、小儿退热颗粒、小儿柴桂退热口服液、小儿柴桂退热颗粒、小儿热速清口服液、小儿热速清颗粒、小儿热速清糖浆、小儿豉翘清热颗粒、小儿感冒口服液、小儿感冒茶、小儿感冒颗粒、小儿感冒宁糖浆、小儿解表颗粒、小儿解感片、抗感颗粒
消导剂	一捻金、一捻金胶囊、七珍丸、儿宝颗粒、儿康宁糖浆、儿童清热导滞丸、小儿七星茶口服液、小儿七星茶颗粒、小儿化食口服液、小儿化食丸、小儿消食片、化积口服液、肥儿丸、保赤散、疳积散、消食退热糖浆
清热剂	万应胶囊、小儿化毒散、小儿肝炎颗粒、小儿泻速停颗粒、小儿泻痢片、小儿清热片、五福化毒丸、五福化毒片、比拜克胶囊、片仔癀、片仔癀胶囊、安儿宁颗粒、抱龙丸、清降片、万应锭
补益扶正剂	小儿扶脾颗粒、小儿腹泻宁糖浆、升血颗粒、龙牡壮骨颗粒、乐儿康糖浆、蚝贝钙咀嚼片、健儿乐颗粒、健儿消食口服液、健脾生血片、健脾生血颗粒、益气维血颗粒
开窍剂	万氏牛黄清心丸、牛黄清宫丸、瓜霜退热灵胶囊、安宫牛黄丸、安宫牛黄散、局方至宝散
治风剂	小儿抗痫胶囊、小儿惊风散、小儿解热丸
耳鼻咽喉科用药	儿童清咽解热口服液、小儿咽扁颗粒
活血化瘀剂	云南白药、云南白药胶囊
理气剂	小儿香橘丸、快胃片
温里剂	小儿敷脐止泻散、安中片
止血剂	三七血伤宁胶囊

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版本	儿童专用中成药数量（种）	儿童可用中成药数量（种）	儿童慎用或禁用中成药数量（种）	儿童用药安全性和有效性尚不明确（种）
2020版	53	55	18	未统计
2025版	100	642	61	158