| 摘要: |
| 目的:分析重庆医科大学附属儿童医院门诊药房中成药药品说明书的标注情况,为促进儿童安全合理用药提供参考。
方法:收集我院门诊药房中成药药品说明书共92 份,依据相关法规对其标注信息进行分析。结果:非处方药占38. 04%,其中
91. 43%缺警示语,1 份缺规格项;处方药占61. 96%,在儿童用药、药物相互作用、临床试验等9 个关键项存在显著缺失。儿童专
用中成药仅占27. 17%,其中80. 00%明确标注了各年龄段剂量;非儿童专用药占72. 83%,仅10. 45%明确标注了儿童剂量。结
论:该院中成药药品说明书标注整体欠完善,儿童用药信息缺失问题突出,儿童专用品种匮乏。建议药品生产企业及时更新和
完善说明书,加快研发适宜儿童的中成药制剂,以提升儿科用药安全性。 |
| 关键词: 儿童医院 中成药 药品说明书 信息 标注 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2025.10.012 |
|
| 基金项目: |
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| Pediatric Medication Information Labeling in Instructions of Chinese Patent Medicines in the OutpatientPharmacy of a Grade Ⅲ, Level A Children’s Hospital |
| Yang Fuju, Liao Lulu |
| ((Children’s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and
Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatric Metabolism
and Inflammatory Diseases, Chongqing 400014, China)) |
| Abstract: |
| Objective: To analyze the current status of information labeling in instructions of Chinese patent medicines in the Outpatient
Pharmacy of Children’s Hospital of Chongqing Medical University, and to promote reference for safe and rational drug use in children.
Methods: A total of 92 instructions of Chinese patent medicines were collected from the Outpatient Pharmacy of our Hospital, and the
labeling information was analyzed in accordance with relevant regulations. Results: Over-the-counter drugs accounted for 38. 04%, of
which 91. 43% lacked warning statements, and one lacked a specification entry. Prescription drugs accounted for 61. 96%, with
significant omissions in nine key items, including pediatric use, drug interactions, and clinical trials. Additionally, medicines
specifically for children accounted for 27. 17% of the total, 80. 00% of which clearly specified dosages for various age groups. Nonpediatric-
specific medicine accounted for 72. 83% of the total, only 10. 45% clearly specified dosages for children. Conclusion: The
information labeling in instructions of Chinese patent medicines in the hospital is generally incomplete, with prominent deficiencies in
pediatric medication information and a scarcity of pediatric-specific formulations. It is recommended that pharmaceutical manufacturers
promptly update and improve the drug instructions and develop varieties of Chinese patent medicines suitable for children to enhance
medication safety in pediatrics. |
| Key words: children’s hospital Chinese patent medicines drug instructions information labeling |
