| 摘要: |
| 目的:了解我国儿童专用复方感冒制剂的种类及药品说明书存在的问题。方法:收集我国儿童专用药品目录,对儿童专
用复方感冒制剂进行筛选,并对药品说明书信息进行统计分析。结果:共收集到29 个品规的儿童专用复方感冒制剂,涉及不同
生产厂家的药品487 种。所有制剂均为非国家基本药物;其中国家医保药品7 种(1. 44%),非医保药品480 种(98. 56%);非处
方药468 种(96. 10%),处方药19 种(3. 90%);国产药品482 种(98. 97%),进口药品5 种(1. 03%);颗粒剂是最常见的剂型(286 种,
58. 73%);解热镇痛药为最主要的成分(470 种,96. 51%);仅8. 62%的药品说明书包含药代动力学信息;部分同一通用名不同生
产厂家的药品在适应证、用法用量、禁忌证等项目存在明显差异。结论:我国儿童专用复方感冒制剂适宜年龄较小儿童的剂型
仍然较为缺乏,多种制剂含有相同或相似的成分,而某些复方感冒制剂中含有的成分用于儿童的安全性与有效性尚需要进一步
论证,儿童说明书内容存在的问题也增加了儿童用药的风险。 |
| 关键词: 儿童专用 复方感冒制剂 药品说明书 分析 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2026.10.005 |
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| 基金项目: |
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| Investigation and Analysis of Anti-Cold Compound Preparations for Children and Drug Instructions inChina |
| Yan Congcong1, Wang Xiaoling2, Zhang Meng2, Wang Qiwei3, Zhang Shengnan1 |
| ((1. Children’s Hospital Affiliated to Zhengzhou University, Zhengzhou 450018, China; 2. Beijing Children’ s Hospital, Capital Medical University, Beijing 100045, China; 3. China National Pharmaceutical Industry Information Center, Shanghai 200040, China)) |
| Abstract: |
| Objective: To investigate the varieties of anti-cold compound preparations for children in China and identify issues in drug
instructions. Methods: The catalogue of child-specific drugs in China were collected, the anti-cold compound preparations for children
were screened and the information of drug instructions were statistically analyzed. Results: A total of 29 specifications of anti-cold
compound preparations for children were collected, covering 487 products from different manufacturers. The study showed that none of
the collected preparations were included in the National Essential Drugs List of China. Among them, 7 preparations (1. 44%) were
included in the National Medical Insurance Catalog of China, while the remaining 480 preparations (98. 56%) were non-medical
insurance drugs. A total of 468 preparations (96. 10%) were over-the-counter drugs and 19 preparations (3. 90%) were prescription
drugs. In terms of manufacturing origin, 482 preparations (98. 97%) were domestically produced, and 5 preparations (1. 03%) were
imported. Granules were the most common dosage form (286 preparations, 58. 73%), while antipyretic analgesics were the most
predominant active ingredients ( 470 preparations, 96. 51%). Only 8. 62% of the drug instructions contained pharmacokinetic
information. Notably, for drugs sharing the same generic name but produced by different manufacturers, substantial discrepancies were
observed across several items, including indications, dosage and administration, and contraindications. Conclusion: There remains a
shortage of dosage forms suitable for younger children among anti-cold compound preparations for children in China. Multiple medications
contain identical or similar components, while the safety and efficacy of some compounds for children need further verification. In
addition, the problems of drug instructions also increase the risk of medication in children. |
| Key words: child-specific anti-cold compound preparations drug instructions analysis |
