Analysis and Suggestions on the Problem of the Unclear Part of the Safety Content Section of Chinese Patent Medicines
10.3870/j.issn.1004-0781.2025.05.009
- VernacularTitle:中成药说明书安全性内容"尚不明确"问题分析及建议
- Author:
Min LI
1
;
Minhua ZHOU
;
Huifei WU
Author Information
1. 广州中医药大学附属中山中医院药学部,中山 528400
- Publication Type:Journal Article
- Keywords:
Chinese patent medicines;
Instructions;
Safety content
- From:
Herald of Medicine
2025;44(5):727-731
- CountryChina
- Language:Chinese
-
Abstract:
Objective The content of the relevant safety items in the instructions of Chinese patent medicines is"Not Clear"to provide a reliable reference for improving the safety and effectiveness of Chinese patent medicines.Methods Search the Chinese Pharmacopoeia 2020,National Essential Medicines List,Handbook of Selected Chinese Patent Drugs in Various Clinical Subjects,and Handbook of Modern Chinese Patent Drugs.Conduct random sampling according to Chinese patent medicines'different efficacy and dosage forms and collect complete basic information and versions.There are a total of 105 latest drug instructions.The safety information in each drug instruction is extracted and entered into Excel 2019.The annotations are summarized and statistically analyzed one by one.Results After summarizing,most instructions are marked with safety item information such as adverse e-vents,contraindications,pharmacology,and toxicology.Howe ver,the degree of detail of each content varies greatly.Common problems include non-standard terminology description,content"avoiding the important and light,passing it off"or inconsistent content with the labeling,and insufficient clinical data research.Conclusions There is a severe lack of research content in the package insert of Chinese patent medicines,and it is still necessary to further strengthen the discussion and research on the mechanism of action of medicines to revise and improve the safety information of the instructions and ensure the safety of clinical use.
