Content Analysis of Safety Information in the Label of Chinese Patent Medicines Containing Cinnabar Based on Comprehensive Drug Evaluation
10.3870/j.issn.1004-0781.2025.05.010
- VernacularTitle:基于药品综合评价的含朱砂类中成药说明书安全性内容分析
- Author:
Hongye GUO
1
;
Shuang ZHANG
;
Pengcheng YUAN
;
Rui JIN
;
Yiheng YANG
Author Information
1. 中国中医科学院西苑医院药学部,北京 100091
- Publication Type:Journal Article
- Keywords:
Cinnabar;
Chinese patent medicines;
Drug label;
Comprehensive drug evaluation;
Safety evaluation
- From:
Herald of Medicine
2025;44(5):732-737
- CountryChina
- Language:Chinese
-
Abstract:
Objective Through the safety evaluation of Chinese patent medicines containing cinnabar,the correlation between the evaluation score and the content of drug instructions was analyzed.And the methods and suggestions for improving the label quality of Chinese patent medicines were proposed.Methods Establish a database of Chinese patent medicines and sim-ple preparations containing cinnabar that meet the screening criteria in the 2020 edition of the Chinese Pharmacopoeia,and quan-titatively score such Chinese patent medicines and simple preparations from the two first level dimensions of safety and toxicity characteristics of Chinese patent medicines and simple preparations,and at the same time,grade the level of safety evidence.Results From the perspective of safety evaluation dimension,Chinese patent medicines and simple preparations with relatively high safety score(safety score ≥ 5 points)has a certain correlation with the content of adverse drug reactions clearly reported in the instructions of this kind of medicine,and 54.55％of the evidence risk of this kind of Chinese patent medicines and simple preparations is controllable,with good safety.From the perspective of the evaluation dimension of toxicity characteristics of Chi-nese patent medicines and simple preparations,the types of toxic ingredients in the compatibility of prescriptions and the scores of daily maximum dosage have certain guiding significance for clinical medication precautions.Conclusion For improving the ad-verse reaction information in the instructions of Chinese patent medicines and simple preparations containing cinnabar,and remin-ding the special population of drug use restrictions,it not only has an important impact on drug safety evaluation and grading,but also provides warning and reference for clinical and patient safety in drug use.
