Safety Content Analysis and Suggestions for Enhancement of Chinese Medicines Containing Bitter Almond
10.3870/j.issn.1004-0781.2025.05.011
- VernacularTitle:含苦杏仁中成药说明书的安全性内容分析与提升建议
- Author:
Jingjing HAN
1
;
Nina DOU
;
Rui JIN
Author Information
1. 河北中石油中心医院药学部,廊坊 065000
- Publication Type:Journal Article
- Keywords:
Bitter almond;
Chinese patent medicine;
Instruction;
Safety;
Warning content
- From:
Herald of Medicine
2025;44(5):738-743
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the problems arising from the safety content in the instructions of Chinese patent medicines containing bitter almonds and to make suggestions.Methods By searching the Chinese patent medicines containing bitter almonds in the"National Basic Medical Insurance,Work Injury Insurance and Maternity Insurance Drug List(2022)"of the Medication Assistant and Yaozhi Online,the article collated their primary functions,composition,adverse reactions,contraindi-cations to medication,warnings,and precautions.The article entered the collected information into the Excel 2021 version,analyzed the summarized data,and made suggestions for the safety warning information in the instructions of Chinese patent medicines con-taining bitter almonds based on the results of the statistics.Results Among the 1 381 kinds of patent medicines listed in the"National Basic Medical Insurance,Work Injury Insurance,and Maternity Insurance Drug List(2022)",there are 67 varieties of Chinese patent medicines containing bitter almonds,and there were missing safety contents in the collected instructions.Among them,only five types were clearly labeled with specific contents of warnings,17 types were clearly labeled with adverse reactions,24 types were clearly labeled with contraindications,and 58 types were clearly labeled with precautions.However,in terms of the content of bitter almonds and prescription ratio,the maximum daily dosage of 2 out of 67 Chinese patent medicines containing bit-ter almonds exceeded the dosage of the Chinese Pharmacopoeia,and the prescription ratio of 14 Chinese patent medicines excee-ded 10％;in terms of the combination and dosing,25 out of 67 Chinese patent medicines containing bitter almond were dosed with other poisonous traditional Chinese medicines,and the above medicines have high safety risks.The information on their safety should be increased,and their safety information should be increased.Conclusions The safety-related warnings in the instruc-tions for Chinese patent medicines containing bitter almonds are not comprehensive enough.It is recommended to strengthen the management of the whole life cycle of drugs,increase the warnings of level 1 high-risk varieties,and improve adverse reactions,contraindications,and precautions according to the Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions(Trial).
