医药导报2025，Vol.44Issue(10)：1588-1594,7.DOI:10.3870/j.issn.1004-0781.2025.10.011
基于国家药品抽检的小儿化痰止咳颗粒质量评价
Quality Evaluation on Xiaoer Huatan Zhike Granules Based on National Drug Sampling and Testing
摘要
Abstract
Objective To identify potential quality risks of Xiaoer Huatan Zhike Granules(Pediatric Phlegm-Resolving and Cough-Relieving Granules)through National Drug Sampling and Inspection,evaluate their overall quality,and propose improvements to the quality standards.Methods Samples from 34 manufacturers were tested using official standards.Exploratory methods were developed to enhance risk analysis,including thin-layer chromatography(TLC)identification,content uniformity testing,quantitative assays,and screening for unauthorized additives(e.g.,colorants).Results All batches met the official standards(100.0%compliance rate).However,deficiencies were observed:most manufacturers lacked controls for ephedrine hydrochloride content uniformity and quantification,omitted key ingredient identifications(e.g.,herbal components),and exhibited insufficient TLC specificity(e.g.,TLC of Ipecac tincture showed only one spot instead of multiple alkaloid-specific spots).Exploratory studies revealed risks in total emetine/cephaeline content,morroniside A/platycodin D content,ephedrine hydrochloride uniformity,and unauthorized colorant addition.Conclusions The overall quality of this variety is good,but the enterprise should improve the quality control measures throughout the entire process and establish stricter internal control standards;The official standards,unchanged for approximately 30 years,fail to address current regulatory requirements.The statutory quality standards need to be revised and improved.Qualitative or quantitative indicators for all drug flavors in the prescription should be added,and the content uniformity inspection of ephedrine hydrochloride should be increased.关键词
小儿化痰止咳颗粒/国家药品抽检/质量评价Key words
Xiaoer Huatan Zhike granules/National drug sampling and testing/Quality evaluation分类
医药卫生引用本文复制引用
尹丽华,杨龙华,陈正伟,邱学伟,宿曼筠,袁航,朱嘉亮..基于国家药品抽检的小儿化痰止咳颗粒质量评价[J].医药导报,2025,44(10):1588-1594,7.基金项目
国家药品抽检计划(国药监药管[2023]2号文). （国药监药管[2023]2号文）
