医药导报2026，Vol.45Issue(5)：771-776,6.DOI:10.3870/j.issn.1004-0781.2026.05.005
基于国家药品抽检的盐酸艾司洛尔注射液质量评价
Quality Evaluation of Esmolol Hydrochloride Injection Based on National Drug Sampling and Testing
摘要
Abstract
Objective To systematically evaluate the quality profile of esmolol hydrochloride injections based on na-tional drug sampling and testing,to assess their safety,efficacy,and potential quality risks,and provide references and suggestions for control in order to improve quality standards.Method A comprehensive evaluation was conducted on 77 sampled batches using statutory standards combined with exploratory studies,including related substances,hemolysis testgenotoxic impurities and other quality indicators.Results The compliance rate under statutory standards was 100.0%.Exploratory analyses revealed var-iations in related substance profiles between the 10 mL∶0.1 g and the 2 mL∶0.2 g specifications,as well as differences in he-molysis rate among products from certain manufacturers.Conclusions Esmolol hydrochloride injections demonstrate satisfacto-ry quality,though existing standards require further refinement related substances for the 2 mL∶0.2 g specification.Manufacturers are advised to optimize their formulations and manufacturing processes.关键词
盐酸艾司洛尔/国家药品抽检/质量评价/有关物质/基因毒性杂质/溶血试验Key words
Esmolol hydrochloride/National drug sampling and testing/Quality evaluation/Related substances/Geno-toxic impurities/Hemolysis test分类
医药卫生引用本文复制引用
李立,杨龙华,丁大中,于德志,杨娟,周星彤,裴琳,朱嘉亮..基于国家药品抽检的盐酸艾司洛尔注射液质量评价[J].医药导报,2026,45(5):771-776,6.基金项目
2025年国家药品抽检计划项目(国药监药管[2025]1号). （国药监药管[2025]1号）
