苯磺顺阿曲库铵注射剂的质量评价  

Quality Evaluation of Cisatracurium Besilate Injection

作　　者：房晶 于新颖 多凯 白璧炜 韩宇 肖可新 马欣莹 刘利群 朱嘉亮[2] FANG Jing;YU Xinying;DUO Kai;BAI Biwei;HAN Yu;XIAO Kexin;MA Xinying;LIU Liqun;ZHU Jialiang(Institute for Chemical Drugs Control,Heilongjiang Institute for Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine,Heilongjiang Provincial Key Laboratory of Quality Research and Evaluation of Traditional Chinese Medicine,Harbin 150088,China;Technology Supervision Center,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]黑龙江省药品检验研究院化药检验研究所,国家药品监督管理局中药质量研究与评价重点实验室,黑龙江省中药质量研究与评价重点实验室,哈尔滨150088 [2]中国食品药品检定研究院技术监督中心,北京100050

出　　处：《医药导报》2025年第1期31-38,共8页Herald of Medicine

摘　　要：目的评价国内不同企业生产的苯磺顺阿曲库铵注射剂的质量。方法采用法定标准结合探索性研究对104批抽验样品进行综合评价,包括有关物质、1,5-戊二醇二丙烯酸酯、残留溶剂、苯磺酸酯类基因毒性杂质、红外光谱、细菌内毒素,综合评价国内产品质量及现行质量标准对产品质量的可控性。结果按照法定检验方法检验104批样品,合格率100.0%。探索性研究结果表明,6家药品生产企业样品杂质水平均远低于限度要求,且均未检测出苯磺酸酯类基因毒性杂质;但1,5-戊二醇二丙烯酸酯、残留溶剂等存在差异。结论目前苯磺顺阿曲库铵注射剂总体质量较好;现行标准需进一步完善,建议增/修订红外光谱鉴别项、有关物质、1,5-戊二醇二丙烯酸酯检测方法,严格控制细菌内毒素限度;建议企业关注原料药质量与注射剂生产过程控制。Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined with exploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0%.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.

关 键 词：苯磺顺阿曲库铵注射剂 质量评价 有关物质 1 5-戊二醇二丙烯酸酯 残留溶剂 

分 类 号：R971.8[医药卫生—药品] R927.11[医药卫生—药学]