溴己新注射剂临床配伍用药研究  

Clinical compatibility of bromhexine injectable preparations

作　　者：刘毅 刘晓强 姚晓 李选堂 郭贤辉 耿颖 裴宇盛 LIU Yi;LIU Xiaoqiang;YAO Xiao;LI Xuantang;GUO Xianhui;GENG Ying;PEI Yusheng(Institute for Chemical Drug Control,National Institutes for Food and Drug Control‚NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629‚China;Changzhou Institute for Drug Control,Changzhou Jiangsu 213002‚China)

机构地区：[1]中国食品药品检定研究院化学药品检定所,化学药品质量研究与评价重点实验室,北京102629 [2]江苏省常州市药品检验所,江苏常州213002

出　　处：《中国药物警戒》2024年第8期884-887,共4页Chinese Journal of Pharmacovigilance

基　　金：中国食品药品检定研究院化学药品检定所重点实验室学科建设项目(2023HYZX25);北京市自然科学基金资助项目(L222010)。

摘　　要：目的考察导致溴己新注射剂临床输液药液混浊原因,为保障该注射剂质量和临床安全使用提供参考。方法结合溴己新溶解度分析实验,开展代表性的临床配伍实验研究,关注非治疗性药物的配伍情况。结果药液p H环境高度影响溴己新的溶解度,结合复方氯化钠注射液和复方电解制注射液的验证性临床配伍实验,溴己新注射剂临床配伍用药的环境p H偏碱性时易出现药液变混浊的不良状况。结论溴己新注射液配伍后浑浊现象的关键影响因素为p H而非输液溶媒,提示非治疗性药物的临床配伍问题应予以重视。Objective To investigate the causes of turbidity that occurs during infusion of bromhexine injectable preparations.Methods Representative clinical compatibility tests for verification were carried out in combination with bromhexine solubility analysis,and the relevant compatibility of non therapeutic drugs was observed.Results The solubility of bromhexine was highly correlated with the pH environment.Combined with confirmatory clinical compatibility tests of compound sodium chloride injection and multiple electrolytes injection,it was confirmed that bromhexine injectable preparations were likely to become turbid when the environmental pH value of the clinical compatibility medication was slightly alkaline.Conclusion The turbidity of bromhexine injectable preparations is chiefly due to pH rather than the infusion solvent,suggesting the need to attach importance to clinical compatibility of non-therapeutic drugs.

关 键 词：溴己新 注射剂 临床配伍 溶解度 酸碱度 氯化钠注射液 非治疗性药物 电解质 溶媒 

分 类 号：R917[医药卫生—药物分析学]