盐酸溴己新注射剂临床配伍的应用性研究  

Applicability Studies on the Clinical Compatibility of Bromhexine Hydrochloride Injectable Preparations

作　　者：刘毅[1] 耿颖[1] 刘晓强 姚晓 李选堂 LIU Yi;GENG Ying;LIU Xiaoqiang;YAO Xiao;LI Xuantang(National Institutes for Food and Drug Control,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,北京102629 [2]常州市药品检验所,江苏常州213002

出　　处：《药品评价》2023年第6期687-690,共4页Drug Evaluation

摘　　要：目的考察导致盐酸溴己新注射剂临床输液时药液混浊的原因。方法研究溴己新溶解度曲线,尝试开展数据拟合的模型分析,并开展代表性的临床配伍试验进行验证。结果溴己新的溶解性与pH环境高度相关,结合验证性的临床配伍试验,确认盐酸溴己新注射剂临床配伍用药的环境pH偏碱性时易出现药液变混浊的不良状况。结论不科学的临床配伍用药是导致盐酸溴己新药液变混浊的主要原因,其中溶解度是重要指标参数,而pH是关键影响因素。Objective To investigate the reason of forming turbid solution during infusion of bromhexine hydrochloride injectable preparations.Methods The solubility curve of bromhexine was studied,mathematical model analysis of data fitting was attempted to develop,and representative clinical compatibility tests for verification have been carried out.Results The solubility of bromhexine was highly correlated with pH environment.Combined with confirmatory clinical compatibility tests,it was confirmed that bromhexine hydrochloride injection was prone to become turbid when the environmental pH value of the clinical compatibility medication was slightly alkaline.Conclusion Unscientific clinical compatibility of medicines was the main reason for the turbidity of bromhexine hydrochloride injections.Solubility was the important indicator parameter,and pH value was the key influencing factor.

关 键 词：溴己新 药物配伍禁忌 药物相关性副作用和不良反应 溶解度 酸碱度 氯化钠注射液 

分 类 号：R969[医药卫生—药理学]