中国药物警戒2024,Vol.21Issue(8) :884-887.DOI:10.19803/j.1672-8629.20230305

溴己新注射剂临床配伍用药研究

Clinical compatibility of bromhexine injectable preparations

刘毅 刘晓强 姚晓 李选堂 郭贤辉 耿颖 裴宇盛
中国药物警戒2024,Vol.21Issue(8) :884-887.DOI:10.19803/j.1672-8629.20230305

溴己新注射剂临床配伍用药研究

Clinical compatibility of bromhexine injectable preparations

刘毅 1刘晓强 2姚晓 2李选堂 1郭贤辉 1耿颖 1裴宇盛1
扫码查看

作者信息

  • 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
  • 折叠

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pH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pH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pH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.

Abstract

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

Key words

bromhexine/injection/clinical compatibility/solubility/pH/sodium chloride injection/non therapeutic drugs/electrolytes/solvent

引用本文复制引用

基金项目

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)

出版年

2024
中国药物警戒
国家药品监督管理局药品评价中心(国家药品不良反应监测中心)

中国药物警戒

CSTPCD
影响因子:1.105
ISSN:1672-8629
段落导航相关论文