摘要
目的:观察氯化钾注射液在5%葡萄糖注射液、10%葡萄糖注射液、0.9%氯化钠注射液和葡萄糖氯化钠注射液四种常用输液液体中的配伍稳定性。方法:采用目测法观察溶液的外观;采用酸度计依据《中国药典》(2015年版)四部通则0631中的相关规定进行pH值的测定;依据通则0903进行不溶性微粒的测定;采用高效液相色谱法进行氯化钾含量测定;采用鳖试剂进行细菌内毒素检查,并行无菌检查。结果:通过目测法观察溶液均为无色澄清液体;供试品溶液在48 h内pH值基本无明显变化,符合要求;不溶性微粒48 h内也符合规定;供试品溶液的氯化钾含量在48 h内均保持在100%~105%,基本稳定。供试品溶液在配伍后0,24,48 h的细菌内毒素和无菌检查均符合相关规定,配伍稳定。结论:预配制的氯化钾注射液经各项检查均符合相关规定,表明其稳定性良好,保障了临床使用的安全性。
Objective:To investigate the compatibility and stability of potassium chloride injection in four common infusions:5%glucose injection,10%glucose injection,0.9%sodium chloride injection and glucose sodium chloride injection.Methods:The appearance of the solution was observed by visual inspection,the pH value was determined by the acidity meter in accordance with the relevant provisions of the Chinese pharmacopoeia(2015 edition)four general rules 0631,and the insoluble particles were determined by general rules 0903,high performance liquid chromatography was used.Carry out content determination,use turtle reagent for bacterial endotoxin test and parallel sterility test.Results:Observed by visual method,the solutions are all colorless and clear liquid.The pH value of the test solution basically has no obvious change within 48 hours,which meets the requirements,and the insoluble particles also meet the requirements within 48 hours.The content of the test solution is within 48 hours.The internal levels are kept between 100%~105%,basically stable.Bacterial endotoxin and sterility inspection of the test solution at 0,24,and 48 hours after compatibility are in compliance with relevant regulations,and the compatibility is stable.Conclusion:The pre-configured potassium chloride injection is in compliance with relevant regulations after various inspections,indicating that its stability is good and the safety of clinical use is guaranteed.
作者
何勇
王丽芳
王嵘娟
廖剑桥
黄小燕
杨鹏
吴江
HE Yong;WANG Lifang;WANG Rongjuan;LIAO Jianqiao;HUANG Xiaoyan;YANG Peng;WU Jiang(Ganzhou People's Hospital,Ganzhou 341000,China)
出处
《临床医药实践》
2021年第9期687-690,共4页
Proceeding of Clinical Medicine
基金
赣州市指导性科技计划项目(项目编号:GZ2020ZSF198)。
关键词
氯化钾注射液
含量测定
细菌内毒素检查
无菌检查
配伍研究
potassium chloride injection
content determination
bacterial endotoxin test
sterility test
compatibility study
