摘要
目的考察美罗培南与3种全营养混合液(total nutrient admixture,TNA)在Y型输液通路中的理化相容性,为临床配伍使用的合理性与可行性提供依据。方法模拟临床实际条件,在室温(25±2℃)不避光环境下,将美罗培南溶液与3种全营养混合液按设定输注速率经三通阀混合输注,收集混合后的配伍溶液。分别于配伍后0,1,2,4 h检测溶液的外观性状、pH值、渗透压、不溶性微粒、脂肪乳粒径大小及分布和Zeta电位,并测定美罗培南含量及其有关物质。结果4 h内,3组配伍溶液外观颜色均未发生变化,未见分层、沉淀、絮凝及挂壁现象;pH值与渗透压无明显改变,不溶性微粒数符合《中国药典》相关规定;乳粒平均粒径(MDD)、多分散指数值(PDI)及Zeta电位与TNA原液相比差异均无统计学意义(P>0.05),组内各时间点间亦无显著差异(P>0.05);在美罗培南含量方面,仅与TNA2配伍的样品在4 h内相对百分含量保持在初始浓度的95%以上;然而所有配伍样品中有关物质在4 h内均超过限度要求。结论美罗培南在TNA中降解较快,临床使用时应避免通过Y型输液通路将其与TNA混合输注。
Objective To investigate the physicochemical compatibility of meropenem with three total nutrient admixtures(TNAs)in Y-site infusion channels,so as to assess the rationality and feasibility of their combined clinical use.Methods Under simulated clinical conditions at room temperature(25±2℃)without light protection,meropenem solution and three TNAs were mixed respectively and infused via a three-way valve at specified rates.The resulting admixtures were collected and the appearance,pH,osmotic pressure,insoluble particulate matter,particle size and distribution and Zeta potential of fat emulsion were analyzed at 0,1,2,4 h after mixing.The content of meropenem and its related substances were also determined.Results Within 4 h,all three admixtures showed no change in appearance and color,and no stratification,precipitation,flocculation,or wall adhesion were observed.pH and osmotic pressure remained stable,and the number of insoluble particulate matter complied with the relevant requirements listed in Chinese Pharmacopoeia.No statistically significant differences were observed in mean droplet diameter(MDD),polydispersity index(PDI),or Zeta potential compared with the original TNAs(P>0.05),and no significant variations were found among different time points within each group(P>0.05).In terms of meropenem content,only the relative percentage content of the meropenem sample combined with TNA2 maintained above 95%of the initial concentration within 4 h.However,the related substances in all admixtures exceeded the acceptable limit within 4 h.Conclusion Meropenem degrades rapidly in TNA,and thus co-administration with TNA via Y-site infusion should be avoided in clinical practice.
作者
岳延涛
冯世杰
王丽果
李元培
娄丽杰
张潇菡
赵亮
YUE Yan-tao;FENG Shi-jie;WANG Li-guo;LI Yuan-pei;LOU Li-jie;ZHANG Xiao-han;ZHAO Liang(Department of Pharmacy,Xuchang Central Hospital Affiliated to Henan University of Science and Technology,Xuchang Key Laboratory of Intelligent Pharmacy and Clinical Application of Drugs,Xuchang 461000,China)
出处
《食品与药品》
2026年第1期1-9,共9页
Food and Drug
基金
河南省医学科技攻关计划项目(编号:LHGJ20210949)。
关键词
美罗培南
全营养混合液
肠外营养
Y型输液通路
相容性
meropenem
total nutrient admixture
parenteral nutrition
Y-site infusion channel
compatibility
