TPE输液器中苯乙烯在六种溶液中的溶出量研究

Study on the Dissolution of Styrene from TPE Infusion Set in Six Solutions

本文以TPE输液器为研究对象,通过选取0.9%氯化钠注射液、0.1mol/L盐酸溶液、0.1mol/L氢氧化钠溶液、65%乙醇溶液、紫杉醇注射液(溶媒5%葡萄糖注射液)以及脂肪乳注射液这六种溶液,涵盖中性、酸性、碱性物质,低极性物质以及临床使用的脂溶性药物,在室温下进行模拟临床滴注试验,从而收集各迁移液,通过气相色谱-质谱联用法测定TPE输液器中苯乙烯在这六种溶液中的溶出量。试验结果表明,苯乙烯在0.1~5μg/mL范围内线性良好,R^(2)=0.998,苯乙烯在这六种溶液中不同浓度的加标回收率在86.0%~126.0%之间,相对标准偏差在2.24%~7.41%之间。该方法准确高效,重复性好,灵敏度高,可用于TPE输液器中苯乙烯的溶出量检测。

In this paper,TPE infusion set as the research object,through the selection of 0.9%sodium chloride injection,0.1mol/L hydrochloric acid solution,0.1mol/L sodium hydroxide solution,65%ethanol solution,paclitaxel injection(solvent 5%glucose injection)and fat emulsion injection of these six solutions,which cover the neutral,acidic and alkaline substances,low polar substances and liposoluble drugs for clinical use,the simulated clinical drip tests were conducted at room temperature to collect the migration liquids,and the dissolution of styrene in the six solutions was determined by gas chromatography-mass spectrometry.The results showed that the linearity of styrene was good in the range of(0.1~5)μg/mL,R2=0.998.The recoveries of different concentrations of styrene in these six solutions ranged from 86.0%to 126.0%,and the relative standard deviations ranged from 2.24%to 7.41%.The method is accurate,efficient,repeatable and sensitive,which can be used for the determination of styrene in TPE infusion set.