中心静脉导管冲洗器中环己酮溶出量的测定  

Determination of Cyclohexanone Dissolution in Central Venous Catheter Irrigator

作　　者：严群 曲亚南 谢新艺[1] 方旻[1] YAN Qun;QU Ya-nan;XIE Xin-yi;FANG Min(Guangdong Medical Devices Quality Surveillance and Test,Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗器械信息》2021年第9期28-30,共3页China Medical Device Information

基　　金：广东省药监局2018年科技创新项目(项目名称:药包材料与药品相容性研究重点实验室,项目编号:2018ZDZ05)。

摘　　要：针对目前国内一次性输液器具中大量使用环己酮类黏结剂的现状,本文通过采用0.9%氯化钠注射液在(37±1)℃的温度下模拟临床使用的方法,使得药液经过中心静脉导管冲洗器,收集不同时间段的浸提液,通过气相色谱法测定浸提液中环己酮的溶出量。试验结果表明,环己酮在0.25~5μg/mL范围内线性良好,相关系数为0.9996,环己酮不同浓度的加标回收率在92.8%~105.0%,相对标准偏差为4.20%。该方法准确高效,操作简便,重复性好,灵敏度高,可用于输液器具中环己酮的溶出量检测。In view of the current situation that a large number of cyclohexanone adhesives are used in disposable infusion apparatus in China, the method of simulating clinical use of 0.9% sodium chloride injection at(37±1) ℃ is adopted in this paper, which makes the solution pass through the central venous catheter irrigator, collect the extraction solution in different periods of time, and determine the dissolution amount of cyclohexanone in the extraction solution by gas chromatography. The results showed that the linearity of cyclohexanone was good in the range of 0.25~5μg/mL, and the correlation coefficient was 0.9996. The standard recovery rates of cyclohexanone at different concentrations ranged from 92.8% to 105.0%, the relative standard deviation was 4.20%. The method is accurate, efficient, simple, repeatable and sensitive, which can be used to detect the dissolution of cyclohexanone in infusion apparatus.

关 键 词：中心静脉导管冲洗器 环己酮 黏结剂 气相色谱法 

分 类 号：R197.39[医药卫生—卫生事业管理]