聚烯烃热塑弹性体输液器中苯乙烯的提取和迁移研究  

Study on the Extraction and Migration of Styrene in Polyolefin Thermoplastic Elastomer Infusion Device

作　　者：高小艳 谢代超 杨婧 卢华 周成 熊峰 Gao Xiaoyan;Xie Daichao;Yang Jing;Lu Hua;Zhou Cheng;Xiong Feng(Sichuan Institute for Drug Control(Sichuan Testing Center of Medical Devices),Industrial Technology Foundation Public Service Platform of the Ministry of Industry and Information Technology,Sichuan,610039)

机构地区：[1]四川省药品检验研究院(四川省医疗器械检测中心)工业和信息化部产业技术基础公共服务平台,四川610039

出　　处：《当代化工研究》2025年第3期75-77,共3页Modern Chemical Research

基　　金：四川省科技计划项目“紫杉醇药物球囊用于治疗颅内血管粥样硬化狭窄的应用研究”(项目编号:2023YFS0008)。

摘　　要：采用气相色谱-质谱联用法(Gas-chromatography-mass Spectrometry,GC-MS),对两个不同厂家的一次性使用聚烯烃热塑性弹性体(Thermoplastic Elastomer,TPE)输液器中苯乙烯单体的含量及其在药物中的迁移情况进行了研究。提取试验:将输液器的各部件剪碎,用GC-MS测定苯乙烯单体的含量。迁移试验:用7种不同类型的注射液和65%乙醇溶液,模拟临床使用条件,经TPE输液器输出后,收集迁移液,通过GC-MS测定苯乙烯在这8种溶液中的迁移量。提取试验表明TPE输液器中存在一定的苯乙烯单体残留。迁移结果表明,苯乙烯在0.2~121 ng/mL范围内线性良好,在8种迁移液中的准确度(回收率)为86.60%~114.90%,该方法精密度、准确度高,稳定性好,可用于TPE输液器中苯乙烯的迁移量检测。两个厂家的TPE输液器在上述8种迁移液中均未检测出苯乙烯单体。The content of monomer styrene in disposable polyolefin thermoplastic elastomer(TPE)infusion sets from two different manu-facturers and its migration in drugs were studied using gas chromatography-mass spectrometry(GC-MS).Extraction test:Cut the components of infusion set into small pieces and measure the content of styene monomer using GC-MS.Migration test:Using seven different types of injection solution and 65%ethanol solution,simulating the clinical use conditions,after the output from the TPE infusion set,the migration fluid was collected,and the migration amount of styrene in these eight solutions was determined by GC-MS.Extraction test showed that some styrene monomer remains in the TPE infusion set.The migration results show that the styrene has good linearity in the range of 0.2~121 ng/mL,and the accuracy(recovery)is 86.60%~114.90%.This method has high precision,accuracy and stability,and can be used to detect the migration of styrene in TPE infusion set.Conclusion:No styrene monomer was detected in the 8 migration solutions.

关 键 词：输液器 TPE 苯乙烯 气相色谱-质谱法 迁移 

分 类 号：TQ32[化学工程—合成树脂塑料工业]