摘要
目的 研究普通聚氯乙烯输液器17种增塑剂在3种模拟液环境中的迁移量的检测方法、数据结果及风险分析。方法 采用气相色谱-质谱联用法(GC-MS)测定PVC输液器中17种增塑剂的迁移量;对比了普通PVC输液器中17种邻苯类增塑剂在0.9%氯化钠注射液、脂肪乳和5%葡萄糖溶液3种注射液中的迁移量结果,随机选取普通PVC输液器共24批次样本进行检测筛查及风险分析研究。结果 外标法测定PVC输液器中17种增塑剂的迁移量,工作曲线良好,相关性均在0.995以上,检出限为0.1μg/L~0.5μg/L,加标回收率为84.8%~98.9%。结论 该方法准确可靠,为PVC输液器中增塑剂迁移量的测定提供了检测依据和数据支持,为相关企业、医院及监管部门提供借鉴参考。
Objective This paper aims to study the detection methods, data results and risks of the migration of 17 plasticizers in three simulated injections. Methods The migration of 17 plasticizers in PVC infusion sets was determined by gas chromatography-mass spectrometry(GC-MS);the migration results of 17 kinds of o-benzene plasticizers in 0.9% sodium chloride injection, fat emulsion and 5% glucose solution in ordinary PVC infusion sets were compared. 24 batches of samples of ordinary PVC infusion sets were randomly selected for detection, screening and risk analysis. Results The migration amount of 17 plasticizers in PVC infusion set was determined by external standard method. The working curve was good, the correlation was more than 0.995, the detection limit was within 0.1 μg/L-0.5 μg/L, and the recovery rate was sithin 84.8%-98.9%. Conclusion The method is accurate and reliable, which provides detection basis and data support for the determination of plasticizer migration in PVC infusion sets, and provides reference for relevant enterprises, hospitals and regulatory departments.
作者
李盼盼
李芳
武笑颖
李林林
LI Pan-pan;LI Fang;WU Xiao-ying;LI Lin-lin(Sixth Medical Center of PLA General Hospital,Bejing 100000,China;不详)
出处
《中国卫生检验杂志》
CAS
2022年第23期2836-2839,共4页
Chinese Journal of Health Laboratory Technology
