一次性使用输液器产品中2-氯乙醇和乙二醇残留量的测定方法研究  

Determination of 2-chloroethanol and ethylene glycol residues in disposable infusion sets

作　　者：刘若锦 刘宝煜 李挥 冯毅 邵文亮 LIU Ruo-jin;LIU Bao-yu;LI Hui;FENG Yi;SHAO Wen-liang(Hebei Institute for Drug and Medical Device Control,Shijiazhuang 050227,China)

机构地区：[1]河北省药品医疗器械检验研究院,石家庄050227

出　　处：《医疗卫生装备》2024年第10期31-36,共6页Chinese Medical Equipment Journal

基　　金：河北省药品监督管理局科技计划项目(2022Z C1027)。

摘　　要：目的:建立有效测定经环氧乙烷(ethylene oxide,EO)灭菌后一次性使用输液器产品中2-氯乙醇(ethylene chlorohydrin,ECH)和乙二醇(ethylene glycol,EG)残留量的方法。方法:选用8890B气相色谱仪,采用液体进样方式,选择DB-WAX色谱柱,以乙醇作为浸提介质,按照一次性使用输液器质量与浸提介质体积比例为0.4 g/mL进行浸提,在37℃浸提10 h后对一次性使用输液器产品中的ECH和EG进行定量测定。结果:该测定方法专属性较强,ECH与EG均在1.25~100.00μg/mL范围内线性关系良好。ECH和EG的检出限分别为0.31和0.11μg/mL。ECH检测精密度的相对标准偏差为0.24%~2.03%,EG检测精密度的相对标准偏差为0.16%~0.87%。ECH检测的平均回收率为95.02%~100.58%,EG检测的平均回收率为99.15%~99.98%。结论:建立的ECH和EG残留量测定方法操作简单、专属性优良、检测准确、重现性好,可满足经EO灭菌的一次性使用输液器产品中ECH和EG残留量的检测需求。Objective To propose an effective method for the determination of 2-chloroethanol(ethylene chlorohydrin,ECH)and ethylene glycol(EG)residues in disposable infusion sets sterilized by ethylene oxide(EO).Methods Extraction with the ratio of the mass of the disposable infusion set to the volume of the medium being 0.4 g/mL was carried out with the 8890B gas chromatograph with liquid injection,DB-WAX column and ethanol extraction medium,and quantitative determination of ECH and EG in disposable infusion sets were implemented after extraction at 37℃for 10 h.Results The method proposely was highly specific,and showed high linearity in the range of 1.25-100.00μg/mL for both ECH and EG.The limits of detection were 0.31 and 0.11μg/mL for ECH and EG,respectively,and the relative standard deviations(RSD)of the precision of ECH was in the range of 0.24%-2.03%and those of EG was in the range of 0.16%-0.87%.The average recoveries were 95.02%-100.58%for ECH and 99.15%-99.98%for EG.Conclusion The method proposed for the determination of ECH and EG residues gains advantages in easy operation,specificity,detection accuracy and reproducibility,and meets the requirements for the determination of ECH and EG residues in EO-sterilized disposable infusion sets.

关 键 词：2-氯乙醇 乙二醇 环氧乙烷灭菌 一次性使用输液器 气相色谱法 

分 类 号：R318.6[医药卫生—生物医学工程] TH789[医药卫生—基础医学]