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中国医药导刊 ›› 2025, Vol. 27 ›› Issue (9): 954-959.

• 检验检测 • 上一篇    下一篇

静脉留置针中苯乙烯在5种药液中的迁移研究

王晓兰1, 谢桂芳2, 江燕1, 张晓倩1, 任锟1*   

  1. 1.四川省药品检验研究院,工业和信息化部产业技术基础公共服务平台,四川 成都 611731;
    2.成都景泽生物制药有限公司,四川 成都 611130
  • 收稿日期:2025-04-07 修回日期:2025-05-20 接受日期:2025-11-12 出版日期:2025-09-28 发布日期:2025-11-18

Study on Migration of Styrene from Disposable Intravenous Indwelling Needle in 5 Kinds of Liquid Medicine

WANG Xiaolan1, XIE Guifang2, JIANG Yan1, Zhang Xiaoqian1, REN Kun1*   

  1. 1.Sichuan Institute for Drug Control MIIT Public Service Platforms for Industrial Technological Base Chengdu 611731, China
    2. Chengdu Jingze biological pharmaceutical Co. Ltd. Chengdu 611130, China
  • Received:2025-04-07 Revised:2025-05-20 Accepted:2025-11-12 Online:2025-09-28 Published:2025-11-18

摘要:

建立GC/MS测定一次性使用静脉留置针模拟临床使用中苯乙烯向碳酸氢钠注射液、脂肪乳注射液、注射用头孢硫脒、紫杉醇注射液和替硝唑葡萄糖注射液的迁移量。采用顶空气相色谱-质谱法,以HP-5 MS 30 m×0.25 mm×0.25 μm)色谱柱,以苯乙烯-d8作为内标,采用程序升温,顶空进样方法,离子监测(SIM)模式进行检测。结果显示:苯乙烯在102000 ng·mL-1范围内线性关系良好,相关系数0.9991。苯乙烯在碳酸氢钠注射液、脂肪乳注射液、注射用头孢硫脒、紫杉醇注射液、替硝唑葡萄糖注射液中的平均回收率依次为101.9%90.6%104.0%96.1%102.9%;检测限为4.1 ng·mL-1,定量限为13.7 ng·mL-1。该方法灵敏、准确,可用于一次性使用静脉留置针模拟临床使用中苯乙烯向碳酸氢钠注射液、脂肪乳注射液、注射用头孢硫脒、紫杉醇注射液和替硝唑葡萄糖注射液迁移量的检测。


关键词: 一次性使用静脉留置针, 苯乙烯, 迁移量, GC/MS

Abstract:

A GC/MS method was established to determine the migration of styrene to sodium bicarbonate injection fat milk injection cefathiamidine injection paclitaxel injection and tinidazole glucose injection in simulated clinical use of disposable intravenous indenture needle. Headspace gas chromatogen-mass spectrometry was used on HP-5 MS 30 m×0.25 mm×0.25 μmcolumn with styrene-d8 as the internal standard. The method of programmed temperature headspace sampling and ion monitoring SIM mode were used for the detection. The linear relationship of styrene was good in the range of 10~2000 ng·mL-1 and the correlation coefficient was 0.9991. The average recovery of styrene in sodium bicarbonate injection fat milk injection cefathiamidine injection paclitaxel injection and tinidazole glucose injection were 101.9% 90.6% 104.0%, ,96.1%102.9% respectively. The limit of detection was 4.1 ng·mL-1 and the limit of quantification was 13.7 ng·mL-1. The method is sensitive and accurate and can be used to detect the migration amount of styrene to sodium bicarbonate injection fat milk injection cefathiamidine injection paclitaxel injection and tinidazole glucose injection in simulated clinical use of disposable intravenous indenture needle.

 

Key words: Disposable intravenous indwelling needle , Styrene , Migration amount , GC/MS

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