GC-MS同时测定药用胶塞中16种物质及其在多西他赛注射液中的迁移量

王晓兰; 任锟; 江燕; 赵代国; 秦译; 张晓倩; 李曦

doi:10.19554/j.cnki.1001-3563.2025.13.023

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包装工程（技术栏目） ›› 2025, Vol. 46 ›› Issue (13) : 205-213. DOI: 10.19554/j.cnki.1001-3563.2025.13.023

自动化与智能化技术

GC-MS同时测定药用胶塞中16种物质及其在多西他赛注射液中的迁移量

王晓兰, 任锟, 江燕, 赵代国^*, 秦译, 张晓倩, 李曦

作者信息 +

Simultaneous Determination of 16 Substances in Medicinal Rubber Stoppers and Their Migration Amounts in Docetaxel Injection by GC-MS

WANG Xiaolan, REN Kun, JIANG Yan, ZHAO Daiguo^*, QI Yi, ZHANG Xiaoqian, LI Xi

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摘要

目的建立气相色谱-质谱联用法（GC-MS）,用于同时考察药用胶塞中16种物质（2-乙基己醇、3种硫化剂和12种增塑剂）的提取情况,以及在多西他赛注射液中的迁移情况。方法在SH-Rxi-5 Sil MS毛细管气相色谱柱（30 m×0.25 mm×0.25 μm）上,以1.2 mL/min的载气流速,选用电轰击电离（EI）离子源进行定量分析。通过考察萃取介质、时间和方式对固液萃取效果的影响,确定最佳前处理方法。结果在30~950 ng/mL浓度范围内线性关系良好,相关系数r≥0.995,提取试验回收率为83.41%~114.94%,相对标准偏差RSD为1.07%~4.93%（n=3）;迁移试验回收率为80.21%~106.63%,相对标准偏差RSD为0.63%~3.63%（n=3）。结论该方法操作简便、专属性强、灵敏高效,可用于药用胶塞中16种物质的提取和多西他赛注射液中的迁移研究。

Abstract

The work aims to establish a gas chromatography-mass spectrometry (GC-MS) method to simultaneously investigate the extraction of 16 substances (2-ethylhexanol, 3 kinds of vulcanizing agents and 12 kinds of plasticizers) in medicinal rubber stoppers and their migration in docetaxel injection. A quantitative analysis was performed on a SH-Rxi-5 Sil MS capillary gas chromatography column (30 m×0.25 mm×0.25 μm) with a carrier gas flow rate of 1.2 mL/min and an electron impact ionization (EI) ion source. The most suitable pre-treatment method was determined by investigating the influence of extraction medium, time and mode on the effect of solid-liquid extraction. Good linear relationships were obtained in the concentration range of 30 ng/mL to 950 ng/mL , with correlation coefficients r≥0.995. The extraction recovery rates were 83.41% to 114.94%, and the relative standard deviations (RSD) were 1.07% to 4.93% (n=3). The migration recovery rates were 80.21% to 106.63%, and the RSDs were 0.63% to 3.63% (n=3). In conclusion, this method is simple to operate, highly specific, sensitive and efficient, and can be used for the extraction of 16 substances in medicinal rubber stoppers and the study of migration in docetaxel injection.

导出引用

王晓兰, 任锟, 江燕, 赵代国, 秦译, 张晓倩, 李曦. GC-MS同时测定药用胶塞中16种物质及其在多西他赛注射液中的迁移量[J]. 包装工程（技术栏目）. 2025, 46(13): 205-213 https://doi.org/10.19554/j.cnki.1001-3563.2025.13.023

WANG Xiaolan, REN Kun, JIANG Yan, ZHAO Daiguo, QI Yi, ZHANG Xiaoqian, LI Xi. Simultaneous Determination of 16 Substances in Medicinal Rubber Stoppers and Their Migration Amounts in Docetaxel Injection by GC-MS[J]. Packaging Engineering. 2025, 46(13): 205-213 https://doi.org/10.19554/j.cnki.1001-3563.2025.13.023

中图分类号： TB484.9 O657.63 R917

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