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,2025,46(13):205-213.
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. |
| 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 |
| Simultaneous Determination of 16 Substances in Medicinal Rubber Stoppers and Their Migration Amounts in Docetaxel Injection by GC-MS |
| 投稿时间：2025-03-13 |
| DOI：10.19554/j.cnki.1001-3563.2025.13.023 |
| 中文关键词: 药用胶塞 气相色谱-质谱联用 多西他赛注射液 迁移 |
| 英文关键词:medicinal rubber stopper gas chromatography-mass spectrometry docetaxel injection migration |
| 基金项目:重庆市科技计划-科研机构绩效激励引导专项(2023-KYSB-036) |
| 作者 | 单位 |
| 王晓兰 | 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，成都 611731 |
| 任锟 | 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，成都 611731 |
| 江燕 | 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，成都 611731 |
| 赵代国 | 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，成都 611731 |
| 秦译 | 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，成都 611731 |
| 张晓倩 | 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，成都 611731 |
| 李曦 | 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，成都 611731 |
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| Author | Institution |
| WANG Xiaolan | Ministry of Industry and Information Technology Industrial Technology Foundation Public Service Platform, Sichuan Institute for Drug Control, Chengdu 611731, China |
| REN Kun | Ministry of Industry and Information Technology Industrial Technology Foundation Public Service Platform, Sichuan Institute for Drug Control, Chengdu 611731, China |
| JIANG Yan | Ministry of Industry and Information Technology Industrial Technology Foundation Public Service Platform, Sichuan Institute for Drug Control, Chengdu 611731, China |
| ZHAO Daiguo | Ministry of Industry and Information Technology Industrial Technology Foundation Public Service Platform, Sichuan Institute for Drug Control, Chengdu 611731, China |
| QI Yi | Ministry of Industry and Information Technology Industrial Technology Foundation Public Service Platform, Sichuan Institute for Drug Control, Chengdu 611731, China |
| ZHANG Xiaoqian | Ministry of Industry and Information Technology Industrial Technology Foundation Public Service Platform, Sichuan Institute for Drug Control, Chengdu 611731, China |
| LI Xi | Ministry of Industry and Information Technology Industrial Technology Foundation Public Service Platform, Sichuan Institute for Drug Control, Chengdu 611731, China |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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