| 冻干胶塞的成分及其安全性分析 |
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| 引用本文： | 袁怡,周姝,陈晓莉,李鹏飞,胡 敏. 冻干胶塞的成分及其安全性分析[J]. 橡胶工业, 2024, 71(6): 0444-0450 |
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| 作者姓名： | 袁怡 周姝 陈晓莉 李鹏飞 胡 敏 |
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| 作者单位： | 湖北省药品监督检验研究院,湖北省药品监督检验研究院,湖北省药品监督检验研究院,湖北省药品监督检验研究院,湖北省药品监督检验研究院 |
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| 摘 要： | 对70批冻干胶塞进行成分及安全性分析。结构表明：通过气相色谱-质谱、电感耦合-等离子体发射光谱、离子色谱和热重分析等多种分析技术联用可以分析冻干胶塞的成分并可以反向推出冻干胶塞的胶料配方；因胶料配方差异导致冻干胶塞的质量差别较大，冻干胶塞中亚硝胺和多环芳烃有不同程度残留；胶料配方、前处理方法、环境湿度和存放时间会影响冻干胶塞的含水量。
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| 关 键 词： | 冻干胶塞；成分分析；安全性 |
| 收稿时间： | 2022-09-20 |
| 修稿时间： | 2022-09-27 |
Composition and Safety Analysis of Lyophilized Rubber Stoppers |
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| YUAN Yi,ZHOU Shu,CHEN Xiaoli,LI Pengfei and HU Min. Composition and Safety Analysis of Lyophilized Rubber Stoppers[J]. China Rubber Industry, 2024, 71(6): 0444-0450 |
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| Authors: | YUAN Yi ZHOU Shu CHEN Xiaoli LI Pengfei HU Min |
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| Affiliation: | Hubei Institute for Drug Control,Hubei Institute for Drug Control,Hubei Institute for Drug Control,Hubei Institute for Drug Control,Hubei Institute for Drug Control |
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| Abstract: | The compositions and safeies of 70 batches of lyophilized rubber stoppers were analyzed.The results showed that，by combining multiple analytical techniques such as gas chromatography-mass spectrometry，inductively coupled plasma-optical emission spectroscopy，ion chromatography and thermal gravimetric analysis，the compositions of the lyophilized rubber stoppers could be analyzed，and the formula of the lyophilized rubber stoppers could be derived in reverse .Due to different compound formulas，there were significant differences in the qualities of the lyophilized rubber stoppers，and the lyophilized rubber stoppers contained varying levels of residual nitrosamines and polycyclic aromatic hydrcarbons.Compound formula，pre-treatment method，environmental humidity and storage time could all affect the moisture content of lyophilized rubber stopper. |
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| Keywords: | lyophilized rubber stopper；composition analysis；safety |
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