张罗红,黄婉莎,张欣,江燕.药用橡胶塞中17种多环芳烃测定方法[J].包装工程,2021,42(17):10-19.
ZHANG Luo-hong,HUANG Wan-sha,ZHANG Xin,JIANG Yan.Determination Methodology of 17 Polycyclic Aromatic Hydrocarbons in Pharmaceutical Rubber Stoppers[J].Packaging Engineering,2021,42(17):10-19. |
| 药用橡胶塞中17种多环芳烃测定方法 |
| Determination Methodology of 17 Polycyclic Aromatic Hydrocarbons in Pharmaceutical Rubber Stoppers |
| 投稿时间：2021-01-25 |
| DOI：10.19554/j.cnki.1001-3563.2021.17.002 |
| 中文关键词: 多环芳烃 微波萃取 药用胶塞 可提取物 气相色谱-串联质谱 |
| 英文关键词:polycyclic aromatic hydrocarbons microwave extraction pharmaceutical rubber stoppers extractable substances gas chromatography-tandem mass spectrometry |
| 基金项目:四川省食品药品检验检测院科研项目(2019-KYYL-012) |
| 作者 | 单位 |
| 张罗红 | 四川省食品药品检验检测院，成都 610000 |
| 黄婉莎 | 四川省食品药品检验检测院，成都 610000 |
| 张欣 | 四川省食品药品检验检测院，成都 610000 |
| 江燕 | 四川省食品药品检验检测院，成都 610000 |
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| Author | Institution |
| ZHANG Luo-hong | Sichuan Institute for Food and Drug Control, Chengdu 610000, China |
| HUANG Wan-sha | Sichuan Institute for Food and Drug Control, Chengdu 610000, China |
| ZHANG Xin | Sichuan Institute for Food and Drug Control, Chengdu 610000, China |
| JIANG Yan | Sichuan Institute for Food and Drug Control, Chengdu 610000, China |
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| 中文摘要: |
| 目的 建立药用橡胶塞中17种多环芳烃的气相色谱-串联质谱测定方法，评估其残留多环芳烃的安全性。方法 采用丙酮/正己烷(V丙酮∶V正己烷=1∶1)作为提取溶剂，微波萃取胶塞中目标物，以D8-萘、D10-芘、D12-苯并[a]芘为内标进行定量分析。结果 该方法在2～200 ng/mL线性良好，相关系数R为0.9984～0.9999，方法检出限范围为0.35～1.25 ng/g，回收率为92.24%~118.47%，测定结果的相对标准偏差为0.86%~13.23%。采用上述方法对市场上8个厂家的17批胶塞进行提取，其中均提取出不同多环芳烃，致癌性多环芳烃检出量为0.0004～0.1278 μg/g;3批胶塞检出苯并[α]芘量为0.0013～0.0042 μg/g;非明确致癌性多环芳烃检出量为0.0004～0.2980 μg/g。结论 该方法准确、灵敏、简便，可用于定量测定胶塞中残留的高风险致癌性多环芳烃(五环以上)。 |
| 英文摘要: |
| This paper developed determination methodology of gas chromatography-tandem mass spectrometry for 17 polycyclic aromatic hydrocarbons of pharmaceutical rubber stoppers to evaluate the safety of residual polycyclic aromatic hydrocarbons. A mixture of acetone-hexane (V丙酮∶V正己烷=1∶1) was used as the extraction solvent, the target substances of rubber stopper were extracted by microwave, and D8-naphthalene, D10-pyrene and D12-benzo[a]pyrene were used as internal standards for quantification analysis. Good linearity was observed within the range of 2-200 ng/mL, the correlation coefficient R was 0.9984-0.9999, and the limit of detection was in the range of 0.35-1.25 ng/g in this methodology. Besides, the recovery ranged from 92.24% to 118.47% (RSD:0.86%-13.23%). The above method was used to extract 17 batches of rubber stoppers from 8 manufacturers on the market, and different polycyclic aromatic hydrocarbons were extracted from them. The detected amount of carcinogenic PAHs was in the range of 0.0004 to 0.1278 μg/g, benzo[α]pyrene from 3 batches of the rubber stoppers were in the range of 0.0013-0.0042 μg/g and the detected amount of unclear carcinogenic PAHs was 0.0004-0.2980 μg/g. This method is accurate, sensitive, simple and suitable for the quantitative determination of the residual high-risk carcinogenic polycyclic aromatic hydrocarbons (above five rings) in rubber stoppers. |
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