| 姚羽,张琳,王文艳,马敏.保和丸中外源性邻苯二甲酸酯类的检测[J].中国药事,2017,(4):441-446 |
| 保和丸中外源性邻苯二甲酸酯类的检测 |
| Detection of Exogenous Phthalate Esters in Baohe Pills |
| 投稿时间：2016-06-30 |
| DOI：10.16153/j.1002-7777.2017.04.016 |
| 中文关键词: 药包材质量 酞酸酯 聚氯乙烯材料 增塑剂 GC 保和丸 GC-MS 药品包装安全性 |
| 英文关键词: pharmaceutical packaging material quality phthalate esters PVC material plasticizer GC Baohe pills GC-MS safety of pharmaceutical packaging |
| 基金项目: |
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| 摘要点击次数: 926 |
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| 中文摘要: |
| 目的：为考察聚氯乙烯固体药用硬片中邻苯二甲酸酯类（PAEs）向保和丸中迁移情况，建立了检测方法。方法：采用Elite-5（30 m×0.32 mm，0.25μm）毛细管色谱柱，氢火焰离子化检测器（FID），进样温度为250℃，检测器温度为300℃，载气为氮气，程序升温，不分流进样，进样量为1μL。并结合气相色谱-质谱法（GC-MS）对样品中的PAEs进行定性确认。结果：6种PAEs在各自的浓度范围内呈良好线性关系，r为0.9994~0.9999，平均加样回收率为96.8%~100.4%（n=9，RSD均小于3.0%）。3批样品的包材和药品中均有PAEs检出。结论：该方法分离效果好、操作简便、快速、灵敏度高、精密度好，适用于保和丸中6种PAEs的同时测定。样品的加速试验表明，聚氯乙烯固体药用硬片中的PAEs存在向药品迁移的现象。 |
| 英文摘要: |
| Objective: To determine the migration of phthalate esters (PAEs) in polyvinyl chloride (PVC) sheet with solid pharmaceutical packaging to Baohe pills, so as to establish a detection method. Methods: The PAEs solvents were separated on Elite-5 capillary column (30 m×0.32 mm, 0.25μm). FID was used as detector with a temperature of 300℃, and the inlet temperature was 250℃. The carrier gas was nitrogen and the column temperature was programmed. Splitless injection was conducted, and the injection volume was 1μL. GC-MS was used for the qualitative confirmation of PAEs of samples. Results: The pick area and concentration of six kinds of PAEs showed good linearity (r=0.9994-0.9999). The average recovery rate was 96.8%-100.4% (n=9, RSD<3.0%). The PAEs were detected in drugs and the drug packaging materials in the three batches of samples. Conclusion: The method showed good separation and was simple, rapid, sensitive and precise, which was suitable for the simultaneous detection of six PAEs in Baohe pills. The accelerated testing showed that PAEs in PVC sheet with solid pharmaceutical packaging could migrate to drugs. |
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