| 摘要: |
| 目的 初探聚酯滴眼剂瓶中的乙醛来源，建立乙醛测定方法。方法 优化乙醛测定法，对常温放置0和90 d的聚酯滴眼剂瓶中的乙醛含量进行测定，观察含量变化，并考察常温下聚酯滴眼剂瓶中的乙醛向滴眼剂中迁移的情况。结果 放置90 d后的滴眼剂瓶中乙醛含量明显下降，同时乙醛迁移到滴眼剂中，乙醛含量的变化值和常温1 a的迁移量均远大于残留的乙醛含量，证明聚酯瓶可在常温下反应生成乙醛。优化后的乙醛测定法中乙醛进样量为0.2~5 μg时线性良好，样品精密度相对标准偏差(RSD)为2.3%，3组供试品的平均回收率由低到高分别为85.2%、87.9%、89.6%，说明优化后的方法可以准确定量乙醛。结论 研究乙醛来源，初步确定聚酯滴眼剂瓶可在常温下降解生成乙醛。优化后的乙醛测定法能快速准确地测定聚酯滴眼剂瓶中的乙醛含量，为聚酯滴眼剂瓶的生产和质量控制提供指导。 |
| 关键词: 乙醛来源 降解 迁移 聚酯滴眼剂瓶 乙醛测定 |
| DOI：10.19554/j.cnki.1001-3563.2025.07.020 |
| 分类号: |
| 基金项目:中国食品药品检定研究院中青年发展研究基金(2023C6) |
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| Preliminary Exploration of the Source of Acetaldehyde in PET Bottles for Eye Drops and Establishment of Acetaldehyde Measurement Method |
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YIN Guang, HAN Xiaoxu, WANG Tianwen, ZHAO Xia
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(National Institutes for Food and Drug Control, Beijing 100050, China)
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| Abstract: |
| The work aims to explore the source of acetaldehyde in polyester eye drop bottle and establish a method for the determination of acetaldehyde. The acetaldehyde content in polyester eye drop bottles placed at room temperature for 0 and 90 days was determined by optimizing acetaldehyde determination method. The change of acetaldehyde content was observed, and the migration of acetaldehyde into the eye drop bottles at room temperature was investigated. The acetaldehyde content in the eye drop bottle decreased significantly after 90 days, and the acetaldehyde migrated to the eye drop bottle. The change value of acetaldehyde content and the migration amount after 1 day at room temperature were much larger than the residual acetaldehyde content, which proved that the polyester bottle could react to produce acetaldehyde at room temperature. Strong linearity was shown, when the acetaldehyde injection volume was 0.2-5 μg, the sample precision RSD was 2.3%, the average recoveries were 85.2%, 87.9% and 89.6% from low to high, respectively, indicating that the optimized method could accurately quantify acetaldehyde. The source of acetaldehyde has been studied, and it is determined that polyester eye drop bottle can produce acetaldehyde at normal temperature. The optimized method can determine the acetaldehyde content in polyester eye drop bottle quickly and accurately, and provide guidance for the production and quality control of polyester eye drop bottle. |
| Key words: acetaldehyde source degradation migration polyester eye drop bottles acetaldehyde determination |
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