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題 名 | 聚氯乙烯(PVC)材質醫療器材中鄰苯二甲酸二(2-乙基己基)酯(DEHP)檢驗方法之建立 =Method for Quantitative Analysis of Di (2-ethylhexyl) phthalate (DEHP) in Polyvinyl Chloride (PVC) Medical Devices |
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作 者 | 傅孝瑜; 黃守潔; 陳玉盆; 闕麗卿; 施養志; | 書刊名 | 食品藥物研究年報 |
卷 期 | 4 2013.11[民102.11] |
頁 次 | 頁277-285 |
分類號 | 412.3 |
關鍵詞 | 聚氯乙烯; 鄰苯二甲酸二(2-乙基己基)酯; 高效能液相層析; PVC; DEHP; Polyvinyl chloride; Di(2-ethylhexyl)phthalate; High performance liquid chromatography; HPLC; |
語 文 | 中文(Chinese) |
中文摘要 | 為降低含 DEHP之塑膠類 (PVC)醫療器材對孩童、懷孕或授乳婦女、青春期男性等敏感族群之健康風險疑慮,行政院衛生署參酌國際作法,於 100.05.23署授食字第 1001603415號公告「高鄰苯二甲酸二 (2-乙基己基 )酯(DEHP)暴露風險之聚氯乙烯 (PVC)材質醫療器材相關標示規定」,公告相關醫療器材須加以標示。為配合行政管理政策,本研究期建立聚氯乙烯材質醫療器材中 DEHP含量分析方法,以應用於市面上該類產品之檢測。檢體經四氫呋喃溶解後,以正己烷沉澱離心,再以甲醇稀釋,以高效能液相層析方法進行分析。層析管柱使用 Lichrospher 100 RP-18e (5μm),乙腈為移動相,以光電二極體陣列 (PDA)偵測器偵測。 DEHP成分標準曲線之線性範圍為 11.85-474.0 μg/mL,線性回歸之判定係數 (r2)為0.9999,同日內及異日間試驗之相對標準偏差分別小於 0.86及0.84%。添加不同濃度之標準品於空白檢體中,回收率介於 89.6-102.3%,相對標準偏差均小於 2.6%,方法之定量極限為 0.3%。 |
英文摘要 | To reduce the possible health risks of phthalates-containing PVC medical devices to the sensitive population, the administrative interpretation NO. 1001603415 was announced by Department of Health, Executive Yuan, R.O.C (Taiwan) May 23, 2011. It is mandatory for PVC medical devices containing DEHP to be labeled to indicate the presence. In line with the policy of the administration, a HPLC method for DEHP analysis was established to examine DEHP in PVC medical devices in this study. Sample was cut into small pieces (less than 2 × 2 × 2 mm), dissolved in tetrahydrofuran and then precipitated with hexane. The supernatant was analyzed by HPLC in combination with photodiode array detector. A C18 column (Lichrospher 100 RP-18e, 5µm) and mobile phase acetonitrile were used. DEHP standard curve ranged from 11.85 μg/mL to 474.00 μg/mL, and the coefficients of determination, r2 was 0.9999. The relative standard deviations for intraday and interday analyses were less than 0.86% and 0.84%, respectively. Three different concentrations of DEHP standards were spiked into blank samples with recoveries ranging from 89.6 to 102.3%. |
本系統中英文摘要資訊取自各篇刊載內容。