目的 建立同時測定抗氧化劑1010、330、168、1076的高效液相色譜法（HPLC），測定五層共擠膜輸液用膜中的4種抗氧化劑，并研究抗氧化劑向0.9%氯化鈉注射液中的遷移情況。方法 采用RP-HPLC方法，色譜柱為伊利特C₁₈柱（250 mm×4.6 mm，5 μm），乙腈-四氫呋喃-水（63∶30∶7）為流動相，柱溫30 ℃，體積流量1 mL/min；檢測波長276 nm，進樣量10 μL。結果 抗氧化劑1010、330、168、1076分別在0.6～253.6、0.6～246.4、0.6～257.6、0.6～251.6 μg/mL線性關系良好，平均回收率分別為90.70%（RSD＝2.35%）、89.11%（RSD＝2.75%）、89.87%（RSD＝3.01%）、92.78%（RSD＝1.81%）。同時測定五層共擠膜輸液用膜中的抗氧化劑1010、330、168、1076，所建立的HPLC法穩(wěn)定性好、準確度高，可用于五層共擠膜輸液用膜中抗氧化劑的測定。結論 四種抗氧化劑在輸液用膜及原材料中的量均符合歐洲藥典標準，遷移試驗在0.9%氯化鈉注射液中均未檢出。

Objective To establish a high performance liquid chromatography method for simultaneous determination of anti-oxidants 1010, 330, 168, and 1076 in five-layer co-extrusion films used for infusion, and to study the migration of anti-oxidants to 0.9% sodium chloride injection. Methods The study was carried out by using RP-HPLC with Yilite C₁₈ column (250 mm × 4.6 mm, 5 μm) and acetonitrile-tetrahydrofuran-water (63:30:7) as mobile phase. The column temperature was 30 ℃, flow rate was 1 mL/min, detection wavelength was 276 nm, and injection volume was 10 μL. Results Under the chromatographic conditions used, anti-oxidants 1010, 330, 168, and 1076 had good linear relationship respectively in the following ranges of 0.6―253.6, 0.6―246.4, 0.6―257.6, and 0.6―251.6 mg/L, and the average recoveries were 90.70% (RSD = 2.35%), 89.11% (RSD = 2.75%), 89.87% (RSD = 3.01%), and 92.78% (RSD = 1.81%). Conclusion This validated method is available for quality evaluation and quality control of anti-oxidants 1010, 330, 168, and 1076 in five-layer co-extrusion films used for infusion. The contents of four kinds of anti-oxidants in infusion films and raw materials meet the standards of European Pharmacopoeia. The migration contents of anti-oxidants to 0.9% sodium chloride injection are not detected.