The infusion bag is mainly made up of polyolefin polymer. Antioxidants are usually added to these polymer materials in the production process to prevent the materials from aging and enhance the stability of the materials. Because of the potential harm of antioxidants to human body, it is necessary to limit the amount of antioxidants migrating to the pharmaceutical solutions. In the present study, we developed and validated the HPLC method for the simultaneous quantification of antioxidants and their degradation products migrating to sodium chloride solution for injection. A total of six antioxidants and six their degradation products were separated and simultaneously determined by using a Waters Symmetry RP18 column (250 × 4.6 mm, 5 μm) and gradient elution of methanol/acetonitrile/acetic acid-water (1 : 99, v/v) at a flow rate of 1.0 mL/min. The detective wavelength was set at 277 nm, and the column temperature was maintained at 35°C. The method was validated in terms of limit of detection (LOD, 0.011–0.151 μg/mL), limit of quantification (LOQ, 0.031–0.393 μg/mL), intraday precision (0.25%–3.17%), interday precision (0.47%–3.48%), linearity (0.1–46.8 μg/mL, r > 0.9994), stability (0.35%–3.29%), and accuracy (80.39%–104.31%). In the extraction experiment, antioxidants, BHT, 1010, 1330, 1076, and 168, and their degradation products, 1310 and DBP, were detected in the packaging materials. Only 1310 was detected in the migration experiment. The maximum daily dosage of sodium chloride for blood transfusion is three bags, and the content of 1310 in long-term testing samples is from 0 to 12 months ranging from 37.44 μg/3 bags to 48.71 μg/3 bags. The daily intake of 1310 did not exceed 48.71 μg, which was much lower than its permitted daily exposure (PDE, 300 μg/day). Therefore, the antioxidants and their degradation products migrating into the drug solution would not cause drug safety risks.

中文翻译：

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输血用氯化钠注射液中抗氧化剂及其降解产物含量的测定。

输液袋主要由聚烯烃聚合物制成。通常在生产过程中将抗氧化剂添加到这些聚合物材料中，以防止材料老化并增强材料的稳定性。由于抗氧化剂对人体的潜在危害，有必要限制迁移到药物溶液中的抗氧化剂的数量。在本研究中，我们开发并验证了同时定量抗氧化剂及其降解产物迁移至注射用氯化钠溶液的HPLC方法。使用Waters Symmetry RP18色谱柱（250×4.6 mm，  5μm）和以1.0mL / min的流速梯度洗脱甲醇/乙腈/乙酸-水（1：99，v / v）。检测波长设定为277nm，柱温保持在35℃。该方法在（LOD，0.011-0.151检测限性进行了验证 μ定量克/毫升），极限（LOQ，0.031-0.393  μ克/毫升），盘中精度（0.25％-3.17％），日间精密度（ 0.47％-3.48％），线性（0.1-46.8  μ克/毫升，ř > 0.9994），稳定性（0.35％–3.29％）和准确性（80.39％–104.31％）。在提取实验中，在包装材料中检测到抗氧化剂BHT，1010、1330、1076和168及其降解产物1310和DBP。在迁移实验中仅检测到1310。氯化钠以进行输血的最大日剂量为三包，和1310长期测试样品中的含量为0至12个月不等的37.44  μ克/ 3袋48.71  μ克/ 3袋。每天摄入1310不超过48.71  μ g，这是远远超过它的允许每日暴露量（PDE，300降低 μ克/天）。因此，抗氧化剂及其降解产物迁移到药物溶液中不会引起药物安全风险。