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首页> 外文期刊>The Journal of automatic chemistry >Determination of the Contents of Antioxidants and Their Degradation Products in Sodium Chloride Injection for Blood Transfusion
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Determination of the Contents of Antioxidants and Their Degradation Products in Sodium Chloride Injection for Blood Transfusion

机译：输血氯化钠注射液中抗氧化剂及其降解产物的测定

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摘要

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? μ m) 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? μ g/mL), limit of quantification (LOQ, 0.031–0.393? μ g/mL), intraday precision (0.25%–3.17%), interday precision (0.47%–3.48%), linearity (0.1–46.8? μ g/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? μ g/3 bags to 48.71? μ g/3 bags. The daily intake of 1310 did not exceed 48.71? μ g, which was much lower than its permitted daily exposure (PDE, 300? μ g/day). Therefore, the antioxidants and their degradation products migrating into the drug solution would not cause drug safety risks.
机译：输液袋主要由聚烯烃聚合物组成。通常将抗氧化剂添加到这些聚合物材料中，以防止材料衰老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的抗氧化剂的量。在本研究中，我们开发并验证了HPLC方法，用于同时定量抗氧化剂及其迁移到注射钠氯化钠溶液的降解产物。分离六种抗氧化剂和六种降解产物，并通过使用水对称性RP18柱同时测定（250××4.6毫米，5Ω·μm）和甲醇/乙腈/乙酸 - 水的梯度洗脱（1 ？：α：99，v / v）流速为1.0？ml / min。检测波长设定为277℃，柱温保持在35℃。该方法在检测限（LOD，0.011-0.151Ω×μg/ ml）的限度方面验证，定量限（LOQ，0.031-0.393Ωμg/ mL），内部精度（0.25％-3.17％），间隔精度（0.47％-3.48％），线性度（0.1-46.8？μg/ ml，r？0.9994），稳定性（0.35％-3.29％），准确度（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，以及其降解产物1310和DBP。在迁移实验中只检测到1310。用于输血氯化钠的最大每日剂量是三个袋子，长期试样中的1310含量为0至12个月，范围为37.44？ μg / 3袋到48.71？ μg / 3袋。每日1310的摄入量不超过48.71？ μg，远低于其允许的每日暴露（PDE，300μl/天）。因此，迁移到药物溶液中的抗氧化剂及其降解产物不会引起药物安全风险。

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