多烯酸乙酯软胶囊的抗氧化剂研究

Study on antioxidant of ethyl polyenoate soft capsules

目的分析比较多烯酸乙酯软胶囊国内外同类产品的过氧化值、甲氧基苯胺值以考察其氧化稳定性。方法采用TSK gel ODS-100V色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇—水(98∶2,V/V)测定多烯酸乙酯软胶囊样品中维生素E的结构形式;初步评价生育酚醋酸酯、α-生育酚作为辅料对ω-3多不饱和脂肪酸乙酯类药物抗氧化作用的影响。结果国产样品中添加的抗氧化剂的主要结构形式为醋酸酯结构,国外同类样品抗氧化剂主要为游离的α-生育酚;生育酚醋酸酯的抗氧化效果不如生育酚的效果佳,维生素E的结构形式对ω-3多不饱和脂肪酸乙酯类药物抗氧化作用有直接影响。结论本研究为科学评价多烯酸乙酯软胶囊中抗氧化剂添加的合理性提供了依据,对有效控制该类药品质量具有积极意义。

Objective To analyze peroxide value and anisidine value of ethyl polyenoate soft capsules and imported drugs and evaluate the oxidative stability.Methods The analysis was carried out on a TSK gel ODS-100 V（250 mm ×4.6 mm,5μm）with methanol-water（98：2,V/V）as the mobile phase to determine the structure of the vitamin E as antioxidant.The influence on the antioxidation effect of tocopherol acetate andα-tocopherol as excipient in omega-3 polyunsaturated fatty acid ethyl ester drugs was evaluated.Results The structure of vitamin E as antioxidant in domestic drugs was acetate, while vitamin E as excipient in foreign drugs had the structure of α-tocopherol monomer.As antioxidant, the antioxidation effect of tocopherol acetate was better thanα-tocopherol.The structure of vitamin E had a direct impact on the antioxidation effect of omega-3 polyunsaturated fatty acid ethyl ester drugs.Conclusion The studies provide the basis for evaluate rationality of antioxidant in ethyl polyenoate soft capsules scientifically, which has positive significance for controlling the quality of the drug effectively.