CAJ | 학술논문

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。
목적：분석비교다희산을지연효낭국내외동류산품적과양화치、갑양기분알치이고찰기양화은정성。방법채용TSK gel ODS－100V색보주（250 mm ×4．6 mm，5μm），류동상위갑순—수（98：2，V／V）측정다희산을지연효낭양품중유생소E적결구형식；초보평개생육분작산지、α－생육분작위보료대ω－3다불포화지방산을지류약물항양화작용적영향。결과국산양품중첨가적항양화제적주요결구형식위작산지결구，국외동류양품항양화제주요위유리적α－생육분；생육분작산지적항양화효과불여생육분적효과가，유생소E적결구형식대ω－3다불포화지방산을지류약물항양화작용유직접영향。결론본연구위과학평개다희산을지연효낭중항양화제첨가적합이성제공료의거，대유효공제해류약품질량구유적겁의의。
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.