药用丁基胶塞溶出物2,6-二叔丁基苯酚检测方法的建立  

The establishment of method for detection of 2,6-di-tert-butylphenol leachables in rubber closures

作　　者：刘雯雯[1,2] 卢奎林 柳海花 高扬 孙勇 林宏辉[1] 

机构地区：[1]四川大学生命科学学院,成都610064 [2]成都蓉生药业有限责任公司,成都610065

出　　处：《四川大学学报（自然科学版）》2017年第3期629-634,共6页Journal of Sichuan University(Natural Science Edition)

基　　金：国家自然科学基金(31570231;31470342;31400211);国家重点基础研究发展计划(973计划)(2015CB150100);国家作物转基因重大专项(2016ZX08009-003-002);四川自然科学基金(2015JY0101;2015JY0223)

摘　　要：根据静注人免疫球蛋白(intravenous human immunoglobulin,pH4)和人血白蛋白的性质,选择高氯酸作为沉淀剂,磷酸三丁酯作为内标,建立血液制品中2,6-二叔丁基苯酚的检测方法,同时利用专属性、准确性、重复性、线性、定量限、范围、中间精密度7个内容确认该方法是否有效.结果表明建立的方法在测定2,6-二叔丁基苯酚过程中无蛋白质干扰,且2,6-二叔丁基苯酚和内标磷酸三丁酯具备较好的分离度,各验证结果均符合预期要求,仪器定量限为0.3μg/mL.According to the properties of intravenous human immunoglobulin （pH4） and human serum albumin, perchloric acid was selected as precipitant reagent and tributyl phosphate as internal standard to detect the 2,6-di-tert-butylphenol content in the blood products. Then the method was verified by the specificity, accuracy, repeatability, linearity, limit of quantification, range and intermediate precision. The results demonstrated this method was feasible without protein interference, 2,6-di-tert-butylphenol and the internal standard of tributyl phosphate were well separated in this method. Moreover, each veri- fication result was consistent with the expectation, and the limit of quantitation was 0.3 μg/mL.

关 键 词：气相色谱 2 6-二叔丁基苯酚 静注人免疫球蛋白 人血白蛋白 

分 类 号：Q819[生物学—生物工程]