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

摘要:

摘 要：目的 血液制品的包装材料药用丁基胶塞在存放样品的过程中，有可能有2,6-二叔丁基苯酚物质的溶出，所以需要对制品中的2,6-二叔丁基苯酚进行检测方法的建立。方法 依据静注人免疫球蛋白（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，通过专属性、准确性、重复性、线性、定量限、范围、中间精密度7个内容确认是否适用于此方法。结果 该方法无蛋白干扰，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0.3ug/ml。结论 本实验首次建立了血液制品中2,6-二叔丁基苯酚杂质含量的检测方法，该方法简单易操作，仪器灵敏度高。

Abstract:

Abstract：Objective The blood products packaging materials of rubber closures in the process of sample store, there might be 2,6-di-tert-butylphenol dissolution, so it is need to establish the 2,6-di-tert-butylphenol testing method of blood products. Method 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 .Then the method is verified by the specificity, accuracy, repeatability, linearity, limit of quantification, range and intermediate precision. Result 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 methold. Moreover, each verification result was consistent with the expectation, and the limit of quantitation was 0.3 ng/mL. Therefore, the testing method was proved to be very effective. Conclusion In this work, a simple and sensitive method was first developed and successfully applied to detect the content of 2,6-di-tert-butylphenol from blood products.