避光输液器中颜料棕25和UV-327的迁移溶出研究  

Study on migration and dissolution of Pigment Brown 25 and UV-327 in disposable light-proof infusion set

作　　者：于风平 代秀梅 赵锐 王彦厚 

机构地区：[1]淄博市食品药品检验检测中心,淄博255086

出　　处：《药物分析杂志》2015年第6期1058-1061,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立颜料棕25和UV-327的痕量检测方法,对一次性使用避光过滤输液器中颜料棕25和UV-327的迁移溶出进行研究。方法：采用高效液相色谱法,颜料棕25选用Inertsil ODS-3色谱柱,以乙腈-0.1%磷酸（80∶20）为流动相,流速1.0m L·min-1,415 nm作为检测波长;UV-327选用Zorbax-C18色谱柱,以甲醇-水（95∶5）为流动相,流速1.2 m L·min-1,346 nm作为检测波长。结果：颜料棕25质量浓度在5.06-404.8 ng·m L-1范围内线性关系良好（r=0.999 9）,平均回收率为100.5%,检出限为1.518 ng·m L-1;UV-327质量浓度在1.163-116.3 ng·m L-1范围内线性关系良好（r=0.999 9）,平均回收率为101.0%,检出限为0.383 8 ng·m L-1;颜料棕25和UV-327在65%乙醇溶液、0.1 mol·L-1氢氧化钠溶液、0.1 mol·L-1盐酸溶液和8种临床输液药物中未发生溶出。结论：本文建立的方法灵敏度高,重复性好,适合对避光输液器中颜料棕25和UV-327的迁移溶出进行检测;颜料棕25和UV-327适合作为输液器的避光材料。Objective：To establish a method for trace determination of Pigment Brown 25 and UV-327 so as to explore the migration and dissolution of Pigment Brown 25 and UV-327 from disposable light-proof infusion set.Methods：Pigment Brown 25 was detected by high performance liquid chromatography（HPLC） method.The Inertsil ODS-3 column was adopted;the mobile phase consisted of acetonitrile-0.1% phosphate acid（80∶ 20） at a flow rate of 1.0 m L·min^-1;the detection wavelength was 415 nm.For UV-327,the Zorbax-C18 column was adopted;the mobile phase consisted of methanol-water（95∶ 5） at a flow rate of 1.2 m L·min^-1;the detection wavelength was 346 nm.Results：The calibration curves of Pigment Brown 25 and UV-327 were linear over the range of 5.06-404.8 ng·m L^-1（r =0.999 9） and 1.163-116.3 ng·m L^-1（r =0.999 9）;the average recoveries were 100.5% and 101.0%;the quantitation limits were 1.518 ng·m L^-1and0.383 8 ng·m L^-1.Pigment Brown 25 and UV-327 were not dissolved in 0.1 mol·L^-1hydrochloric acid,0.1 mol·L^-1sodium hydroxide,0.1 mol·L^-1hydrochloric acid as well as in 8 infusion solutions.Conclusion：The method is sensitive and reproducible,which is suitable for the dissolution test of Pigment Brown 25 and UV-327 in disposable light-proof infusion set.Pigment Brown 25 and UV-327 is suitable to be used as the light-proof materials of infusion set.

关 键 词：药品包装材料 避光输液器 颜料棕25 苯并咪唑酮 UV-327 高效液相色谱 颜料迁移溶出 

分 类 号：R917[医药卫生—药物分析学]