SEC-ELSD法测定中药注射液中聚山梨酯80的含量  

SEC-ELSD determination of polysorbate 80 in traditional Chinese medicine injections

作　　者：吴毅[1,2] 梁成罡[1] 金少鸿[1] 杨美琴[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]中国药科大学药学院,南京210009

出　　处：《药物分析杂志》2008年第1期12-15,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家“十一五”攻关支撑计划项目(编号:2006BA114B06)

摘　　要：目的:建立测定中药注射液中聚山梨酯80含量的分子排阻-蒸发光散射(SEC—ELSD)方法。方法:采用 TSKgel G2000SW_(XL)色谱柱(7.8 mm×30 cm,5μm),以20 mmoL·L^(-1)醋酸铵-乙腈(90∶10)为流动相,流速:0.6 mL·min^(-1);柱温:30℃;蒸发光散射器的漂移管温度:110℃,氮气流速:2.3 L·min^(-1)。结果:聚山梨酯80浓度在1～20mg·mL^(-1)范围内呈良好的对数线性关系,r=0.9968;鱼腥草注射液、新鱼腥草素钠注射液及柴胡注射液的平均加样回收率(n=9)分别为101.1%,100.5%,99.6%。结论:该方法专属、准确,适用于测定鱼腥草注射液、新鱼腥草素钠注射液、柴胡注射液中聚山梨酯80的含量。Objective ： To present a novel method for the quantitative analysis of polysorbate 80 in injections by size exclusion chromatography -evaporate laser scattering detection（ SEC -ELSD）. Method：The chromatographic analysis were carried out on a TSKgel G2000 SWxL column （7.8 mm × 30 cm ,5μm） , and the mobile phase consisted of 20 mmoL · L^-1 ammonium acetate and acetonitrile（90： 10）. Flow rate was 0.6 mL ·min^-1, and the column temperature was 30 ℃. The flow rate N2 in ELSD was 2. 3 L· min^-1. The temperature of drift tube was 110 ℃. Results：Polysorbate 80 calibration curves were linear in the range of 1 -20 mg · mL^-1. The average recoveries （n = 9） of Yuxingcao injection, sodium new houttuyfonate injection and Bupleuri injection were 101.1%, 100. 5%, 99.6%, respectively. Conclusion：The method is specific, accurate and reproducible, which is suitable for the determination of polysorbate 80 in Yuxingcao injection, sodium new houttuyfonate injection and Bupleuri injection.

关 键 词：聚山梨酯80 分子排阻-蒸发光散射法 鱼腥草注射液 新鱼腥草素钠注射液 柴胡注射液 

分 类 号：R917[医药卫生—药物分析学]