| 姚令文,刘瑞,聂黎行,王钢力,戴忠,马双成.UPLC-ELSD法快速测定生脉注射液中果糖、葡萄糖、蔗糖、麦芽糖含量[J].中国药事,2019,33(1):67-72 |
| UPLC-ELSD法快速测定生脉注射液中果糖、葡萄糖、蔗糖、麦芽糖含量 |
| Rapid Determination of Fructose, Glucose, Sucrose and Maltose in Shengmai Injection by UPLC-ELSD Method |
| 投稿时间：2018-01-28 |
| DOI：10.16153/j.1002-7777.2019.01.012 |
| 中文关键词: 生脉注射液 果糖 葡萄糖 蔗糖 麦芽糖 超高效液相色谱 蒸发光散射检测器 |
| 英文关键词: Shengmai Injection fructose glucose sucrose maltose ultra performance liquid chromatography evaporative light scattering detector |
| 基金项目:国家自然科学基金（编号81303194）；国家中医药管理局中药标准化建设项目（编号ZYBZH-C-JS-32）；中国食品药品检定研究院学科带头人培养基金（编号2017X1） |
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| 中文摘要: |
| 目的：建立生脉注射液中主要单糖和双糖含量的快速测定方法。方法：采用超高效液相色谱结合蒸发光散射检测器（UPLC-ELSD）同时测定果糖、葡萄糖、蔗糖、麦芽糖含量。样品经ACQUITYUPLC BEH Amide（2.1 mm×150 mm，1.7 μm）色谱柱分离，柱温35℃。流动相为乙腈（含0.2%三乙胺）-水（75：25），流速0.2 mL·min-1。ELSD检测器漂移管温度55℃，氮气压力40.0 psi。结果：4个成分在各自范围内线性关系良好。果糖、葡萄糖、蔗糖、麦芽糖的平均回收率分别为101.6%、99.1%、99.6%、97.9%。生脉注射液中果糖含量最高，3个生产企业的7批样品糖类成分含量差异较大。结论：该方法简便、快速、灵敏、准确，可为中药注射剂的质量控制和物质基础研究提供参考。 |
| 英文摘要: |
| Objective:To establish a rapid determination method of the main monosaccharides and disaccharides in Shengmai Injection. Methods:Fructose, glucose, sucrose and maltose were determined simultaneously by ultra performance liquid chromatography (UPLC) method combined with evaporative light scattering detector (ELSD). Separation was performed on an ACQUITY UPLC BEH Amide (2.1 mm×150 mm, 1.7 μm) column and the column temperature was 35℃. The mobile phase consisted of acetonitrile (containing 0.2% triethylamine)-water (75:25) at a flow rate of 0.2 mL·min-1. The temperature for the evaporator tube of ELSD was maintained at 55℃ and the gas pressure for nitrogen was 40.0 psi. Results:The calibration curves of the 4 components showed good linearity within their test ranges. The average recoveries for fructose, glucose, sucrose and maltose were 101.6%, 99.1%, 99.6% and 97.9%, respectively. The highest content of sugar in Shengmai Injection was fructose and there was a great variation among contents of sugars in 7 batches of samples from 3 manufactures. Conclusion:The established method was simple, rapid, sensitive and accurate, and could provide references for quality control and substance basis investigation of Traditional Chinese Medicine (TCM) injections. |
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