牛黄清胃丸中辅料炼蜜的质量评价方法研究

Quality evaluation of refined honey in Niuhuang Qingwei pills

目的:建立牛黄清胃丸中果糖、葡萄糖和麦芽糖含量的快速测定方法,用于评价辅料炼蜜的质量。方法:采用超高效液相色谱结合蒸发光散射检测器(UPLC-ELSD),样品经ACQUITY UPLC BEH Amide色谱柱(150 mm×2.1 mm,1.7μm)分离;柱温为50℃;流动相为乙腈(含0.2%三乙胺)-水(76∶24);流速为0.2 mL·min^-1。ELSD检测器漂移管温度为50℃,氮气压力为40.0 psi。结果:3个成分在各自范围内线性关系良好。果糖、葡萄糖、麦芽糖的平均回收率分别为103.1%,103.3%和104.0%。18个厂家49批次牛黄清胃丸的辅料炼蜜合格率为85.71%,不合格的项目集中在果糖-葡萄糖含量比值。结论:该方法简便、快速、灵敏、准确,可为大蜜丸中辅料的质量控制提供参考。

Objective: To establish a rapid method to determine fructose, glucose and maltose in Niuhuang Qingwei pills so as to evaluate the quality of the refined honey. Methods: Ultra high performance liquid chromatography method combined with evaporative light scattering detector(UPLC-ELSD) was performed on an ACQUITY UPLC BEH Amide column(150 mm×2.1 mm,1.7 μm), the temperature of which was set at 50 ℃. The mobile phase consisted of acetonitrile(containing 0.2% triethylamine)-water(76∶24) at a flow rate of 0.2 mL·min-1. The temperature for the evaporator tube of ELSD was maintained at 50 ℃ and the gas pressure was 40.0 psi. Results: The calibration curves of the 3 components showed good linearity within their test ranges. The average recoveries for fructose, glucose and maltose were 103.1%, 103.3%, and 104.0%, respectively. The qualification rate of refined honey for 49 batches of samples from 18 manufactures was 85.71%, and the unqualified items were concentrated on the content ratio of fructose to glucose. Conclusion: The developed method was simple, fast, sensitive and accurate, which can provide reference for quality control of refined honey in big honeyed pills.