【摘要】 目的 采用高效液相色谱-电喷雾检测器（HPLC-CAD）检测技术建立元胡止痛口服液中糖类成分的定量指纹图谱分析方法。方法 采用NH2P-50 4E（4.6 mm×250 mm,5μm）色谱柱，以水（A）-乙腈（B）为流动相进行梯度洗脱，柱温为30℃，进样量为10μL，流速为0.6 mL·min^-1,CAD雾化温度为35℃，采样频率10 Hz，幂函数1.0。结果 定量成分在定量范围内线性关系良好，R²>0.999，仪器精密度、中间精密度、方法重复性的RSD均<3%，供试品溶液在24 h内稳定，低、中、高3个浓度水平的平均加样回收率为97.15%～101.13%。指纹图谱中含共有峰5个，其仪器精密度、重复性、稳定性的RSD值均<4%。结论 建立的分析方法稳定、准确、重复性好，能够检测制剂中的糖类辅料。更多还原

【Abstract】 OBJECTIVE To establish a quantitative fingerprint analysis method for sugar components in Yuanhu Zhitong oral liquid using high performance liquid chromatography-charged aerosol detection（HPLC-CAD）. METHODS Chromatographic column was NH2P-50 4E（4.6 mm×250 mm, 5 μm） column. Water（A） and acetonitrile（B） were used as the mobile phase in the gradient elute mode. The column temperature was 30 ℃. The injection volume was 10 μL. The flow rate was 0.6 mL·min^-1. The evaporation temperature of CAD was 35 ℃. The acquisition frequency was 10 Hz. The power function value was 1.0.RESULTS The linear relationship of the quantitative component was good within the quantitative range, with R²>0.999. The relative standard deviations（RSDs） of instrument precision, intermediate precision and method repeatability were all <3%.The test solution was stable within 24 h. The average recoveries at low, medium and high concentration levels ranged97.15%-101.13%. There were 5 common peaks in the fingerprint. The RSDs of instrument precision, method repeatability and sample stability were all <4%. CONCLUSION The established analytical method is stable, accurate and reproducible. It can be used to detect sugar excipients in the preparations.更多还原