基于HPLC-CAD的元胡止痛口服液糖类成分定量指纹图谱研究  

Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Yuanhu Zhitong Oral Liquid Using HPLC-CAD

作　　者：兰婧 颉佳乐 曹智铭 关建丽 王毅[1,2,4] 龚行楚 LAN Jing;XIE Jiale;CAO Zhiming;GUAN Jianli;WANG Yi;GONG Xingchu(College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,China;Innovation Institute for Artificial Intelligence in Medicine,Zhejiang University,Hangzhou 310018,China;Henan Fusen Pharmaceutical Co.,Ltd.,Nanyang 474450,China;State Key Laboratory of Chinese Medicine Modernization,Zhejiang University,Hangzhou 310058,China)

机构地区：[1]浙江大学药学院,杭州310058 [2]浙江大学智能创新药物研究院,杭州310018 [3]河南福森药业有限公司,南阳474450 [4]现代中药创制全国重点实验室,杭州310058

出　　处：《中国现代应用药学》2024年第12期1694-1698,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：国家中医药管理局创新团队与人才支持计划(ZYYCXTD-D-202002);河南省重大科技专项项目(201111310800)。

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-504E(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,R^(2)>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。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-504E(4.6 mm×250 mm,5μm)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 10μL.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 R^(2)>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 ranged 97.15%−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.

关 键 词：高效液相色谱-电喷雾检测器 元胡止痛口服液 糖类 定量指纹图谱 

分 类 号：R917.101[医药卫生—药物分析学]