基于液相色谱-串联质谱法的养阴清肺丸中麦冬投料情况研究

殷世宁; 陈安珍; 王友兰; 尹丽华; 吴爱英; 卢京光

文章摘要

殷世宁,陈安珍,王友兰,尹丽华,吴爱英,卢京光.基于液相色谱-串联质谱法的养阴清肺丸中麦冬投料情况研究[J].中国药事,2023,(1):76-86

基于液相色谱-串联质谱法的养阴清肺丸中麦冬投料情况研究

Study on the Feeding Situation of Ophiopogonis Radix in Yangyin Qingfei Pills by HPLC-MS/MS

DOI：10.16153/j.1002-7777.2023.01.009

中文关键词: 养阴清肺丸麦冬山麦冬高效液相色谱-三重四极杆串联质谱

英文关键词: Yangyin Qingfei pills Ophiopogonis Radix Liriopes Radix HPLC-MS/MS

基金项目:

作者	单位
殷世宁	青岛市食品药品检验研究院国家药品监督管理局海洋中药质量研究与评价重点实验室,青岛 266071
陈安珍	青岛市食品药品检验研究院国家药品监督管理局海洋中药质量研究与评价重点实验室,青岛 266071
王友兰	青岛市食品药品检验研究院国家药品监督管理局海洋中药质量研究与评价重点实验室,青岛 266071
尹丽华	青岛市食品药品检验研究院国家药品监督管理局海洋中药质量研究与评价重点实验室,青岛 266071
吴爱英	青岛市食品药品检验研究院国家药品监督管理局海洋中药质量研究与评价重点实验室,青岛 266071
卢京光	青岛市食品药品检验研究院国家药品监督管理局海洋中药质量研究与评价重点实验室,青岛 266071

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中文摘要:

目的：建立养阴清肺丸中同时测定甲基麦冬黄烷酮A、甲基麦冬黄烷酮B、山麦冬皂苷B和短葶山麦冬皂苷C的分析方法，判断麦冬的投料情况。方法：应用高效液相色谱-三重四极杆串联质谱 (HPLC-MS/MS)技术，采用Agilent Poroshell 120 EC-C₁₈(3.0 mm×100 mm，2.7μm)色谱柱，以乙腈-0.1%甲酸溶液为流动相，流速0.3 mL·min^-1，柱温35 ℃，进样量5 μL；采用电喷雾离子源 (ESI)，正、负离子2种模式，以多反应监测模式(MRM)进行分析。结果：4个成分在相应的范围内线性关系良好(r＞0.9991)，平均回收率为96.61% ~98.65%。59批养阴清肺丸样品中有39批存在以山麦冬替代或者混入麦冬投料问题。结论：建立的方法简单、准确、可靠，可用于判断养阴清肺丸中麦冬的投料情况及市场监管。

英文摘要:

Objective: To establish a method for the simultaneous determination of Methylophiopogonanone A, Methylophiopogonanone B, Liriopesides B and Liriopemuscari baily saponins C in Yangyin Qingfei pills and determine the feeding situation of Ophiopogonis Radix. Methods: The high performance liquid chromatographytriple quadruple mass spectrometry (HPLC-MS/MS) was performed on an Agilent Poroshell 120 EC-C₁₈ column (3.0 mm × 100 mm, 2.7 μm) with mobile phase consisting of acetonitrileand 0.1% aqueous formic acid. The fl ow rate was controlled at 0.3 mL•min^-1, and the column temperature was set at 35 ℃, and the sample volume was 5 μL. A mass spectrometer equipped with electrospray ionization source was used as detector operated in positive and negative ion mode. Multiple reaction monitoring (MRM) was performed. Results: Four components showed good linear correlation within their ranges (r＞0.9991), and the averaged recoveries ranged from 96.61% to 98.65%. In the 59 batches of Yangyin Qingfei pills, 39 batches had the feeding problem of using Liriopes Radix instead of Ophiopogonis Radix or mixing in Ophiopogonis Radix. Conclusion: The established method is simple, accurate, reliable, and could be used in the determination of the feeding situation of Ophiopogonis Radix in Yangyin Qingfei pills and market regulation.

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