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采用标准化参考提取物定量策略对人参汤剂进行液质联用检测的质量控制。

An application of the standardised reference extract quantification strategy in the quality control of ginseng infusions by liquid chromatography with mass spectrometric detection.

机构信息

Chemistry Department, Lomonosov Moscow State University, Moscow, Russia.

Federal Hygienic and Epidemiological Center of Rospotrebnadzor, Moscow, Russia.

出版信息

Phytochem Anal. 2022 Aug;33(6):838-850. doi: 10.1002/pca.3133. Epub 2022 May 11.

Abstract

INTRODUCTION

Limited availability of individual standards is a bottleneck for quality control of functional foods and natural medicines. The use of standard mixtures or secondary standards is a possible alternative in this case. Earlier, an approach known as standardised reference extract (RE) strategy was introduced for HPLC-UV analysis of different plant materials; however, its application in HPLC-MS analysis has not been investigated.

OBJECTIVE

To establish an HPLC-MS-based RE method for determination of ginsenoside content in ginseng infusions using commercially available extract reference material of Panax quinquefolius L.

RESULTS

The developed HPLC-MS method was validated as precise (1.1%-9.4% intra-day variation; 1.6%-12.8% inter-day variation) and highly sensitive [limit of detection (LOD): 1-40 ng/mL; limit of quantification (LOQ): 4-120 ng/mL]. The stability of samples was satisfactory (5.7%-16.3%). The RE quantification method was compared with the external standard method, and the obtained difference was not significant, mostly in the range of 5%-10%. Matrix effects for the diluted samples of RE and ginseng infusions, determined via the standard addition method, were in the range of 85%-115% and 80%-126%, respectively, and were also positively correlated with the ginsenoside concentration. Eleven batches of ginseng infusions from different manufacturers were analysed using the established method.

CONCLUSION

The method for HPLC-MS-based ginsenoside quantification using RE as a secondary standard was established for the first time. The results of this study demonstrate that the application of the standardised RE strategy in HPLC-MS can minimise the matrix effect-related error in addition to the cost-effective quality control of herbal products, foods, and traditional medicines.

摘要

简介

个体标准的有限可用性是功能食品和天然药物质量控制的瓶颈。在这种情况下,使用标准混合物或次级标准可能是一种替代方法。早些时候,人们提出了一种称为标准化参考提取物(RE)策略的方法,用于不同植物材料的 HPLC-UV 分析;然而,其在 HPLC-MS 分析中的应用尚未得到研究。

目的

建立一种基于 HPLC-MS 的 RE 方法,用于使用市售的西洋参提取物参考物质测定人参浸液中的人参皂苷含量。

结果

所开发的 HPLC-MS 方法具有良好的精密度(1.1%-9.4%日内变异;1.6%-12.8%日间变异)和高灵敏度[检测限(LOD):1-40ng/mL;定量限(LOQ):4-120ng/mL]。样品稳定性令人满意(5.7%-16.3%)。RE 定量方法与外标法进行了比较,得到的差异不显著,主要在 5%-10%范围内。通过标准添加法测定 RE 和人参浸液的稀释样品的基质效应分别在 85%-115%和 80%-126%范围内,且与人参皂苷浓度呈正相关。使用建立的方法分析了来自不同制造商的 11 批人参浸液。

结论

首次建立了基于 RE 作为次级标准的 HPLC-MS 人参皂苷定量方法。本研究结果表明,标准化 RE 策略在 HPLC-MS 中的应用除了可以控制草药产品、食品和传统药物的成本效益外,还可以最小化与基质效应相关的误差。

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