Key Laboratory of Traditional Chinese Medicine Resource and Compound Prescription, Ministry of Education, Hubei University of Chinese Medicine, Wuhan 430065, China.
School of Basic Medicine, Hubei University of Chinese Medicine, Wuhan 430065, China.
J Pharm Biomed Anal. 2023 Apr 1;227:115276. doi: 10.1016/j.jpba.2023.115276. Epub 2023 Jan 31.
Renshen-Yangrong Pill (RYP) is a classical traditional Chinese medicine (TCM) preparation for the treatment of asthenic symptoms, while its multiple herbal compositions bring a wide variety of unclear chemical components which seriously hinder the effective quality control and clinical practice. The present study aimed to investigate the overall chemical profile of RYP by UPLC-LTQ/Orbitrap/MS, and further obtain the quantitative distributions of representing components in the preparations. A total of 132 components in RYP including flavonoids, triterpenoid saponins, phenylpropanoids, and monoterpenoid glycosides were identified or tentatively characterized by authentic compounds or accurate masses and fragmentation, in which 52 characteristic components were selected for further quantitation by UPLC-MS/MS. The assay was validated in terms of linearity, precision, repeatability, recovery and successfully applied for the quality control of 40 batches of RYP. Hesperidin and paeoniflorin were revealed as the most abundant constituents in RYP, and the samples of different origins and dosage forms were clearly classified based on hierarchical cluster analysis. This study provided a deep insight into the chemical profiling of RYP, as well as a new approach for determining the marker compounds, which laid a valuable foundation for further investigation of potential effective components and comprehensive quality control of RYP and related preparations.
人参养荣丸（RYP）是一种经典的中药方剂，用于治疗虚证症状，但其多种草药成分带来了广泛的不明化学成分，严重阻碍了有效的质量控制和临床实践。本研究旨在通过 UPLC-LTQ/Orbitrap/MS 研究 RYP 的整体化学特征，并进一步获得制剂中代表性成分的定量分布。通过鉴定或推测真实化合物或准确质量和碎片，在 RYP 中鉴定或初步表征了 132 种成分，包括黄酮类、三萜皂苷、苯丙素和单萜苷，其中 52 种特征成分被选择用于通过 UPLC-MS/MS 进一步定量。该测定方法在线性、精密度、重复性、回收率方面进行了验证，并成功应用于 40 批 RYP 的质量控制。橙皮苷和芍药苷被认为是 RYP 中含量最丰富的成分，根据层次聚类分析，可以清楚地对不同来源和剂型的样品进行分类。本研究深入了解了 RYP 的化学特征，并提供了一种确定标记化合物的新方法，为进一步研究潜在有效成分和全面控制 RYP 及相关制剂的质量奠定了有价值的基础。
