Simultaneous Quantification of Multiple Representative Components in the Xian-Ling-Gu-Bao Capsule by Ultra-Performance Liquid Chromatography Coupled with Quadrupole Time-of-Flight Tandem Mass Spectrometry.

Zhi-Hong Yao,Xin-Luan Wang,Ling Qin,Zi-Fei Qin,Xiao-Meng Wu,Xin-Sheng Yao,Yi Dai,Hong Cheng,Wen-Cai Ye

doi:10.3390/molecules22060927

Abstract

Xian-Ling-Gu-Bao capsule (XLGB), a famous traditional Chinese medicine prescription, is extensively used for the treatment of osteoporosis in China. However, few studies on the holistic quality control of XLGB have been reported. In this study, a reliable method using 18 representative components in XLGB was successfully established and applied to evaluate 34 batches of XLGB samples by ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC/Q-TOF-MS). The choice of quantitative markers mostly followed four principles, i.e., absorbed components in plasma, bioactive compounds with in vitro anti-osteoporosis activity, those derived from multiple individual medicinal herbs in XLGB with multiple representative structure types, and quantitative chemical markers in the Chinese Pharmacopoeia. The results showed chemical consistency was good except for individual batches. Multivariate statistical analysis indicated that asperosaponin VI from Radix Dipsaci, epimedin C, magnoflorine, and icariin from Herba Epimedii as well as timosaponin BII from Rhizoma Anemarrhenae varied significantly in multiple samples, which hinted an assay for these four components should be completed during all of the manufacturing processes. Taken together, this study provided a feasible method for holistic quality control of XLGB by multiple chemical markers, which could play a vital role in guaranteeing the safety, effectiveness, and controllability of administering the capsules as a medication in clinics.

Highlights

Over the last few decades, traditional Chinese medicines (TCMs) have gained increasing globalization and use worldwide for human health care due to their long clinical practice in treating chronic and complex diseases [1,2]
The Xian-Ling-Gu-Bao capsule (XLGB), the anti-osteoporosis traditional Chinese medicine prescriptions (TCMPs) listed in the 2017 edition of the China National Basic Drugs Catalogue [7], is widely used for the prevention and treatment of osteoporosis [8,9]
The combination of major representative chemical components from multiple individual medicinal herbs and in vivo absorbed bioactive components will be inevitably increasingly popular for the selection of quantitative markers when we hope to establish an overall quality control-oriented assay for their contents in TCMPs. This method could distinguish the consistency of multiple XLGB samples based on the quantified measurement of 18 analytes, thereby ensuring the quality of XLGB samples

Summary

Introduction

Over the last few decades, traditional Chinese medicines (TCMs) have gained increasing globalization and use worldwide for human health care due to their long clinical practice in treating chronic and complex diseases [1,2]. The multiple bioactive components that contribute most to the efficacies of TCMs or TCMPs should be selected as representative constituents for developing the quality control method [5,6]. The Xian-Ling-Gu-Bao capsule (XLGB), the anti-osteoporosis TCMP listed in the 2017 edition of the China National Basic Drugs Catalogue [7], is widely used for the prevention and treatment of osteoporosis [8,9]. It consists of the following six commonly used TCMs: Herba Epimedii (70%), Radix Dipsaci (10%), Fructus Psoraleae (5%), Rhizoma Anemarrhenae (5%), Radix Salviae Miltiorrhizae (5%), and Radix Rehmanniae (5%) [10]. In view of its notable curative effects and widespread use, quality control of the XLGB deserves more attention

Methods

Results

Conclusion