UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in Clinic

Frontiers in Pharmacology

Zheng-Yuan Shi¹  Shi-Jun Yue¹  Zhi-Rui Yang¹  Dan Yan¹  Xin-Tong Meng¹  Cheng Peng²  Wu-Wen Feng²  Jin-Fa Tang³  Chang-Yun Wang⁴  Da-Li Meng⁵  Yan Yan⁵  Zi-Hao Wang⁵ 

[1] Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing Shijitan Hospital, Capital Medical University, Beijing, China;Department of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, China;Department of Pharmacy, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China;Key Laboratory of Marine Drugs (Ministry of Education of China), School of Medicine and Pharmacy, Ocean University of China, Qingdao, China;School of Traditional Chinese Materia Medica, Shenyang Pharmaceutical University, Shenyang, China;

关键词: Xueshuantong lyophilized powder;    quality fluctuation;    adverse drug reaction;    UPLC-QTOF/MSE;    bioassay;   

DOI  :  10.3389/fphar.2018.00633

来源: DOAJ

【 摘 要 】

Xueshuantong Lyophilized Powder (XST), consisting of a series of saponins extracted from Panax notoginseng, is widely applied to treat acute cerebral infarction, stroke, and coronary heart disease in China. However, most adverse drug reactions (ADR) in clinic are caused by quality problems of XST. In this study, six batches of certainly abnormal, four batches of possibly abnormal XST, and eight batches of normal XST were obtained from the clinical practice. Their quality fluctuations were identified by ultra-performance liquid chromatography coupled with an electrospray ionization quadrupole time-of-flight mass spectrometry operating in MSE mode (UPLC-QTOF/MSE) and bioassays including antithrombin and proplasmin assay. Fourteen potential components responsible for clinical ADR were identified by UPLC-QTOF/MSE, especially ginsenoside Rg1, Rg3, Rb1 and notoginsenoside R1. In addition, 83.3% (5/6) and 50.0% (3/6) certainly abnormal samples could be identified by UPLC-QTOF/MSE and bioassay, respectively. Interestingly, further integration of the two methods could entirely identify all the certainly abnormal samples and inferred that all the possibly abnormal samples were closely related to their quality fluctuation. It indicates that it is advisable to combine UPLC-QTOF/MSE and bioassay for identifying quality fluctuation of XST, and thus reduce its ADR in clinic.

【 授权许可】

Unknown