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

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. I...

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Main Authors: Zhi-Rui Yang, Zi-Hao Wang, Jin-Fa Tang, Yan Yan, Shi-Jun Yue, Wu-Wen Feng, Zheng-Yuan Shi, Xin-Tong Meng, Cheng Peng, Chang-Yun Wang, Da-Li Meng, Dan Yan
Format: Article
Language:English
Published: Frontiers Media S.A. 2018-06-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/article/10.3389/fphar.2018.00633/full
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author Zhi-Rui Yang
Zi-Hao Wang
Zi-Hao Wang
Jin-Fa Tang
Yan Yan
Shi-Jun Yue
Wu-Wen Feng
Zheng-Yuan Shi
Xin-Tong Meng
Cheng Peng
Chang-Yun Wang
Da-Li Meng
Dan Yan
author_facet Zhi-Rui Yang
Zi-Hao Wang
Zi-Hao Wang
Jin-Fa Tang
Yan Yan
Shi-Jun Yue
Wu-Wen Feng
Zheng-Yuan Shi
Xin-Tong Meng
Cheng Peng
Chang-Yun Wang
Da-Li Meng
Dan Yan
author_sort Zhi-Rui Yang
collection DOAJ
description 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.
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spelling doaj.art-b03412c3647f4ea695aff420c6653fe62022-12-22T01:22:41ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122018-06-01910.3389/fphar.2018.00633376909UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in ClinicZhi-Rui Yang0Zi-Hao Wang1Zi-Hao Wang2Jin-Fa Tang3Yan Yan4Shi-Jun Yue5Wu-Wen Feng6Zheng-Yuan Shi7Xin-Tong Meng8Cheng Peng9Chang-Yun Wang10Da-Li Meng11Dan Yan12Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing Shijitan Hospital, Capital Medical University, Beijing, ChinaBeijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing Shijitan Hospital, Capital Medical University, Beijing, ChinaSchool of Traditional Chinese Materia Medica, Shenyang Pharmaceutical University, Shenyang, ChinaDepartment of Pharmacy, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, ChinaSchool of Traditional Chinese Materia Medica, Shenyang Pharmaceutical University, Shenyang, ChinaBeijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing Shijitan Hospital, Capital Medical University, Beijing, ChinaDepartment of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaBeijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing Shijitan Hospital, Capital Medical University, Beijing, ChinaBeijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing Shijitan Hospital, Capital Medical University, Beijing, ChinaDepartment of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaKey Laboratory of Marine Drugs (Ministry of Education of China), School of Medicine and Pharmacy, Ocean University of China, Qingdao, ChinaSchool of Traditional Chinese Materia Medica, Shenyang Pharmaceutical University, Shenyang, ChinaBeijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing Shijitan Hospital, Capital Medical University, Beijing, ChinaXueshuantong 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.https://www.frontiersin.org/article/10.3389/fphar.2018.00633/fullXueshuantong lyophilized powderquality fluctuationadverse drug reactionUPLC-QTOF/MSEbioassay
spellingShingle Zhi-Rui Yang
Zi-Hao Wang
Zi-Hao Wang
Jin-Fa Tang
Yan Yan
Shi-Jun Yue
Wu-Wen Feng
Zheng-Yuan Shi
Xin-Tong Meng
Cheng Peng
Chang-Yun Wang
Da-Li Meng
Dan Yan
UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in Clinic
Frontiers in Pharmacology
Xueshuantong lyophilized powder
quality fluctuation
adverse drug reaction
UPLC-QTOF/MSE
bioassay
title UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in Clinic
title_full UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in Clinic
title_fullStr UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in Clinic
title_full_unstemmed UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in Clinic
title_short UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in Clinic
title_sort uplc qtof mse and bioassay are available approaches for identifying quality fluctuation of xueshuantong lyophilized powder in clinic
topic Xueshuantong lyophilized powder
quality fluctuation
adverse drug reaction
UPLC-QTOF/MSE
bioassay
url https://www.frontiersin.org/article/10.3389/fphar.2018.00633/full
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