Mechanism Based Quality Control (MBQC) of Herbal Products: A Case Study YIV-906 (PHY906)

YIV-906 (PHY906), a four-herb Chinese medicine formulation, is inspired by an 1800 year-old Chinese formulation called Huang Qin Tang which is traditionally used to treat gastrointestinal (GI) symptoms. In animal studies, it could enhance anti-tumor activity of different classes of anticancer agents...

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Main Authors: Wing Lam, Yongshen Ren, Fulan Guan, Zaoli Jiang, William Cheng, Chang-Hua Xu, Shwu-Huey Liu, Yung-Chi Cheng
Format: Article
Language:English
Published: Frontiers Media S.A. 2018-11-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/article/10.3389/fphar.2018.01324/full
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author Wing Lam
Yongshen Ren
Fulan Guan
Zaoli Jiang
William Cheng
Chang-Hua Xu
Chang-Hua Xu
Shwu-Huey Liu
Yung-Chi Cheng
author_facet Wing Lam
Yongshen Ren
Fulan Guan
Zaoli Jiang
William Cheng
Chang-Hua Xu
Chang-Hua Xu
Shwu-Huey Liu
Yung-Chi Cheng
author_sort Wing Lam
collection DOAJ
description YIV-906 (PHY906), a four-herb Chinese medicine formulation, is inspired by an 1800 year-old Chinese formulation called Huang Qin Tang which is traditionally used to treat gastrointestinal (GI) symptoms. In animal studies, it could enhance anti-tumor activity of different classes of anticancer agents and promote faster recovery of the damaged intestines following irinotecan or radiation treatment. Several clinical studies have shown that YIV-906 had the potential to increase the therapeutic index of cancer treatments (chemotherapy, radiation) by prolonging life and improving patient quality of life. Results of animal studies demonstrated five clinical batches of YIV-906 had very similar in vivo activities (protection of body weight loss induced by CPT11 and enhancement of anti-tumor activity of CPT11) while four batches of commercial–made Huang Qin Tang, HQT had no or lower in vivo activities. Two quality control platforms were used to correlate the biological activity between YIV906 and HQT. Chemical profiles (using analysis of 77 peaks intensities) obtained from LC-MS could not be used to differentiate YIV-906 from commercial Huang Qin Tang. A mechanism based quality control (MBQC) platform, comprising 18 luciferase reporter cell lines and two enzymatic assays based on the mechanism action of YIV-906, could be used to differentiate YIV-906 from commercial Huang Qin Tang. Results of MBQC could be matched to their in vivo activities on irinotecan. In conclusion, the quality control of an herbal product should be dependent on its pharmacological usage. For its specific usage appropriate biological assays based on its mechanism action should be developed for QC. Chemical fingerprints comparison approach has limitations unless irrelevant chemicals have been filtered out. Additionally, using a similarity index is only useful when relevant information is used. A MBQC platform should also be applied on other herbal products.
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spelling doaj.art-0ffbb151879f4e1cb0b76abdf48b83752022-12-21T19:05:42ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122018-11-01910.3389/fphar.2018.01324422021Mechanism Based Quality Control (MBQC) of Herbal Products: A Case Study YIV-906 (PHY906)Wing Lam0Yongshen Ren1Fulan Guan2Zaoli Jiang3William Cheng4Chang-Hua Xu5Chang-Hua Xu6Shwu-Huey Liu7Yung-Chi Cheng8Department of Pharmacology, Yale University School of Medicine, New Haven, CT, United StatesDepartment of Pharmacology, Yale University School of Medicine, New Haven, CT, United StatesDepartment of Pharmacology, Yale University School of Medicine, New Haven, CT, United StatesDepartment of Pharmacology, Yale University School of Medicine, New Haven, CT, United StatesDepartment of Pharmacology, Yale University School of Medicine, New Haven, CT, United StatesDepartment of Pharmacology, Yale University School of Medicine, New Haven, CT, United StatesCollege of Food Science and Technology, Shanghai Ocean University, Shanghai, ChinaYiviva Inc., New York, NY, United StatesDepartment of Pharmacology, Yale University School of Medicine, New Haven, CT, United StatesYIV-906 (PHY906), a four-herb Chinese medicine formulation, is inspired by an 1800 year-old Chinese formulation called Huang Qin Tang which is traditionally used to treat gastrointestinal (GI) symptoms. In animal studies, it could enhance anti-tumor activity of different classes of anticancer agents and promote faster recovery of the damaged intestines following irinotecan or radiation treatment. Several clinical studies have shown that YIV-906 had the potential to increase the therapeutic index of cancer treatments (chemotherapy, radiation) by prolonging life and improving patient quality of life. Results of animal studies demonstrated five clinical batches of YIV-906 had very similar in vivo activities (protection of body weight loss induced by CPT11 and enhancement of anti-tumor activity of CPT11) while four batches of commercial–made Huang Qin Tang, HQT had no or lower in vivo activities. Two quality control platforms were used to correlate the biological activity between YIV906 and HQT. Chemical profiles (using analysis of 77 peaks intensities) obtained from LC-MS could not be used to differentiate YIV-906 from commercial Huang Qin Tang. A mechanism based quality control (MBQC) platform, comprising 18 luciferase reporter cell lines and two enzymatic assays based on the mechanism action of YIV-906, could be used to differentiate YIV-906 from commercial Huang Qin Tang. Results of MBQC could be matched to their in vivo activities on irinotecan. In conclusion, the quality control of an herbal product should be dependent on its pharmacological usage. For its specific usage appropriate biological assays based on its mechanism action should be developed for QC. Chemical fingerprints comparison approach has limitations unless irrelevant chemicals have been filtered out. Additionally, using a similarity index is only useful when relevant information is used. A MBQC platform should also be applied on other herbal products.https://www.frontiersin.org/article/10.3389/fphar.2018.01324/fullYIV-906Chinese medicinemechanismquality controlchemical fingerprintherbal products
spellingShingle Wing Lam
Yongshen Ren
Fulan Guan
Zaoli Jiang
William Cheng
Chang-Hua Xu
Chang-Hua Xu
Shwu-Huey Liu
Yung-Chi Cheng
Mechanism Based Quality Control (MBQC) of Herbal Products: A Case Study YIV-906 (PHY906)
Frontiers in Pharmacology
YIV-906
Chinese medicine
mechanism
quality control
chemical fingerprint
herbal products
title Mechanism Based Quality Control (MBQC) of Herbal Products: A Case Study YIV-906 (PHY906)
title_full Mechanism Based Quality Control (MBQC) of Herbal Products: A Case Study YIV-906 (PHY906)
title_fullStr Mechanism Based Quality Control (MBQC) of Herbal Products: A Case Study YIV-906 (PHY906)
title_full_unstemmed Mechanism Based Quality Control (MBQC) of Herbal Products: A Case Study YIV-906 (PHY906)
title_short Mechanism Based Quality Control (MBQC) of Herbal Products: A Case Study YIV-906 (PHY906)
title_sort mechanism based quality control mbqc of herbal products a case study yiv 906 phy906
topic YIV-906
Chinese medicine
mechanism
quality control
chemical fingerprint
herbal products
url https://www.frontiersin.org/article/10.3389/fphar.2018.01324/full
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