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Integrated identification, qualification and quantification strategy for pharmacokinetic profile study of Guizhi Fuling capsule in healthy volunteers

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      Abstract

      Guizhi Fuling capsule (GZFL), a traditional Chinese medicine formulation, is widely used in China to relieve pain from dysmenorrhea and is now in a Phase II clinical trial in the USA. Due to the low exposure of the five main medicative ingredients (amygdalin, cinnamic acid, gallic acid, paeoniflorin and paeonol) of GZFL in human, a strategy was built to qualitatively and quantitatively identify the possible metabolites of GZFL and to describe the pharmacokinetic profiles of GZFL in human. In this strategy, LC-Q-TOF/MS was used to identify and structurally elucidate the possible metabolites of GZFL in vivo; and a time-based metabolite-confirming step (TBMCs) was used to confirm uncertain metabolites. The simultaneously quantitation results by LC-MS/MS showed low exposure of the five medicative ingredients. According to the strategy we built, a total of 36 metabolites were found and structurally elucidated. The simultaneously semi-quantitative analysis by LC-MS/MS showed that obvious time-concentration curves could be established for 12 of the metabolites, and most of them showed a relatively higher exposure. This study provides a better understanding of the metabolic processes of GZFL in human.

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      Investigation on Chinese herbal medicine for primary dysmenorrhea: implication from a nationwide prescription database in Taiwan.

      Primary dysmenorrhea is a common gynecological condition, for which Chinese herbal medicine (CHM) has been widely used in addition to western medicine. The aim of this study is to explore CHM commonly used to treat dysmenorrhea in young Chinese women. Observational retrospective study. The National Health Insurance Research Database in Taiwan. Women aged from 13 to 25 years with single diagnosis of primary dysmenorrhea. CHM prescriptions made for primary dysmenorrhea women during 1998-2008 were extracted to build up CHM prescription database. Association rule mining was used to explore the prevalent CHM combination patterns in treating primary dysmenorrhea. Prevalence and mechanisms of CHM combinations. Totally 57,315 prescriptions were analyzed and, on average, 5.3 CHM was used in one prescription. Dang-Gui-Shao-Yao-San (DGSYS) was the most commonly used herbal formula (27.2%), followed by Jia-Wei-Xiao-Yao-San (JWXYS) (20.7%) and Wen-Jing-Tang (WJT) (20.5%). Corydalis yanhusuo and Cyperus rotundus were the most commonly used single herb, found in 33.1% and 29.2% of all prescriptions. Additionally, C. yanhusuo with C. rotundus is the most commonly used two CHM in combination, accounting for 14.24% of all prescriptions, followed by DGSYS with C. yanhusuo (10.47%). Multi-target effects on primary dysmenorrhea, such as analgesia, mood modifying and hormone adjustment, were found among commonly prescribed CHM in this study. This study discovered the potential importance of C. yanhusuo, C. rotundus and DGSYS in treating primary dysmenorrhea. Further clinical trials or bench studies are warranted based on the results. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.
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        Diagnostic fragment-ion-based extension strategy for rapid screening and identification of serial components of homologous families contained in traditional Chinese medicine prescription using high-resolution LC-ESI- IT-TOF/MS: Shengmai injection as an example.

        The paper presents a modified and universally applicable diagnostic fragment-ion-based extension strategy (DFIBES) to efficiently process the information acquired by liquid chromatography-electrospray ionization source in combination with hybrid ion trap and high-resolution time-of-flight mass spectrometry [LC-(ESI)-IT-TOF/MS], facilitating the structural determination of serial components contained in traditional Chinese medicine prescription (TCMP). The key advantage of DFIBES is that it facilitates the rapid classification of the complicated peaks into well-known chemical families, which significantly simplifies the complicated procedures of structural characterization. Moreover, considering that a certain family of compounds usually produces identical fragment ions, the DFIBES would be widely applicable to many other families of compounds identification besides the presently validated ginsenosides and lignans. Shengmai injection, composed of Panax ginseng, Radix ophiopogonis, and Schisandra chinensis, was taken as a TCMP example to conduct and validate the proposed DFIBES. Diagnostic fragment ions (DFI) for each chemical family contained in Shengmai injection was firstly determined or proposed from the separated analysis of 15 authentic standards and the extract of S. chinensis. The ESI-MSn fragmentation patterns of ginsenosides and lignans were then systematically studied for developing the 'structure extension' approach. Upon LC-IT-TOF/MS analysis and DFIBES, more than 30 ginsenosides and 20 lignans have been rapidly detected and identified from Shengmai injection, supporting that the DFIBES is a very powerful strategy and would be widely applicable for the complicated components identification from TCMP and other complicated mixtures. Copyright (c) 2008 John Wiley & Sons, Ltd.
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          Recent advances in analysis of Chinese medical plants and traditional medicines.

          Chinese herbal medicine is gaining increasing popularity worldwide for health promotion and adjuvant therapy. Thus, selective and efficient analytical methods are required not only for quality assurance but also for authentication of the plant material. Applications of both chromatographic and electrophoretic techniques to the analysis of medicinal plants and Chinese traditional medicine preparations over the last 3 years are outlined in this review. The role of chemical fingerprinting is highlighted and a brief survey of determination of toxic components, natural and synthetic adulterants is also included. Moreover, different sample pretreatment and extraction methods are discussed.
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            Author and article information

            Affiliations
            [1 ]Key Lab of Drug Metabolism and Pharmacokinetics, State Key Laboratory of Natural Medicines, China Pharmaceutical University , Nanjing, Jiangsu, China
            [2 ]China Application Center, SCIEX , Beijing, China
            [3 ]State Key Lab of New-tech for Chinese Medicine Pharmaceutical Process, Jiangsu Kanion Pharmaceutical Co. Ltd , Lianyungang, Jiangsu, China
            Author notes
            Journal
            Sci Rep
            Sci Rep
            Scientific Reports
            Nature Publishing Group
            2045-2322
            16 August 2016
            2016
            : 6
            27527657
            4985661
            srep31364
            10.1038/srep31364
            Copyright © 2016, The Author(s)

            This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

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