Simultaneous determination of fourteen components of Gumiganghwal-tang tablet in human plasma by UPLC-ESI-MS/MS and its application to pharmacokinetic study

Seung-Hyun Jeong; Ji-Hun Jang; Guk-Yeo Lee; Seung-Jung Yang; Hea-Young Cho; Yong-Bok Lee

doi:10.1016/j.jpha.2020.08.003

Volume 11 Issue 4

Aug. 2021

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Seung-Hyun Jeong, Ji-Hun Jang, Guk-Yeo Lee, Seung-Jung Yang, Hea-Young Cho, Yong-Bok Lee. Simultaneous determination of fourteen components of Gumiganghwal-tang tablet in human plasma by UPLC-ESI-MS/MS and its application to pharmacokinetic study[J]. Journal of Pharmaceutical Analysis, 2021, 11(4): 444-457. doi: 10.1016/j.jpha.2020.08.003

Citation:

Seung-Hyun Jeong, Ji-Hun Jang, Guk-Yeo Lee, Seung-Jung Yang, Hea-Young Cho, Yong-Bok Lee. Simultaneous determination of fourteen components of Gumiganghwal-tang tablet in human plasma by UPLC-ESI-MS/MS and its application to pharmacokinetic study[J]. Journal of Pharmaceutical Analysis, 2021, 11(4): 444-457. doi: 10.1016/j.jpha.2020.08.003

Citation:

Seung-Hyun Jeong, Ji-Hun Jang, Guk-Yeo Lee, Seung-Jung Yang, Hea-Young Cho, Yong-Bok Lee. Simultaneous determination of fourteen components of Gumiganghwal-tang tablet in human plasma by UPLC-ESI-MS/MS and its application to pharmacokinetic study[J]. Journal of Pharmaceutical Analysis, 2021, 11(4): 444-457. doi: 10.1016/j.jpha.2020.08.003

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Simultaneous determination of fourteen components of Gumiganghwal-tang tablet in human plasma by UPLC-ESI-MS/MS and its application to pharmacokinetic study

doi: 10.1016/j.jpha.2020.08.003

a. College of Pharmacy, Chonnam National University, 77 Yongbong-ro, Buk-gu, Gwangju, 61186, Republic of Korea;
b. National Development Institute of Korean Medicine, 288 Udeuraendeu-gil, Anyang-myeon, Jangheung-gun, Jeollanam-do, 59338, Republic of Korea;
c. Department of Oriental Rehabilitation Medicine, Dongshin University Gwangju Korean Medicine Hospital, 141 Wolsan-ro, Nam-gu, Gwangju, 61619, Republic of Korea;
d. College of Pharmacy, CHA University, 335 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13488, Republic of Korea

Funds:

This work was supported by a grant from the National Development Institute of Korean Medicine (NIKOM) funded by the Korean Ministry of Health and Welfare (MOHW), Republic of Korea.

Received Date: Feb. 19, 2020
Accepted Date: Aug. 06, 2020
Rev Recd Date: Jun. 16, 2020
Available Online: Jan. 24, 2022
Publish Date: Aug. 15, 2021

Abstract

Abstract

Gumiganghwal-tang is a traditional herbal medicine widely used for its anti-inflammatory, analgesic, and antipyretic effects. However, the safety and efficacy of its active ingredients based on an in vivo pharmacokinetic (PK) study have yet been investigated. We have established a sensitive and accurate UPLC-ESI-MS/MS method and conducted a PK study on 14 constituents of Gumiganghwal-tang through human plasma analysis. Analytical conditions were optimized according to the physicochemical properties of the 14 compounds to facilitate efficient separation and eliminate overlap or interference between peaks. KINETEX-C₁₈ and Inertsil-C₈ columns were used as UPLC stationary phases, and acetonitrile and aqueous formic acid were used as mobile phases. All the analytes were quantified with a triple quadrupole mass spectrometer using electrospray ionization in multiple reaction monitoring mode. The chromatograms of 14 bioactive compounds showed excellent elution and sensitivity, and each peak was selectively separated and quantified without interference with each other or impurities. The established analytical method was based on international guidelines and was successfully used to perform PK studies of 14 herbal ingredients in humans after oral administration with Gumiganghwal-tang tablets. The oral absorption of most active components of Gumiganghwal-tang was relatively rapid and remained considerably long in the body to be quantified in plasma up to 48 h after administration.
- Gumiganghwal-tang,
- Fourteen bioactive ingredients,
- Simultaneous analysis,
- UPLC-ESI-MS/MS,
- Pharmacokinetics,
- Clinical study

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References(28)

References

I.-S. Shin, J.-H. Kim, H.-K. Ha, et al., Acute toxicity study on Gumiganghwal-tang (Jiuweiqianghuo-tang) in Sprague-Dawley rats, Herb. Formula Sci. 18 (2010) 79-85

I.-S. Shin, C.-S. Seo, M.-Y. Lee, et al., In vitro and in vivo evaluation of the genotoxicity of Gumiganghwal-tang, a traditional herbal prescription, J. Ethnopharmacol. 141 (2012) 350-356

J.B. Weon, J. Lee, M.R. Eom, et al., Cognitive enhancing effect of the fermented Gumiganghwal-tang on scopolamine-induced memory impairment in mice, Nutr. Neurosci. 19 (2016) 125-130

S.-J. Kim, H.-J. Jeong, P.-D. Moon, et al., Anti-inflammatory activity of Gumiganghwaltang through the inhibition of nuclear factor-κB activation in peritoneal macrophages, Biol. Pharm. Bull. 28 (2005) 233-237

S.-H. Jeong, J.-H. Jang, S.-H. Ham, et al., Simultaneous UPLC-MS/MS determination of four components of Socheongryong-tang tablet in human plasma: Application to pharmacokinetic study, J. Chromatogr. B 1095 (2018) 214-225

X.S. Fang, J. Hao, H. Zhou, et al., Pharmacological studies on the sedative-hypnotic effect of Semen Ziziphi spinosae (Suanzaoren) and Radix et Rhizoma Salviae miltiorrhizae (Danshen) extracts and the synergistic effect of their combinations, Phytomedicine 17 (2010) 75-80

J. Calixto, Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents), Braz. J. Med. Biol. Res. 33 (2000) 179-189

P. Mehta, V. Dhapte, A comprehensive review on pharmacokinetic profile of some traditional chinese medicines, New J. Sci. 2016 (2016). https://doi.org/10.1155/2016/7830367

C.-W. Huang, I.-H. Hwang, Y.-H. Yun, et al., Population-based comparison of traditional medicine use in adult patients with allergic rhinitis between South Korea and Taiwan, J. Chin. Med. Assoc. 81 (2018) 708-713

S.-H. Jeong, J.-H. Jang, G.-Y. Lee, et al., Simultaneous determination of fourteen main active components in Gumiganghwal-tang tablet by using a newly developed UPLC-ESI-MS/MS method, J. Chromatogr. B 1126-1127 (2019). https://doi.org/10.1016/j.jchromb.2019.121743

C.-C. Lin, D.-E. Shieh, The anti-inflammatory activity of Scutellaria rivularis extracts and its active components, baicalin, baicalein and wogonin, Am. J. Chin. Med. 24 (1996) 31-36

M.N. Asl, H. Hosseinzadeh, Review of pharmacological effects of Glycyrrhiza sp. and its bioactive compounds, Phytother. Res. 22 (2008) 709-724

H.-B. Li, F. Chen, Preparative isolation and purification of bergapten and imperatorin from the medicinal plant Cnidium monnieri using high-speed counter-current chromatography by stepwise increasing the flow-rate of the mobile phase, J. Chromatogr. A 1061 (2004) 51-54

M.Y. Lai, S.L. Hsiu, S.Y. Tsai, et al., Comparison of metabolic pharmacokinetics of baicalin and baicalein in rats, J. Pharm. Pharmacol. 55 (2003) 205-209

N.-I. Baek, E.-M. Ahn, H.-Y. Kim, et al., Furanocoumarins from the root of Angelica dahurica, Arch. Pharm. Res. 23 (2000) 467-470

B.-R. Yun, J.B. Weon, B. Lee, et al., Quantitative analysis of atractylenolides I and III in Atractylodes japonica, Korean J. Pharmacogn. 44 (2013) 53-59

C. Liu, R. Ma, L. Wang, et al., Rehmanniae Radix in osteoporosis: A review of traditional Chinese medicinal uses, phytochemistry, pharmacokinetics and pharmacology, J. Ethnopharmacol. 198 (2017) 351-362

C.-S. Seo, H.-K. Shin, Quantitative analysis of the seven marker components in Asarum sieboldii using the LC-MS/MS and GC-MS, Korean J. Pharmacogn. 44 (2013) 350-361

M. Kobayashi, M. Fujita, H. Mitsuhashi, Studies on the constituents of Umbelliferae plants. XV. Constituents of Cnidium officinale: occurrence of pregnenolone, coniferylferulate and hydroxyphthalides, Chem. Pharm. Bull. 35 (1987) 1427-1433

C.-M. Kim, Y.-K. Park, The effects of different extracts of Ostericum koreanum on the production of inflammatory mediators in LPS-stimulated RAW264. 7 cells, Korea J. Herbol. 24 (2009) 169-178

FDA, Bioanalytical Method Validation Guidance for Industry, in, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Rockville, MD, 2018

L. Ngo, P. Tran, S.-H. Ham, et al., Simultaneous determination of imperatorin and its metabolite xanthotoxol in rat plasma and urine by LC-MS/MS and its application to pharmacokinetic studies, J. Chromatogr. B 1044-1045 (2017) 30-38

S. Chen, Y. Ren, X. Xu, et al., Development and validation of an LC-MS/MS method for determination of catalpol and harpagide in small volume rat plasma: Application to a pharmacokinetic study, Yangtze Med. 2 (2018) 95-107. 10.4236/ym.2018.22011

B. Zan, R. Shi, T. Wang, et al., Simultaneous quantification of multiple active components from Xiexin decoction in rat plasma by LC-ESI-MS/MS: application in pharmacokinetics, Biomed. Chromatogr. 25 (2011) 816-826

T. Ichikawa, S. Ishida, Y. Sakiya, et al., Biliary excretion and enterohepatic cycling of glycyrrhizin in rats, J. Pharm. Sci 75 (1986) 672-675

J. Xing, X. Chen, D. Zhong, Absorption and enterohepatic circulation of baicalin in rats, Life Sci. 78 (2005) 140-146

J.-H. Kim, Pharmacokinetic analysis of atractylenolide III in rat plasma after oral administration of Atractylodes japonica rhizome extract by ultra-performance liquid chromatography-ion trap mass spectrometry, Acta Chromatogr. 31 (2018) 266-271

Z. Zhao, Y. Egashira, H. Sanada, Ferulic acid is quickly absorbed from rat stomach as the free form and then conjugated mainly in liver, J. Nutr. 134 (2004) 3083-3088

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