Two flavone C-glycosides as quality control markers for the manufacturing process of ephedrine alkaloids-free Ephedra Herb extract (EFE) as a crude drug preparation

As part of our continuing study of ephedrine alkaloids-free Ephedra Herb extract (EFE) in pursuit of its approval as a crude drug preparation, we identified two quantitative markers for the quality control of the manufacturing process of EFE and sought to establish cost-effective and simple methods...

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Veröffentlicht in:Journal of natural medicines 2018, Vol.72 (1), p.73-79
Hauptverfasser: Oshima, Naohiro, Maruyama, Takuro, Yamashita, Tadatoshi, Uchiyama, Nahoko, Amakura, Yoshiaki, Hyuga, Sumiko, Hyuga, Masashi, Nakamori, Shunsuke, Takemoto, Hiroaki, Kobayashi, Yoshinori, Hakamatsuka, Takashi, Odaguchi, Hiroshi, Hanawa, Toshihiko, Goda, Yukihiro
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container_title Journal of natural medicines
container_volume 72
creator Oshima, Naohiro
Maruyama, Takuro
Yamashita, Tadatoshi
Uchiyama, Nahoko
Amakura, Yoshiaki
Hyuga, Sumiko
Hyuga, Masashi
Nakamori, Shunsuke
Takemoto, Hiroaki
Kobayashi, Yoshinori
Hakamatsuka, Takashi
Odaguchi, Hiroshi
Hanawa, Toshihiko
Goda, Yukihiro
description As part of our continuing study of ephedrine alkaloids-free Ephedra Herb extract (EFE) in pursuit of its approval as a crude drug preparation, we identified two quantitative markers for the quality control of the manufacturing process of EFE and sought to establish cost-effective and simple methods for quantitative analyses. We analysed Ephedra Herb extracts grown in different habitats and collection years by liquid chromatography/high-resolution mass spectrometry (LC/HRMS) and detected two notable peaks common to each extract. These peaks were identified as vicenin-2 ( 1 ) and isovitexin 2″- O -rhamnoside ( 2 ). Quantitative analyses using the isocratic condition of LC/MS showed that the content percentages of 1 and 2 in EFE were 0.140–0.146% and 0.350–0.411%, respectively. We concluded that 1 and 2 were adequate quality control markers for quantitative analysis of EFE. Furthermore, we quantitatively analysed apigenin ( 3 ), an aglycon common to 1 and 2 , and found that the conversion factors of 1 to 3 and 2 to 3 were 1.3 and 1.5, respectively. Therefore, we concluded that 3 was a secondary standard for quantifying the contents of 1 and 2 in EFE. A series of results obtained from this study will be valuable for the quality control of EFE.
doi_str_mv 10.1007/s11418-017-1111-8
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subjects Bans
Biomedical and Life Sciences
Biomedicine
Complementary & Alternative Medicine
Drug Compounding - methods
Ephedra - chemistry
Ephedrine - analysis
Ephedrine - chemistry
Flavones - chemistry
Glycosides - metabolism
Herbal medicine
Medicinal Chemistry
Original Paper
Pharmacology/Toxicology
Pharmacy
Phytochemicals
Plant Sciences
Quality Control
title Two flavone C-glycosides as quality control markers for the manufacturing process of ephedrine alkaloids-free Ephedra Herb extract (EFE) as a crude drug preparation
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