Safety evaluation of Astragalus extract mixture HT042 and its constituent herbs in Sprague–Dawley rats

Jungbin Song, Donghun Lee, Byoungjae Min, Jin Sook Bae, Gyu Tae Chang, Hocheol Kim

Research output: Contribution to journalArticlepeer-review

22 Citations (Scopus)

Abstract

Background Astragalus extract mixture HT042 is a combination of three standardized extracts from Astragalus membranaceus root, Eleutherococcus senticosus stem, and Phlomis umbrosa root, which has proven to stimulate children's height growth. Purpose The aim of this study was to demonstrate the safety of HT042 and its three constituent herbs when administered orally. Methods Acute and sub-chronic oral toxicity studies were conducted using male and female Sprague–Dawley rats. In the acute toxicity study, HT042 and each of the herbs was administered at single doses of up to 5000 mg/kg. In the 13-week sub-chronic toxicity study, HT042 was administered at repeated doses of up to 4000 mg/kg/day. Results In the acute toxicity study of HT042 and each of the herbs, no deaths occurred and there was no indication of toxicity, on the basis of clinical signs, body weight, and necropsy findings. In the sub-chronic toxicity study of HT042, there were no deaths and no changes in clinical signs or the findings of ophthalmic examinations. Although there were some treatment-related changes in other findings, these alterations were not considered toxicologically significant because they remained within normal ranges or recovered during the recovery period. Conclusion The oral approximate lethal doses of HT042 and each of the herbs were > 5000 mg/kg, and the no-observed-adverse-effect level of HT042 was 4000 mg/kg/day in male and female rats.

Original languageEnglish
Pages (from-to)59-67
Number of pages9
JournalPhytomedicine
Volume32
DOIs
Publication statusPublished - 15 Aug 2017

Bibliographical note

Publisher Copyright:
© 2017 Elsevier GmbH

Keywords

  • Astragalus extract mixture
  • Astragalus membranaceus
  • Eleutherococcus senticosus
  • HT042
  • Phlomis umbrosa
  • Toxicity

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