4.4 Article

Acute and sub-chronic toxicity studies of the extract of Thunberg Fritillary Bulb

Journal

REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 68, Issue 3, Pages 370-377

Publisher

ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2014.01.007

Keywords

Thunberg Fritillary Bulb; Acute toxicity; Sub-chronic toxicity

Funding

  1. National Science and Technology Major Projects for Major New Drugs Innovation and Development [2009ZX09103-346]

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The aim of this study was to investigate the acute and sub-chronic toxicity of extract of Thunberg Fritillary Bulb. For the acute toxicity tests, graded doses of the extract were administered orally to mice. The animals were observed for toxic symptoms and mortality daily for 14 days. In the sub-chronic toxicity study, rats were orally administered the extract at doses of 1 and 3 mg/kg body weight (BW) for 26 weeks. After 26 weeks, the rats were sacrificed for hematological, biochemical and histological examination. In the acute toxicity tests, the estimated median lethal dosage (LD50) was 52.2 mg/kg body weight in the mice. In the sub-chronic toxicity tests, a dose of 1 mg/kg body weight presented no toxicity. Above the 1 mg/kg dose, the main adverse signs observed in male rats were body or head tremor and spontaneous motor activity reduction. There were no other significant changes observed in hematology, blood biochemistry, organ weight and organ histology. The overall findings of this study indicate that the extract of Thunberg Fritillary Bulb is non-toxic up to 1 mg/kg body weight, which can be considered a safe application dose. (C) 2014 Elsevier Inc. All rights reserved.

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