Acute toxicity and safety profile evolution of aqueous extracts of Sanren decoction using in vivo models

J Ethnopharmacol. 2022 Apr 6:287:114940. doi: 10.1016/j.jep.2021.114940. Epub 2021 Dec 27.

Abstract

Ethnopharmacological relevance: Sanren decoction (SRD) is a well-known traditional Chinese medicine prescription containing eight kinds of materials. SRD has been used mainly in China for more than 200 years for the treatment of respiratory disorders that co-occur with a bad fever after midday.

Aim of the study: To evaluate the acute and 28-day subacute toxicity of an aqueous extract of SRD using in vivo methods.

Materials and methods: To determine acute toxicity, SRD was administered by gavage at a dosage of 58.5 g/kg/day to male and female mice for 7 days. To determine subacute toxicity, SRD was administered at 3.3, 6.5, or 13 g/kg/day to male and female rats for 28 days. The general behavior, body weight, biochemical and hematological parameters, organ coefficients and pathological morphology of the treated animals were analyzed.

Results: Neither acute nor subacute concentrations of SRD caused significant changes in the body weights, general behavior, hematology and biochemical parameters, organ weights, or histopathological appearances of the liver, kidney, spleen, brain, lung or heart in mice or rats.

Conclusions: The administration of SRD can be considered safe within the conditions of this study.

Keywords: Acute toxicity; Safety evaluation; Sanren decoction; Subacute toxicity.

MeSH terms

  • Animals
  • Animals, Outbred Strains
  • Body Weight / drug effects*
  • Dose-Response Relationship, Drug
  • Drugs, Chinese Herbal / administration & dosage
  • Drugs, Chinese Herbal / toxicity*
  • Female
  • Male
  • Mice
  • Organ Size / drug effects*
  • Rats
  • Rats, Sprague-Dawley
  • Toxicity Tests, Acute
  • Toxicity Tests, Subacute

Substances

  • Drugs, Chinese Herbal

Supplementary concepts

  • Kunming mice