Report: Safety and toxicological evaluation of herbal formulation on rodents

Pak J Pharm Sci. 2018 Nov;31(6):2545-2551.

Abstract

Herbal medicines are still most popular, abundant and affordable remedies for curing various ailments. Garlina is one of the herbal formulations of Hamdard Laboratories (waqf) Pakistan used to treat cardiovascular diseases and elevated sugar level. However, there is no scientific data available regarding the potential toxicity. Therefore, the present study was to assess the acute and sub-chronic toxicity in rats. The single dose of Garlina 5000mg/kg were administered orally and observed for 14 days. A sub-chronic toxicity test was performed at 2000mg/kg of Garlina daily for 30 days. Control rats received saline. The biochemical, hematological and histopathological analysis was carried out. The acute toxicity LD50 was determined to be <5000mg/kg. The result of acute and sub-chronic toxicity revealed no mortality and sign of toxicity. Garlina did not elicit any significant change in body weight, hematological and histopathology analysis when compared to saline treated rats. The relative weight of organs was not affected by the treatment. While the daily dose of Garlina for humans is 20mg/kg. However, the sub-chronic toxicity at 2000mg/kg dose of Garlina exhibited significant increase in gamma glutamyltransferase while total protein significantly decreased. Results obtained from study demonstrated that there is wide margin of safety for the therapeutic use of Garlina and significant decrease in LDL, atherogenic index, GGT and bilirubin direct at the dose of 5000mg/kg further strengthen the use as hypolipidemic and hypoglycemic agent.

MeSH terms

  • Administration, Oral
  • Animals
  • Biomarkers / blood
  • Biopsy
  • Female
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / toxicity*
  • Hypolipidemic Agents / administration & dosage
  • Hypolipidemic Agents / toxicity*
  • Lethal Dose 50
  • Male
  • Plant Preparations / administration & dosage
  • Plant Preparations / toxicity*
  • Rats, Sprague-Dawley
  • Risk Assessment
  • Time Factors
  • Toxicity Tests, Acute*
  • Toxicity Tests, Subchronic*

Substances

  • Biomarkers
  • Hypoglycemic Agents
  • Hypolipidemic Agents
  • Plant Preparations