Acute and Subchronic Oral Toxicity Study of a Hepatoprotective Polyherbal Formulation ‘Liver Capsule’ in Rats Publisher



Monirvaghefi A^{1, 2} ; Jeivad F^{1, 2} ; Albooyeh S^{1, 2} ; Aliasl F^{3, 4} ; Gholami M^{1, 2} ; Khadem E⁴ ; Hassanzadeh G⁵ ; Rahimifard N⁶ ; Keshavarzmaleki R^{1, 2} ; Sabzevari O^{1, 2} Show Affiliations
Source: Pharmaceutical Chemistry Journal Published:2023

Abstract

A liver capsule is a hepatoprotective polyherbal formulation that has been traditionally used for the treatment of various diseases, particularly liver disorders. The present study aimed to assess the safety of the liver capsule by investigating acute and subchronic toxicity in rats. Acute toxicity test was performed on rats that orally received a single dose of 500, 1000, 2000 mg/kg. In a subchronic toxicity assay, the animals received 300 and 600 mg/kg of the liver capsule for 45 consecutive days. All animals were daily evaluated for signs of toxicity and biochemical and hematological parameters and histopathological tissues examination were assessed at the end of the study. The liver capsule did not produce any mortality in the acute toxicity study, although a histopathological examination showed toxicity signs in the liver tissue. In the subchronic study, there was no mortality or changes in behavior, daily food and water intake; however, levels of alanine transaminase (ALT), lactate dehydrogenase (LDH), and Creatine kinase (CK) were increased and albumin and glucose levels decreased in treated groups. Also, liver and kidney tissues showed pathological changes in the treated animals. The LD50 value of the liver capsule is thought to be more than 2000 mg/kg. A low doseof the liver capsule (300 mg/kg) caused little change in biochemical parameters and histopathology of the liver tissue in a subchronic study. The employed dose was more than 10 times greater than the maximum human daily dose for liver disease treatment (20 – 30 mg/kg). Thus, it can be concluded that the recommended human dose of liver capsules is generally safe. © 2024, Springer Science+Business Media, LLC, part of Springer Nature.