Toxicity study

SUMMARY RESULTS

ACUTE AND SUB-CHRONIC TOXICITY STUDY OF

GANODERMA LUCIDUM POLYSACCHARIDE PEPTIDE (GLPP)

 

The purpose of this study is to examine the acute and chronic toxicity of polysaccharide peptide from Ganodema Lucidum mycelia extract (PsP). The result of this study is to serve as a foundation in proving the safety of the extract consumption in humans. If this product is proven to be effective and safe for people and those with cardiovascular disease risk, it would then be recommended as a safe standard drug. Subsequently, our industrial partners could increase the production. In the second year of this study the acute and subchronic toxicity tests were carried out which in previous years the preclinical study of the PsP as an anti-inflammatory and antioxidant in atherosclerosis and diabetes mellitus had been conducted. The acute toxicity test was performed by using Balb/c mice with 5 variations of dose (0 mg/kg, 625 mg/kg, 1250 mg/kg, 2500 mg/kg, and 5000 mg/kg) for a period of 7 days, observed daily. Acute toxicity test results were obtained after 24 hours of PsP administration, when there were no change in behavior, symptoms of poisoning, and other pathological signs. Observation until the seventh day showed no mortality in all groups. The subchronic toxicity test was performed by using male and female Rattus novergicus Strain Wistar with 5 variations of dose (0 mg/kg, 300 mg/kg, 600 mg/kg, 1200 mg/kg and 2400 mg/kg) for a period of 3 months. PsP was administered orally 1 ml/mice. Parameters measured in subchronic toxicity test were blood chemistry, histopathology of kidney, lung, heart, aorta and liver. Subchronic toxicity test results shown that there were no significant difference of blood chemistry levels (SGOT, SGPT, ALP, ureum, creatinine), complete blood profile (lipid profile, erythrocytes, platelets), and histopathology of gross anatomy of organs (kidney, lung, heart, aorta, spleen and liver) between the normal group (without PsPadministration) and the treatment group of PsP for 90 days at all doses. Based on these data it can be concluded that the acute administration of PsP up to a dose of 5000 mg/kg declared safe. While the subchronic administration of PsP declared safe at doses of 0 mg/kg, 300 mg/kg, 600 mg/kg, 1200 mg/kg and 2400 mg/kg against the parameters of blood chemistry and  histopathology of kidney, lung, heart, aorta, spleen and liver.

Keywords: polysaccharide peptide (Ganoderma lucidum), acute toxicity, subchronic toxicity, cardiovascular disease

 

Malang – East Java (Indonesia) , January 20, 2015

Reported by :

DR. Titin Andri Wihastuti, S.Kp., M.Kes,

III C Lecturer, Research and Teaching Staff

Faculty of Medicine Brawijaya University

 

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