ACUTE AND SUBACUTE TOXICITY STUDIES OF THE ANTIDIABETIC POLYHERBOMINERAL FORMULATION BSL-150 IN EXPERIMENTAL ANIMAL MODELS
Vaishali R. Undale*1, Chandrashekhar D. Upasani2
Abstract
A polyherbomineral formulation BSL-150 is an anitidabetic
formulation manufactured by Indu Pharma and consists of
combination of herbs and various bhasmas. It is used for the treatment
of diabetes mellitus. The purpose of this study is to investigate the
formulation for its safety and toxicity effects after oral administration
in Swiss albino mice. Each tablet of BSL-150 weighing 500 mg
contains Gymnema sylvestere, Tinospora cardiofolia, Embellica
officinalis and various bhasmas. In an acute toxicity study the BSL
150 suspended in 5% CMC was administered orally at the dose of
2000 mg/kg and were observed closely for 72 hrs with special
attention for first 4 hrs. No any mortality was observed at the dose of
2000 mg /kg. In sub acute toxicity studies BSL 15o was administered
orally at the dose of 250, 500, and 1000 mg /kg to animals for 28
days. Then the animals were sacrificed and various serum parameters
were measured. The histopathological changes in liver, kidney, and pancreas were studied.
The results of the 28 day sub acute toxicity study shows no any change in the hematological,
serum parameters and histological studies.
It is concluded that the BSL 150 is safe at the dose of 2000 mg/kg of oral dose per day. The
results indicate the safety of the formulation in the long term treatment with the BSL 150.
Keywords: Diabetes mellitus, BSL-150, acute and sub acute toxicity.
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