Abstract

ThIs research evaluated the acute and subchronic toxicities of BTL lozenges through oral administration in experimental animals. The acute toxicity was determined by Litchfield Wilcoxon method in Swiss mice. The subchronic toxicity was evaluated by the recommendation of WHO and OECD in Wistar rats with oral doses of 720 g/kg body weight/day (equal to recommended human dose) and 1440 g/kg body weight/day (2 times as high as recommended human dose) in 90 consecutive days. As a result, BTL lozenges at the highest dose used for mice (12 lozenges/kg body weight) did not express acute toxicity in mice. In terms of the subchronic toxicity test, after oral administration of BTL lozenges, hematological parameters, hepato-renal functions and microscopic images of liver and kidney at an equivalent to the human recommended dose were unchanged as compared with the control group. In conclusion, BTL lozenges with both doses 720 g/kg body weight/day and 1440 g/kg body weight/day did not produce acute and subchronic toxicities in Swiss mice and Wistar rats.

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