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Nilesh Patel, Dr. Janmejay Patel, Achal Patel and Prof. Dr. Upendra U. Zala*


Introduction: The herbal drugs mentioned in classics for treatment of airway infections are better than modern drugs like anti-tussive, expectorants, mucolytics etc., as they have no any side effect. Aim: To evaluate acute oral toxicity on swiss albino mice and anti tussive effect in So2 induced cough model of Kofarex Syrup (Anti-tussive poly-herbal formulation). Method: The present study was conducted according to OECD guideline AOT-425 to know single dose toxicity of Kofarex Syrup on swiss albino mice. IAEC No. for the study is SKPCPER/IAEC/2016-02/02. The study was conducted using 5 swiss albino mice. The male and female animals were selected for study of 8 - 12 weeks old with weight range of within ± 20% of mean body weight at the time of randomization. A limit dose of 2000 mg/kg of extract was used involving five mice. Each mouse was treated with a single oral dose of 2000 mg/kg of extract in sequence at 48 h intervals. Animals were observed individually at least once during the first 30 min after dosing, periodically during the first 24h and daily thereafter, for a total of 14 days for any clinical signs of toxicity or mortality. Body weight of all animals was recorded once in a week. The anti tussive effect was evaluated in SO2 induced cough model in mice by method as describe by Miyagoshi et al., 1986 with modified and simplified. Results: There were no physical and behavioral changes observed in swiss albino mice during 14 days. Body weight of all animals did not reveal any significant change as compared to vehicle control group. Mortality was not observed in any animal of a group. Kofarex Syrup showed significant decrease in cough bouts in compression to standard treated (codeine sulphate) group. Conclusion: The study shows that Kofarex Syrup (Anti -tussive poly-herbal formulation) did not produce any toxic effect at dose of 2000 mg/kg. So No-Observed-Adverse-Effect-Level (NOAEL) of Kofarex Syrup is 2000 mg/kg. The significant decrease in cough bouts proves potential anti tussive activity of Kofarex Syrup.

Keywords: Anti-tussive poly-herbal formulation, Acute oral toxicity, Kofarex Syrup, Mortality, Swiss Albino Mice.

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