Abstract

ACUTE ORAL TOXICITY OF ANACID SYRUP (HERBO-MINERAL FORMULATION) WITH ITS ULCER PROTECTIVE AND ANTI OXIDANT ACTIVITIES IN PYLORUS LEGATED INDUCED PEPTIC ULCER

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

Abstract

Aim: To evaluate acute oral toxicity of Anacid syrup (Herbo-mineral formulation) on swiss albino mice and to evaluate ulcer protective and antioxidant effect of Anacid syrup against peptic ulcer in pylorus ligation induced ulcer model. Method: The present study was conducted according to OECD guideline AOT-425 to know single dose toxicity of Anacid syrup (Herbo-mineral formulation) on swiss albino mice. The IAEC no. for the study is SKPCPER/IAEC/2016- 02/01. 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 24 h 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 ulcer protective effect of test drug was performed in Pylorus ligation induced ulcer model in Albino Wister Rats. The anti oxidant activities of Anacid syrup was carried out by its effect on various oxidative stress markers i.e. Superoxide dismutase (SOD), Catalase and Lipid peroxidation (LPO-MDA). 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. The statistically significant increase in pH and decrease in gastric volume, total acidity, free acidity and ulcer index was found in Anacid syrup treated group in compression to various control and standard drug treated group which proves potential ulcer protective and antacid effect of this combination. The results of test drug on oxidative stress markers favor its anti oxidant properties. Conclusion: This study reveals that Anacid syrup (Herbo-mineral formulation) does not have any toxic effect at dose of 2000 mg/kg. So No-Observed-Adverse-Effect-Level (NOAEL) of Anacid syrup is 2000 mg/kg. The obtained results suggest that, tested Herbo-mineral formulation (Anacid syrup) has anti ulcer and anti oxidant effect without any major side effects or mortality.

Keywords: Herbo-Mineral formulation, Anacid syrup, OECD Guideline, Mortality, NOAEL Peptic ulcer, Antioxidant.