Abstract

ACUTE ORAL TOXICITY OF GASTEON SYRUP (POLYHERBAL FORMULATION) WITH ITS ULCER PROTECTIVE AND ANTI OXIDANT ACTIVITIES IN PYLORUS LEGATED INDUCED PEPTIC ULCER

Nilesh Patel, Dr. Janmejay Patel*, Achal Patel, Payal Patel and Dr. Ankitkumar M. Paneliya*

ABSTRACT

Introduction: The use of traditional herbal drugs is increasing now a day due to its effectiveness without any side effect in compression to conventional drugs. The toxicity profile of newly developed drug is require to provide scientific base and wide acceptance. Aim: To evaluate acute oral toxicity with ulcer protective and anti oxidant activities of Gasteon Syrup (polyherbal formulation) against Peptic ulcer. Method: The protocol of present study was certified by IAEC (SKPCPER/IAEC/2016-02/01) as per the CPCSEA. The acute oral toxicity was assessed according to OECD guideline AOT-425 to know single dose (2000 mg/kg) toxicity of test drug on swiss albino mice. The effectiveness of test drug on peptic ulcer was assessed in Pylorus ligation induced ulcer model in Albino Wister Rats. The effect of test drug on gastric parameters (gastric volume, pH, free & total acidity, ulcer index) and oxidative stress marker level (superoxide dismutase- SOD, catalase, malondialdehyde- MDA,) were assessed in comparison with various controlled groups. Results: There were no any physical - behavioral changes and mortality observed in any animal during 14 days. Body weight of all animals did not reveal any significant change as compared to vehicle control group. Significant increase in pH and decrease in gastric volume, total acidity, free acidity and ulcer index was found in test drug treated group in comparison to various control and standard drug treated group. Significant effect was obtained on antioxidant marker level in test drug treated group as compare to other groups. Conclusion: The No-Observed-Adverse- Effect-Level (NOAEL) of Gasteon syrup is 2000 mg/kg as it did not produce any toxic effect at that dose. The obtain results are suggestive of ulcer protective and antioxidant effect of Gasteon Syrup.

Keywords: Poly herbal formulation, Gasteon Syrup, OECD Guideline, NOAEL, Peptic ulcer, Antioxidant.