EVALUATION OF TEST FORMULATION FOR ANTI-ULCERATIVE ACTIVITY USING ALCOHOL INDUCED ULCER IN EXPERIMENTAL RAT

 

EVALUATION OF TEST FORMULATION FOR ANTI-ULCERATIVE ACTIVITY USING ALCOHOL INDUCED ULCER IN EXPERIMENTAL RAT

1.0 INTRODUCTION:

Gastric ulceration is a benign lesion on the mucosal epithelium upon exposure of the stomach to excess acid and aggressive pepsin activity. It possibly due to disturbance in balance between the aggressive factors like pepsin, acid and H. pylori and the defensive factors such as bicarbonate, gastric mucus, and prostaglandins.

 

2.0 TEST SYSTEM DETAILS:

Species             : Rattus norvegicus

Strain                : Sprague dawley; Wistar.

Age                   : 6-8 Weeks

Body Wight        : 150-200g

Sex                   : Male or Female

No. of animals    : 8 /Group

Total animal       : 56 + 5 Extra = 61

3.0  ALLOCATION OF GROUPS:

Groups	Treatment	Dose; ROA	No. of Animals
G1	Normal Control	0.9% Normal saline /Na-CMC	8
G2	Ulcerated Control	0.9% Normal saline/Na-CMC	8
G3	Reference Drug- Omeprazole	30 mpk; p.o.	8
G4	Test Formulation	X mpk; p.o.	8
G5	Test Formulation	XX mpk; p.o.	8
G6	Test Formulation	X mpk; p.o.	8
G7	Test Formulation	XX mpk; p.o.	8

# 5 extra animals will be taken extra due to variability in the disease development and possibilities of animal mortalities

 

4.0 METHOD:

·       Animals will be acclimatized for 7 days prior to main experiment and maintained all standard condition as per CPCSEA guidelines.

·       Animals will be randomly divided into seven groups containing eight animals in each.

·       To induce ulcer the overnight fasted animals will be administered ethanol (80% v/v; 1.0ml/100g) orally after 45 min of drug, vehicle and test compound treatment.

·       Drug treatment will be initiated from day 0 (prophylactic) to Day 20 (after the ulcer development).

·       Group of animals G1 will be served as normal control (without ulceration) and administered with 0.25% sodium CMC at 10ml/kg.

·       Group of animals G2 will be served as ulcerated control and administered with 0.25% sodium CMC at 10ml/kg.

·       Group of animals G3 will be served as reference drug and administered with omeprazole at the dose of 30mg/kg p.o.

·       Similarly, group of animals G4 to G7 will be administered with test compound/test sample at different dose level.

·       4 h post ulcer induction, the animals will be humanely sacrificed by high dose of thiopental sodium.

·       The stomach opened along greater curvature and gastric content will be drained into a centrifuge tube.

·       5ml of distilled water will be added and the resultant solution will be centrifuged at 3000 rpm for 10 min. The supernatant will be separated and stored for biochemical analyses.

·       The cleaned stomachs will be preserved in 0.1 M phosphate saline buffer (1:4 (w/v), pH 7.4) prior to macroscopic examination and homogenization.

·       Cleaned stomachs will be scored using dissecting microscope with square-grid eyepiece based on grading on a 0–5 scale (depicting severity of vascular congestions and lesions/hemorrhagic erosions).

·       Mean ulcer score for each animal will be expressed as ulcer index (U.I) and the percentage of inhibition against ulceration will be determined using the expressions:

 

U.I. = [Ulcerated area/total stomach area] × 100.

 

%Ulcer inhibition = [U.I. in control − U.I. in test] × 100/U.I. in control

 

5.0 End Point Parameter:

·       Ulcer Index

·       % Ulcer inhibition

·       Histopathology of stomach tissue

·       pH of GI content

·       Superoxide dismutase (SOD) and malondialdehyde (MDA) (In stomach homogenate)

6.0  REFERENCE(S):

 

6.1 Mastewal Abebaw Bharat Mishra Dessalegn Asmelashe Gelayee. Evaluation of anti-ulcer activity of the leaf extract of Osyris quadripartita Decne. (Santalaceae) in rats. Journal of Experimental Pharmacology 2017:9

6.2 Poornima Nagulsamy, Revathi Ponnusamy, Parimelazhagan Thangaraj. Evaluation of antioxidant, anti-inflammatory, and antiulcer properties of Vaccinium leschenaultii Wight: A therapeutic supplement. Journals of food mand drug analysis 2 3 (2 0 1 5) 3 7 6 e3 8 6378.

6.3 Sung Hwa Song, Ji Eun Kim, Ji Eun Sung, Hyun Ah Lee, Woo Bin Yun, Young Hee Lee, HyunKeun Song, DaeYoun Hwang. Anti-ulcer effect of Gallarhois extract with anti-oxidant activity in an ICR model of ethanol/hydrochloride acid-induced gastric injury. Journal of Traditional and Complementary Medicine 9 (2019) 372e382.

6.4 Mousa, A.M., El-Sammad, N.M., Hassan, S.K. et al. Antiulcerogenic effect of Cuphea ignea extract against ethanol-induced gastric ulcer in rats. BMC Complement Altern Med 19, 345 (2019). https://doi.org/10.1186/s12906-019-2760-9

                                     END OF DOCUMENT

You may like to read theses links:   

1. List of All SOPs and Documents for In-vivo Laboratory

2. List of All SOPs and Documents for Study Protocol

3. List of Pharmacological Study Models with details about disease Inducing agent, Standard or Reference Drug and related parameters.

4.List of OECD Guidelines or Toxicological Studies

5.List of Pharmacopeial Test or Quality Control Test or Batch Testing Parameters (In-vivo)

6.STUDY PROTOCOL: EVALUATION OF ANTI-ULCER ACTIVITY OF NATURAL PROBIOTIC FORMULATION USING EXPERIMENTAL ANIMALS

7.EVALUATION OF TEST FORMULATION FOR ANTI-ULCERATIVE ACTIVITY USING PYLORUS LIGATION INDUCED ULCER IN EXPERIMENTAL RAT

8.EVALUATION OF TEST FORMULATION FOR ANTI-ULCERATIVE ACTIVITY USING INDOMETHACIN INDUCED ULCER IN EXPERIMENTAL RAT

9.EVALUATION OF TEST FORMULATION FOR ANTI-ULCERATIVE ACTIVITY USING STRESS INDUCED ULCER IN EXPERIMENTAL RAT

  

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