Gastric Ulceration or Anti-ulcer Activity animal study design includes following headlines:
1.0 TEST SYSTEM DETAILS:
Species : Rattus norvegicus (Rat)
Strain : Wistar or Sprague Dawley
Age : 8-10 weeks
Body Wight : 120-200 g
Sex : Male/Female
No. of animals : 8 /Group
Total Animals : Model-1(40+05 Extra= 45); Model-2(40+ 05 Extra= 45)
Study Duration: 10 Days
2.0 ALLOCATION OF GROUPS:
..mm.jpg)
Model -1: Pyloric Ligation
|
Groups |
Treatment |
Dose;
ROA* |
No. of
Animals |
|
G1 |
Normal Control |
Normal saline or 0.25% Na-CMC |
8 |
|
G2 |
Negative Control |
Pyloric ligation group |
8# |
|
G3 |
Reference Drug- Ranitidine |
30 mg/kg; p.o. |
8# |
|
G4 |
Test Formulation-1 |
X mg/kg; p.o. |
8# |
|
G5 |
Test Formulation -2 |
XX mg/kg; p.o. |
8# |
*The doses and ROA (Routes of administration) will be decided based on the type of reference drug # 10 extra (~20%) animals will be taken extra due to a surgery procedure is needed in the ulcer development and possibilities of animal mortalities
Model -2: Ethanol induced ulcer
|
Groups |
Treatment |
Dose;
ROA |
No. of
Animals |
|
GI |
Normal Control |
Normal saline 1ml |
8 |
|
GII |
Negative Control |
Ethanol1ml/kg group |
8 |
|
GIII |
Reference Drug- Ranitidine |
30 mg/kg; p.o. |
8 |
|
GIV |
Test Formulation-1 |
X mg/kg; p.o. |
8 |
|
GV |
Test Formulation -2 |
XX mg/kg; p.o. |
8 |
3.0 METHOD:
Model-1
· Ulcerate will be induced in rats by pyloric ligation (abdomen opened by a small midline incision below the xiphoid process. The pyloric portion of the stomach is identified, slightly lifted out and ligated. The stomach is then replaced careful and the abdominal wall is closed with sutures).
· Animals are deprived of both food and water during the postoperative period and are sacrificed at the end of 4 h after the operation.
· The stomach is dissected out as a whole by passing a ligature at the esophageal end.
· The stomach is then separated from the surrounding tissues and organs and bring out as a whole along with its contents.
· Rats are fasted for 48 h prior to the surgical procedure and kept on raising mesh bottomed cages to avoid coprophagy.
· The contents are subjected to centrifugation [3000 Revolutions per minute (rpm) for 10 minutes (min)] and analyzed for volume, pH, free and total acidity, ulcer score ulcer index and gastric wall mucus content.
· Ketamine hydrochloride anesthesia [45 mg/kg, intra peritoneal (i.p.)]
· Ulcerate animals will be randomized into four groups of 8 animals each.
· Group G1 and G2 animals will be treated as normal control (without Ulcer) and Negative control (with Pyloric ligation) respectively.
· Both the groups will be administered with normal saline or 0.25% Na- CMC.
· Animals of group G3 will be treated as reference control and administered Ranitidine at the dose of 30 mg/kg; p.o.
· Similarly, animals of group G4 to G5 will be administered with natural probiotic formulation(s) at different dose ratio.
· Animals will be humanely sacrificed; stomach will be isolated, weighed and processed for histopathological analysis.
Model-2
· All formulation are administered orally 30 min prior to ethanol administration.
· The GI serve as normal control which receives normal saline (1 ml/p.o.) whereas animals in GII receive ethanol.
· GIII animals received reference drug ranitidine. Rats in GIV and V received natural probiotic formulation at 2 different dose ratio p.o. respectively.
· The animals are administered with absolute ethanol (99 %) at the dose of 1 ml/kg of animal orally after the 30 min of treatment with natural probiotic formulation and reference drug ranitidine.
· After 1h the animals were sacrificed and the stomachs were cut along the greater curvature and washed carefully with saline, after which they were observed for ulcer score and ulcer index.
4.0 END POINT PARAMETER(S):
· Clinical observation
· Feed water consumption
· Body Weight.
· The stomach will be isolated, weighed
· The contents are subjected to centrifugation [1000rpm for10min] and analyzed for volume, pH, free and total acidity, ulcer score ulcer index and gastric wall mucus content.
· Antioxidant-activity- Lipid peroxidation & Catalase of Gastric tissue.
· Histopathology of Gastric tissue.
5.0 REFERENCE(S):
5.1 S. K. Das, P. V. Pansuriya & S. T. Shukla & K. J. Gohil & S. P. Roy & A. Choudhury & V. N. Sutariya (2013) Preclinical evaluation of Vallaris solanacea (roth) kuntze stem for its antiulcer and antioxidant activity in wistar albino. Orient Pharm Exp Med. DOI 10.1007/s13596-013-0133
5.2 Robert A, Nezamis JE, Lancaster C, Hanchar AJ (1979) Cytoprotection by prostaglandins in rats. Prevention of gastric necrosis produced by alcohol, HCl, NaOH, hypertonic NaCl, and thermal injury. Gastroenterology 77(3):433–443
5.3 Kumara A, Singh V, Chaudharya A (2011) Gastric antisecretory and antiulcer activities of Cedrus deodara (Roxb) Loud. In wistar rats. J Ethnopharmacol 134:294–297
5.4 Ray A, Chaudhuri SR, Majumdar B, Bandyopadhyay S (2002) Antioxidant activity of ethanol extract of rhizome of Picrorhiza kurroa on indomethacin induced gastric ulcer during healing. Ind J Clin Biochem 17:44–51
END OF DOCUMENT
You may like to read theses links:
Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.
0 comments:
Post a Comment