EVALUATION OF THE ANTI-FIBROTIC ACTIVITY OF TEST FORMULATIONS IN MOUSE MODEL OF BLEOMYCIN INDUCED PULMONARY FIBROSIS
1.0
TEST SYSTEM DETAILS:
Species : Mus musculus (Mice)
Strain : C57BL/6
Age :
6-8 weeks
Body Wight : 20- 25g
Sex : Male/Female
No. of animals : 8
/Group
Total animals : 56
Study duration : 40 days
2.0 ALLOCATION OF GROUPS:
|
Groups |
Treatment |
Dose, RoA |
Animals |
|
G1 |
Normal Control |
0.5% MC, p.o. |
8 |
|
G2 |
Disease Control |
0.5% MC, p.o. |
8 |
|
G3 |
Reference Control – Pirfenidone |
300 mpk, p.o. |
8 |
|
G4 |
Test Formulation 1 |
X1 mpk; p.o. |
8 |
|
G5 |
Test Formulation 1 |
X2 mpk; p.o. |
8 |
|
G6 |
Test Formulation 1 |
X3 mpk; p.o. |
8 |
|
G7 |
Test Formulation 1 |
X4 mpk; p.o. |
8 |
No extra animals will be taken; X1, X2, X3, and X4 are defined as the incremental doses of the Test formulation 1 respectively. MC-Methyl Cellulose; ROA-route of administration; mpk-mg/kg, p.o.-per os
3.0 METHOD:
Healthy animals will be selected, randomized based on body weight and allocated into 7, different groups consisting of 8 animals each.
Animals will be anaesthetized by ketamine & xylazine at the dose of 85 &10 mg/kg respectively.
Mice will be held in a vertical position and then administered 5 mg/kg of Bleomycin once in a volume of 50 µL by intratracheal instillation.
Animals of the Group G1 will serve as normal control and receive 0.5% MC, p.o.
Disease control (G2) animals will receive 0.5% MC, p.o.
Animals of group G3 will be treated with reference drug Pirfenidone-300 mg/kg.
Animals of group G4-G7 will be treated with Test formulation at different dose levels for 4 weeks.
4.0
ENDPOINT PARAMETER(S):
·
Bodyweight & lung
weight
·
Total and differential leukocyte count in BALF
·
BALF cytokines level
·
Hydroxyproline content of lungs
·
Nrf-2, HO-1, GPx-1, GSH, SOD, CAT, Bach-1, MCP-1, TNF-α, IFN-γ, IL-6,
·
Serum & Bal MDA
·
Cell viability assay
· Lung collagen content
5.0
REFERENCE(S):
I.
You-Seok Kim, Qiang Li, Hwa-Young Youn and Dae Young Kim, Oral
Administration of Chitosan Attenuates Bleomycin-induced Pulmonary Fibrosis in
Rats. In vivo., 2019, 33, 1455-1461.
II.
Xiaohe Li, Zhun Bi, Shuaishuai Liu, Shaoyan Gao, Yunyao Cui,
Kai Huang, Mengying Huang, Jiahe Mao, Lixin Li, Jingjing Gao, Tao Sun 1,
Honggang Zhou and Cheng Yang, Antifibrotic Mechanism of Cinobufagin in
Bleomycin-Induced Pulmonary Fibrosis in Mice. Frontiers in Pharmacology, 2019,
10, 1021.
III.
Sarasadat Hosseini, Mohsen Imenshahidi, Hossein Hosseinzadeh,
Gholamreza Karimi, Effects of plant extracts and bioactive compounds on attenuation
of bleomycin-induced pulmonary fibrosis. Biomedicine & Pharmacotherapy, 2018,
107, 1454–1465.
IV.
Nergiz H. Turgut, Haki Kara, Sahende Elagoz, Koksal Deveci,
Huseyin Gungor, and Emre Arslanbas, The Protective Effect of Naringin against
Bleomycin-Induced Pulmonary Fibrosis in Wistar Rats. Pulmonary Medicine, 2016.
V.
Yuan Liu, Fuai Lu, Lirong Kang, Zhihua Wang and Yongfu Wang, Pirfenidone
attenuates bleomycin-induced pulmonary fibrosis in mice by regulating Nrf2/Bach1
equilibrium. BMC Pulmonary Medicine, 2017, 17:63.
END OF THE DOCUMENT
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