EVALUATION OF EFFICACY OF TEST FORMULATION FOR ESTROGENIC ACTIVITY USING OVERECTEMIZED RATS
1.0 TEST SYSTEM DETAILS:
Species : Rattus norvegicus (Rat)
Strain : Wistar or Sprague Dawley
Age : 6-10 weeks
Body Wight : 200-250 g
Sex : Female
No. of animals : 7 /Group
Total animals : 42
2.0 ALLOCATION OF GROUPS:
3.0 METHOD:
· Healthy
animals will be selected, randomized based on body weight and divided into 7
into different groups consisting of 7 animals each.
· Estrogenic
activity on ovariectomized rats will be studied according to the modified
method of Mitra SK, et al.
· All
the animals will be subjected to ovariectomy i.e. both the ovaries from each
animal will be removed according to the surgical procedure.
· Ketamine-
xylazine will be used to anesthetize the animals.
· Care
will be taken to avoid any infections to the wound by using Neosporin
antibiotic powder.
· After
recovery from the surgery (approx. 7 days), the animals will be randomized and
divided into different groups.
· The
animals of G1 will serve as the vehicle control and will be administered normal
drinking water.
· Group
G2 animals will be served as disease control and treated 0.25% Na- CMC.
· G3
will be served as reference control group and treated with Estradiol at the dose
of 0.02 mg/kg respectively.
· All
other animals (G4, G5 & G6) will be treated with test comounds
at different dose levels.
· Drug
treatment will be done once daily for 21 days.
· Blood
will be withdrawn and serum will be processed for the estimation of estrogen
and progesterone levels.
· On
the 22th day, all the animals will be sacrificed; uterus of each animal will be
removed and weighed separately.
· Percentage
estrogenic activity will be calculated from the weight of the uteri.
4.0 END POINT PARAMETER(S):
· Body
weight change
· Weight
of Uterus
· Estimation
of Estrogen and progesterone levels in blood serum
· Histopathology of Uterine tissue
5.0 REFERENCE(S): Mitra SK, Gopumadhavan, S, Venkataranganna, MV, Sarma, DNK and Anturlikar, SD. Uterine Tonic Activity of U-3107 (EveCare), a Herbal Preparation in Rats. Indian Journal of Pharmacology 1999; 31; 200-203.
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