Acute Oral Toxicity Study on M.VITA CAPSULE OF Sponsor Study Centre: VIRGO UAP PHARMA PVT.LTD. PHARMACOLOGY LABORATORY MAHAGUJARAT IND.ESTATE , SDM CENRE FOR RESEARCH IN PLOT NO. 423/98-B. AYURVEDA AND ALLIED SCIENCES SARKHEJ – BAVLA HIGHWAY LAXMI NARAYANA NAGAR, KUTHPADY, VILL – MORAIYA, TA – SANAND UDUPI - 574118 DIST – AHMEDABAD - 382213 Email: [email protected]Web: www.virgouap.com
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ACUTE TOXICITY STUDY - Virgo UAP · Acute oral toxicity study of test drug “M.Vita Capsule” on rats ... 12- Javantri Myristica fragrans Aerial Part A.B. 10 mg ... Wistar albino
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Acute Oral Toxicity Study on
M.VITA CAPSULE
OF
Sponsor Study Centre:
VIRGO UAP PHARMA PVT.LTD. PHARMACOLOGY LABORATORY MAHAGUJARAT IND.ESTATE , SDM CENRE FOR RESEARCH IN PLOT NO. 423/98-B. AYURVEDA AND ALLIED SCIENCES SARKHEJ – BAVLA HIGHWAY LAXMI NARAYANA NAGAR, KUTHPADY, VILL – MORAIYA, TA – SANAND UDUPI - 574118 DIST – AHMEDABAD - 382213 Email: [email protected] Web: www.virgouap.com
highway, Vill - MORAIYA, Ta - Sanand Dist - AHMEDABAD -
382213(GUJARAT)
2.2- TEST CONDITIONS
1. Animal species : Rats
2. Strain : Wistar albino
3. Source : Animal house attached to SDM Research centre, SDM
Ayurveda College Udyavara
4. Selection : A total of 5 healthy either sex of body weight 150-200g
Rats were selected according to AOT software .
5. Acclimatization period : All the selected animals were kept under
acclimatization For 7 days before dosing.
6. Numbering and identification : The animal were marked with saturated
Picric acid solution in water for proper
identification. The marking within the
cages is as follows.
Animal number
Marking
1 Head
2 Neck
3 Middle of the back
4 Base of the tail
5 No mark
8
The group number, animal number and sex of the animal were identified with the help of cage cards,
as presented in following table.
Sl. no
Identification of animals
Desired dose (according to AOT)
Body weight (grams )
Calculated dose (ml)
1 Head 175mg/kg 125 0.5ml
2 Neck 550mg/kg 155 1.03 ml
3 Back 2000mg/kg 130 3.2ml
4 Base of the tail 2000mg/kg 160 3.25ml
5 No mark 2000mg/kg 225 5.6ml
Husbandry condition:
1. Housing : Rats were housed in each cage of poly propylene with stainless steel top
grill. The dry husk was used as bedding material and was changed every
morning.
2. Environment : The animal were exposed to 12 hours light and 12 hours dark cycle with
The relative humidity 50 to 70 % and the ambient temperature was
22 ± 03®c.
3. Diet : Amruth brand rat pellete feed supplied by Pranav Agro Ltd, was provided
throughout the study period except on previous night of dosing i.e
(overnight) fasting before dosing. The drinking water was given ad
libitum Propylene bottles with stainless steel sipper tube.
9
.
2.4 Preparation of Test formulation for administration:
1. Test drug : M-VITA CAPSULE
2. Vehicle : Gum acacia 3. Dose preparation : The test formulation supplied by the sponsor was made in to Fine suspension in vehicle with suitable concentration All the animal were dosed constant dose volume (1 ml/ 100g body weight) 175mg/kg , 550mg/kg, 2000mg/kg 4. Schedule : Single dose per animal a) Administration : The test formulation was administered through oral route at different dose levels to respective animal through oral feeding needle on to disposable syringe b) Dose fixation : According to the AOT Software. C) Route : Oral d) Dose : 175mg/kg, 550mg/kg, 2000mg/kg test substance
e) Dose volume : 1ml/100g animal
3. Observation:
3.1 Examination of Physical and Behavioural changes :
The animal was observed continuously for 4 hours after the dosing. The careful cage side
observation was done without disturbing the animal attention and at the end of the every hour
the animal were individually exposed to open arena for recording the behavioural changes like
increased or decreased motor activity , convulsions, straub’s reaction, muscle spasm, catatonia,
Vasodilatation - - - - - - - - Grip strength(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N
Piloerection - - - - - - - -
13
Pharmacology Laboratory
SDM Centre for Research in Ayurveda & Allied Sciences, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES
Vasodilatation - - - - - - - - Grip strength(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N
Piloerection - - - - - - - -
14
Pharmacology Laboratory
SDM Centre for Research in Ayurveda & Allied Sciences, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES
Vasodilatation - - - - - - - - Grip strength(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N
Piloerection - - - - - - - -
15
Pharmacology Laboratory
SDM Centre for Research in Ayurveda & Allied Sciences, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES
Vasodilatation - - - - - - - - Grip strength(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N
Piloerection - - - - - - - -
16
Pharmacology Laboratory
SDM Centre for Research in Ayurveda & Allied Sciences, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES
Vasodilatation - - - - - - - - Grip strength(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N
Piloerection - - - - - - - -
17
Pharmacology Laboratory
SDM Centre for Research in Ayurveda & Allied Sciences, Udupi Proforma for recording effect on gross behaviour
Drug : M. Vita Capsule Date : 13/01/12
Group: 175mg/kg Route: Oral
Animal: Rat1 (125) Study: acute oral toxicity
Experiment conducted by: Head of the lab (Director):
Rat
No
.1
Tim
e o
f d
rug
ad
min
istr
ati
on
Tim
e i
nte
rval
(min
)
Exit
us
CNS Depression
ANS
CNS Stimulation
An
alg
esi
a
Oth
ers
Hyp
o a
ctiv
ity
Pass
ivit
y
Rel
ax
ati
on
Ata
xia
Narc
osi
s
Pto
sis
Exop
hth
alm
os
es
Hyp
era
ctiv
ity
Irri
tab
ilit
y
Ste
reo
typ
y
Tre
mors
Con
vu
lsio
n
Str
au
b t
ail
Basal - - - - -- - - - - - - - - - -
11.00
30 - - - - - - - - + + - - - - -
60 - - - - - - - - + + - - - - -
120 - - - - - - - - - - - -- - - -
180 - - - -- - - - - - - - -- -- - -
240 - - - - - - - - - - - - - --
24
h
- - - - - - - - - - - - - - -
48
h
- - - - - - - - - - - - - - -
18
Pharmacology Laboratory
SDM Centre for Research in Ayurveda and Allied sciences, Kuthpady, Udupi-
574118.
Pro forma for assessing Gross behaviour
Drug : M. Vita Capsule Date : 16/01/12
Group : 550mg/kg Route: Oral
Animal: Rat -2 155g Study: Acute oral toxicity
Experiment conducted by: Head of the lab (Director):
Rat
No.2
Tim
e of
dru
g
ad
min
istr
ati
on
Tim
e i
nte
rval
(min
)
Exit
us
CNS Depression
ANS
CNS Stimulation
An
alg
esi
a
Oth
ers
Hyp
o a
ctiv
ity
Pass
ivit
y
Rel
axati
on
Ata
xia
Narc
osi
s
Pto
sis
Exop
hth
alm
os
es
Hyp
eract
ivit
y
Irri
tab
ilit
y
Ste
reoty
py
Tre
mors
Con
vu
lsio
n
Str
au
b t
ail
Basal - - - - -- - - - - - - - - - -
11.00
30 - - - - - - - - + + - - - - -
60 - - - - - - - - + + - - - - -
120 - - - - - - - - + + - -- - - -
180 - - - -- - - - - - - - -- -- - -
240 - - - - - - - - - - - - - --
24
h
- - - - - - - - - - - - - - -
48
h
- - - - - - - - - - - - - - -
19
Pharmacology Laboratory
SDM Centre for Research in Ayurveda and Allied sciences, Kuthpady, Udupi-
574118.
Pro forma for assessing Gross behaviour
Drug : M.Vita Capsule Date : 19/01/12
Group : 2000mg/kg Route: Oral
Animal: Rat -3(130g) Study: Acute oral toxicity
Experiment conducted by: Head of the lab (Director):
Rat
No.3
Tim
e of
dru
g
ad
min
istr
ati
on
Tim
e i
nte
rval
(min
)
Exit
us
CNS Depression
ANS
CNS Stimulation
An
alg
esi
a
Oth
ers
Hyp
o a
ctiv
ity
Pass
ivit
y
Rel
axati
on
Ata
xia
Narc
osi
s
Pto
sis
Exop
hth
alm
os
es
Hyp
eract
ivit
y
Irri
tab
ilit
y
Ste
reoty
py
Tre
mors
Con
vu
lsio
n
Str
au
b t
ail
Basal - - - - -- - - - - - - - - - -
11.15
30 - - - - - - - - - + - - - - -
60 - - - - - - - - - + - - - - -
120 - - - - - - - - - + - -- - - -
180 - - - -- - - - - - - - -- -- - -
240 - - - - - - - - - - - - - --
24
h
- - - - - - - - - - - - - - -
48
h
- - - - - - - - - - - - - - -
20
Pharmacology Laboratory
SDM Centre for Research in Ayurveda and Allied sciences, Kuthpady, Udupi-
574118.
Pro forma for assessing Gross behaviour
Drug : M. Vita Capsule Date : 21/01/12
Group : 2000mg/kg Route: Oral
Animal: Rat-4(160g) Study: acute oral toxicity
Experiment conducted by: Head of the lab (Director):
Rat
No.4
Tim
e of
dru
g
ad
min
istr
ati
on
Tim
e i
nte
rval
(min
)
Exit
us
CNS Depression
ANS
CNS Stimulation
An
alg
esi
a
Oth
ers
Hyp
o a
ctiv
ity
Pass
ivit
y
Rel
axati
on
Ata
xia
Narc
osi
s
Pto
sis
Exop
hth
alm
os
es
Hyp
eract
ivit
y
Irri
tab
ilit
y
Ste
reoty
py
Tre
mors
Con
vu
lsio
n
Str
au
b t
ail
Basal - - - - -- - - - - - - - - - -
12.00
30 - - - - - - - - - - - - - - -
60 - - - - - - - - + + - - - - -
120 - - - - - - - - - + - -- - - -
180 - - - -- - - - - - - - -- -- - -
240 - - - - - - - - - - - - - --
24
h
- - - - - - - - - - - - - - -
48
h
- - - - - - - - - - - - - - -
21
Pharmacology Laboratory
SDM Centre for Research in Ayurveda and Allied sciences, Kuthpady, Udupi-
574118.
Pro forma for assessing Gross behaviour
Drug : M. Vita Capsule Date : 23/01/12
Group : 2000mg/kg Route: Oral
Animal: Rat-5(225g) Study: Acute oral toxicity
Experiment conducted by: Head of the lab (Director):