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English
name: Bitter gourd, Bitter melon. |
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Family:
Curcurbitaceae |
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Part
used: Fruit. |
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Traditional
uses :
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The
fruits are bitter, stimulant, purgative,
acrid, digestive , carminative, cardiotonic,
laxative 1,2. Useful in diabetes, colic,
anaemia, anthelmentic, |
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The
antidiabetic activity of Momordica
charantia L. (Cucurbitaceae) has
been evaluated extensively for anti-diabetic
and hypolipidemic properties. The oral
hypoglycemic activity was observed with
the aqueous extract powder for fresh
unripe whole fruts at a dose of 20mg/kg
b.wt of rat reducing the fasting glucose
levels. The extract was also evaluated
for hepatotoxicity and nephrotoxicity
and was found to be safe3.
A water soluble extract of the fruits
significantly improved glucose tolerance
levels in rats was found not associated
with increase in serum insulin response4
which was proven clinically in type
2 diabetic patients5. Drinking
of aqueous homogenized suspension of
the vegetable pulp by type 1 (Non insulin
dependent) diabetic cases lead to the
reduction of both fasting and post-prandial
serum glucose levels6. Regular
diet supplementation of freeze –dried
bitter melon at a dose of 0.75% or higher,
showed improved insulin and leptin levels,
but raised serum free fatty acid concentration7.
Thus Momordica charantia appears to
have multiple influence on glucose and
lipid metabolism. |
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Total
Bitters.
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Diabetes and Hepatoprotective.
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References: |
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1. |
Indian Medicinal Plants,
A Compendium of 500 species,Orient Longman
Ltd., Madras, 1995,4, 48- |
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51. |
2. |
Nadkarni K. M. Indian Materia
Medica, Vol. 1, Popular Prakashan, 1993,
page 805-806. |
3. |
Virdi J, Sivakami S, Shanani
S, Suthar AC, Banavalikar MM, Biyan MK,
(2003), J. Ethnopharmacol |
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88(1):
107-11 |
4. |
Leatherdale BA, Panesar
PK, Singh G, Atkins TW, Bailey CJ, Bigne
AH, (1981), Br. Med. J (Clin Res |
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Ed) 282(6279): 1823-4. |
5. |
Welihinda J, Karunanayake
EH, Sheriff MH, Jayasinghe KS, (1986),
J. Ethnopharmacol. 17(3): |
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227-82. |
6. |
Ahmad N, Hassan MR, Halder
H, Bennoor KS (1999), Bangladesh Med Res
Counc Bull. 25(1): 11 – |
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3. |
7. |
Chen
Q, Chan LL, Li Et, (2003), J. Nutr.
133(4): 1088-93. |
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DOC
NO. |
: |
NR/QCD/SPC/052 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: MOMORDICA
CHARANTIA EXTRACT (³
3%
TOTAL BITTERS) |
| Plant
part |
: |
Fruit |
Fresh/Dry
|
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Light
yellowish brown to Dark brown powder |
| 2.
|
Identification |
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 7.0 |
As per USP <921> Method III |
| Loss
on drying (%w/w) |
| Acid
insoluble Ash (%w/w) |
< 5.0 |
| pH
of 5% w/v solution |
4.0 - 7.5 |
As per USP <791> |
| 4.
|
Particle
Size |
0.20 - 0.80 |
As per USP <616> 1913-1914
Method - I |
| Bulk
Density (g/cc) |
| Tapped
bulk density |
0.25 - 0.90 |
| Material passing through 30# BS/35 ASTM (%w/w) |
> 99.0 |
As per USP <786> Particle
Size distribution. |
| 5.
|
Heavy
metal analysis |
< 10 ppm |
AAS / ICP -ES |
| Lead |
| Arsenic |
< 2 ppm |
| Cadmium |
< 1 ppm |
| Mercury
|
< 0.1 ppm |
| 6.
|
Microbiological
analysis |
< 104 cfu g-1 |
As per WHO/PHARMA/92.559/Rev.1
Pg.49-52 / As
per USP <61> & <62> |
| As per FIP Guidelines
|
| Total
Viable Aerobic Count |
| Total
Enterobacteriaceae |
< 102 org g-1 |
| Total
Fungal Count |
< 102 fs g-1 |
| 7.
|
Test
for Specific Pathogen |
Absent |
| As per FIP Guidelines |
| E.coli (1g) |
| Salmonella
Sp.
(10g) |
Absent |
| S.aureus (1g) |
Absent |
| 8.
|
Mycotoxin
analysis |
< 5 ppb |
As per USP Test for Aflatoxins |
| Aflatoxins
(B1 + B2 + G1
+ G2) |
| 9.
|
Pesticide
residue analysis |
To comply with USP |
As per AOAC / USP. |
| As per USP & BP
Limits |
| Organochlorine
Pesticides |
| Organophosphorus
Pesticides |
| Synthetic
pyrethroids |
| 10. |
Phytochemical
analysis |
> 3.0 |
By Gravimetry |
| Total bitters (%w/w) |
|
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DOC
NO. |
: |
NR/QCD/SPC/0053 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: MOMORDICA
CHARANTIA EXTRACT (³
8%
TOTAL BITTERS) |
| Plant
part |
: |
Fruit |
Fresh/Dry
|
: |
Dry |
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|
Sl.. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Light
brown to Dark brown powder |
| 2.
|
Identification |
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method III |
| Loss
on drying (%w/w) |
| Acid
insoluble Ash (%w/w) |
< 7.0 |
As per USP <561> |
| 4.
|
Particle
Size |
0.20 - 0.80 |
As per USP <616> Method -
I |
| Bulk
Density (g/cc) |
| Tapped
bulk density |
0.20 - 0.90 |
| Material passing through 30# BS/35 ASTM(%w/w) |
> 99.0 |
As per USP <786> Particle Size distribution. |
| 5.
|
Heavy
metal analysis |
< 10 ppm |
AAS / ICP -ES |
| Lead |
| Arsenic |
< 2 ppm |
| Cadmium |
< 1 ppm |
| Mercury |
< 0.1 ppm |
| 6.
|
Microbiological
analysis |
< 104 cfu g-1 |
As per WHO/PHARMA/92.559/Rev.1
Pg.49-52 / As
per USP <61> & <62> |
| As per FIP Guidelines
|
| Total
Viable Aerobic Count |
| Total
Enterobacteriaceae |
< 102 org g-1 |
| Total
Fungal Count |
< 102 fs g-1 |
| 7.
|
Test
for Specific Pathogen |
Absent |
| As per FIP Guidelines |
| E.coli (1g) |
| Salmonella
Sp.
(10g) |
Absent |
| S.aureus (1g) |
Absent |
| 8.
|
Mycotoxin
analysis |
|
As per USP Test for Aflatoxins |
| Aflatoxins
(B1 + B2 + G1
+ G2) |
< 5 ppb |
| 9.
|
Residual
solvent analysis |
< 3000 |
As per USP |
| As per ICH Guidelines |
| Methanol
(ppm) |
| 10. |
Pesticide
residue analysis |
To comply with USP |
As per AOAC / USP. |
| As per USP & BP
Limits |
| Organochlorine
Pesticides |
| Organophosphorus
Pesticides |
| Synthetic
pyrethroids |
| 11. |
Phytochemical
analysis |
³ 8.0 |
By gravimetry |
| Total bitters (%w/w) |
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