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English
name: Periploca of the woods |
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Family:
Asclepediaceae |
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Part
used: Leaves |
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The plant
is stomachic, stimulant, laxative,
diuretic and useful in cough.
The leaves of the plant, when
chewed possess the remarkable
property of paralysing the sense
of taste for sweet and bitter
substance for sometime. The
leaves are used as a remedy
for diabetes. |
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The
major bioactive constituents
of Gymnema sylvestre
are a group of oleanane type
triterpenoid saponins known
as “gymnemic acids”3,4.
The latter contain several acylated
(tigloyl, methylbutyroyl etc.,)
derivatives of deacylgymnemic
acid (DAGA) which is 3-O-b-glucuronide of gymnemagenin ( 3b, 16b, 21b, 22a, 23,
28-hexahydroxy-olean-12-ene)4.
The individual gymnemic acids
(saponins) include gymnemic
acids I-VII, gymnemosides a-f,
gymnemasaponins3-5
etc.
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| Gymnema
sylvestre has potent antidiabetic6-8
agent as reported in studies.
In addition it has been reported
for its hepatoprotective9,
hypolipidemic10
and antiatherosclerotic10
effects. |
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Marker
constituent: Gymnemic acids
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| Main
use: Anti-diabetic |
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References: |
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1. |
Warrier
PK, Nambiar VPK, Ramankutty C. (1995)
Indian Medicinal Plants, a
Compendium of 500 species, |
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Orient Longman Ltd., Madras,
India. 3, 107-109. |
| 2. |
Anonymous. (1998) The
Wealth of Asia, Council of Scientific
and Industrial Research. New Delhi |
| 3. |
Yoshikawa K, Amimoto K,
Arihara S, Matsuura K. (1989) Tetrahedron
letters, 30(9): 1103-1106. |
| 4. |
Liu HM, Kiuchi F, Tsuda
Y. (1992) Chem. Pharm. Bull. 40(6): 1366-1375. |
| 5.
|
Yoshikawa M, Murakami T,
Kadoya M, Li Y, Murakami N, Yamahara J,
Matsuda H . (1997) Chem. Pharm. |
| |
Bull. 45(10): 1671-1676. |
|
6. |
Shanmugasundaram ERB, Gopinath
KL, Shanmugasundaram KR, Rajendran VM.
(1990) J. Ethnopharmacol. |
| |
30: 265-279. |
| 7. |
Shanmugasundaram ERB, Rajeswari
G, Baskaran K, Kumar BRR. (1990) J. Ethnopharmacol.
30: 281-294. |
| 8. |
Bombarde A, Bombarde DT.
(1994) Sachitra Ayurved, 47(2): 108-111. |
| 9. |
Rana AC, Avadhoot Y. (1992)
Fitoterapia, 63(1): 60-62. |
| 10. |
Bishayee A, Chatterjee
M. (1994) Phytother. Res. 8: 118-120. |
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|
 |
DOC
NO. |
: |
NR/QCD/SPC/047 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: GYMNEMA SYLVESTRE EXTRACT (³ 25% TOTAL GYMNEMIC ACIDS) |
| Plant
part |
: |
Leaves |
Fresh/Dry
|
: |
Dry |
|
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Dark
green to Greenish brown powder. |
| 2.
|
Identification |
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method II |
| Moisture
(%w/w) |
| Ash
content (%w/w) |
< 7.5 |
As per USP<561> |
| Acid
insoluble Ash (%w/w) |
< 3.0 |
| 4.
|
Particle
Size |
0.20 - 0.80 |
As per USP <616> Method -
I |
| Bulk
Density (g/cc) |
| Tapped
bulk density (g/cc) |
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 |
< 5 ppb |
As per USP Test for Aflatoxins |
| Aflatoxins
(B1 + B2 + G1
+ G2) |
| 9.
|
Residual
solvent analysis |
< 3000 ppm |
As per USP |
| As per ICH Guidelines |
| Methanol |
| 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 25.0 |
By Gravimetry |
| Total
Gymnemic acids (%w/w) |
|
|
DOC
NO. |
: |
NR/QCD/SPC/048 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: GYMNEMA SYLVESTRE EXTRACT (³ 50% TOTAL GYMNEMIC ACIDS) |
| Plant
part |
: |
Leaves |
Fresh/Dry
|
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Dark
green to Greenish brown powder. |
| 2.
|
Identification
|
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method II |
| Moisture
(%w/w) |
| Ash
content (%w/w) |
< 7.5 |
As per USP<561> |
| Acid
insoluble Ash (%w/w) |
< 3.0 |
| 4.
|
Particle
Size |
0.20 - 0.80 |
As per USP <616> Method -
I |
| Bulk
Density (g/cc) |
| Tapped
bulk density (g/cc) |
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 |
< 5 ppb |
As per USP Test for Aflatoxins |
| Aflatoxins
(B1 + B2 + G1
+ G2) |
| 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 50.0 |
By Gravimetry |
| Total
Gymnemic acids (%w/w) |
|
|
DOC
NO. |
: |
NR/QCD/SPC/049 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: GYMNEMA SYLVESTRE EXTRACT (³
75% TOTAL GYMNEMIC ACIDS) |
| Plant
part |
: |
Leaves |
Fresh/Dry
|
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Dark
green to Greenish brown powder. |
| 2.
|
Identifiation |
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method II |
| Moisture
(%w/w) |
| Ash
content (%w/w) |
< 7.5 |
As per USP<561> |
| Acid
insoluble Ash (%w/w) |
< 3.0 |
| 4.
|
Particle
Size |
0.20 - 0.80 |
As per USP <616> Method -
I |
| Bulk
Density (g/cc) |
| Tapped
bulk density (g/cc) |
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 |
< 5ppb |
As per USP Test for Aflatoxins |
| Aflatoxins
(B1 + B2 + G1
+ G2) |
| 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 75.0 |
By Gravimetry |
| Total
Gymnemic acids (%w/w) |
|
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