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English name : Periploca
of the woods
Sanskrit:
Madhunashini
Family : Asclepediaceae
Part used : Leaves
Extraction
method: |
CO2
extracts | Fortified extracts
Solvent extracts | Whole herb extracts |
More
info |
 Traditional
uses: 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.
Phytochemistry:
The major bioactive constituents of Gymnema sylvestris
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-ß-glucuronide
of gymnemagenin ( 3ß, 16ß, 21ß, 22a,
23, 28-hexahydroxy-olean-12-ene)4. The individual gymnemic
acids (saponins) include gymnemic acids I-VII, gymnemosides
a-f, gymnemasaponins3-5 etc.
Pharmacology:
Gymnema sylvestris has potent antidiabetic agent
as reported in studies. In addition it has been reported
for its hepatoprotective9, hypolipidemic10 and antiatherosclerotic
effects.
Marker constituent:
Gymnemic acids
Main use: Anti-diabetic
Specification:
25% Gymnemic acid
| SL NO |
TESTS |
LIMITS |
PROTOCOL |
| 1. |
Description
|
Dark green to greenish brown powder. |
| 2. |
Physico-chemical analysis |
|
|
| Moisture (%w/w) |
< 5.0 |
As per USP <921> Method II |
| Ash content (%w/w) |
< 7.5 |
As per USP<561> |
| Acid insoluble Ash (%w/w) |
< 3.0 |
| 3. |
Particle Size |
|
|
| Bulk Density (g/cc) |
0.20 – 0.80 |
As per USP <616> Method –
I |
| 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. |
| 4. |
Heavy metal analysis |
|
AAS / ICP –ES |
| Lead |
< 10 ppm |
| Cadmium |
< 1 ppm |
| Arsenic |
< 2 ppm |
| 5. |
Microbiological analysis |
|
|
| As per FIP Guidelines |
|
|
| Total Viable Aerobic Count |
< 104 cfu g-1 |
As per WHO/PHARMA/92.559/Rev.1 |
| Total Enterobacteriaceae |
< 102 org g-1 |
| Total Fungal Count |
< 102 fs g-1 |
| 6. |
Test for Specific Pathogen |
|
| As per FIP Guidelines |
|
| E.coli (1g) |
Absent |
| Salmonella Sp. (10g) |
Absent |
| S.aureus (1g) |
Absent |
| 7. |
Mycotoxin analysis |
< 5 ppb |
As per USP Test for Aflatoxins |
| Aflatoxins (B1 + B2 + G1 + G2) |
| 8. |
Residual solvent analysis |
<3000 ppm |
As per USP <467> |
| As per ICH Guidelines |
| Methanol |
| 9. |
Pesticide residue analysis |
To comply with USP |
As per AOAC / USP |
| Pesticide residue analysis |
| Organochlorine Pesticides |
| Organophosphorus Pesticides |
| Synthetic pyrethroids |
| 10. |
Phytochemical analysis |
25.0 |
By Gravimetry |
| Total Gymnemic acid (%w/w) |
Note:
1. Gymnema sylvestris extract also available with 75%
& 50%w/w Gymnemic acid.
2. Approved pharmaceutical grade excipients are added
if required.
3. Residual solvent analysis and residual pesticide
analysis are performed only on request
4. Ethanolic extract is also available on demand.
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