English name: Indian
Bedellium Tree
Sanskrit name:
Guggulu
Family: Burseraceae
Part used: Gum resin,
Stem, Leaf
Extraction
method: |
CO2
extracts | Fortified extracts
Solvent extracts | Whole herb extracts |
More
info |
Traditional uses:
The gum is bitter, acrid, astringent, aromatic, antiinflammatory
and rejuvenating. The main indications for guggul are
in disease due to increased vata and kapha. It is described
to be especially useful in arthritis and medoroga (obesity).
Phytochemistry:
The major bioactive constituents of Commiphora mukul
are two isomeric phytosteroids viz. guggulsterone E
& Z. The gum resin also contains phytosterols5 viz.
guggulsterol I, II and III and other pregnane
derivatives; lignans3 mainly sesamin.
Pharmacology
: The oleoresin contains 0.37% essential oil
containing mainly myrecene, dimyrecene, and polymyrecene.
Alcohol extraction gives a soluble resin and an insoluble
carbohydrate gum. Solvent extraction, hydrolysis and
column chromatography over silica gel of guggul resin
identifies a number of compounds -a diterpene hydrocarbon,
a diterpene alcohol, Z-guggulsterone E-guggul- sterone,
guggulsterol-I gugguisterol-II and guggulsterol-III
Cholesterol, sesamin and camphorene are also found.
Commiphora mukul has been reported for its potent hypolipidemic,
antiinflammatory. Commiphora mukul also has effect on
fibrinolysis, platelet adhesiveness thereby used coronary
heart disease.
Major constituents:
Guggulsterones, specifically Guggulsterone E and Guggulsterone
Z
Main use:
Hypolipidemic.
Specification: 2.5% Total
Gugulsterones
| SL NO |
TESTS |
LIMITS |
PROTOCOL |
| 1. |
Description
|
Light yellow to light brownish-yellow
powder. |
| 2. |
Physico-chemical analysis
|
|
|
| Moisture (%w/w) |
< 10.0 |
As per USP <921> Method II |
| Acid insoluble Ash (%w/w) |
< 15.0 |
As per USP<561> Vegetable Drugs |
| 3. |
Particle Size |
|
|
| Bulk Density (g/cc) |
0.20 – 0.80 |
As per USP <616> Method – I |
| 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 WHO/PHARMA/92.559/Rev.1 Pg.49-52 |
| As per FIP Guidelines |
|
| Total Viable Aerobic Count |
< 104 cfug-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 |
<5ppb |
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 |
| As per USP & BP Limits |
| Organochlorine Pesticides |
| Organophosphorus Pesticides |
| Synthetic pyrethroids |
| 10. |
Phytochemical analysis
|
|
By HPLC |
| Total Gugulsterones (%w/w) |
> 2.5 |
| Gugulsterones E & Z (%w/w) |
> 1.0 |
Note:
1. Commiphora mukul extract is also available with =
5%w /w Total
Gugulsterones and 2.5%w/w E & Z Gugulsterones in
paste form.
2. Approved pharmaceutical grade excipients are added.
3. Residual solvent analysis and residual pesticide
analysis are performed only on request.
4. Ethanolic extract is also available on demand.
|
