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English
name: Olibanum, Frankincense |
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Family:
Burseraceae |
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Part
used: Gum |
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The gum is credited with astringent,
stimulant, expectorant, diuretic, diaphoretic,
antipyretic, stomachic, emmenagogue
and antiseptic properties. It is reported
to be useful in ulcers, tumours, goitre.
It is used in the preparation of an
ointment for sores and is used with
butter in syphilis. The gum resin is
sweet, bitter, astringent, antipyretic,
antidysenteric, expectorant, diaphoretic,
diuretic, stomachic, and emmenagogue.
It is useful in fevers, diaphoresis,
convulsions, dysentery, urethrorrhea,
orchiopathy, bronchitis, asthma, cough,
stomatitis, syphilitic diseases, chronic
laryngitis, jaundice and arthritis. |
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The
major bioactive constituents of Boswellia
serrata are pentacyclic triterpene acids3
viz., b-boswellic
acid, acetyl-b-boswellic
acid, 11-keto-b-boswellic
acid, acetyl-11-keto-b-boswellic
acid and tetracylic triterpene acids4
viz. elemolic acid and elemonic acid.
The gum contains sugars viz. D-galactose,
D-arabinose, D-xylose and D-mannose.
It also contains volatile oil and uronic
acids1. |
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Boswellia
serrata a gum resin has been reported
to have analgesic5, antiinflammatory6,7,
antiarthritic8 and antipyretic9-11
activity. The other activity studied
are antihyperlipidimic6,7,
antiatherosclerotic6,7 and
anticancer12. |
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b-Boswellic
acid, Acetyl-b-boswellic acid, 11-keto-b-boswellic acid,
Acetyl-11-keto-b-boswellic acid.
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Main
uses: Anti-inflammatory,
Antiarthritic. |
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References: |
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| 1. |
Anonymous.
(1998) The Wealth of Asia, Council of
Scientific and Industrial Research.
New Delhi. |
| 2. |
Warrier PK, Nambiar VPK,
Raman Kutty C. (1993) Indian Medicinal
Plants a Compendium of 500 |
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species, Orient Longman Ltd., Madras,
India. 1: 267-270. |
| 3. |
Pardhy
RS, Bhattacharyya SC. (1978) Indian
J. Chem. 16(B): 176-178. |
| 4. |
Pardhy RS, Bhattacharyya
SC. (1978) Indian J. Chem. 16(B): 174-175. |
| 5. |
Kar
A, Menon MK. (1969) Life Sciences, 8(1):
1023-1028. |
| 6. |
Atal CK, Singh GB, Batra S, Sharma S,
Gupta OP. (1980) Indian J. Pharmacol.
12: 59. |
| 7. |
Atal
CK, Gupta OP, Singh GB. (1981) Br. J.Pharmacol.
74: 203. |
| 8. |
Singh GB, Singh B, Atal CK. (1984) Indian
J. Pharmacol, 16: 51. |
| 9. |
Singh
GB, Gupta OP, Kour S, Singh B, Atal
CK.(1981) Indian J. Pharm. 13,97. |
| 10. |
Atal
CK, Sharma ML, Koil A, Khajuria A, Singh
GB. (1983) Indian J. Pharm, 15,58. |
| 11. |
Pachnanda
VK, Kant S, Singh D, Singh GB, Gupta
OP, Atal CK. (1981) Indian J. Pharmacol.
13: 63. |
| 12. |
Shao Y, HO CT, Chin CK,
Badmaev V, Ma W, Haung MT. (1998) Planta
Med. 64: 328-331. |
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DOC
NO. |
: |
NR/QCD/SPC/010 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: BOSWELLIA SERRATA EXTRACT (³60%
BOSWELLIC ACIDS) |
| Plant
part |
: |
Gum |
Fresh/Dry
|
: |
Dry |
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|
Sl. No. |
Tests |
Limits |
Protocol |
| 1. |
Description |
Cream to yellowish brown powder with characteristic odour. |
| 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) |
< 2.0 |
As per USP<561> |
| Acid insoluble Ash (%w/w) |
< 0.5 |
| pH of 5% w/v suspension |
4.5 - 7.0 |
As per USP <791> |
| 4. |
Particle Size |
0.20 - 0.60 |
As per USP <616> Method - I |
| Bulk Density (g/cc) |
| Tapped bulk density (g/cc) |
0.20 - 0.60 |
| 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 Pathogens |
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) |
| Hexane (ppm) |
< 290 |
| 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 60.0 |
By Titrimetric |
| Total organic acids as; Boswellic acids (%w/w) |
| Boswellic acid [a+b] (% w/w) |
> 15.0 |
By HPLC |
| Acetyl-boswellic acid [a+b] (% w/w) |
> 4.0 |
| 11-keto-b-boswellic acid (% w/w) |
> 3.0 |
| Acetyl-11-keto-b-boswellic acid (% w/w) |
> 2.0 |
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DOC
NO. |
: |
NR/QCD/SPC/011 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: BOSWELLIA SERRATA EXTRACT (³70%
BOSWELLIC ACIDS) |
| Plant
part |
: |
Gum |
Fresh/Dry
|
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Cream to yellowish brown powder with characteristic odour. |
| 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) |
< 2.0 |
As per USP<561> |
| pH
of 5% w/v suspension |
4.5 - 7.0 |
As per USP <791> |
| 4.
|
Particle
Size |
0.20 - 0.60 |
As per USP <616> Method -
I |
| Bulk
Density (g/cc) |
| Tapped
bulk density (g/cc) |
0.20 - 0.60 |
| 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) |
| Hexane
(ppm) |
< 290 |
| 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 70.0 |
By Titrimetric |
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Total organic acids as; Boswellic acids (%w/w)
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| Boswellic acid [a+b] (% w/w) |
³ 15.0 |
By HPLC |
| Acetyl-boswellic acid [a+b] (% w/w) |
³ 4.0 |
| 11-keto-b-boswellic
acid (% w/w) |
³ 3.0 |
| Acetyl-11-keto-b-boswellic
acid (% w/w) |
³ 2.0 |
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