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English
name: Gotukola |
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Family:
Apiaceae |
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Part
used: Whole Plant / Aerial Parts |
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Traditional
uses : |
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Centella
asiatica has been used in the indigenous
system of medicine as a tonic in skin
diseases1. It is useful in
vitiated conditions of pitta, insomnia,
cardiac debility, epilepsy, hoarseness,
asthma, bronchitis, hiccough, amentia,
abdominal disorders, leprosy and fever.
The plant has also been used as cardio
tonic, nervine tonic, stomachic, carminative,
antileprotic, diuretic and febrifuge.
The leaves are useful in abdominal disorders
due to dysentery in children2-5. |
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C.asiatica
has been reported to contain triterpene
acids (like Asiatic and madecassic acid),
alkaloids (like hydrocotylin), glycosides
(like asiaticoside and centelloside),
mesoinositol, oligosaccharide, centellose,
kaempferol, quercetin etc. |
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Centella
asiatica has been reported to be effective
in the treatment of skin diseases9-12.
It also possess wound healing13,14,
antioxidant15,16, anti-inflammatory17,
memory enhancing18-19, antitumour20,
immunomodulatory, hepatoprotective,
antiprotozoal and antispasmodic activities21. |
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Skin
health, general tonic, anti-wrinkle
and wound healing.
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References: |
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| 1. |
Chopra RN et al., Glossary
of Indian Medicinal Plants. CSIR, New
Delhi. 1956: pp 58. |
| 2. |
Indian Medicinal Plants,
A Compendium of 500 species, Part II,
by Orient Longman Publications, |
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1994,p.52-55. |
| 3. |
Misra
B, Bhavaprakasha Nighantu, 5th edition,
Chowkambha Publications, 1969, p.462. |
| 4. |
Nadakarni, Indian Materia
Medica, 1993, Vol. 1, p. 662-666. |
| 5. |
Medicinal
Plants of India, Vol. 1, ICMR, p. 216-220. |
| 6. |
The wealth of India: A
dictionary of Indian raw materials and
industrial products-raw materials |
| |
series. Publications and information
Directorate, SIR, New Delhi, Revser,
1992, vol.3, 428-430. |
7. |
Physicians Desk Reference
for herbal drugs, Medical Economics Company
Montvale, New |
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Jersy,2000,pp.359-361.
|
8. |
Singh B and Rastogi RP,
A reinvestigation of the triterpenes of
Centella asiatica, Phytochemistry, |
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1969,8,917. |
| 9. |
Bonte F et al., Planta Med. 1994: 60:
pp 133-135. |
| 10. |
Martelli et al, “International
Journal of Cosmetic Science, 2000:22(3):
pp 201 -206. |
| 11. |
Young GL, et al, Cochrane
Database Syst Rev. 2000;(2): Cd000066. |
| 12. |
Ryu JS et al., Skin Research
and Technology. 2005: 11(3): pp 157-164. |
| 13. |
Tenni R et al, Ital J
Biochem,1988,37,2,69-77. |
| 14. |
maquart F X. 1999,Eur
J Dermatol,9,4,289-296. |
| 15. |
Rona C et al., J Cosmet
Dermatol. 2004 : 3(1): pp 26-34. |
| 16. |
Afaz F et al., Exp Dermatol.
2006:15(9): pp 678-84. |
| 17. |
Guo JS et al, Planta Med.
2004,70(12):1150-4. |
| 18. |
Nalini K et al,Fitoterapia,1992,63,232-237. |
| 19. |
Veerendra Kumar M.H and
Gupta Y.K ,Clin Exp Pharmacol Physiol,2003,30,5-6,336-342. |
| 20. |
Babu T.D. et al,J Ethnopharmacol,1995,48,1,53-57. |
| 21. |
Jamil S.S.et al,Natural
Product Radiance,2007, 6,2,158-170. |
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DOC
NO. |
: |
NR/QCD/SPC/020 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: CENTELLA ASIATICA EXTRACT (³10%
ASIATICOSIDE) |
| Plant
part |
: |
Leaves |
Fresh/Dry
|
: |
Dry |
|
| Sl. No. |
Tests |
Limits |
Protocol |
| 1. |
Description |
Light green to Green powder. |
| 2. |
Identification |
To
pass the test |
By
TLC |
| 3. |
Physico-chemical analysis |
<
10.0 |
As
per USP <921> Method II |
| Moisture (%w/w) |
| Acid insoluble Ash (%w/w) |
<
3.0 |
As
per USP<561> |
| 4. |
Particle
Size |
0.20
- 0.80 |
As
per USP <616> Method -
I |
| Bulk Density (g/cc) |
| Tapped bulk density (g/cc) |
0.25
- 0.95 |
| 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>
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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 |
|
|
As per
FIP Guidelines |
| E.coli
(1g) |
Absent |
| 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 |
|
As
per USP |
|
As per
ICH Guidelines |
| Methanol (ppm) |
<
3000 |
| Acetone (ppm) |
<
5000 |
| 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
10.0 |
By
HPLC |
| Asiaticoside
(%w/w) |
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 |
|
DOC
NO. |
: |
NR/QCD/SPC/158 |
| ISSUE
DATE |
: |
23-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: CENTELLA ASIATICA EXTRACT [³40%
TRITERPENES (ASIATICOSIDES)] |
| Plant
part |
: |
Leaves |
Fresh/Dry
|
: |
Dry |
|
| Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Light green to Green powder. |
| 2.
|
Identification |
To
pass the test |
By
TLC |
| 3.
|
Physico-chemical analysis |
<
10.0 |
As
per USP <921> Method II |
| Moisture (%w/w) |
| Acid insoluble Ash (%w/w) |
<
3.0 |
As
per USP<561> |
| 4.
|
Particle Size |
0.20
- 0.80 |
As
per USP <616> Method - I |
| Bulk Density (g/cc) |
| Tapped bulk density |
0.25
- 0.95 |
| 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
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) |
| Acetone (ppm) |
<
5000 |
| 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
40.0 |
By
HPLC |
| Total
triterpenese
(Sum of Asiaticoside, Madecassoside,
Asiatic acid and Madecassic acid)
(%w/w) |
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