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English
name: Coleus |
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Family:
Labiatae |
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Part
used: Roots |
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Traditional
uses 1
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The
leaves are used in the treatment of
stomach ailments, people chew fresh
roots to relieve abdominal pains. They
are reported to kill intestinal worms.
A few drops of roots extract mixed with
milk is given to infants as a remedy
against abdominal pains and constipation. |
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The
major bioactive constituent of Coleus
forskohlii is forskolin, a diterpene2. Other diterpenes
of the roots include deacetylforskolin1,9-dideoxy forskolin 1,9-dideoxy-7-deacetylforskolin,
coleol etc.3,4 The roots
contain volatile oil comprising of b-thujene,
b and b-pinenes,
camphene, myrcene, 3-nonanone, p-cymene
, b-phellandrene,
3-decanone, b-copaene,
bornyl acetate, humulene, b-cis-bergamotene,
b-curcumene,
b-curcumene,
b-bisabolene,
b-elemene,
b-selinene,cuparene
and b and b- ionones.5 |
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Coleus
forskohlii has been reported for
its effect on intra-ocular pressure6-8 and hypotensive9,10. Coleus
forskohlii has also been reported to
have antianaphylactic11, amoebicidal12, antiplatelet13,14, gastroprotective15, bronchodilating16 and anti
cancer17 activity.
It also prevents hair graying18.
Forskolin is used as a research tool
assessing the adenylate cyclase &
cyclic AMP in cellular physiology19. |
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Forskolin
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Main use: Cardiotonic. |
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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. |
Tandon JS, Dhar MM. (1977)
Indian J. Chem. 15B: 880-883. |
| 3. |
Gabetta
B, Zini G, Danieli B. (1989) Phytochemistry,
28(3): 859-862 |
| 4. |
Akhila A, Rani K, Thakur
RS. (1990) Phytochemistry. 29(3): 821-824.
|
| 5. |
Rastogi
RP, Mehrotra BN. (1995) Compendium of
Indian Medicinal Plant. CDRI (Lucknow).
4: 211. |
| 6. |
Meyer BH, Stulting AA,
Muller FO. (1987) S. Afr. Med. J. 71(9):
570-571. |
| 7. |
Nakagawa K et al, J Agric Food Chem,
1999, 47, 10, 3967-73. |
| 8. |
Agarwal RHC, Sood NN,
Gupta SK. (1993) Afro-Asian J. Opthalmol.
12(3): 349-353. |
| 9. |
Caprioli J, Sears M, Bausher
L, Gregory D, Mead A. (1984) Invest. Opthalmol.
Vis. Sci. 25(3): 268-277. |
| 10 |
Baumann G, Felix S, Sattelberger U,
Klein G. (1990) J. Cardiovasc. Pharmacol.
16(1): 93-100. |
| 11. |
Dubey
MP, Srimal RC, Nityanand S, Dhawan BN.
(1981) J. Ethnopharmacol. (3): 1-13. |
| 12 |
Gupta PP, Srimal RC, Tandon
JS. (1993) Int. J. of Pharmacog. 31(1):
15-18. |
| 13. |
Varma N, Srivastava V,
Tandon JS, Krishna BN, Chitravanshi VC.
(1990) Int. J. of Crude Drug Res. |
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28 (1): 1-3.
|
| 14. |
1 Agarwal KC, Zielinsk
BA, Maitra RS. (1989) Thromb. Haemost.
61(1): 106-110. |
| 15. |
Christenson JT, Thulesius
O, Nazzal MM. (1995) Vasa. 24(1): 56-61. |
| 16. |
Chang J, Hand JM, Schwalm
S, Dervinis A, Lewis AJ. (1984) Eur. J.
Pharmacol. 101: 271-274. |
| 17. |
Agarwal KC, Parks RE Jr.
(1983) Int. J. Cancer, 32(6): 801-804. |
| 18. |
Keikichi S, Koji T, Akira
F. (1988) Eur. Pat. Appl. EP. 295, 903. |
| 19.
|
Valdes III LJ, Mislankar
SG, Paul AG. (1987) Econ. Bot. 41(4):
474-483. |
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DOC
NO. |
: |
NR/QCD/SPC/021 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: COLEUS
FORSKOHLII EXTRACT (³10%
FORSKOLIN) |
| Plant
part |
: |
Roots |
Fresh/Dry
|
: |
Dry |
|
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Dark
reddish brown to 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) |
| Acid
insoluble Ash (%w/w) |
< 5.0 |
As per USP<561> |
| 4.
|
Particle
Size |
0.20 - 0.60 |
As per USP <616> Method -
I |
| Bulk
density (g/cc) |
| Tapped bulk density (g/cc) |
0.20 - 0.80 |
| Material passing through 30# BS/35 ASTM |
> 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 |
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|
| As per ICH Guidelines |
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|
| Methanol
(ppm) |
< 3000 |
As per USP |
| 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 10.0 |
By HPLC |
| Forskolin
(%w/w) |
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|
DOC
NO. |
: |
NR/QCD/SPC/023 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: COLEUS
FORSKOHLII EXTRACT (³20%
FORSKOLIN) |
| Plant
part |
: |
Roots |
Fresh/Dry
|
: |
Dry |
|
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Dark reddish brown to 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) |
| Acid
insoluble Ash (%w/w) |
< 2.0 |
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 - 0.90 |
| Material passing through 30# BS/35 ASTM |
> 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 20.0 |
By HPLC / HPTLC |
| Forskolin
(%w/w) |
|
|
DOC
NO. |
: |
NR/QCD/SPC/160 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: COLEUS
FORSKOHLII EXTRACT (³40%
FORSKOLIN) |
| Plant
part |
: |
Roots |
Fresh/Dry
|
: |
Dry |
|
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Dark reddish brown to 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) |
| Acid
insoluble Ash (%w/w) |
< 2.0 |
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 - 0.90 |
| Material passing through 30# BS/35 ASTM |
> 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 40.0 |
By HPLC / HPTLC |
| Forskolin
(%w/w) |
| Note:
Super critical fluid (SCF) extracts
available on request |
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