Andrographis
Paniculata Nees |
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English
name: King of Bitters, The Creat |
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Family:
Acanthaceae |
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Part
used: Leaves. |
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Traditional
uses 1,2: |
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The
herb is reported to possess astringent, anodyne,
tonic and alexipharmic properties and is helpful
in dysentery, cholera, diabetes, influenza,
bronchitis, piles, gonorrhoea, hepatomegaly,
skin disorders, fever and worm infestation.
The plant is bitter, acrid, cooling, laxative,
vulnerary, antiperiodic, anti-inflammatory,
expectorant, depurative, digestive and stomachic.
It is useful in burning sensation, wounds,
ulcers, chronic bronchitis, leprosy, pruritis,
flatulence, colic and diarrhoea |
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Phytochemistry:
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The major
bioactive chemical constituents of Andrographis
Paniculata are diterpene lactones. Among these,
major constituent is andrographolide and minor
constituents include neoandrographolide, 14-deoxy-11,12-didehydroandrographolide,
andrograpanin3 andrographiside
and many other closely related diterpenes4.
The leaves contain flavonoids viz., oroxylin,
wogonin, andrographidines5 A, B,
C, D, E, and F. |
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Pharmacology: |
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Andrographis
Paniculata has been evaluated for different
pharmacological activities. Andrographis paniculata
has been reported for its potent hepatoprotective6,7.
Andrographis paniculata has been reported
to have antisecretory8 (antidiarrhoeal),
immuno stimulant9, antimalarial10,
antifilarial11 activity. It is
also reported to have anti cancer12,
anti HIV13, anti-inflammatory14,
hypotensive15 action. In addition,
it has found to be effective in myocardial
infraction16. |
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Marker
constituents: |
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Andrographolide, 14-deoxy-11,
12-didehydroandrographolide, Andrograpanin and
Neoandrographolide.
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| Main use: Hepatoprotective. |
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References: |
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1. |
Anonymous. (1998) The
Wealth of Asia, Council of Scientific and Industrial
Research. New Delhi. |
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2. |
Warrier PK, Nambiar VPK,
Ramankutty C. (1993) Indian Medicinal Plants
a Compendium of 500 |
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species,
Orient Longman Ltd., Madras, India, 1: 135-138. |
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3. |
Fujita T, Fujitani R,
Takeda Y, Takaishi Y, et al.( 1984) Chem. Pharm.
Bull. 32: 2117-2125. |
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4. |
Matsuda T, Kuroyanagi
M, Sugiyama S, Umehara K, Ueno A, Nishi K. (1994)
Chem. Pharm. Bull. |
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42(6): 1216-1225. |
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5. |
Anonymous. (1998) Indian
Herbal Pharmacopoeia, Joint Publication of Indian
Drug Manufacturer’s |
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Association,
Mumbai and Regional Research Laboratory, Jammu-Tawi.
1: 18-29. |
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6. |
Visen PKS, Shukla B,
Patnaik GK, Dhawan BN. (1993) J. Ethnopharmacol.
40(2): 131-136. |
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7. |
Kapil A, Koul IB, Banerjee
SK, Gupta BD. (1993) Biochem. pharmacol. 46(1):
182-185. |
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Gupta S, Yadava JNS,
Tandon JS. (1993) Int. J. Pharmacog. 31(3),
198-204. |
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8. |
Puri A, Saxena R, Saxena
RP, Saxena KC, Srivastava V, Tandon JS. (1993)
J. Nat.Prod. 56(7): |
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995-999. |
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9. |
Misra P, Pal NL, Guru
PY, Katiyar JC, Srivastava V, Tandon JS. (1992)
Int. J. Pharmacog. 30(4): |
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263-274. |
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10. |
Dutta A, Sukul NC. (1982)
J. Helminthol. 56:81-84. |
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11. |
Umehara K, Tatefuji T,
Kuroyanagi M, Takagi R, Sugawa A, Ueno A, Taki
T. (1990) J. Phar.Bio-Dyn. |
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13(3): S51 |
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12. |
Yao XJ, Wainberg MA,
Parniak MA. (1992) Virology, 187: 56-62. |
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13. |
Madav S, Tripathi HC,
Tandan, Mishra SK. (1995) Indian J.Pharm. Sci.
57(3): 121-125. |
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14. |
Zang CY, Tan BK. (1996)
Clin. Exp. Pharmacol. Physiol. 23(8): 675-678. |
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15. |
Hua-yne Z, Wei-yi F.
(1991) Chin. Med. J. 104(9): 770-775. |
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DOC
NO. |
: |
NR/QCD/SPC/005 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: ANDROGRAPHIS PANICULATA EXTRACT
(³10%
ANDROGRAPHOLIDE) |
| Plant
part |
: |
Leaves |
| Fresh/Dry |
: |
Dry |
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Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Brownish
green to Brown powder with bitter
taste. |
| 2.
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Identification
|
To pass the test |
By TLC |
| 3.
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Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method II |
| Moisture
(%w/w) |
| Acid insoluble Ash (%w/w) |
< 7.0 |
| 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 (%w/w) |
> 99.0 |
As per USP <786> Particle Size distribution |
| 5.
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Heavy
metal analysis |
< 10 ppm |
AAS / ICP -ES |
| Lead |
| Arsenic |
< 2 ppm |
| Cadmium |
< 1 ppm |
| Mercury |
< 0.1 ppm |
| 6.
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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 |
< 5ppb
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As per USP Test for Aflatoxins
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| Aflatoxins
(B1 + B2
+ G1 + G2) |
| 9.
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Residual
solvent analysis |
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| As per ICH Guidelines |
| Methanol |
< 3000 ppm |
As per USP |
| 10.
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Pesticide
residue analysis |
To comply with USP |
As per AOAC / USP |
| As per USP & BP
Limits |
| Organochlorine
Pesticides |
| Organophosphorus
Pesticides |
| Synthetic
pyrethroids |
| 11.
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Phytochemical
analysis |
³ 10.0 |
By HPLC |
| Andrographolide (%w/w) |
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DOC
NO. |
: |
NR/QCD/SPC/006 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: ANDROGRAPHIS PANICULATA EXTRACT
(³20%
ANDROGRAPHOLIDE) |
| Plant
part |
: |
Whole
plant / Leaves |
| Fresh/Dry |
: |
Dry |
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Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Green
to Brownish green powder with
bitter taste. |
| 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) |
< 3.0 |
As per USP <561> |
| 4.
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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 (%w/w) |
> 99.0 |
As per USP <786> Particle Size distribution. |
| 5.
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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.
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Test
for Specific Pathogen |
Absent |
| As per FIP Guidelines |
| E.coli
(1g) |
| Salmonella
Sp.
(10g) |
Absent |
| S.aureus (1g) |
Absent |
| 8.
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Mycotoxin
analysis |
< 5 ppb
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As per USP Test for Aflatoxins
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| Aflatoxins
(B1 + B2
+ G1 + G2) |
| 9.
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Residual
solvent analysis |
< 3000 |
As per USP |
| As per ICH Guidelines |
| Methanol
(ppm) |
| 10.
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Pesticide
residue analysis |
To comply with USP |
As per AOAC / USP |
| As per USP & BP
Limits |
| Organochlorine
Pesticides |
| Organophosphorus
Pesticides |
| Synthetic
pyrethroids |
| 11.
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Phytochemical
analysis |
³ 20.0 |
By HPLC |
| Andrographolide (%w/w) |
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DOC
NO. |
: |
NR/QCD/SPC/007 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: ANDROGRAPHIS PANICULATA EXTRACT (³30%
ANDROGRAPHOLIDE) |
| Plant
part |
: |
Leaves |
| Fresh/Dry |
: |
Dry |
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Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Green
to Brownish green powder with
bitter taste. |
| 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) |
< 3.0 |
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 (%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) |
| Ethyl
acetate (%w/w) |
< 0.5 |
- |
| 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 30.0 |
By HPLC |
| Andrographolide (%w/w) |
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