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English
Name: Malabar nut |
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Family:Acanthaceae |
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Part
used: Root, leaf, flower, fruit. |
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Traditional
Uses: |
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The
leaves, flowers, fruits and roots are extensively
used for treating cold, cough, whooping cough,
chronic bronchitis and asthma. The leaves
are used as sedative, expectorant and antispasmodic.
It is used in diarrhea, dysentery and glandular
tumour scabies and other skin complaints.
The powder is reported to be used as poultice
on rheumatic joints, as counter-irritant on
inflammatory swellings, on fresh wounds, urticaria
and in neuralgia1-3. |
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Phytochemistry4,5:
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The major
bioactive chemical constituents of Adhatoda
vasica are the alkaloids like Vasicine, Vasicinone,
Vasicinol, Vasicol, Vasicinolone, Vasicinine
and adhatodine etc. |
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Pharmacology:
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Adhatoda
vasica has been reported to possess antitussive6,
antiasthmatic7, hepatoprotective8,
anticlatogenic/antimutagenic9,
anti-tubercular10, anti-inflammatory11,
uterotonic abortifacient12, anti-implantation13
and antioxidant activities9.
It has also been reported to possess protective
effect on respiratory infections14. |
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Indications:
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Cough suppressant, Bronchodilator. |
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References: |
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1. |
Kokate,C.K.et al.,Pharmacognosy,Nirali
Prakashan,1996,pp-631. |
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2. |
Sharma P.C et al., Database
on medicinal plants used in Ayurveda, Central
council for Research in |
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Ayurveda
and Siddha, New Delhi, 2000, pp496. |
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3. |
Wealth of Asia, CD- ROM,
1998, NISCOM publication. |
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4. |
Bhatt V.S. ,et al, “Adhatoda
vasica Nees – An Ayurvedic Medicinal Plant”,
Indian |
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Drugs,1978:15(4):
62-65. |
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5. |
Dr.Rajpal, Standardization
of Botanicals, vol-2, Eastern publishers, New
Delhi, 2005, 1. |
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6. |
Dhuley
JN., “Antitussive effect of Adhatoda
vasica extract on mechanical or chemical |
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stimulation-induced
coughing in animals.” J Ethnopharmacol.
1999:30; 67(3):361-5. |
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7. |
Dorsch
W, et al, “New antiasthmatic drugs from
traditional medicine?” Int Arch Allergy
Appl |
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Immunol.
1991:94(1-4):262-5. |
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8. |
Bhattacharyya D, et al,
“Hepatoprotective activity of Adhatoda
vasica aqueous leaf extract on |
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D-galactosamine-induced
liver damage in rats.” Fitoterapia. 2005:76(2):223-5. |
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9. |
Jahangir
T, et al, “Reversal of cadmium chloride-induced
oxidative stress and genotoxicity by |
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Adhatoda
vasica extract in Swiss albino mice.”
Biol Trace Elem Res. 2006:111(1-3):217-28. |
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10. |
Grange JM, et al, “Activity
of bromhexine and ambroxol, semi-synthetic derivatives
of vasicine |
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from the
Indian shrub Adhatoda vasica, against Mycobacterium
tuberculosis in vitro. J |
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Ethnopharmacol.
1996 :50(1):49-53. |
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11. |
Chakraborty A, et al,
“Study of alkaloids from Adhatoda vasica
Nees on their anti-inflammatory |
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activity.”
Phytother Res. 2001:15(6):532-4. |
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12. |
Gupta OP, et al, “Vasicine,
alkaloid of Adhatoda vasica, a promising uterotonic
abortifacient.” |
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Indian J
Exp Biol. 1978:16(10):1075-7. |
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13. |
Prakash AO, et al, “Anti-implantation
activity of some indigenous plants in rats.”
Acta Eur Fertil. |
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1985 :16(6):441-8. |
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14. |
Narimanian M, et al,
“Randomized trial of a fixed combination
(KanJang) of herbal extracts |
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containing
Adhatoda vasica, Echinacea purpurea and Eleutherococcus
senticosus in patients with |
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upper respiratory
tract infections.” Phytomedicine. 2005:12(8):539-47 |
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DOC
NO. |
: |
NR/QCD/SPC/002 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: ADHATODA VASICA EXTRACT (³ 1%
VASICINE) |
| Plant
part |
: |
Leaves |
| Fresh/Dry |
: |
Dry |
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Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Light greenish brown to Dark
brown powder |
| 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) |
| Ash
content (%w/w) |
< 30.0 |
As per USP<561> |
| Acid
insoluble Ash (%w/w) |
<
3.0 |
| Total soluble solids (%w/w) |
> 90.0 |
| pH of 5% w/v solution. |
4.5 – 7.5 |
As per USP<791> |
| 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.
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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>
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| As per FIP Guidelines
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| 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 |
As per USP Test for Aflatoxins |
| Aflatoxins
(B1 + B2
+ G1 + G2) |
| 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 |
³ 1.0 |
By HPLC |
| Vasicine (%w/w). |
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DOC
NO. |
: |
NR/QCD/SPC/001 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: ADHATODA VASICA EXTRACT (³ 2.5%
VASICINE) |
| Plant
part |
: |
Leaves |
| Fresh/Dry |
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Dry |
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Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Green
to Greenish brown powder. |
| 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) |
< 30.0 |
As per USP<561> |
| Acid
insoluble Ash (%w/w) |
< 2.0 |
| 4.
|
Particle Size |
0.20 – 0.80 |
As per USP <616> Method –
I |
| Bulk
density (g/cc) |
| Tapped
bulk density (g/cc) |
0.20 – 0.90 |
| 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
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| 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.
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Mycotoxin
analysis |
< 5 ppb |
As per USP Test for Aflatoxins |
| Aflatoxins
(B1 + B2
+ G1 + G2) |
| 9.
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Residual
solvent analysis |
< 3000 ppm |
As per USP |
| As per ICH Guidelines |
| Methanol |
| 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 2.5 |
By HPLC |
| Vasicine (%w/w). |
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