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English
Name: Wild asparagus |
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Family: liliaceae |
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Part
used: Tuberous roots. |
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Traditional
Uses: |
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Asparagus
racemosus (Shatavari) is recommended
in Ayurvedic texts for prevention
and treatment of gastric ulcers,
dyspepsia and as a galactogogue.
A. racemosus has also been used
successfully by some Ayurvedic practitioners
for nervous disorders, inflammation,
liver diseases and infectious diseases1.
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Phytochemistry:
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A.
racemosus contains Steroidal saponins,
known as shatavarins I-IV. It also
contains polycyclic alkaloid, asparagamine
A and disaccharide2. |
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Pharmacology: |
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Asparagus
has been reported to possess immunomodulatory3-4,
anti-inflammatory5, Anti-diabetic6,
anti-oxidant7 and anti-microbial
activities8-9. It has
also been reported as one of the
most powerful galactogogue10-13. |
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Indication: General
tonic, Immune health. |
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References: |
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1. |
Goyal RK, Singh
J, Lal H. Asparagus racemosus--an
update. Indian J Med Sci 2003;57(9):408-414 |
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2. |
Sharma P.C
et al, Database on medicinal plants
used in Ayurveda.vol-1, Central council
for research |
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in
ayurveda & siddha, New Delhi,
2000, pp-420. |
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3. |
Thatte, U.,
Chhabria, S., Karandikar, S.M. and
Dahanukar, S. 1987. hnmunotherapeutic
modification |
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of
Escherichia coli induced abdominal
sepsis and mortality in mice by Indian
medicinal plants. Indian |
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Drugs
25: 95-96. |
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4. |
Rege, N.N.,
Nazareth, H.M., Isaac, A., Karandikar,
S.M. and Dahanukar, S.A. 1989. |
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Immunotherapeutic
modulation of intraperitoneal adhesion
by Asparagus racemosus. J Postgrad
Med |
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35,
199-203. |
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5. |
MandaI, S.C.,
Mukherjee, P.K., Nandy, A., Pal, M.
and Saba, B.P. 1996a. Some pharmacognostical
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characteristi
of Asparagus racemosus Willd. roots.
Ancient Sci Life 15: 282. |
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6. |
Kar, A Choudhary,
B.K. and Bandyopadhyay, N.G. 1999.
Preliminary studies on the inorganic
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constituents
of some indigenous hypoglycaemic herbs
on oral glucose tolerance test. J
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Ethnopharutacol
64: 179-184. |
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7. |
Wiboonpun N,
Phuwapraisirisan P, Tip-pyang S. Identification
of antioxidant compound from |
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Asparagus
racemosus. Phytother Res 2004;18(9):771-773. |
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8. |
Singh, L. and
Shanna, M. 1978. Antifungal properties
of some plant extracts. Geobios 5:
49-53. |
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9. |
Ahmad, N.,
Mehmood, Z. and Mohammad, F. 1998.
Screening of some Indian medicinal
plants for |
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their
antimicrobial properties. J Ethnopharmacol,
62: 183-19. |
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10. |
Nadkarni AK.
Indian Materia Medica. Bombay: Popular
Book Depot; 1954. Vol I. pp.153-5. |
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11. |
Joglekar
et al., Indian Med J. 1967: 61(7):
pp 165. |
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12. |
Sabins PB et
al., Indian J Exp Biol. 1968: 6: pp
55-57. |
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13. |
Meites J. Proceedings
of the first international pharmacology
meeting. London: Pergamon |
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Press.1962:
Vol I: pp 151. |
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DOC
NO. |
: |
NR/QCD/SPC/100 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: ASPARAGUS RACEMOSUS
EXTRACT (³1.5%
SHATAVARIN) |
| Plant
part |
: |
Roots |
| Fresh/Dry |
: |
Dry |
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Sl. No. |
Tests |
Limits |
Protocol |
| 1. |
Description |
Light
brown to Brown hygroscopic
powder |
| 2.
|
Identification |
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 7.0 |
As per USP <921> Method II |
| Moisture
(%w/w) |
| Acid
insoluble Ash (%w/w) |
< 9.0 |
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 - 0.90 |
| 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> |
| 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) |
| 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 1.5 |
By HPTLC |
| Shatavarin (%w/w) |
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DOC
NO. |
: |
NR/QCD/SPC/083 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: ASPARAGUS RACEMOSUS
EXTRACT (³4.0%
SHATAVARIN) |
| Plant
part |
: |
Roots |
| Fresh/Dry |
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1. |
Description |
Light
brown to Brown powder |
| 2. |
Identification |
To pass the test |
By TLC |
| 3. |
Physico-chemical
analysis |
< 7.0 |
As per USP <921> Method II |
| Moisture
(%w/w) |
| Acid
insoluble Ash (%w/w) |
< 9.0 |
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 - 0.90 |
| 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> |
| 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) |
| 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 4.0 |
By HPTLC |
| Shatavarin (%w/w) |
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