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English
name: Thyme leaved gratiola |
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Family:
Scrophulariaceae |
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Part
used: Whole plant |
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Traditional
uses 1-3: |
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It
is astringent, bitter and cooling and is reported
to improve the intellect. It is used in the
treatment of asthma, hoarseness, insanity,
epilepsy and as a potent nerve tonic, cardiotonic
and diuretic. It has been reported to be an
anti-anxiety agent having adaptogenic effect.
The leaves are also useful as diuretic and
aperient. The juice of the leaves is given
to children for relief in bronchitis and diarrhoea. |
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Phytochemistry: |
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The major
bioactive constituents of Bacopa monnieri
are tetracyclic triterpenoid saponins, having
pseudojujubogenin and jujubogenin aglycones.
Among these, bacoside A (a crystalline mixture
of several saponins) is predominant. The individual
saponins reported from B. monnieri includes
bacoside A1, A2 and A3, bacopasaponins A,
B, C, D, E and F, and bacopaside I and II
alkaloids viz., herpestine and brahmine; flavonoids
viz., luteolin-7-glucoside, glucoronyl-7-apigenin
and glucoronyl-7-luteolin; common phytosterols
3-7. |
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Pharmacology: |
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Bacopa
monnieri has been proved to have memory
enhancing6-9,
sedative13,
antiepileptic11
activity. Bacopa monnieri is also reported
for its antispasmodic13
and anticancer11,12
activity. In addition it is evaluated for
its cardiotonic10,13,14
and hypotensive10
activity. |
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Marker
constituent: Bacoside A (mixture of
several saponins with bacoside A3 as one of
the components). |
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References: |
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1. |
Warrier PK, Nambiar VPK,
Raman Kutty C. (1993) Indian Medicinal Plants
a compendium of 500 |
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species, Orient
Longman Publications, Madras, India. 1, 209-213. |
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2. |
Nadkarni KM. (1993) Indian
Materia Medica, 1: 624-625. |
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3. |
Anonymous. (1998) The
Wealth of Asia, Council of Scientific and
Industrial Research. New Delhi, |
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India. |
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4. |
Chakravarty AK, Sarkar
T, Masuda K, Shiojima K, Nakane T, Kawahara
N. (2001) Phytochemistry, |
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58:553-556. |
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5. |
Anonymous. (1998)
Indian Herbal Pharmacopoeia, Joint Publication
of Indian Drug |
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Manufacturer’s Association,
Mumbai and Regional Research Laboratory, Jammu-Tawi.
1: 30-37. |
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6. |
Singh HK, Dhawan BN.
(1982) J. Ethnopharmacol. 5: 205-214. |
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7. |
Singh HK, Dhawan BN.
(1997) Indian J. Pharmacol. 29: S359-S365. |
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8. |
Dubey GP, Pathak SR,
Gupta BS. (1994) Pharmaco. Psycho.
Ecologic. 7(3): 249-251. |
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9. |
Sharma R, Chaturvedi
C, Tewari PV. (1987) Jour. Res.
Edu. Ind. Med. 3: 1-10. |
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10. |
Malhotra CL, Das PK.
(1959) Ind. Jour. Med. Res. 47(3):
294-305. |
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11. |
Elangovan V, Govindasamy
S. (1995) Fitoterapia. 66(3): 211-215. |
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12. |
Kumar EP, Elshurafa AA,
Elango K, Subburaju T, Suresh B. (1998) Ancient
Sci. Life. 17(3): 228- |
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234. |
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13. |
Aithal HN,
Sirsi M. (1961) Indian J. Pharm. 23(1):
2-5. |
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14. |
Dar A, Channa
S. (1997) Phytother. Res. 11: 323-325. |
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DOC
NO. |
: |
NR/QCD/SPC/092 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: BACOPA MONNIERI EXTRACT (³ 10%
TOTAL BACOSIDES) |
| Plant
part |
: |
Whole
plant / leaves |
| Fresh/Dry |
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Brown
to Yellowish 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) |
< 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 |
|
| 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 |
< 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 10.0 |
By HPLC / HPTLC |
| Total Bacosides (%w/w) |
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DOC
NO. |
: |
NR/QCD/SPC/008 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: BACOPA MONNIERI EXTRACT (³20%
TOTAL BACOSIDES) |
| Plant
part |
: |
Whole
plant / leaves |
| Fresh/Dry |
: |
Dry |
|
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Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Light
green to yellowish green 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) |
< 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 Pathogens |
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| 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 |
< 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 20.0 |
By HPTLC/ HPLC |
| Total Bacosides (%w/w) |
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DOC
NO. |
: |
NR/QCD/SPC/009 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
|
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: BACOPA MONNIERI EXTRACT (³40%
TOTAL BACOSIDES) |
| Plant
part |
: |
Whole
plant / leaves |
| Fresh/Dry |
: |
Dry |
|
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Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Light
green to Yellowish green powder. |
| 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 Pathogens |
|
| 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 |
< 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 40.0 |
By HPLC / HPTLC |
| Total Bacosides (%w/w) |
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