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English
name: Indian senna, Senna. |
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Family:
Caesalpinaceae. |
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Part
used: Pods, Stems and Leaves. |
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Traditional
uses :
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Besides
being used as an excellent laxative,
it is used as an expectorant, a wound
dressing, an antidysenteric, a carminative
agent, and for the treatment of gonorrhoea,
skin diseases, dyspepsia, fever, and
haemorrhoides1-2. |
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The
major bioactive constituents of C.angustifolia
are hydroxyanthracene glycosides viz,
sennoside A,B. The leaves also contain
several other hydroxy anthracene derivatives
viz, sennoside C and D, aloe emodin
dianthrone diglucosides, rhein-8-glucoside,
chrysophanol glucosides together with
free anthroquinones. Other constituents
of the leaves includes naphthalene glycoside
viz, tinnevellin glucoside, flavonoides.3,4,5. |
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Cassia
angustifolia has been reported to have
potent laxative6-8, antiviral9,
antimicrobial, antibacterial, antitumour,
antifungal and hypotensive activities5.
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Laxative
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References: |
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1. |
Youngken HW, Textbook of
pharmacognosy, 6th ed.1950, Philadelphia,
Blakiston. |
2. |
Leng-Peschow E, Journal
of pharmacy and pharmacology, 1986, 38,606-610. |
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Anonymous, British Herbal
Compendium, 1992, The British Herbal Medicine
Association |
| 3. |
(Bournemouth)
1,199-205. |
| 4. |
Lemli J, Fitoterapia, 1986,
57, 33-40. |
5. |
Billore K.V et al., Database
on medicinal plants used in Ayurveda,
Central council for Research in |
| 6. |
Ayurveda
and Siddha, New Delhi, 2004, pp376. |
| 7. |
Nakajima K et al, J.Pharm,
Pharmacol, 37,703-706. |
| 8. |
Mascolo N et al, J.Pharmacol,
1988, 40,882-884. |
| 9. |
Ogunti EO,Elujoba AA,Fitoterapia,1993,64,5,437-439. |
| 10. |
Sydiskis RJ et al, Antimicrob
Agents Chemother. 1991 Dec;35(12):2463-6.
|
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 |
DOC
NO. |
: |
NR/QCD/SPC/017 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: CASSIA
ANGUSTIFOLIA EXTRACT (³10%
SENNOSIDES) - CALCIUM SENNOSIDES |
| Plant
part |
: |
Leaves |
Fresh/Dry
|
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Greenish brown to Brown powder, soluble in water &
aqueous alcohol. |
| 2.
|
Identification
|
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method III |
| Loss
on drying (%w/w) |
| pH
of 10% w/v solution |
6.0 - 8.5 |
As per USP<791> |
| 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 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 10.0
|
By BP Method / Spectrophotometry |
| Hydroxyanthracene glycosides as; Sennosides B (%w/w). |
|
|
DOC
NO. |
: |
NR/QCD/SPC/095 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: CASSIA
ANGUSTIFOLIA EXTRACT (³
20%
SENNOSIDES) - CALCIUM SENNOSIDES |
| Plant
part |
: |
Leaves |
Fresh/Dry
|
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Greenish brown to brown powder, soluble in water &
aqueous alcohol. |
| 2.
|
Identification |
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method III |
| Loss
on drying (%w/w) |
| pH
of 10% w/v solution. |
6.0 - 8.5 |
As per USP<791> |
| 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) |
| 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 BP Method / Spectrophotometry |
| Hydroxyanthracene glycosides as; Sennosides B (%w/w). |
|
|
DOC
NO. |
: |
NR/QCD/SPC/108 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: CASSIA
ANGUSTIFOLIA EXTRACT (³
45%
SENNOSIDES) - CALCIUM SENNOSIDES |
| Plant
part |
: |
Leaves |
Fresh/Dry
|
: |
Dry |
|
|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Greenish brown to Dark brown powder |
| 2.
|
Identification |
To pass the test |
By T:C |
| 3.
|
Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method III |
| Loss
on drying (%w/w) |
| pH
of 10% w/v solution |
6.0 - 8.5 |
As per USP<791> |
| 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 |
< 0.1ppm |
| 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 45.0 |
By BP Method / Spectrophotometry |
| Hydroxyanthracene glycosides as; Sennosides B (%w/w). |
|
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