Title: Composition for treating gastric ulcer and a process for preparing the same
Abstract: The present invention relates to a novel synergistic herbal composition for the treatment of gastric ulcer, a method for preparing said synergistic herbal composition and a process for the treatment of gastric ulcer using said composition and more particularly, the present invention relates to a novel synergistic herbal composition which is effective against pyloric ligation induced ulcer model and histamine induced ulcer model.
Patent Number: 6,855,347 Issued on 02/15/2005 to Rao, et al.
| Inventors:
|
Rao; Janaswamy Madhusudana (Hyderabad, IN);
Sampathkumar; Upparapalli (Hyderabad, IN);
Sastry; Boggavarapu Subrahmanya (Hyderabad, IN);
Yadav; Jhillu Singh (Hyderabad, IN);
Raghavan; Kondapuram Vijaya (Hyderabad, IN);
Palit; Gautam (Lucknow, IN);
Rai; Deepak (Lucknow, IN);
Varier; Panniyampally Madhavankutty (Kerala, IN);
Muraleedharan; Trikovil Sankaran (Kerala, IN);
Muraleedharan; Kollath (Kerala, IN)
|
| Assignee:
|
Council of Scientific and Industrial Research (New Delhi, IN)
|
| Appl. No.:
|
103738 |
| Filed:
|
March 25, 2002 |
| Current U.S. Class: |
424/734; 424/725; 424/756; 424/761; 424/763; 424/765; 424/766; 424/769; 424/773; 424/774; 424/775; 424/776; 424/777; 424/778; 424/779; 514/925; 514/926; 514/927 |
| Intern'l Class: |
A61K 035//78; A01N 065//00 |
| Field of Search: |
424/725,734,756,761,763,765,766,769,773-779
514/925-927
|
References Cited [Referenced By]
U.S. Patent Documents
| 2003/0185913 | Oct., 2003 | Pushpangadan et al. | 424/739.
|
| Foreign Patent Documents |
| 174417 | Mar., 1994 | IN.
| |
Primary Examiner: Pak; John
Attorney, Agent or Firm: Piper Rudnick LLP, Kelber; Steven B.
Claims
What is claimed is:
1. A composition comprising an extract obtained from the plant parts of
Aegle marmelos and Withania somnifra and from the plant parts of at least
one member selected from the group consisting of Blechnum orientate, Vitis
vinifera, Feronia elephantum, Punica granatum, Zingiber officinale, Piper
nigrum, Piper longum and Azadirachta indica and optionally with one or
more pharmaceutically acceptable additive(s) or carrier(s) wherein the
composition comprises:
4-10% by wt. of an extract from Aegle marmelos and 4-11% by wt. of an
extract from Withania somnifra and further comprises at least one of 5-8%
by wt. of an extract from Blechnum orientale, 5-11% by wt. of an extract
from Vitis vinifera, 5-9% by wt. of an extract from Feronia elephantum,
8-11% by wt. of an extract from Punica granatum, 4-9% by wt. of an extract
from Zingiber officinale, 2-11% by wt. of an extract from Piper nigrum,
8-12% by wt. of an extract from Piper longum and 2-11% by wt. of an
extract from Azadirachta indica and optionally with one or more
pharmaceutically acceptable additive(s) or carrier(s).
2. A composition as claimed in claim 1, wherein the extract is an aqueous
extract.
3. A composition as claimed in claim 1, wherein the plant part of Aegle
marmelos, Withania somnifra and Blechnum orintale is a root.
4. A composition as claimed in claim 1, wherein the plant part of Vitis
vinifera, Feronia elephantum, Piper nigrum and Piper longum is a fruit.
5. A composition as claimed in claim 1, wherein the plant part of Punica
grantum is a fruit rind.
6. A composition as claimed in claim 1, wherein the plant part of Ziniber
officnale is a rhizome.
7. A composition as claimed in claim 1, wherein the plant part of
Azadirachta indica is a bark.
8. A process for the preparation of a composition, said process comprising:
obtaining an extract from the plant parts of Aegle marmelos and Withania
somnifra and from the plant parts of at least one member selected from the
group consisting of Blechnum orientale, Vitis vinifera, Feronia
elephantum, Punica granatum, Zingiber officinale, Piper nigrum, Piper
longum and Azadirachta indica and, optionally
mixing the extract(s) with one or more pharmaceutically acceptable
additive(s) or carrier(s) combining:
4-10% by wt. of an extract from Aegle marmelos and 4-11% by wt. of an
extract from Withania somnifra and mixing said extracts with at least one
of 5-8% by wt. of an extract from Blechnum orientale, 5-11% by wt. of an
extract from Vitis vinifera, 5-9% by wt. of an extract from Feronia
elephantum, 8-11% by wt. of an extract from Punica granatum, 4-9% by wt.
of an extract from Zingiber officinale, 2-11% by wt. of an extract from
Piper nigrum, 8-12% by wt. of an extract from Piper longum and 2-11% by
wt. of an extract from Azadirachta indica and optionally mixing the
extract(s) with one or more pharmaceutically acceptable additive(s) or
carrier(s).
9. A process as claimed in claim 8, wherein the extract is an aqueous
extract.
10. A process as claimed in claim 8, wherein the plant part of Aegle
marmelos, Withania somnifra and Blechnum orintale is a root.
11. A process as claimed in claim 8, wherein the plant part of Vitis
vinifera, Feronia elephantum, Piper nigrum and Piper longum is a fruit.
12. A process as claimed in claim 8, wherein the plant part of Punica
grantum is a fruit rind.
13. A process as claimed in claim 8, wherein the plant part of Ziniber
officnale is a rhizome.
14. A process as claimed claim 8, in the plant part of Azadirachta indica
is a bark.
15. A composition for the treatment of gastric ulcer, said composition
comprising an extract obtained from the plant parts of Aegle marmelos and
Withania somnifra and from the plant parts of at least one member selected
from the group consisting of Blechnum orientale, Vitis vinifera, Feronia
elephantum, Punica granatum, Zingiber officinale, Piper nigrum, Piper
longum and Azadirachta indica and optionally with one or more
pharmaceutically acceptable additive(s) or carrier(s) wherein the
composition comprises:
4-10% by wt. of an extract from Aegle marmelos and 4-11% by wt. of an
extract from Withania somnifra and further comprises at least one of an
extract from Blechnum orientale, an extract from Vitis vinifera, an
extract from Feronia elephantum, an extract from Punica granatum, an
extract from Zingiber officinale, an extract from Piper nigrum, an extract
from Piper longum and an extract from Azadirachta indica and optionally
with one or more pharmaceutically acceptable additive(s) or carrier(s).
Description
FIELD OF THE INVENTION
The present invention relates to a novel synergistic herbal composition for
the treatment of gastric ulcer. More particularly, the present invention
relates to a novel synergistic herbal composition which is effective
against pyloric ligation induced ulcer model and histamine induced ulcer
model. The present invention also relates to a method for the preparation
of the composition. The present invention further relates to a process for
the treatment of gastric ulcer using the composition.
BACKGROUND OF THE TECHNOLOGY
Various theories have been proposed with respect to a cause of ulcer in
human. In particular, it has been elucidated that stress, taking of
non-steroidal anti-inflammatory drugs for curing rheumatic diseases, and
the like are closely related to ulcer formation, mainly due to relatively
excess gastric or duodenal acid secretion. Accordingly it is important to
suppress the acid secretion in order to prevent ulcer formation and to
cure it.
On the other hand it has been considered that Helicobacter pylori, which is
a rod normally existing in stomach, generates ammonia due to its strong
urease activity, thereby inducing ulcer. Since it persistently lives
within mucus and mucosa, it becomes the greatest cause for recurrence of
ulcer. Accordingly, it has been considered that the recurrence of ulcer
can be prevented if this bacterium is sterilized.
A reference may be made to K. M. Nadkarni in Indian Materia Medica (1976)
Vol. 1, p1287, published by Popular Prakashan Pvt. Ltd., Mumbai and K. R.
Kirtikar in Indian Medicinal Plants (1975) Vol. 1, p 608 published by
Bishen Singh Mahendrapal Singh, Dehradun for the medicinal properties of
Blechnum orintale.
A reference may be made to P. K. Warrier in Indian Medicinal Plants--A
compendium of 500 species (1994-1996) Vol. 5, p 396, and The Wealth of
India (1950-1980), Vol.10 p. 556 published by Council of Scientific and
Industrial Research for the various medicinal properties of Vitis
vinifera.
A reference may be made to K. Narayana Iyer and M. Kolammal in
Pharmacognosy of Ayurvedic Drugs (1963) Vol.2, p. 80, published by
Department of Pharmacognosy, University of Kerala, Trivandrum and The
Wealth of India (1950-1980) Vol. 1, p. 34, published by Council of
Scientific and Industrial Research for the various medicinal properties of
Aegle marmelos.
A reference may be made to K. M. Nadkarni in Indian Materia Medica (1976)
Vol. 1, p. 1239-94, published by Popular Prakashan Pvt. Ltd., Mumbai; K.
R. Kirtikar in Indian Medicinal Plants (1975) Vol. 2, p 1776 published by
Bishen Singh Mahendrapal Singh, Dehradun; P. K. Warrier in Indian
Medicinal Plants--A compendium of 500 species (1994-1996) Vol. 5, p 409;
K. Narayana Iyer and M. Kolammal in Pharmacognosy of Ayurvedic Drugs
(1963) Vol.8, p. 34, published by Department of Pharmacognosy, University
of Kerala, Trivandrum, The Wealth of India (1950-1980) Vol. 10, p. 585,
published by Council of Scientific and Industrial Research and S. S. Handa
in Indian Herbal Pharmacopoeia (1998), Vol. 1, p.171, published by
Regional Research Laboratory, Jammu and IDMA, Mumbai for the various
medicinal properties of Withania somnifra.
A reference may be made to K. M. Nadkarni in Indian Materia Medica (1976)
Vol. 1, p 536, published by Popular Prakashan Pvt. Ltd., Mumbai; K. R.
Kirtikar in Indian Medicinal Plants (1975) Vol. 1, p 997 published by
Bishen Singh Mahendrapal Singh, Dehradun; P. K. Warrier in Indian
Medicinal Plants--A compendium of 500 species (1994-1996) Vol. 3, p.
327-29, and The Wealth of India (1950-1980) Vol. 4, p. 19, published by
Council of Scientific and Industrial Research of the various medicinal
properties of Feronia elephantum.
A reference may be made to K. M. Nadkarni in Indian Materia Medica (1976)
Vol. 1, p1031, published by Popular Prakashan Pvt. Ltd., Mumbai; P. K.
Warrier in Indian Medicinal Plants--A compendium of 500 species
(1994-1996) Vol. 4, p 396, and in Illustrated manual of herbal drugs used
in Ayurveda (1996) by Y. K. Sarin p.218 for the various medicinal
properties of Punica grantum.
A reference may be made to K. M. Nadkarni in Indian Materia Medica (1976)
Vol. 1, p1309, published by Popular Prakashan Pvt. Ltd., Mumbai; K. R.
Kirtikar in Indian Medicinal Plants (1975) Vol. 4, p 2436 published by
Bishen Singh Mahendrapal Singh, Dehradun; P. K. Warrier in Indian
Medicinal Plants--A compendium of 500 species (1994-1996) Vol. 5, p. 431,
published by orient Longman, Chennai, and The Ayurvedic Pharmacopoeia of
India (1986), Vol. 1, p. 104, published by Ministry of Health and Family
Welfare, India for the various medicinal properties of Ziniber officnale.
A reference may be made to K. M. Nadkarni in Indian Materia Medica (1976)
Vol. 1, p. 478, published by Popular Prakashan Pvt. Ltd., Mumbai; P. K.
Warrier in Indian Medicinal Plants--A compendium of 500 species
(1994-1996) Vol. 2, p. 368, published by orient Longman, Chennai;
Medicinal plants of India (1987) by G. V. Satyavati Vol. 2 p.429 published
by Indian Council of Medical Research; The Wealth of India (1950-1980)
Vol. 8, p. 98, published by Council of Scientific and Industrial Research,
and Y. K. Sarin in Illustrated manual of herbal drugs used in Ayurveda
(1996), p. 268 for the various medicinal properties of Piper nigrum.
A reference may be made to K. M. Nadkarni in Indian Materia Medica (1976)
Vol. 1, p. 966, published by Popular Prakashan Pvt. Ltd., Mumbai; P. K.
Warrier in Indian Medicinal Plants--A compendium of 500 species
(1994-1996) Vol. 4, p. 290, published by orient Longman, Chennai; K.
Narayana Iyer and M. Kolammal in Pharmacognosy of Ayurvedic Drugs (1963)
Vol.9, p. 49, published by Department of Pharmacognosy, University of
Kerala, Trivandrum, and The Wealth of India (1950-1980) Vol. 8, p. 98,
published by Council of Scientific and Industrial Research for the various
medicinal properties of Piper longum.
A reference may be made to K. R. Kirtikar in Indian Medicinal Plants (1975)
Vol. 1, p536-540 published by Bishen Singh Mahendrapal Singh, Dehradun; P.
K. Warrier in Indian Medicinal Plants--A compendium of 500 species
(1994-1996) Vol. 1, p. 203-5, published by orient Longman, and K. Narayana
Iyer and M. Kolammal in Pharmacognosy of Ayurvedic Drugs (1963) Vol.3, p.
23, published by Department of Pharmacognosy, University of Kerala,
Trivandrum for the various medicinal properties of Azadirachta indica.
The composition of the present invention should not be treated as an
obvious one as none of the citations are able to provide all the
advantages of the present invention. .
Objects of the Invention
The main object of the present invention is to provide a novel synergistic
herbal composition for the treatment of gastric ulcer.
Yet another object of the present invention is to provide a process for the
preparation of the composition.
Still another object of the present invention is to provide a method for
the treatment of gastric ulcer using the composition.
SUMMARY OF THE INVENTION
The present invention provides a novel synergistic herbal composition for
the treatment of gastric ulcer. More particularly, the present invention
relates to a novel synergistic herbal composition which is effective
against pyloric ligation induced ulcer model and histamine induced ulcer
model. Also, the present invention provides a process for the preparation
of the composition. The present invention further provides a method for
the treatment of gastric ulcer using said composition.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
In accordance with the first object of the present invention, there is
provided a novel synergistic herbal composition for the treatment of
gastric ulcer, said composition comprises an extract essentially obtained
from one or more parts of Aegle marmelos and Withania somnifra and
optionally from one or more parts of Blechnum orintale, Vitis vinifera,
Feronia elephantum, Punica grantum, Ziniber officnale, Piper nigrum, Piper
longum and Azadirachta indica along with one or more pharmaceutically
acceptable additives/carriers.
More particularly, the present invention provides a novel synergistic
herbal composition for the treatment of gastric ulcer, said composition
essentially comprises 4-10% by wt. of an extract from Aegle marmelos and
4-11% by wt. of an extract from Withania somnifra and optionally comprises
5-8% by wt. of an extract from Blechnum orintale, 5-11% by wt. of an
extract from Vitis vinifera, 5-9% by wt. of an extract from Feronia
elephantum, 8-11% by wt. of an extract from Punica grantum, 4-9% by wt. of
an extract from Ziniber officnale, 2-11% by wt. of an extract from Piper
nigrum, 8-12% by wt. of an extract from Piper longum and 2-11% by wt. of
an extract from Azadirachta indica along with one or more pharmaceutically
acceptable additives/carriers.
In an embodiment of the present invention, the extract is an aqueous
extract.
In another embodiment of the present invention, the plant part of Aegle
marmelos, Withania somnifra and Blechnum orintale is root.
In still another embodiment of the present invention, the plant part of
Vitis vinifera, Feronia elephantum, Piper nigrum and Piper longum is
fruit.
In yet another embodiment of the present invention, the plant part of
Punica grantum is fruit rind.
In one more embodiment of the present invention, the plant part of Ziniber
officnale is rhizome.
In one another embodiment of the present invention, the plant part of
Azadirachta indica is bark.
In accordance with the second object of the present invention, there is
provided a process for the preparation of the novel synergistic herbal
composition for the treatment of gastric ulcer, said process comprising
obtaining an extract essentially from one or more parts of Aegle marmelos
and Withania somnifra and optionally from one or more parts of Blechnum
orintale, Vitis vinifera, Feronia elephantum, Punica grantum, Ziniber
officnale, Piper nigrum, Piper longum and Azadirachta indica and mixing
them with one or more pharmaceutically acceptable additives/carriers.
In an embodiment of the present invention, said process extract is obtained
by grinding 4-10% by wt. of an extract from Aegle marmelos and 4-11% by
wt. of an extract from Withania somnifra and optionally 5-8% by wt. of an
extract from Blechnum orintale, 5-11% by wt. of an extract from Vitis
vinifera, 5-9% by wt. of an extract from Feronia elephantum, 8-11% by wt.
of an extract from Punica grantum, 4-9% by wt. of an extract from Ziniber
officnale, 2-11% by wt. of an extract from Piper nigrum, 8-12% by wt. of
an extract from Piper longum and 2-11% by wt. of an extract from
Azadirachta indica to a fine paste and mixing them with one or more
pharmaceutically acceptable additives/carriers.
In another embodiment of the present invention, the extract is an aqueous
extract.
In still another embodiment of the present invention, the plant part of
Aegle marmelos, Withania somnifra and Blechnum orintale is root.
In yet another embodiment of the present invention, the plant part of Vitis
vinifera, Feronia elephantum, Piper nigrum and Piper longum is fruit.
In one more embodiment of the present invention, the plant part of Punica
grantum is fruit rind.
In one another embodiment of the present invention, the plant part of
Ziniber officnale is rhizome.
In an embodiment of the present invention, the plant part of Azadirachta
indica is bark.
In accordance with the third object of the present invention, there is
provided a method of treating gastric ulcer in a subject, said method
comprises administering an effective amount of the synergistic herbal
composition essentially comprises 4-10% by wt. of an extract from Aegle
marmelos and 4-11% by wt. of an extract from Withania somnifra and
optionally comprises 5-8% by wt. of an extract from Blechnum orintale,
5-11% by wt. of an extract from Vitis vinifera, 5-9% by wt. of an extract
from Feronia elephantum, 8-11% by wt. of an extract from Punica grantum,
4-9% by wt. of an extract from Ziniber officnale, 2-11% by wt. of an
extract from Piper nigrum, 8-12% by wt. of an extract from Piper longum
and 2-11% by wt. of an extract from Azadirachta indica along with one or
more pharmaceutically acceptable additives/carriers.
In an embodiment of the present invention, the subject is a mammal
including human being.
In another embodiment of the present invention, 50 to 100 mg of the
composition is administered per Kg of body weight to the subject.
In yet another embodiment of the present invention, the composition can be
in the form of tablets, capsules, syrup or by any other form known in the
art.
In still another embodiment of the present invention, the composition is
administered orally, intra-muscularly, and by any other conventional
methods.
In one more embodiment of the present invention, the composition may be
used for therapeutic as well as prophylactic treatment of gastric ulcer.
In one another embodiment of the present invention, the subject may be
administered a single bolus dose or a multiple dose.
BRIEF DESCRIPTION OF THE TABLES
In the tables accompanying the specification,
Table 1 represents the effect of Omeprazole (a standard drug) and the new
herbal composition (HF) against Cold Restraint Ulcer (CRU) Model.
Table 2 compares the percentage protection of Omeprazole and the Herbal
composition (HF) against Cold Restraint Ulcer (CRU) Model.
Table 3 gives the effect of Omeprazole and the Herbal composition (HF)
against Aspirin induced ulcer model.
Table 4 gives the percentage protection of Omeprazole and the Herbal
composition (HF) against aspirin induced ulcer model.
Table 5 gives the effect of Omeprazole and the Herbal composition (HF)
against histamine induced duodenal ulcer in Guinea pig.
Table 6 gives the percentage protection of Omeprazole and the Herbal
composition (HF) against histamine induced duodenal ulcer in Guinea pigs.
able 7 gives the effect of Omeprazole and the Herbal composition (HF)
against Ethanol Induced Ulcer Model.
Table 8 gives the percentage protection of Omeprazole and the Herbal
composition (HF) against Alcohol induced Ulcer Model.
Table 9 gives the effect of Omeprazole and the Herbal composition (HF)
against pyloric ligation induced Ulcer.
Table 10 gives the percentage protection of Omeprazole and the Herbal
composition (HF) against pyloric ligation induced Ulcer.
Table 11 gives the composition of the Herbal composition (HF) of the
present invention.
The present invention is further described with reference to the following
experiments which are given by way of illustration and therefore should
not be construed to limit the scope of the invention in any manner.
EXPERIMENTAL PROTOCOL
Invivo Experiments
The Applicants have carried out several experiments under different induced
ulcer conditions and the effect of the herbal composition were studied and
are tabulated herebelow. The effect of the herbal composition has been
compared with respect to a known anti-ulcer drug "Omeprazole".
EXPERIMENT 1
Effect on Cold Restraint Ulcers (CRU) Model
Method:
Adult rats of either sex, weighing 150-175 grams are fasted for 24 hours in
metallic cages with raised mesh bottoms to prevent coprophagia and were
allowed free access to water. The test drugs were administered 45 minutes
before immobilizing the animals. The rats were immobilized in the
restraint cage and kept at 4.degree. C. in BOD incubator for 2 hours
(According to the method of Senay and Levine 1967). The animals were
sacrificed immediately after the restraint period. The abdomen was cut
opened; stomach was taken out and incised along the greater curvature to
observe the gastric lesions with the help of Magnascope (5.times.
magnification)
The following arbitrary scoring system was used to grade the severity and
intensity of the lesions:
1. Shedding of epithelium=10
2. Petechial and frank hemorrhages=20
3. One or two ulcers=30
4. More than two ulcers=40
5. Perforated ulcers=50
The presence of any of these lesions was considered as a positive
ulcerogenic response which has been shown as percentage of rats showing
gastric lesions. The severity of ulcers is expressed in terms of ulcer
index, which is the mean score of gastric lesions of all the rats in a
group. The term Ulcer Index is defined as:
Ulcer Index (U.I.)=Us+Up.times.10.sup.-1
where Us=Mean severity of ulcer score and
Up=Percentage of animals with Ulcer incidences
The percentage protection is calculated as follows:
Percentage protection=(C-T/C).times.100.
where C=Number of animals showing ulcer response in control group and
T=Number of animals showing ulcer response in test group.
The effect of the herbal composition of the present invention hereafter
referred to as "HF" against Cold Restraint Ulcer Model (CRU) is given in
Table 1. The effect of the standard drug "Omeprazole" is also given in
Table 1 given at the end of the description. Percentage protection of the
herbal composition of the present invention (HF) and Omeprazole against
CRU model are tabulated in Table 2 given at the end of the description.
Inference:
The composition of the present invention is significantly effective in CRU
model.
EXPERIMENT 2
Effect on Aspirin Induced Gastric Ulcer Model
Method:
Gastric ulceration was induced by aspirin according to the method of
Djahanguiri (1969). Aspirin (150 mg/Kg.) was administered per orally as a
suspension in gum-acacia and the animal was sacrificed 5 hr. after the
aspirin treatment and the ulcer index with protection index were
calculated.
The effect of HF against aspirin induced gastric ulcer is given in Table 3.
The effect of the standard drug "Omeprazole" is also given in Table 3
given at the end of the description.
Percentage protection of the herbal composition of the present invention
(HF) and Omeprazole against this model are tabulated in Table 4 given at
the end of the description.
Inference:
The herbal composition of the present invention is effective against
Aspirin induced gastric ulcer model.
EXPERIMENT 3
Effect on Histamine Induced Ulcer Model
Method:
1. Animals were fasted for 24 hours with access to water.
2. The drug was given orally 1 hour prior to the histamine administration.
3. Histamine was administered in a dose of 0.25 mg/Kg, i.m. at 30 minutes
interval for 7 times and it induced 100% duodenal ulceration in guinea pig
(According to the method of Watt and Eagleton 1964).
4. The animals were sacrificed after half an hour of last injection under
ether anesthesia.
5. The stomach along with duodenum were removed washed thoroughly and
examined for the lesions. Ulcer index and protection index were
calculated.
The effect of HF against Histamine induced duodenal ulcer is given in Table
5. The effect of the standard drug "Omeprazole" is also given in Table 5
given at the end of the description.
Percentage protection of the herbal composition of the present invention
(HF) and Omeprazole against Histamine induced duodenal ulcer are tabulated
in Table 6 given at the end of the description.
Inference:
The Herbal composition of the present invention "HF" shows significant anti
ulcer effect against this model.
EXPERIMENT 4
Effect on Alcohol Induced Gastric Ulcers in Rats
Method:
1. Adult rats of either sex were taken; weighing 150-175 grams were fasted
for 24 hours with free access to water.
2. The test drugs were administered (p.o.) 45 minutes before alcohol
administration.
3.1 ml of chilled absolute alcohol was administered (p.o.) to the rats
(According to the Wittetal).
4. Immediately after 1 hour, the animals were anesthetized, abdomen was cut
opened stomach was taken out and incised along the greater curvature to
observe the gastric lesions.
The ulcers are examined under the 5.times. magnification with the help of
magnascope.
Absolute ethanol lesions appears as blackish lesions grouped in patches of
varying size, usually parallel to the major axis of the stomach.
5. The lengths of the lesions are measured and summated to give a total
lesion score, then calculated and expressed in percentage.
The effect of HF against alcohol induced ulcer model is given in Table 7.
The effect of the standard drug "Omeprazole" is also given in Table 7
given at the end of the description.
Percentage protection of the herbal composition of the present invention
(HF) and Omeprazole against alcohol induced ulcer model are tabulated in
Table 8 given at the end of the description.
Inference:
The composition of the present invention does not show any significant
effect against alcohol induced gastric ulcer model.
EXPERIMENT 5
Effect on Pyloric Ligation Induced Ulcer Model
Method:
1. Animals were fasted for 24 hours in the raised mesh bottom cages to
prevent coprophagia and were allowed free access to water.
2. The control group of rats was feed with the vehicle and the experimental
groups with their respective drugs 45 minutes prior to the ligation.
3. The animal was anesthetized, abdomen was cut opened under xiphoid
process, and the pyloric portion of the stomach was slightly lifted and
ligated avoiding any damage to the adjacent blood vessels (According to
the method of Shay et al. 1945).
4. The animals were stitched and kept for 4 hours with free access to
water.
5. After 4 hours the animals were sacrificed under ether anesthesia and the
stomach was dissected out incised along the greater curvature.
6. The stomach was washed thoroughly and the ulcer index was scored as per
in other ulcer models.
The effect of HF against pyloric ligation induced ulcer is given in Table
9. The effect of the standard drug "Omeprazole" is also given in Table 9
given at the end of the description. Percentage protection of the herbal
composition of the present invention (HF) and Omeprazole against pyloric
ligation induced ulcer are tabulated in Table 10 given at the end of the
description.
Inference:
On comparison, Herbal composition shows high anti ulcer activity. The anti
ulcer activity of the herbal composition is higher than that of
Omeprazole.
EXPERIMENT 6
Herbs and Preparation of the Composition
Method:
For the purpose of conducting animal experiment all the herbs are washed
dried and pulverized. All the herbs are taken in the proportion as shown
in Table 11. To this water was added and boiled and concentrated to
appropriate consistency. The components and their proportions of the
standard "herbal composition" (HF) according to one embodiment of the
present invention are listed in Table 11 given at the end of the
description. The parts of the herbs which can be used is also mentioned.
The placebo preparation is designed to taste, smell and look like an
Ayurvedic herbal formulation.
TABLE 1
Effect of New herbal composition (HF) against Cold Restraint Ulcer
Model (CRU) with Omeprazole as a standard drug.
Percentage of
Ulcer severity_(type ulcer incidence
of lesions) Mean (No. of rats
Scores (No. of rats showing severity showing ulcer/
Compound lesions/No. of rats tested) of ulcer total No. of Ulcer
Protection
and Doses 10 20 30 40 50 score rats used) index
index
Control -- 6/10 4/10 -- -- 24 100 (10/10) 12.4 00
CRU
CRU + HF 4/10 2/10 -- -- -- 08 60 (6/10) 6.8
45.16
(50 mg/Kg,
p..o.)
CRU + 3/10 2/10 -- -- -- 07 50 (5/10) 5.7
54.03
Omeprazole (10
mg/Kg,
p.o.)
In the table, 10 = Shedding of epithelium; 20 = Petechial and frank
hemorrhages; 30 = One or two ulcers; 40 = More than two ulcers; 50 =
Perforated ulcers.
TABLE 2
Percentage protection of Herbal composition against Cold Restraint Ulcer
Model (CRU) taking Omeprazole as a standard drug.
GROUP PERCENTAGE PROTECTION
Herbal composition (HF) of the present invention (50 83.58
mg/Kg)
*Omerprazole (10 mg/Kg) 100%
*The protection of Omeprazole was taken as 100% as it was the standard
compound and the percentage protections of other compounds are in respect
to the protection of Omeprazole.
TABLE 3
Effect of Herbal composition against Aspirin induced ulcer model with
Omeprazole as a standard drug.
Ulcer severity (type of
lesions) Scores (No. of Mean Percentage of ulcer
rats showing lesions/ severity incidence (No. of rats
Compound No. of rats tested) of ulcer showing ulcer/total Ulcer
Protection
and Doses 10 20 30 40 50 score No. of rats used) index index
Control -- 2/6 4/6 -- -- 26.6 100 (6/6) 12.66 00
Aspirin (150
mg/Kg, p.o.)
Aspirin + 2/6 3/6 -- -- -- 13.3 83.3 (5/6) 9.66 23.69
Herbal
composition
(100 mg/Kg)
Aspirin + 2/6 1/6 -- -- -- 6.6 50 (3/6) 5.66 54.81
Omeprazole
(20 mg/Kg)
In the table, 10 = Shedding of epithelium; 20 = Petechial and frank
hemorrhages; 30 = One or two ulcers; 40 = More than two ulcers; 50 =
Perforated ulcers.
TABLE 4
Percentage protection of Herbal composition against aspirin induced ulcer
model taking Omeprazole as a standard drug.
Compound Percentage protection
Herbal composition (50 mg/Kg) 60.12
*Omeprazole (10 mg/Kg) 100
*The protection of Omeprazole was taken as 100% as it was the standard
compound and the percentage protections of other compounds are in respect
to the protection of Omeprazole.
TABLE 5
Effect of Herbal composition against histamine induced duodenal ulcer in
Guinea pig with Omeprazole as a standard drug
Ulcer severity (type Percentage of
of lesions) ulcer incidence
Groups Score (No. Guinea Mean (No. of animals
and pig showing lesions/ severity showing
Volume of
doses of No. Guinea pig tested) of ulcer ulcer/total No. of Ulcer %
gastric
compounds 10 20 30 40 50 score animals used) index Protection
fluid (mL)
Ulcer -- -- 1/3 2/3 -- 36.6 100 (3/3) 13.66 00
4.33 .+-. 1.1
Control
(Histamine
(25 mg/Kg,
i.m.)
Histamine + -- -- -- 1/3 -- 13.33 33.3 (1/3) 4.66 65.88
2.7 .+-. 0.37
HF (50
mg/Kg.,
p.o.)
Histamine + -- 1/3 -- -- -- 6.66 33.33 (1/3) 3.99 70.79
1.0 .+-. 0.2
Omeprazole
(10 mg/Kg,
p.o.)
TABLE 6
Percentage protection of Herbal composition against histamine induced
duodenal ulcer in Guinea pig taking Omerprazole as a standard drug.
COMPOUND PERCENTAGE PROTECTION
Herbal composition 93.07
*Omeprazole 100
*The protection of Omeprazole was taken as 100% as it was the standard
compound and the percentage protections of other compounds are in respect
to the protection of Omeprazole.
TABLE 7
Effect of Herbal composition against Ethanol Induced Ulcer Model
with Omeprazole as a standard drug.
LENGTH OF
HEMORRHAGIC
COMPOUND BANDS (mm .+-. SE)
Ethanol Control 73.5 .+-. 1.5
Herbal composition (HF) of the present 69.0 .+-. 7.0
invention (100 mg/Kg, p.o.) + Ethanol
Omeprazole (100 mg/Kg, p.o.) + Ethanol 56.0 .+-. 9.12
TABLE 8
Percentage protection of Herbal composition against Alcohol induced
Ulcer Model taking Omeprazole as a standard drug.
COMPOUNDS PROTECTION
Herbal composition 25.71
*Omerprazole 100.0
*The protection of omeprazole was taken as 100% as it was the standard
compound and the percentage protections of other compounds are in respect
to the protection of omeprazole.
TABLE 9
Effect of Herbal composition against pyloric ligation induced Ulcer taking
Omeprazole as a Standard drug
Ulcer Protection
Groups Index Index
Ligation Control 16.6 00
Ligation + Herbal composition (50 mg/Kg, p.o.) 4.2 65.89
Ligation + Omeprazole (10 mg/Kg, p.o.) 6.6 51.44
TABLE 10
Percentage protection of Herbal composition against pyloric ligation
induced Ulcer Model taking Omeprazole as a standard drug.
COMPOUNDS PROTECTION
Herbal composition 124.0
*Omeprazole 100
*The protection of Omeprazole was taken as 100% as it was the standard
compound and the percentage protections of other compounds are in respect
to the protection of Omeprazole.
TABLE 11
Composition of the Herbal composition (HF) of the present invention.
S. NO. NAME OF THE INGREDIENT (PART USED) %
1 Blechnum orintale (root) 5-6%
2 Vitis vinifera (Fruit) 5-9%
3 Aegle marmelos (Root) 4-7%
4 Withania somnifra (Root) 4-8%
5 Feronia elephantum (Fruit) 5-8%
6 Punica grantum (Fruit) 8-10%
7 Ziniber officnale (Rhizome) 4-8%
8 Piper nigrum (Fruit) 2-9%
9 Piper longum (Fruit) 8-10%
10 Azadirachta indica (Bark) 2-9%
*
