U.S. patent application number 10/702607 was filed with the patent office on 2004-05-27 for antiallergic composition.
This patent application is currently assigned to KABUSHIKI KAISHA HONEN CORPORATION. Invention is credited to Kamo, Shuichi, Ohtani, Yutaka, Sato, Toshiro, Ueno, Yasushi.
Application Number | 20040102416 10/702607 |
Document ID | / |
Family ID | 29543763 |
Filed Date | 2004-05-27 |
United States Patent
Application |
20040102416 |
Kind Code |
A1 |
Sato, Toshiro ; et
al. |
May 27, 2004 |
Antiallergic composition
Abstract
The present invention provides a safe and excellent antiallergic
composition, and more particularly a preventive and therapeutic
composition for atopic dermatitis, including an antiallergic
composition blended with stachyose as an effective ingredient, and
a medicine, food and beverage containing the composition.
Inventors: |
Sato, Toshiro; (Iwata-shi,
JP) ; Kamo, Shuichi; (Iwata-gun, JP) ; Ohtani,
Yutaka; (Iwata-gun, JP) ; Ueno, Yasushi;
(Yokohama-shi, JP) |
Correspondence
Address: |
OLIFF & BERRIDGE, PLC
P.O. BOX 19928
ALEXANDRIA
VA
22320
US
|
Assignee: |
KABUSHIKI KAISHA HONEN
CORPORATION
Chiyoda-ku
JP
|
Family ID: |
29543763 |
Appl. No.: |
10/702607 |
Filed: |
November 7, 2003 |
Current U.S.
Class: |
514/61 |
Current CPC
Class: |
A23V 2250/28 20130101;
A23V 2002/00 20130101; A61P 17/00 20180101; A61K 31/715 20130101;
A23V 2002/00 20130101; A23L 33/21 20160801; Y10S 514/861 20130101;
A61P 37/08 20180101; A23V 2250/632 20130101 |
Class at
Publication: |
514/061 |
International
Class: |
A61K 031/715 |
Foreign Application Data
Date |
Code |
Application Number |
May 2, 2002 |
JP |
2002-130875 |
Claims
What is claimed is:
1. An antiallergic composition comprising stachyose as an effective
ingredient.
2. The antiallergic composition according to claim 1, wherein the
stachyose is originated from soybeans.
3. The antiallergic composition according to any one of claims 1
and 2. wherein an antiallergic function is an action for
suppressing atopic dermatitis.
4. The antiallergic composition according to any one of claims 1 to
3, wherein the antiallergic function is an action for suppressing a
delayed allergy.
5. A medicine, and beverage and food comprising the antiallergic
composition according to any one of claims 1 to 4.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to an antiallergic
composition, particularly to an antiallergic composition usable for
daily intake for preventing onset of atopic dermatitis, and
medicines, beverages and foods using the composition.
[0003] 2. Description of the Related Art
[0004] Allergic diseases such as atopic dermatitis have caused
severe problems in recent years. Atopic dermatitis occurs as dry
lichen like eczema, and is an intractable disease accompanying
severe itch. While little is known about the mechanism of the onset
of eczema of the atopic dermatitis, it has been made clear that the
disease is related to allergic reactions type I and type IV. A type
I allergy is an immediate allergy mainly related to IgE antibodies,
wherein chemical transmitters such as histamine and leukotriene,
and enzymes are released upon reaction of allergenic substances
(allergens) with IgE on mast cells and basophils to cause
inflammatory reactions on the skin. However, type I allergies are
considered not to be directly related to lesions of eczema caused
by the atopic dermatitis. A type IV allergy is called as a delayed
allergy or cell mediated allergy that causes an inflammatory
reaction related to lymphocytes, and the onset of the disease takes
24 to 72 hours after sensitization.
[0005] Many protective and therapeutic actions have been attempted
for preventing atopic dermatitis. Representative examples thereof
include (1) an external medication using external medicines such as
adrenocortical hormones, and (2) administration of medicines that
suppress immediate reactions such as antihistamine agents. However,
the effect of medication is not always sufficient depending on the
physical conditions of patents, and the medication has a risk of
rebound.
[0006] In addition, people with allergic physical conditions have
been increasing every year. In extreme examples, the allergic
symptom is so sever that daily life of the patient is hindered,
which leads to social problems. Under these situations, there is an
urgency to develop safe and excellent antiallergic medicines to
solve the above mentioned problems, particularly prophylactics and
medicaments of the atopic dermatitis.
SUMMARY OF THE INVENTION
[0007] It is an object of the present invention to provide a safe
and excellent antiallergic composition, particularly preventive and
therapeutic compositions of the atopic dermatitis by solving the
problems above on allergic diseases.
[0008] The inventors have found, through intensive studies for
attaining the objects above, that stachyose has an antiallergic
action, particularly an action for suppressing atopic dermatitis,
and have completed the present invention.
[0009] The present invention provides an antiallergic composition
comprising stachyose as an effective ingredient.
[0010] Stachyose is a tetrasaccharide contained, for example, in
soy beans. Stachyose is a hardly digestible oligosaccharide, and
has been known as a factor for activating Lactobacillus bifidus
known to have an intestinal function controlling drug among
intestinal bacteria, and for accelerating absorption of calcium
through the digestive intestine. However, the action for
suppressing atopic dermatitis as disclosed in the present invention
has not been known in the art.
[0011] While the content of stachyose in the antiallergic
composition is not particularly restricted, a standard of the
desirable amount of intake is 1 to 15 g per day. A content of less
than 1 g is not so effective, while a content of more than 20 g may
induce temporary diarrhea, although it depends on physical
conditions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a graph showing the scores of dermatitis in the
stachyose administration group and control group;
[0013] FIG. 2 is a graph showing the scores of dermatitis in the
saccharose administration group and control group;
[0014] FIG. 3 is photographs of appearances of test mice;
[0015] FIG. 4 is a graph showing the IgE levels in the stachyose
administration group, and saccharose administration group and
control group; and
[0016] FIG. 5 is a graph showing scores of dermatitis in the
stachyose administration group and conrol group in the conventional
NC/Nga mice.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Performance Evaluation Test 1
[0017] The performance of stachyose mixed in livestock feeds was
evaluated against the dermatitis induced by repeated application of
hapten on an NC/Nga mouse frequently used as an atopic dermatitis
model animal (M. Okada et al., Oyo Yakuri/Pharmcometrics, vol. 59,
135-139 (2000)).
Test Method
[0018] NC/Nga Tnd Crj male mice at six weeks of age (purchased from
Nihon Charles River) were habituated for two weeks. The animals
decided as healthy were used for the experiments after an
observation of general conditions and body weight measurement. The
mice were divided into three groups so that the body weight was
averaged One group was composed of nine mice. A purified livesock
feed (AIN93G produced by Oriental Yeast Co.) was used as a basic
feed.
[0019] The mice in Group 1 (a control group) was fed with the
purified feed, while the mice in Groups 2 and 3 were fed with a
feed prepared by adding the test samples as shown in Table 1 in the
basic feed.
1 TABLE 1 Group 1 AIN93G feed Group 2 AIN93G feed + stachyose 0.5%
Group 3 AIN93G feed + saccharose 0.5%
[0020] Stachyose used in this test was purified to a purity of 98%
by ion exchange chromatography after extracting from soybeans with
70% ethanol. Saccharose used in this test was purchased from Wako
Junyaku Kabushiki Kaisha.
[0021] The mice at eight weeks of age were used for sensitization
as follows. The abdomen of the mouse anesthetized with ether was
clipped with a pair of hair clippers and a solution of
2,4,6-trinitrochlorobenzen- e (named as picryl chloride (PiCl)
hereinafter) for sensitization was applied on the abdomen after
clipping and on the footpad in a proportion of 150 .mu.L/one
animal. Induction was started four days after sensitization, and
repeated once a week for five weeks. In the induction period, the
back of the mouse anesthetized with ether was clipped with a pair
of hair clippers, and the PiCl solution (150 .mu.L/one animal) was
applied on the clipped back and right and left ears (at the outer
and inner sides of each ear). The hair was clipped after the second
induction depending on the growth of the hair.
[0022] The symptoms of the atopic dermatitis were observed as
follows. The skin condition was observed twice a week starting from
a day before the first induction, and the following items were
evaluated based on the criteria of clinical syndromes of the human
atopic dermatitis. Each mouse was photographed on the day of
autopsy.
[0023] (1) Observed items
[0024] a. pruritus/itching
[0025] b. erythema/hemorrhage
[0026] c. edema
[0027] e. excoriation/erosion
[0028] f. scaring/dryness
[0029] (2) Evaluation point
[0030] 0 no syndrome
[0031] 1 mild syndrome
[0032] 2 intermediate syndrome
[0033] 4 severe syndrome
[0034] The serum total IgE concentration was measured as follows.
The blood was extracted on day four before administration, and on
43rd day after administration (the day for starting administration
is counted as the first day). The blood (200 .mu.L) is sampled from
the orbital plexus venosus using a heparinated capillary. The blood
sampled was placed in a tube, centrifuged (at about 4.degree. C.
and 1660 g for 15 minutes), and IgE in the supernatant was used for
the serum total IgE measurement by an enzyme-linked immunosorbent
assay (EIA).
[0035] The score of dermatitis, serum total IgE concentration, and
the average body weight and standard deviation thereof were
calculated. The significant difference was evaluated by the
student's test. A significance level of 5% was evaluated as
significant, and the results of the Students t-test were expressed
by dividing into a level of less than 5% (P<0.05) and less than
1% (P<0.01).
Results and Discussion
[0036] The data of the score of dermatitis are shown in FIGS. 1 and
2. As shown in FIG. 1, progress of the atopic dermatitis was
evidently bred in the stachyose administration group (Group 2). No
effects were observed in the saccharose administration group (Group
3) as shown in FIG. 2. The photograph of the appearance of a
representative mouse in each group is shown in FIG. 3. An evident
difference of the appearance of the skin was observed in the mouse
in the stachyose administration group as compared with the mouse in
the control group (Group 1).
[0037] The levels of the serum total IgE as an immediate type (type
I) allergy inducing substance are shown in FIG. 4. These levels
were not different from the level in the control group.
[0038] While the expression mechanism of the anti-atopic dermatitis
action of stachyose has not been made clear yet, it may be
conjectured that stachyose probably acts on intestinal
microorganisms to improve immunity of the digestive intestine.
Otherwise, stachyose may directly act on the cells related to
immunity of the digestive intestine. While the atopic dermatitis is
considered to be related to the immediate allergy and delayed
allergy (type IV), it was made clear from the results of the
present invention that stachyose has a function against the delayed
allergy since stachyose does not influence the level of IgE. While
it is known in the art that raffinose as a minute component of the
soy bean oligosaccharide has an ant-atopic dermatitis action
(Japanese Patent Application Laid-open No. Hei 11-255656),
raffinose has an action for suppressing production of IgE (Japanese
Patent Application Laid-open No. 2001-288093). Accordingly, the
action of stachyose shown in the present invention is evidently
different from the action of raffinose.
Performance Evaluation Test 2
[0039] The effect of stachyose on the dermatitis was investigated
using conventional grade NC/Nga mice that spontaneously start the
atopic dermatitis without applying any haptens (H. Matsuda et al.,
International Immunology, vol. 9. 461-466 (1997)).
Test Method
[0040] Conventional grade female NC/Nga mice at four weeks of age
(purchased from Nihon SLC) were habituated for one week The mice
were divided into two groups so that the body weight was averaged.
One group was composed of six mice. All the mice were freely fed on
the purified livestock feed (AIN93G) before grouping, and the
stachyose administration group was fed on a feed supplemented with
1% stacyose after grouping. The sldn conditions were observed and
evaluated once per two weeks from the day of start of grouping. The
evaluation method was the same as in performance evaluation method
1.
Results
[0041] While the dermatitis was observed on the face of five of six
mice in the control group on the week four after grouping, no onset
of the dermatitis was observed in the stachyose administration
group. While evident dermatitis was observed not only on the face
but also on the ears in the control group 6 to 8 weeks after
grouping, no onset of dermatitis was observed at all in the
stachyose administration group. The scores of dermatitis are shown
in FIG. 5. The scores of dermatitis show that the effect of
stachyose is evident
[0042] The origin and production method of stachyose used in the
present invention are not particularly rested, and any one of
natural stachyose, chemically synthesized stachyose and
enzymatically synthesized stachyose may be used. However, stachyose
originating from soy beans is economically advantageous. Since
stachyose is a principal ingredient of the soybean oligosaccharide,
the oligosaccharide may be direly used as the stachyose source, or
it may be used after purification by ion exchange
chromatography.
EXAMPLES
[0043] While the present invention is described with reference to
examples, the present invention is by no means restricted by the
examples as set forth below.
Example 1
[0044]
2 [Ingredient of Capsule] Starting Material Blend (mg) per 1
Capsule (1) Stachyose 50 (2) DHA Oil 50 (3) Beefsteak Plant Oil 50
(4) Bee Wax 50
[0045] These materials were capsulated using gelatin after
mixing.
Example 2
[0046]
3 [Tablet] Starting Material Blend (mg) per 1 Capsule (1) Stachyose
100 (2) Lactose 100 (3) Cellulose Powder 50 (4) Reduced Maltose 30
(5) Processed Starch 10 (6) Calcium Carbonate 1
[0047] These materials were formulated into tablets after
mixing.
Example 3
[0048]
4 [Beverage] Starting Material Blend (g) per 1 Bottle (1) Soy Bean
Oligosaccharide (Stachyose 50%) 2 (2) Sucrose 10 (3) Coffee Powder
5 (4) Cow Milk 183
[0049] Beverage supplemented with soy bean oligosaccharide and
stachyose was produced with sterilization after mixing.
[0050] It is evident that the composition blended with stachyose of
the present invention exhibits an atopic dermatitis suppressing
effect.
* * * * *