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Title:
Compositions for treating and/or preventing pollinosis
United States Patent: 7,569,235
Issued: August 4, 2009
Inventors: Tsuchida; Yuuzou
(Tokyo, JP), Tsuchida; Kotarou (Tokyo, JP), Tsuchida; Kenjirou (Tokyo, JP)
Assignee: Hououdou Co.,
Ltd. (Tokyo, JP)
Appl. No.: 11/484,679
Filed: July 12, 2006
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Pharm Bus Intell
& Healthcare Studies
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Abstract
The present invention provides a
composition for treating and/or preventing pollinosis which comprises an
extract from Sasa albo-marginata in an amount ranging from 1 to 10% by
mass as expressed in terms of the solid content of the extract. The
composition of the present invention comprises a Sasa albo-marginata
extract in a concentration considerably higher than that conventionally
used and accordingly, it shows a high effect of treating and/or preventing
various symptoms associated with serious pollinosis, which has been quite
difficult to treat and/or prevent with the conventional anti-histamic
agents or steroidal drugs, without accompanying any side-effect.
Description of the
Invention
TECHNICAL FIELD
The present invention relates to a composition for treating and/or
preventing pollinosis, which comprises an extract from Sasa albo-marginata
(Bambooseae Sasa) as an effective component.
BACKGROUND ART
Recently, there have rapidly been increased the number of patients
suffering from allergic symptoms (hereunder referred to as "pollinosis")
accompanied by, for instance, conjunctivitis (itching and congestion of
eyes), rhinitis (sneezing, snivel and nasal congestion) and bronchial
asthma, which are caused due to the allergic hypersensitivity against
pollens of, for instance, hinoki (white cedar), sugi (Japanese cedar) and
ragweed (Ambrosia artemisiifolia), and dead bodies of, for instance, ticks
or mites. In respect of pollinosis, a steroidal drug has been used for
alleviating the related symptoms, but the symptoms have never been
alleviated in a large number of patients even if such a steroidal drug is
administered to these patients. Accordingly, there has been desired for
the development of an effective means for treating and/or alleviating
pollinosis.
DISCLOSURE OF THE INVENTION
It is thus an object of the present invention to provide a composition for
treating and/or preventing pollinosis, which can ensure a high effect of
treating and/or preventing pollinosis.
According to the present invention, there is provided a composition for
treating and/or preventing pollinosis, which comprises an extract from
Sasa albo-marginata (Bambooseae Sasa) in an amount ranging from 1 to 10%
by mass as expressed in terms of the solid content of the extract.
The term "pollinosis" as used herein means the allergic symptoms (pollinosis
in a broad sense), which are caused due to the allergic hypersensitivity
against pollens of, for instance, hinoki (white cedar), sugi (Japanese
cedar) and ragweed (Ambrosia artemisiifolia), and dead bodies of, for
instance, ticks or mites and which are accompanied by, for instance,
conjunctivitis (itching and congestion of eyes), rhinitis (sneezing,
snivel and nasal congestion) and bronchial asthma, and more specifically,
the term means the allergosis (pollinosis in a narrow sense), which are
caused due to the allergic hypersensitivity against pollens and
accompanied by, for instance, conjunctivitis (itching and congestion of
eyes), rhinitis (sneezing, snivel and nasal congestion) and bronchial
asthma.
BEST MODE FOR CARRYING OUT THE INVENTION
The present invention relates to a composition for treating and/or
preventing pollinosis, which comprises an extract from Sasa albo-marginata
in an amount ranging from 1 to 10% by mass, preferably 2 to 8% by mass and
more preferably 3 to 6% by mass, as expressed in terms of the solid
content of the extract. In this respect, if the content of the extract
from Sasa albo-marginata is less than 1% by mass, the resulting
composition is insufficient in the intended effect of treating and/or
preventing the pollinosis, while if the content thereof exceeds 10% by
mass, the composition would be too stimulative to the skin.
Conventionally, the Sasa albo-marginata extract has been prepared in the
form of an extract having a solid content ranging from 0.5 to 10% by mass
and has been used in a variety of applications. The extract having such a
solid content has been used in such a manner that the content thereof in a
final product in general ranges from about 1 to 10% by mass and therefore,
the solid content of the Sasa albo-marginata extract in the final product
in general ranges from about 0.05 to 0.8% by mass and at highest on the
order of less than 1% by mass. The reason for this is, for instance, that
the Sasa albo-marginata extract is relatively expensive, that the extract
would show the anti-inflammatory effect and antibiotic action even in such
a low concentration to some extent and that it would be unreasonable to
increase the added amount of the effective component to a level of not
less than 10% by mass. However, the product having such a low content of
the extract is almost ineffective in the treatment and/or prevention of
pollinosis.
The inventors of this invention have found that if the Sasa albo-marginata
extract is present in a final product in a solid content ranging from 1 to
10% by mass, preferably 2 to 8% by mass and more preferably 3 to 6% by
mass, the product shows a highly improved effect of treating and/or
preventing pollinosis, which have never been recognized when using a
conventional extract having a low solid content. Thus, the inventors of
this invention have completed the present invention on the basis of these
findings.
The Sasa albo-marginata extract per se has long been known, but there has
never been tried any attempt to use an extract in such a high solid
content. The reason for this has not yet been elucidated, but it has
surprisingly been recognized that the use of such an extract in a
concentration higher than that of the conventionally used one (not less
than 10 times) would permit the significant improvement of the effect of
treating and/or preventing pollinosis.
The Sasa albo-marginata used in the present invention, as a raw material
for the extract thereof is not restricted to any specific one and any
plant belonging to the genus Sasa may be used herein. Specific examples
thereof include those specified below: Kumai Sasa; Sasa albo-marginata
Makino et Shibata (Kuma Sasa); ground bamboo; Okuyama Sasa; Ezo-Miyama
Sasa; Sasa Paniculata Makino et Shibata; Yahiko Sasa; Oba Sasa; Miyama
Sasa; Sendai Sasa; Yukawa Sasa; Aboi Sasa; and Onuka Sasa. Among these,
specific examples of commercially available ones include Kumai Sasa and
Kuma Sasa (Chugoku Sasa and Hida Sasa). For instance, preferably used
herein are extracts derived from, for instance, Kumai Sasa and/or Kuma
Sasa collected in, for instance, TESHIO Mountains in Hokkaido during the
term extending from July to October.
The Sasa albo-marginata extract used in the present invention is
preferably one prepared by extracting raw leaves or dried leaves of Sasa
albo-marginata, preferably dried leaves thereof with water maintained at a
temperature ranging from 100 to 180.degree. C. at ordinary pressure or
while applying a pressure.
The extraction method is not restricted to any particular one, but usable
herein includes, for instance, that disclosed in Japanese Patent No.
3,212,278 (Japanese Un-Examined Patent Publication Hei 11-196818). More
specifically, leaves of Sasa albo-marginata are extracted at a temperature
ranging from 100 to 180.degree. C. for 5 to 30 minutes using a pressurized
hot water extraction device, the resulting extract is separated into a
moisture-containing solid content (moisture content: 40 to 70%) in a
moisture separator, thereafter the moisture-containing solid content is
treated at a temperature ranging from 100 to 200.degree. C. for 5 to 60
minutes in a saturated vapor-heating device, the solid content thus
treated is again treated at 100 to 180.degree. C. for 5 to 30 minutes
using a pressurized hot water extraction device and the extracts obtained
in the first and second extraction steps are combined prior to practical
use. Alternatively, it is also possible to use an extract obtained by
extracting dried leaves of Sasa albo-marginata with, for instance, water
heated to 60 to 100.degree. C. for 30 minutes to 12 hours.
There has been known "AHSS" available from CHLOROLAND.MOSHIRI CO., LTD as
an example of commercially available one having a content of the Sasa
albo-marginata extract of 50% by mass as expressed in terms of the solid
content of the extract.
The Sasa albo-marginata extract thus obtained contains sulfur-containing
components and the content thereof as expressed in terms of the amount of
sulfur ranges from about 4 to 10 mg and usually about 6 to 9 mg per one
gram of the solid content of the Sasa albo-marginata extract. Principal
constituents of the sulfur-containing components are considered to be
sulfur-containing amino acids.
The composition for treating and/or preventing pollinosis according to the
present invention comprises such sulfur-containing components derived from
the Sasa albo-marginata extract in an amount preferably ranging from 4 to
500 mg, more preferably 8 to 250 mg and most preferably 16 to 150 mg per
100 g of the composition, as expressed in terms of the amount of sulfur.
Moreover, the solid content of the Sasa albo-marginata extract contains
tannin and the content thereof in the solid contents is in the order of
about 5 to 15% by mass based on the mass of the solid contents present in
the extract.
It is desirable that the composition for treating and/or preventing
pollinosis according to the present invention comprise the tannin derived
from the Sasa albo-marginata extract in an amount preferably ranging from
0.05 to 7.5% by mass and more preferably 0.1 to 6% by mass as expressed in
terms of the concentration of the solid contents thereof.
The composition for treating and/or preventing pollinosis according to the
present invention may comprise only the Sasa albo-marginata extract as an
effective component or the simultaneous use of a reasonable amount of an
organic acid would permit the further improvement of the resulting
composition in its effect of treating and/or preventing pollinosis.
Examples of such organic acids include malic acid, citric acid, lactic
acid, oxalic acid, malonic acid, succinic acid, fumaric acid, acetic acid,
benzoic acid, phenyl-acetic acid, salicylic acid and phenols.
The amount of such an organic acid used in the composition for treating
and/or preventing pollinosis according to the present invention preferably
ranges from 0.01 to 5% by mass, more preferably 0.02 to 3% by mass and
most preferably 0.05 to 1.5% by mass based on the total mass of the
composition.
In the preparation of the composition for treating and/or preventing
pollinosis according to the present invention, there may be used, for
instance, a basic component such as an oily component, a moisture
retentive agent and/or a preservative (or an antiseptic), which are
commonly used in pharmaceutical compositions, cosmetics and compositions
applied to the skin, in addition to a desired amount of the foregoing Sasa
albo-marginata extract.
The origins of the water used in the composition are not restricted to
particular ones and examples thereof include tap water, natural water and
purified water, but preferably used herein is highly purified water such
as ion-exchange water.
Examples of oily components usable herein are oils derived from animals
such as squalane, tallow, lard, horse fat, lanolin and beeswax; oils
derived from vegetables such as olive oil, grape seed oil, palm oil,
jojoba oil and germ oil (such as rice germ oil); and synthetic or
semi-synthetic oils such as liquid paraffin, higher fatty acid esters
(such as octyl palmitate, isopropyl palmitate and octyl dodecyl myristate)
and silicone oil.
The oily components are used in appropriate combinations depending on the
performance requirement, for instance, an ability of protecting the skin,
an effect of imparting emollient (or an effect of preventing drying of the
skin and imparting softness and resilience to the skin through the
coverage of the skin surface with a thin film) and an ability of imparting
refreshed feeling to the skin. In one of preferred examples of such
combinations, the oily component comprises squalane, olive oil and octyl
dodecyl myristate.
The composition comprises a solid oil component such as stearic acid,
stearyl alcohol, behenic acid, cetanol and vaseline to control the
hardness and flowability of the composition and the composition preferably
comprises stearic acid and cetanol in combination.
When preparing the composition for treating and/or preventing pollinosis
according to the present invention in the form of a cream composition, a
creaming agent is used to convert the mixture of the Sasa albo-marginata
extract, water and an oily component into a cream. Such a creaming agent
is not restricted to any particular one, but glycerin monostearate and a
self-emulsifiable glycerin monostearate (a product obtained by
incorporating an emulsifying agent into glycerin monostearate) are in
general used in combination.
Moreover, the composition for treating and/or preventing pollinosis
according to the present invention may, if necessary, contain other
additives such as a stabilizer, a moisture retentive agent, a
wound-healing agent, a preservative and/or a surfactant.
Examples of stabilizers are a combination of a carboxy vinyl polymer with
potassium hydroxide, and polyethylene glycol distearate. In particular,
polyethylene glycol sesquistearate (a 1:1 mixture of polyethylene glycol
distearate and polyethylene glycol monostearate) (molecular weight of the
polyethylene glycol ranging from 1000 to 20,000) is preferably used herein
since it has high stability, it is never separated into water and oil and
the hardness required when the composition is applied to the skin in the
form of a cream composition can effectively be controlled.
Examples of moisture retentive agents usable herein are sodium salt of
hyaluronic acid, collagen, aloe extract (in particular, aloe extract (2)
derived from Aloe arborescens is preferred), urea, 1,3-butylene glycol,
glycerin, trehalose, sorbitol, amino acids and sodium salt of pyrrolidone
carboxylic acid.
Examples of wound-healing agents usable herein are allantoin, dipotassium
glycyrrhizinate, glycyrrhiza extract and mugwort extract.
The preservative (or antiseptic) is used subsidiarily since the Sasa
albo-marginata extract has an antibiotic effect by nature. Examples of
such preservatives are sodium benzoate, lower alkyl esters of p-hydroxy
benzoic acid (for instance, so-called paraben such as methyl, ethyl,
propyl or butyl ester), sodium propionate, mixed fatty acid esters (a
mixture of capric acid glyceryl, lauric acid polyglyceryl-2 and lauric
acid polyglyceryl-10), phenoxytal, and light-sensitive substance No. 201
(yellow dye), with paraben and mixed fatty acid esters being preferably
used herein.
Examples of surfactants are sodium N-acyl-L-glutamate and polyoxyethylene
sorbitan monostearate.
In addition, the composition may, if required, comprise aroma components
such as orange oil, lemon oil, bitter orange peel oil and perfumes.
Water and, if necessary, an organic acid are added to the foregoing
components to make the total amount of the resulting composition 100% by
mass.
The following Table 1 (see Original Patent) shows preferred amounts (% by
mass) of the foregoing ingredients required for preparing the composition
for treating and/or preventing pollinosis according to the invention in
the form of a cream composition. The amount of each component other than
water corresponds to the mass thereof free of any moisture.
The foregoing components are introduced into a heating-mixing kettle
equipped with a stirring blade and preferably an emulsification apparatus
and they are then admixed together at 70 to 90.degree. C. for one to two
hours to form a composition for treating and/or preventing pollinosis
according to the invention.
The composition for treating and/or preventing pollinosis according to the
invention may be used in various dosage forms other than a cream
composition such as an ointment, a liquid, a jelly, an eye drop and other
forms, with a cream composition being preferred because it can easily be
used and shows a considerable effect.
Alternatively, the composition of the present invention may likewise be
used in the form of a mask obtained by impregnating a substrate such as
absorbent gauze with the Sasa albo-marginata extract at a high temperature
of preferably not less than 80.degree. C. in an amount ranging from 1 to
10% by mass as expressed in terms of the solid content of the extract and
then drying the impregnated substrate and the resulting mask is also
effectively used for treating and/or preventing pollinosis.
It is sufficient to apply the composition of the present invention to the
affected part, after cleaning the same, in an appropriate amount thereof,
for instance, 0.1 to 1 g per 100 cm.sup.2 of the skin in case of a cream
composition over 1 to 5 times, usually 1 to 3 times a day.
In case of, for instance, the itching of eyes, it is likewise sufficient
to apply a cream composition to the eyelids, in particular, the periphery
thereof and/or the lower eyelid of a patient. It is also possible to apply
an eye drop to the eyes of a patient. Such an eye drop may desirably
comprise 2 to 8% by mass and preferably 2 to 3% by mass of the Sasa
albo-marginata extract as expressed in terms of the solid content thereof.
The amount and number of application of the composition or the number of
dropping thereof in the eyes may appropriately be changed while taking
into consideration, for instance, the extent of pollinosis. When applying
the composition for treating and/or preventing pollinosis according to the
invention to the affected part, the typical symptoms of pollinosis (such
as itching and congestion of eyes, sneezing, snivel and nasal congestion)
would rapidly be alleviated or eliminated within the term generally
ranging from about 5 to 10 minutes.
The composition of the present invention comprises 1 to 10% by mass of the
Sasa albo-marginata extract as expressed in terms of the solid content and
accordingly, the composition would show a considerable effect of improving
various symptoms associated with the pollinosis.
The following are preferred embodiments of the composition for treating
and/or preventing pollinosis according to the present invention. 1. A
composition for treating and/or preventing pollinosis, which comprises the
Sasa albo-marginata extract (1 to 10% by mass as expressed in terms of the
solid content), water, an oily component and a creaming agent. 2. The
composition according to the foregoing item 1 in which the oily component
is at least one member selected from the group consisting of animal oil,
vegetable oil, synthetic oil and semi-synthetic oil. 3. The composition
according to the foregoing item 1 in which the oily component is at least
one member selected from the group consisting of squalane, tallow, lard,
horse fat, lanolin, beeswax, olive oil, grape seed oil, palm oil, jojoba
oil, germ oil, liquid paraffin, octyl palmitate, isopropyl palmitate,
octyl dodecyl myristate, silicone oil, stearic acid, stearyl alcohol,
behenic acid, cetanol and vaseline. 4. The composition according to any
one of the foregoing items 1 to 3 in which the creaming agent is a
combination of glycerin monostearate with self-emulsifiable glycerin
monostearate. 5. The composition according to any one of the foregoing
items 1 to 4 which further comprises at least one component selected from
the group consisting of a stabilizer, a moisture retentive agent, a
wound-healing agent, a preservative and a surfactant. 6. The composition
according to the foregoing item 5 in which the stabilizer is at least one
member selected from the group consisting of a combination of a carboxy
vinyl polymer with potassium hydroxide, and polyethylene glycol distearate.
7. The composition according to the foregoing item 5 in which the moisture
retentive agent is at least one member selected from the group consisting
of sodium salt of hyaluronic acid, collagen, aloe extract, urea,
1,3-butylene glycol, glycerin, trehalose, sorbitol, amino acids and sodium
salt of pyrrolidone carboxylic acid. 8. The composition according to the
foregoing item 5 in which the wound-healing agent is at least one member
selected from the group consisting of allantoin, dipotassium
glycyrrhizinate, glycyrrhiza extract and mugwort extract. 9. The
composition according to the foregoing item 5 in which the preservative is
at least one member selected from the group consisting of sodium benzoate,
lower alkyl esters of p-hydroxy benzoic acid, sodium propionate, mixed
fatty acid esters, phenoxytal, and yellow dye. 10. The composition
according to the foregoing item 5 which further comprises at least one
member selected from the group consisting of orange oil, lemon oil, bitter
orange peel oil and perfumes. 11. The composition according to the
foregoing item 10, which comprises a Sasa albo-marginata extract, water,
an oily component, a creaming agent, a stabilizer, a moisture retentive
agent, a wound-healing-promoting agent, a preservative and a surfactant,
wherein the oily component is at least one member selected from the group
consisting of squalane, tallow, lard, horse fat, lanolin, beeswax, olive
oil, grape seed oil, palm oil, jojoba oil, germ oil, liquid paraffin,
octyl palmitate, isopropyl palmitate, octyl dodecyl myristate, silicone
oil, stearic acid, stearyl alcohol, behenic acid, cetanol and vaseline;
the creaming agent is a combination of glycerin monostearate with self-emulsifiable
glycerin monostearate; the stabilizer is at least one member selected from
the group consisting of a combination of a carboxy vinyl polymer with
potassium hydroxide and polyethylene glycol distearate; the moisture
retentive agent is at least one member selected from the group consisting
of sodium salt of hyaluronic acid, collagen, aloe extract, urea,
1,3-butylene glycol, glycerin, trehalose, sorbitol, amino acids and sodium
salt of pyrrolidone carboxylic acid; the wound-healing agent is at least
one member selected from the group consisting of allantoin, dipotassium
glycyrrhizinate, glycyrrhiza extract and mugwort extract; the preservative
is at least one member selected from the group consisting of sodium
benzoate, lower alkyl esters of p-hydroxy benzoic acid, sodium propionate,
mixed fatty acid esters, phenoxytal, and yellow dye; and the surfactant is
sodium N-acyl-L-glutamate. 12. The composition as set forth in the
foregoing item 11 which further comprises at least one member selected
from the group consisting of orange oil, lemon oil, bitter orange peel oil
and perfumes. 13. The composition as set forth in the foregoing item 1
which comprises a Sasa albo-marginata extract, water, squalane, olive oil,
glycerin monostearate, self-emulsifiable glycerin monostearate, a carboxy
vinyl polymer, potassium hydroxide, urea, 1,3-butylene glycol, allantoin,
a lower alkyl ester of p-hydroxy benzoic acid, stearic acid, sodium N-acyl-L-glutamate
and lemon oil. 14. The composition as set forth in the foregoing item 1
which comprises a Sasa albo-marginata extract, water, squalane, olive oil,
octyl dodecyl myristate, cetanol, glycerin monostearate, self-emulsifiable
glycerin monostearate, a carboxy vinyl polymer, potassium hydroxide, urea,
1,3-butylene glycol, allantoin, a mixed fatty acid ester, stearic acid,
sodium N-acyl-L-glutamate and orange oil. 15. The composition as set forth
in any one of the foregoing items 1 to 14 which comprises polyethylene
glycol sesquistearate. 16. A composition for treating and/or preventing
pollinosis which comprises an aqueous solution containing a Sasa
albo-marginata extract (1 to 10% by mass as expressed in terms of the
solid content). 17. The composition of the foregoing item 16 in which it
is in the form of an eye drop or a mouthwash.
Claim 1 of 26 Claims
1. A method for treating pollinosis in a
patient in need thereof, comprising administering a composition comprising
an extract of Sasa albo-marginata to the patient in need thereof, in an
amount sufficient to treat the pollinosis, wherein the composition
comprises from 1 to 10% by mass of the Sasa albo-marginata extract, as
expressed in terms of the solid content of the extract, wherein the
composition comprises components comprising sulfur, wherein the components
are obtained from the Sasa albo-marginata extract, and wherein the
components are present in an amount ranging from 4 to 100 mg per 100 g of
the composition as expressed in terms of the amount of sulfur. ____________________________________________
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