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  Pharmaceutical Patents  

 

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


 

Pharm Bus Intell & Healthcare Studies


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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