JP5187935B2 - Wound healing promoting composition containing Rahan fruit extract and application method - Google Patents
Wound healing promoting composition containing Rahan fruit extract and application method Download PDFInfo
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- JP5187935B2 JP5187935B2 JP2007227157A JP2007227157A JP5187935B2 JP 5187935 B2 JP5187935 B2 JP 5187935B2 JP 2007227157 A JP2007227157 A JP 2007227157A JP 2007227157 A JP2007227157 A JP 2007227157A JP 5187935 B2 JP5187935 B2 JP 5187935B2
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- 230000029663 wound healing Effects 0.000 title description 10
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Landscapes
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Description
本発明は、羅漢果由来の成分を含む、創傷または潰瘍などの、皮膚の上皮組織における損傷を処置するための間接投与用医薬組成物に関する。本発明はまた、羅漢果由来の成分を含む、創傷または潰瘍などの、皮膚の上皮組織における損傷を処置するための食品組成物に関する。 The present invention relates to a pharmaceutical composition for indirect administration for treating damage in epithelial tissues of skin, such as wounds or ulcers, comprising a component derived from Rahan fruit. The present invention also relates to a food composition for treating damage in the epithelial tissue of the skin, such as a wound or ulcer, comprising a component derived from Luo Han Fruit.
創傷または潰瘍などの、皮膚の上皮組織における損傷に対し、主に、抗生物質の経口投与又は外傷への直接的な塗布による細菌感染症の予防、抗炎症剤の投与による炎症の低減、鎮痛剤投与による疼痛の軽減などの治療が行われている。しかしながらこれらの治療は、細菌感染、炎症、疼痛などの２次的な障害を低減しようとする治療でしかなく、皮膚症状の治癒は生体の皮膚再生能力に頼ることが多いため、生体に備わる皮膚の上皮組織における損傷の治癒効果を積極的に促進する薬物の開発が望まれている。 Prevention of bacterial infections by oral administration of antibiotics or direct application to trauma, reduction of inflammation by administration of anti-inflammatory agents, analgesics, mainly for damage to epithelial tissues of the skin, such as wounds or ulcers Treatment such as relief of pain by administration is performed. However, these treatments are only treatments for reducing secondary disorders such as bacterial infection, inflammation, and pain, and the healing of skin symptoms often relies on the body's ability to regenerate the skin. Development of a drug that positively promotes the healing effect of damage in the epithelial tissue is desired.
現在、そのような生体に備わる皮膚の上皮組織における損傷の治癒能を積極的に促進する皮膚の上皮組織における損傷の治癒促進効果を有するものの一つとして、羅漢果抽出物を含む局所塗布用の組成物が知られている（特許文献１および特許文献２を参照のこと）。羅漢果は、中国広西省の桂林周辺に生育する、ウリ科、ツルレイシ属の植物の果実である。羅漢果の乾燥果実から得られる羅漢果エキスは、強い甘味質を有する薬用の甘味料として知られている。また、特許文献３、特許文献４および特許文献５は、肌荒れ等の防止または改善のための、羅漢果抽出物を含む化粧料を開示している。 Currently, a composition for topical application containing Luohan fruit extract as one of the skin healing epithelial tissue that actively promotes the healing ability of the skin epithelial tissue, which is provided in such a living body. Things are known (see patent document 1 and patent document 2). Rahan fruit is a fruit of the plant of the genus Cucurbitaceae and the genus Turreci that grows around Guilin in Guangxi Province, China. Rahan fruit extract obtained from the dried fruit of Rahan fruit is known as a medicinal sweetener having a strong sweetness quality. Patent Literature 3, Patent Literature 4 and Patent Literature 5 disclose cosmetics containing Rakan fruit extract for preventing or improving rough skin.
しかしながら、このような局所塗布用の組成物においては、細菌などの夾雑物または不純物の混入の副作用の危険性が非常に大きい。そのため、直接的な局所塗布ではない投与形態によって投与可能な、皮膚の上皮組織における損傷の治癒の促進のための組成物が望まれている。 However, in such a composition for topical application, there is a very high risk of side effects of contamination such as bacteria or contamination. Therefore, a composition for promoting healing of damage in skin epithelial tissue that can be administered by a dosage form that is not direct topical application is desired.
上述のように、羅漢果抽出物については、副作用の危険の大きい局所塗布によって皮膚の上皮組織における損傷の治癒促進効果を奏することが知られているものの、局所塗布以外の投与形態によって皮膚の上皮組織における損傷の治癒が促進されるということは、報告されていない。羅漢果抽出物は、甘味料として経口的に利用されているが、この利用はあくまで甘味料としてのものであり、皮膚の上皮組織における損傷の治癒促進については何ら意図されていない。 As described above, the Luohan fruit extract is known to have an effect of promoting the healing of damage in the epithelial tissue of the skin by topical application with a high risk of side effects. However, the epithelial tissue of the skin depends on the administration form other than the topical application. It has not been reported that healing of the injury in can be promoted. Luohan fruit extract is orally used as a sweetener, but this use is only as a sweetener and is not intended to promote healing of damage in the epithelial tissue of the skin.
局所塗布によってある標的部位に対して効果を奏する成分が経口投与によっても同じ効果を奏するためには、その成分が代謝されずにその標的部位に達することが必要である。しかしながら、消化管における分解を受ける可能性、その後、吸収され血中に輸送されたとしても肝臓等における代謝を受ける可能性が高く、当然かなりの割合の有効成分が代謝され、そのまま標的部位に達することはない。そのため、経口投与では、局所塗布と同等のレベルの効果を望むことは困難であり、局所塗布によって効果を奏する成分が経口投与によって同等の効果を奏することは、極めて稀有である。例えば特許文献１は、羅漢果抽出物含有組成物を経口投与することを記載してはいるが、経口投与による効果については何ら実証されていない。
本発明は、皮膚の上皮組織における損傷の治癒に関わる生体の再生能を積極的に促進し、皮膚の上皮組織における損傷の完治までの時間の短縮を達成し、且つ副作用の危険が有意に低減された安全性の高い組成物を提供することを課題とする。 The present invention actively promotes the regenerative ability of the living body involved in the healing of damage in the epithelial tissue of the skin, achieves a shortened time to complete damage in the epithelial tissue of the skin, and significantly reduces the risk of side effects It is an object of the present invention to provide a highly safe composition.
本発明者らは、上記課題を鑑みて鋭意研究を重ねた結果、羅漢果（Ｓｉｒａｉｔｉａ ｇｒｏｓｖｅｎｏｎｉｉ Ｃ．Ｊｅｆｆｒｅｙ ｅｘ Ａ． Ｍ． Ｌｕ ＆ Ｚｈｉ Ｙ．Ｚｈａｎｇ （Ｍｏｍｏｒｄｉｃａ ｇｒｏｓｖｅｎｏｒｉ Ｓｗｉｎｇｌｅ））由来の成分を間接投与することにより、皮膚の上皮組織における損傷の治癒が飛躍的に促進され、かつ副作用も生じないことを見出し、上記課題を解決した。本発明の組成物は、創傷または潰瘍などの、皮膚の上皮組織における損傷の治癒過程の初期段階である炎症期（マクロファージの活性化、タンパク分解から、壊死組織の除去などが起こる）を速やかかつ効率的に経過させることにより、創傷治癒までの時間を顕著に短縮し得る。本発明は、皮膚の上皮組織における損傷の治癒に関わる生体の再生能を積極的に促進し、皮膚の上皮組織における損傷の完治までの時間の短縮を達成し、且つ副作用の危険が有意に低減された安全性の高い組成物を提供する。予想外にも、本発明の組成物は、局所塗布用組成物と同等の皮膚の上皮組織における損傷の治癒促進効果を、間接投与によって達成することができる。 As a result of intensive studies in view of the above problems, the present inventors indirectly administer a component derived from Siraitia grosvenoniii C. Jeffrey ex A. M. Lu & Zhi Y. Zhang (Modica grosvenori Swingle). As a result, it was found that healing of the damage in the epithelial tissue of the skin was dramatically promoted and no side effects occurred, and the above problems were solved. The composition of the present invention promptly and quickly undergoes the inflammatory phase (the activation of macrophages, the proteolysis, the removal of necrotic tissue, etc.), which is the initial stage of the healing process of damage in the epithelial tissue of the skin, such as a wound or ulcer By allowing it to pass efficiently, the time to wound healing can be significantly shortened. The present invention actively promotes the regenerative ability of the living body involved in the healing of damage in the epithelial tissue of the skin, achieves a shortened time to complete damage in the epithelial tissue of the skin, and significantly reduces the risk of side effects And a highly safe composition. Unexpectedly, the composition of the present invention can achieve the effect of promoting healing of damage in the epithelial tissue of the skin equivalent to the composition for topical application by indirect administration.
上記課題を解決するために、本発明は、以下を提供する。 In order to solve the above problems, the present invention provides the following.
一つの局面において、本発明は、羅漢果由来の成分を含む、皮膚の上皮組織における損傷を処置するための間接投与用医薬組成物を提供する。 In one aspect, the present invention provides a pharmaceutical composition for indirect administration for treating damage in epithelial tissue of skin, comprising a component derived from Luohan fruit.
一つの実施形態において、上記間接投与は、上記処置されるべき部位以外の部位に投与することによって達成される。 In one embodiment, the indirect administration is accomplished by administering to a site other than the site to be treated.
一つの実施形態において、上記間接投与は、経口投与、経鼻投与、経管投与または経腸投与である。 In one embodiment, the indirect administration is oral administration, nasal administration, tube administration or enteral administration.
一つの実施形態において、上記間接投与は経口投与である。 In one embodiment, the indirect administration is oral administration.
一つの実施形態において、上記処置されるべき部位は、創傷または潰瘍である。 In one embodiment, the site to be treated is a wound or ulcer.
一つの実施形態において、上記成分は、羅漢果抽出物である。 In one embodiment, the said component is a rahan fruit extract.
一つの実施形態において、上記羅漢果抽出物は少なくとも１種の羅漢果配糖体を含む。 In one embodiment, the Rahan fruit extract comprises at least one Rahan fruit glycoside.
一つの実施形態において、上記羅漢果配糖体は、モグロサイドＩＶ、モグロサイドＶ、シアメノサイドＩ、および１１−オキソ−モグロサイドＶからなる群より選択される。 In one embodiment, the Rahan fruit glycoside is selected from the group consisting of mogroside IV, mogroside V, siamenoside I, and 11-oxo-mogroside V.
一つの局面において、本発明は、羅漢果由来の成分を含む、皮膚の上皮組織における損傷を処置するための食品組成物を提供する。 In one aspect, the present invention provides a food composition for treating damage in the epithelial tissue of the skin comprising a component derived from Luo Han Fruit.
一つの実施形態において、上記処置されるべき部位は、創傷である。 In one embodiment, the site to be treated is a wound.
一つの実施形態において、上記成分は羅漢果抽出物である。 In one embodiment, the component is a Rakan fruit extract.
一つの実施形態において、上記羅漢果抽出物は少なくとも１種の羅漢果配糖体を含む。 In one embodiment, the Rahan fruit extract comprises at least one Rahan fruit glycoside.
一つの実施形態において、上記羅漢果配糖体は、モグロサイドＩＶ、モグロサイドＶ、シアメノサイドＩ、および１１−オキソ−モグロサイドＶからなる群より選択される。 In one embodiment, the Rahan fruit glycoside is selected from the group consisting of mogroside IV, mogroside V, siamenoside I, and 11-oxo-mogroside V.
本発明の組成物は、経口投与のような間接投与によって投与されて創傷または潰瘍などの、皮膚の上皮組織における損傷の治癒を促進する。本発明の組成物は局所塗布によって投与されるものではないため、細菌などの夾雑物または不純物の混入の副作用の危険性が顕著に低減される。 The compositions of the invention are administered by indirect administration, such as oral administration, to promote healing of damage in the epithelial tissue of the skin, such as a wound or ulcer. Since the composition of the present invention is not administered by topical application, the risk of side effects of contamination such as bacteria or contamination is significantly reduced.
本発明により、創傷または潰瘍などの、皮膚の上皮組織における損傷の治癒に関わる生体の再生能を積極的に促進し、皮膚の上皮組織における損傷の完治までの時間の短縮を達成し、且つ副作用の危険が有意に低減された安全性の高い組成物が提供される。 According to the present invention, it is possible to actively promote the regenerative ability of a living body involved in the healing of damage in skin epithelial tissue such as a wound or ulcer, to achieve a reduction in time to complete cure of skin epithelial tissue, and to have side effects A highly safe composition with a significantly reduced risk is provided.
以下に本発明を、必要に応じて、添付の図面を参照して例示の実施例により記載する。本発明を以下に説明する。本明細書の全体にわたり、単数形の表現は、特に言及しない限り、その複数形の概念をも含むことが理解されるべきである。また、本明細書において使用される用語は、特に言及しない限り、当該分野で通常用いられる意味で用いられることが理解されるべきである。したがって、他に定義されない限り、本明細書中で使用される全ての専門用語および科学技術用語は、本発明の属する分野の当業者によって一般的に理解されるのと同じ意味を有する。矛盾する場合、本明細書（定義を含めて）が優先する。 The invention will now be described by way of example, with reference to the accompanying drawings, where appropriate. The present invention will be described below. Throughout this specification, it should be understood that the singular forms also include the plural concept unless specifically stated otherwise. In addition, it is to be understood that the terms used in the present specification are used in the meaning normally used in the art unless otherwise specified. Thus, unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the present specification, including definitions, will control.
以下に提供される実施形態は、本発明のよりよい理解のために提供されるものであり、本発明の範囲は以下の記載に限定されるべきではない。本明細書中の記載を参酌して、本発明の範囲内で適宜改変を行うことができることは、当業者に明らかである。 The embodiments provided below are provided for a better understanding of the present invention, and the scope of the present invention should not be limited to the following description. It will be apparent to those skilled in the art that modifications can be made as appropriate within the scope of the present invention in consideration of the description in the present specification.
本発明者らは、羅漢果由来の成分を含有する組成物を、皮膚の上皮組織における損傷を有する被験体に適用することにより、種々の皮膚の上皮組織における損傷の治癒が促進され、かつ副作用も生じないことを見出し、本発明を完成した。本発明の組成物は、創傷または潰瘍などの、皮膚の上皮組織における損傷の治癒過程の初期段階である炎症期（マクロファージの活性化、タンパク分解から、壊死組織の除去などが起こる）を速やかに、かつ効率的に経過させることにより、その損傷の治癒までの時間を顕著に短縮し得る。本発明は、皮膚の上皮組織における損傷の完治までの時間の短縮を達成し、且つ安全性の極めて高い組成物を提供する。 By applying a composition containing a component derived from Luo Han Fruit to a subject having damage in the epithelial tissue of skin, healing of damage in various skin epithelial tissue is promoted, and side effects are also caused. As a result, the present invention was completed. The composition of the present invention rapidly accelerates the inflammatory phase (macrophage activation, proteolysis, and removal of necrotic tissue occurs), which is the initial stage of the healing process of damage in the epithelial tissue of the skin, such as a wound or ulcer In addition, the time until healing of the damage can be remarkably shortened by passing it efficiently. The present invention provides a composition that achieves a reduction in the time to complete healing of the injury in the epithelial tissue of the skin and is extremely safe.
羅漢果（学名：Ｍｏｍｏｒｄｉｃａｅ Ｇｒｏｓｖｅｎｏｒｉ）は、ウリ科の多年生草本の薬用植物であり、古代より中国の民間薬として広く利用されており、現在でも中国広西省チアン族自治区の桂林周辺の高冷地で栽培される特産品の一つである。羅漢果の果実の有する薬効は、のどの荒れおよび痛みの緩和、咳止め、去痰、気管支炎の緩和、扁桃腺炎の緩和、解熱、胃腸の機能促進、ストレス解消、利尿、便秘解消など多数にのぼる。近年ではさらに、羅漢果の果実には、高血圧症、糖尿病などを防止する作用、老化防止作用、フリーラジカル消去作用および抗過酸化効果などを有する成分が含まれていることが明らかになっている（「基礎と臨床」２７（８）、３１５９−３１６６（１９９３））。 Rakanka (Scientific name: Mordicicae Grosvenori) is a perennial herbaceous medicinal plant of the Cucurbitaceae family and has been widely used as a Chinese folk medicine since ancient times. It is still cultivated in a cold area around Guilin, Guangxi Province, China One of the special products. The fruits of Luo Han Fruit have many benefits such as relief of rough throat and pain, cough, expectoration, relief of bronchitis, relief of tonsillitis, antipyretic, promotion of gastrointestinal function, relief of stress, diuresis and constipation . In recent years, it has become clear that the fruits of Rahan fruit contain components that have an action to prevent hypertension, diabetes, etc., an anti-aging action, a free radical scavenging action and an anti-peroxidation effect ( "Basic and clinical" 27 (8), 3159-3166 (1993)).
本明細書中で使用される場合「羅漢果由来の成分」とは、羅漢果に由来する任意の成分をいう。この成分は、羅漢果から抽出・単離等を行っていない成分（例えば、羅漢果の粉末）であってもよいし、羅漢果から抽出・単離された成分（例えば、羅漢果抽出エキス）であってもよい。代表的には、羅漢果由来の成分は、羅漢果抽出物である。本発明において羅漢果抽出物を得る方法としては、水蒸気蒸留法、圧搾法、アルコール等の溶剤による溶剤抽出法、超臨界抽出法等が挙げられるが、これらに限定されない。好ましい羅漢果抽出物としては、熱抽出物が挙げられ、６０℃〜１００℃、好ましくは８０℃〜１００℃、より好ましくは９０℃〜１００℃の温度の加温水で抽出し、濃縮したものである。この水としては、水道水、イオン交換水、蒸留水等が挙げられ、好ましくはイオン交換水または蒸留水が用いられるが、これらに限定されない。 As used herein, “a component derived from Rahan fruit” refers to an arbitrary component derived from Rahan fruit. This component may be a component that has not been extracted / isolated from Luohan fruit (for example, Luo Han fruit powder), or a component that has been extracted / isolated from Luo Han fruit (for example, Luo Han fruit extract). Good. Typically, the ingredients derived from Rahan fruit are Rahan fruit extracts. Examples of the method for obtaining the Rakan fruit extract in the present invention include, but are not limited to, a steam distillation method, a pressing method, a solvent extraction method using a solvent such as alcohol, and a supercritical extraction method. Preferable Rakan fruit extract includes a heat extract, which is extracted with heated water at a temperature of 60 ° C. to 100 ° C., preferably 80 ° C. to 100 ° C., more preferably 90 ° C. to 100 ° C., and concentrated. . Examples of the water include tap water, ion-exchanged water, distilled water, and the like. Preferably, ion-exchanged water or distilled water is used, but not limited thereto.
本明細書中で使用される場合、「皮膚の上皮組織における損傷」とは、皮膚の上皮組織に生じる任意の損傷をいい、例えば創傷または潰瘍が含まれる。本明細書中で「創傷」とは、外的、内的要因によって起こる体表組織の物理的な損傷を意味し、その形状及び受傷機転により、切創、裂創、刺創、咬創、銃創、挫創、挫傷等が挙げられる。本明細書中で「潰瘍」とは、生体表面における連続性が離断した任意の状態をいい、主に皮膚または粘膜に欠損が生じた状態をいう。本発明における皮膚症状は、代表的には創傷である。 As used herein, “damage in skin epithelial tissue” refers to any damage that occurs in skin epithelial tissue, including, for example, wounds or ulcers. In the present specification, the term “wound” means physical damage to the body surface tissue caused by external and internal factors, and depending on the shape and injury mechanism, the wound, tear, stab wound, bite wound, gun wound, Examples include wounds and bruises. As used herein, “ulcer” refers to any state where continuity on the surface of a living body is cut off, and mainly refers to a state in which a defect has occurred in the skin or mucous membrane. The skin symptom in the present invention is typically a wound.
本明細書中で使用される場合、「間接投与」とは、皮膚の上皮組織における損傷患部への直接的な局所塗布以外の、処置されるべき部位以外の部位への任意の投与をいう。患部への直接的な局所塗布ではなく、かつ細菌等の夾雑による副作用が局所塗布と比較して低減されるような投与形態は全て、本発明の「間接投与」に含まれる。本発明における間接投与とは、例えば、経口投与、経鼻投与、経管投与または経腸投与であるが、これらに限定されない。本発明の組成物は、代表的には、経口投与によって投与される。 As used herein, “indirect administration” refers to any administration to a site other than the site to be treated other than direct topical application to the affected lesion in the epithelial tissue of the skin. All forms of administration that are not directly applied locally to the affected area and that reduce side effects due to contamination such as bacteria as compared to the topical application are included in the “indirect administration” of the present invention. Indirect administration in the present invention is, for example, oral administration, nasal administration, tube administration or enteral administration, but is not limited thereto. The compositions of the invention are typically administered by oral administration.
本発明の組成物は、投与開始から１日後に、滅菌精製水を投与した被験体（コントロール）の場合と比較して、創部面積の減少率を有意に増大させ得る。創部面積は、例えば以下のように測定し得る。まず創部にパラフィルムをあて、写し取った創部の境界線に沿ってパラフィルムを切り取り、その重量を測定する。次いで、面積既知のパラフィルムの重量を基準に、その創部の面積を算出する。 The composition of the present invention can significantly increase the rate of reduction of the wound area one day after the start of administration, compared to the case of a subject (control) administered with sterile purified water. The wound area can be measured, for example, as follows. First, parafilm is applied to the wound, and the parafilm is cut along the boundary line of the wound, and the weight is measured. Next, the area of the wound is calculated based on the weight of the known parafilm.
一つの実施形態において、本発明の組成物は、間接投与された場合に、コントロールと比較して、投与開始から１日後、２日後、３日後、４日後または５日後に、創部面積の減少率を少なくとも５％、６％、７％、８％、９％、１０％、１１％、１２％、１３％、１４％、１５％、１６％、１７％、１８％、１９％または２０％、あるいはそれ以上増大させ得る。 In one embodiment, when the composition of the present invention is administered indirectly, the rate of reduction in wound area is 1 day, 2 days, 3 days, 4 days or 5 days after the start of administration compared to the control. At least 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19% or 20%, Or it can be increased further.
本発明において、被験体とは、本発明の組成物の投与を目的とする任意の生物（例えば、動物（たとえば、脊椎動物、無脊椎動物））をいう。好ましくは、脊椎動物（たとえば、メクラウナギ類、ヤツメウナギ類、軟骨魚類、硬骨魚類、両生類、爬虫類、鳥類、哺乳動物など）であり、より好ましくは、哺乳動物（例えば、単孔類、有袋類、貧歯類、皮翼類、翼手類、食肉類、食虫類、長鼻類、奇蹄類、偶蹄類、管歯類、有鱗類、海牛類、クジラ目、霊長類、齧歯類、ウサギ目など）であり得る。例示的な被験体としては、例えば、ウシ、ブタ、ウマ、ニワトリ、ネコ、イヌなどの動物が挙げられるがそれらに限定されない。さらに好ましくは、霊長類（たとえば、チンパンジー、ニホンザル、ヒト）が被験体であり得る。最も好ましくはヒトが被験体であり得る。 In the present invention, a subject refers to any organism (for example, animals (for example, vertebrates, invertebrates)) for the purpose of administering the composition of the present invention. Preferably, it is a vertebrate (for example, larvae, lampreys, cartilaginous fish, teleosts, amphibians, reptiles, birds, mammals, etc.), more preferably mammals (for example, single holes, marsupials, Rodents, crustaceans, wings, carnivores, carnivores, long noses, odd hoofs, even hoofs, rodents, scales, sea cattle, cetaceans, primates, rodents , Rabbit eyes, etc.). Exemplary subjects include, but are not limited to, animals such as cows, pigs, horses, chickens, cats, dogs and the like. More preferably, a primate (eg, chimpanzee, Japanese monkey, human) can be the subject. Most preferably a human can be the subject.
（羅漢果抽出物）
本発明において、羅漢果由来の成分は、代表的には羅漢果抽出物である。本発明において、羅漢果抽出物は、少なくとも１種の羅漢果配糖体を含む。羅漢果配糖体は、一般には黄色〜黄褐色粉末の形状である。羅漢果配糖体は、例えば、羅漢果の果実を洗浄し、粉砕した後、水で抽出して得られた抽出液について濾過、カラム吸収、カラム分離、回収、濃縮、乾燥などの工程を行なうことにより製造される。羅漢果配糖体は、日本国内で市販品として入手可能である。
(Rakan fruit extract)
In the present invention, the ingredients derived from Rahan fruit are typically Rahan fruit extracts. In the present invention, the Rahan fruit extract contains at least one Rahan fruit glycoside. Rahan fruit glycoside is generally in the form of yellow to tan powder. Rahan fruit glycosides, for example, by washing, pulverizing the fruit of Luo Han fruit and performing extraction, extraction, water, filtration, column absorption, column separation, recovery, concentration, drying, etc. Manufactured. Rahan fruit glycoside is commercially available in Japan.
本明細書中で、羅漢果配糖体とは、羅漢果に含まれる任意の配糖体を意味し、モグロサイドＶ、モグロサイドＩＶ、１１−オキソ−モグロサイドＶ、シアメノサイドＩなどの高甘味度を有する配糖体を包含する。本明細書において「配糖体」との用語は配糖体の混合物をも包含する。 In the present specification, Rahan fruit glycoside means any glycoside contained in Rahan fruit, and has a high sweetness such as Mogroside V, Mogroside IV, 11-oxo-mogroside V, and siamenoside I. Includes the body. As used herein, the term “glycoside” also includes a mixture of glycosides.
モグロサイドＶ、モグロサイドＩＶ、１１−オキソ−モグロサイドＶおよびシアメノサイドＩは、以下の一般式で示される。 Mogroside V, mogroside IV, 11-oxo-mogroside V and siamenoside I are represented by the following general formula.
１つの実施態様では、本発明の組成物は、医薬品、食品、または飼料のいずれかであり得る。好ましい実施態様では、本発明の組成物は食品であって、上記の羅漢果配糖体を添加する組成物を包含する。 In one embodiment, the composition of the invention can be either a pharmaceutical, a food, or a feed. In a preferred embodiment, the composition of the present invention is a food product, and includes a composition to which the above-mentioned Rahan fruit glycoside is added.
羅漢果配糖体は、天然の羅漢果植物体から抽出および単離してもよいし、合成してもよい。羅漢果配糖体は、当業者に公知の抽出および分離方法を用いて製造され得る。具体的には、例えば、羅漢果配糖体は、以下の方法により得ることができる。羅漢果の果実をメタノール抽出してメタノールエキスを得る。メタノールエキスを水と混合し、Ｎ−ヘキサンで脱脂する。脱脂後のメタノールエキスをカラムクロマトグラフィーにかけて８０％メタノール、１００％メタノール、およびアセトンで順次溶出し、粗配糖体画分である８０％メタノール画分を得る。得られた粗配糖体画分をメタノールに溶解した後、シリカゲルと混合し、乾燥し、次いでこのシリカゲルをクロロホルム−メタノールの混合溶媒で溶出することにより、配糖体画分を得る。得られた配糖体画分を液体クロマトグラフィーにかけることにより、さらに高純度の配糖体画分を入手し得る。本発明の組成物には、単独種または複数種の羅漢果配糖体が含有され得る。本発明の組成物は、医薬品、食品のいずれかであり得る。 The Rahan fruit glycoside may be extracted and isolated from a natural Rahan fruit plant, or may be synthesized. Rahan fruit glycosides can be produced using extraction and separation methods known to those skilled in the art. Specifically, for example, Rahan fruit glycoside can be obtained by the following method. Methanol extract of Rakan fruit is obtained. Methanol extract is mixed with water and degreased with N-hexane. The degreased methanol extract is subjected to column chromatography and eluted successively with 80% methanol, 100% methanol and acetone to obtain an 80% methanol fraction which is a crude glycoside fraction. The obtained crude glycoside fraction is dissolved in methanol, mixed with silica gel, dried, and then this silica gel is eluted with a chloroform-methanol mixed solvent to obtain a glycoside fraction. By subjecting the obtained glycoside fraction to liquid chromatography, a higher-purity glycoside fraction can be obtained. The composition of the present invention may contain one kind or a plurality of kinds of Rahan fruit glycosides. The composition of the present invention can be either a pharmaceutical product or a food product.
本発明の好ましい実施態様では、羅漢果の果実を収穫後に乾燥することなく、配糖体の抽出工程を行う。本発明に用いられる羅漢果の果実の水分含量は、代表的には約３０％、好ましくは約５０％以上、より好ましくは約７０％以上である。１つの好ましい実施態様では、羅漢果の果実の水分含量は、約７０％〜８０％である。完熟した羅漢果の果実を原料とすることが好ましい。当業者は、羅漢果が完熟していることを、果実の色合い、果実の形状などから経験的に判断し得る。本発明の羅漢果エキスは、当業者に公知の抽出および分離方法を用いて製造され得る。 In a preferred embodiment of the present invention, the glycoside extraction step is carried out without drying the fruits of Rakan fruit after harvesting. The water content of the fruits of Rakan fruit used in the present invention is typically about 30%, preferably about 50% or more, more preferably about 70% or more. In one preferred embodiment, the water content of the Luohan fruit is about 70% -80%. It is preferable to use a ripe fruit of Rakan fruit as a raw material. A person skilled in the art can empirically determine that Rakan fruit is ripe from the color of the fruit, the shape of the fruit, and the like. The Rakan fruit extract of the present invention can be produced using extraction and separation methods known to those skilled in the art.
具体的には、例えば、本発明の羅漢果エキスは、以下の方法により得られ得る。羅漢果の果実をメタノール抽出してメタノールエキスを得る。メタノールエキスを水と混合し、Ｎ−ヘキサンで脱脂する。脱脂後のメタノールエキスをカラムクロマトグラフィーにかけて８０％メタノール、１００％メタノール、およびアセトンで順次溶出し、粗配糖体画分である８０％メタノール画分を得る。得られた粗配糖体画分をメタノールに溶解した後、シリカゲルと混合し、乾燥し、次いでこのシリカゲルをクロロホルム−メタノールの混合溶媒で溶出することにより、配糖体画分を得る。得られた配糖体画分を液体クロマトグラフィーにかけることにより、さらに高純度の配糖体画分を入手し得る。 Specifically, for example, the Rakan fruit extract of the present invention can be obtained by the following method. Methanol extract of Rakan fruit is obtained. Methanol extract is mixed with water and degreased with N-hexane. The degreased methanol extract is subjected to column chromatography and eluted successively with 80% methanol, 100% methanol and acetone to obtain an 80% methanol fraction which is a crude glycoside fraction. The obtained crude glycoside fraction is dissolved in methanol, mixed with silica gel, dried, and then this silica gel is eluted with a chloroform-methanol mixed solvent to obtain a glycoside fraction. By subjecting the obtained glycoside fraction to liquid chromatography, a higher-purity glycoside fraction can be obtained.
（医薬組成物）
本発明の医薬組成物は、薬学的に許容される原材料をさらに含み得る。例としては、ラクトース、デキストロース、スクロース、ソルビトール、マンニトール、デンプン、アカシアゴム、リン酸カルシウム、アルギン酸塩、珪酸カルシウム、微結晶性セルロース、ポリビニルピロリドン、セルロース誘導体、トラガカント、ゼラチン、シロップ、ヒドロキシ安息香酸メチル、タルク、ステアリン酸マグネシウム、水、鉱油などが挙げられる。本発明の医薬組成物は、これらの原材料を単独種または複数種含み得る。
(Pharmaceutical composition)
The pharmaceutical composition of the present invention may further comprise pharmaceutically acceptable raw materials. Examples include lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia gum, calcium phosphate, alginate, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose derivatives, tragacanth, gelatin, syrup, methyl hydroxybenzoate, talc , Magnesium stearate, water, mineral oil and the like. The pharmaceutical composition of the present invention may contain one or more of these raw materials.
本発明の医薬組成物は、潤沢剤、乳化剤、懸濁化剤、酸化防止剤、防腐剤、甘味剤および香味剤など、ならびに水溶性ビタミン類および油溶性ビタミン類などを含む他の成分の１種以上を含み得る。 The pharmaceutical composition of the present invention is one of other ingredients including a lubricant, an emulsifier, a suspending agent, an antioxidant, an antiseptic, a sweetener and a flavoring agent, and water-soluble vitamins and oil-soluble vitamins. May contain more than species.
本発明の医薬組成物は、当該分野で周知の方法によって製造される。例えば、純粋な羅漢果配糖体を添加する工程を包含する方法によって製造してもよいし、羅漢果配糖体を含有する組成物を添加する工程を包含する方法によって製造してもよい。 The pharmaceutical composition of the present invention is produced by methods well known in the art. For example, it may be produced by a method including a step of adding pure Luohan fruit glycoside, or may be produced by a method including a step of adding a composition containing Luohan fruit glycoside.
本発明の医薬組成物の形態は、特に限定されない。本発明の医薬組成物の形態の例としては、錠剤、丸剤、粉剤、シロップ剤、乳濁剤、液剤、懸濁剤、ゼラチンカプセル剤などの形態；スプレー剤などの形態を挙げることができる。スプレー剤などの形態の医薬組成物は、鼻内などの経路によっても投与し得る。 The form of the pharmaceutical composition of the present invention is not particularly limited. Examples of the form of the pharmaceutical composition of the present invention include forms such as tablets, pills, powders, syrups, emulsions, solutions, suspensions, gelatin capsules, and the like; sprays and the like. . Pharmaceutical compositions in the form of sprays and the like can also be administered by routes such as intranasal.
以下に本発明の医薬組成物の一般的な調製法を示す。 The general preparation method of the pharmaceutical composition of this invention is shown below.
本発明の、羅漢果由来成分含有組成物は、必要に応じて、薬学的に受容可能なキャリアと配合し、経口的に投与することもできるし、注射剤、懸濁剤、溶液剤、スプレー剤等の液状製剤として非経口的に投与することができる。薬学的に受容可能なキャリアとしては、賦形剤、滑沢剤、結合剤、崩壊剤、崩壊阻害剤、吸収促進剤、吸着剤、保湿剤、安定化剤、溶剤、溶解補助剤、懸濁化剤、等張化剤、緩衝剤、無痛化剤等が挙げられる。また、必要に応じ、防腐剤、抗酸化剤、着色剤、甘味剤等の製剤添加物を用いることができる。また、本発明の組成物には、羅漢果由来の成分以外の物質を配合することも可能である。 The composition containing the ingredients derived from Rahan fruit of the present invention can be blended with a pharmaceutically acceptable carrier, if necessary, and orally administered, or an injection, suspension, solution, or spray. It can be administered parenterally as a liquid formulation. Pharmaceutically acceptable carriers include excipients, lubricants, binders, disintegrants, disintegration inhibitors, absorption enhancers, adsorbents, humectants, stabilizers, solvents, solubilizers, suspensions Agents, tonicity agents, buffers, soothing agents and the like. In addition, formulation additives such as preservatives, antioxidants, colorants, sweeteners and the like can be used as necessary. Moreover, it is also possible to mix | blend substances other than the component derived from Rakan fruit in the composition of this invention.
賦形剤としては、例えば、グルコース、ラクトース、スクロース、Ｄ−マンニトール、結晶セルロース、デンプン、炭酸カルシウム、軽質無水ケイ酸、塩化ナトリウム、カオリンおよび尿素等が挙げられる。 Examples of the excipient include glucose, lactose, sucrose, D-mannitol, crystalline cellulose, starch, calcium carbonate, light anhydrous silicic acid, sodium chloride, kaolin and urea.
吸収促進剤としては、例えば、第四級アンモニウム塩基類およびラウリル硫酸ナトリウム等が挙げられるがそれらに限定されない。 Examples of the absorption promoter include, but are not limited to, quaternary ammonium bases and sodium lauryl sulfate.
安定化剤としては、例えば、ヒト血清アルブミン、ラクトース等が挙げられるがそれらに限定されない。 Examples of the stabilizer include, but are not limited to, human serum albumin and lactose.
液状製剤における溶剤の好適な例としては、注射用水、アルコール、プロピレングリコール、マクロゴール、ゴマ油およびトウモロコシ油等が挙げられる。 Preferable examples of the solvent in the liquid preparation include water for injection, alcohol, propylene glycol, macrogol, sesame oil and corn oil.
液状製剤における溶解補助剤の好適な例としては、ポリエチレングリコール、プロピレングリコール、Ｄ−マンニトール、安息香酸ベンジル、エタノール、トリスアミノメタン、コレステロール、トリエタノールアミン、炭酸ナトリウムおよびクエン酸ナトリウム等が挙げられるがそれらに限定されない。 Preferable examples of the solubilizer in the liquid preparation include polyethylene glycol, propylene glycol, D-mannitol, benzyl benzoate, ethanol, trisaminomethane, cholesterol, triethanolamine, sodium carbonate and sodium citrate. It is not limited to them.
液状製剤における懸濁化剤の好適な例としては、ステアリルトリエタノールアミン、ラウリル硫酸ナトリウム、ラウリルアミノプロピオン酸、レシチン、塩化ベンザルコニウム、塩化ベンゼトニウム、モノステアリン酸グリセリン等の界面活性剤、例えば、ポリビニルアルコール、ポリビニルピロリドン、カルボキシメチルセルロースナトリウム、メチルセルロース、ヒドロキシメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース等の親水性高分子等が挙げられるがそれらに限定されない。 Suitable examples of the suspending agent in the liquid preparation include surfactants such as stearyltriethanolamine, sodium lauryl sulfate, laurylaminopropionic acid, lecithin, benzalkonium chloride, benzethonium chloride, glyceryl monostearate, Examples include, but are not limited to, hydrophilic polymers such as polyvinyl alcohol, polyvinyl pyrrolidone, sodium carboxymethyl cellulose, methyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxyethyl cellulose, and hydroxypropyl cellulose.
液状製剤における等張化剤の好適な例としては、塩化ナトリウム、グリセリン、Ｄ−マンニトール等が挙げられるがそれらに限定されない。 Preferable examples of the isotonic agent in the liquid preparation include, but are not limited to, sodium chloride, glycerin, D-mannitol and the like.
液状製剤における緩衝剤の好適な例としては、リン酸塩、酢酸塩、炭酸塩およびクエン酸塩等の緩衝液等が挙げられるがそれらに限定されない。 Preferable examples of the buffer in the liquid preparation include, but are not limited to, buffers such as phosphate, acetate, carbonate and citrate.
液状製剤における無痛化剤の好適な例としては、ベンジルアルコール、塩化ベンザルコニウムおよび塩酸プロカイン等が挙げられるがそれらに限定されない。 Preferable examples of the soothing agent in the liquid preparation include, but are not limited to, benzyl alcohol, benzalkonium chloride, procaine hydrochloride and the like.
液状製剤における防腐剤の好適な例としては、パラオキシ安息香酸エステル類、クロロブタノール、ベンジルアルコール、２−フェニルエチルアルコール、デヒドロ酢酸、ソルビン酸等が挙げられるがそれらに限定されない。 Preferable examples of the preservative in the liquid preparation include, but are not limited to, paraoxybenzoic acid esters, chlorobutanol, benzyl alcohol, 2-phenylethyl alcohol, dehydroacetic acid, sorbic acid and the like.
液状製剤における抗酸化剤の好適な例としては、亜硫酸塩、アスコルビン酸、α−トコフェロールおよびシステイン等が挙げられるがそれらに限定されない。 Preferable examples of the antioxidant in the liquid preparation include, but are not limited to, sulfite, ascorbic acid, α-tocopherol and cysteine.
注射剤として調製する際には、液剤および懸濁剤は殺菌され、かつ血液または他の目的とする注入部位における媒体と等張であることが好ましい。通常、これらは、バクテリア保留フィルター等を用いるろ過、殺菌剤の配合または照射によって無菌化する。さらにこれらの処理後、凍結乾燥等の方法により固形物とし、使用直前に無菌水または無菌の注射用希釈剤（塩酸リドカイン水溶液、生理食塩水、ブドウ糖水溶液、エタノールまたはこれらの混合溶液等）を添加してもよい。 When prepared as an injection, solutions and suspensions are preferably sterilized and isotonic with blood or other media at the intended infusion site. Usually, these are sterilized by filtration using a bacteria retention filter or the like, blending with a bactericidal agent, or irradiation. Furthermore, after these treatments, solidify by freeze-drying or other methods, and add sterile water or sterile diluent for injection (lidocaine hydrochloride aqueous solution, physiological saline, aqueous glucose solution, ethanol, or a mixed solution thereof) just before use. May be.
さらに、必要ならば、医薬組成物は、着色料、保存剤、香料、矯味矯臭剤、甘味料等、ならびに他の薬剤を含んでいてもよい。 Furthermore, if necessary, the pharmaceutical composition may contain coloring agents, preservatives, flavors, flavoring agents, sweeteners, and the like, as well as other agents.
別の実施形態において、本発明において、注入は静脈内または皮下で行われ得る。全身投与されるとき、本発明において使用される医薬は、発熱物質を含まない、薬学的に受容可能な水溶液の形態であり得る。そのような薬学的に受容可能な組成物の調製は、ｐＨ、等張性、安定性などを考慮することにより、当業者は、容易に行うことができる。 In another embodiment, in the present invention, infusion can be performed intravenously or subcutaneously. When administered systemically, the medicament used in the present invention may be in the form of a pharmaceutically acceptable aqueous solution free of pyrogens. Such a pharmaceutically acceptable composition can be easily prepared by those skilled in the art by considering pH, isotonicity, stability and the like.
本発明の方法において使用される組成物の量は、使用目的、対象疾患（種類、重篤度など）、患者の年齢、体重、性別、既往歴、細胞の形態または種類などを考慮して、当業者が容易に決定することができる。本発明の方法を被験体（または患者）に対して施す頻度もまた、使用目的、対象疾患（種類、重篤度など）、患者の年齢、体重、性別、既往歴、および治療経過などを考慮して、当業者が容易に決定することができる。頻度としては、例えば、毎日−数ヶ月に１回（例えば、１週間に１回−１ヶ月に１回）の投与が挙げられる。１週間−１ヶ月に１回の投与を、経過を見ながら施すことが好ましい。 The amount of the composition used in the method of the present invention is determined in consideration of the purpose of use, the target disease (type, severity, etc.), the patient's age, weight, sex, medical history, cell morphology or type, etc. A person skilled in the art can easily determine. The frequency of applying the method of the present invention to a subject (or patient) also considers the purpose of use, target disease (type, severity, etc.), patient age, weight, gender, medical history, treatment course, etc. Thus, it can be easily determined by those skilled in the art. Examples of the frequency include administration every day to once every several months (for example, once a week to once a month). It is preferable to administer once a week to once a month while observing the course.
本発明において、羅漢果由来成分含有組成物の投与量は、被験体の年齢、体重、症状または投与方法などにより異なり、特に限定されないが、通常成人１日あたり、約５．０ｍｇ〜約１ｇなどであり得る。 In the present invention, the dose of the composition containing the ingredients derived from Rahan fruit varies depending on the age, weight, symptom or administration method of the subject and is not particularly limited, but is usually about 5.0 mg to about 1 g per day for an adult. possible.
本発明の医薬組成物に用いられる羅漢果配糖体は、広い用量範囲にわたって有効である。従って、羅漢果配糖体の一日あたりの用量の下限は、３．０ｍｇ、４．０ｍｇ、５．０ｍｇ、６．０ｍｇ、７．０ｍｇ、８．０ｍｇ、９．０ｍｇまたは１０．０ｍｇ、２０．０ｍｇ、３０．０ｍｇ、４０．０ｍｇ、５０．０ｍｇである。羅漢果配糖体の一日あたりの用量の上限は、５．０ｇ、１０．０ｇ、１１．０ｇ、１２．０ｇ、１３．０ｇ、１４．０ｇ、１５．０ｇ、１６．０ｇ、１７．０ｇ、１８．０ｇまたは１９．０ｇである。本発明において、羅漢果配糖体の一日当たりの用量の上限および下限は、上述の値の任意の組み合わせである。しかしながら、皮膚症状の治癒を促進する限り、この用量には限定されない。この用量を、１回または数回に分けて投与する。実際の用量は、処置を受ける対象の年齢、体重および症状の重篤度、ならびに選択した投与経路などを配慮した上で決定される。 The Rahan fruit glycoside used in the pharmaceutical composition of the present invention is effective over a wide dose range. Therefore, the lower limit of the daily dose of Rahan fruit glycoside is 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 7.0 mg, 8.0 mg, 9.0 mg or 10.0 mg, 20. 0 mg, 30.0 mg, 40.0 mg, and 50.0 mg. The upper limit of the daily dosage of Rahan fruit glycoside is 5.0 g, 10.0 g, 11.0 g, 12.0 g, 13.0 g, 14.0 g, 15.0 g, 16.0 g, 17.0 g, 18.0 g or 19.0 g. In the present invention, the upper limit and the lower limit of the daily dose of Rahan fruit glycoside are any combination of the above values. However, the dose is not limited as long as it promotes healing of skin symptoms. This dose is administered in one or several divided doses. The actual dose is determined in consideration of the age, weight and severity of symptoms of the subject to be treated, and the selected route of administration.
本発明の組成物が医薬組成物（医薬品）である場合、当該組成物のうち、当該作用を有する羅漢果配糖体の乾燥重量は、代表的には、下限は０．００１重量％、０．００２重量％、０．００３重量％、０．００４重量％、０．００５重量％、０．０１重量％。０．０５重量％または０．１重量％であり、上限は１０重量％、２０重量％、３０重量％、４０重量％、５０重量％、６０重量％、７０重量％、８０重量％、９０重量％または１００重量％であり得る。本発明において、羅漢果配糖体の乾燥重量の上限および下限は、上述の値の任意の組み合わせである。しかしながら、皮膚症状の治癒を促進する限り、この用量には限定されない。好ましくは０．００２重量％〜１重量％である。 When the composition of the present invention is a pharmaceutical composition (pharmaceutical), the dry weight of Rakan Glucose Glycoside having the action is typically 0.001% by weight at the lower limit, and 0. 002 wt%, 0.003% wt, 0.004 wt%, 0.005 wt%, 0.01 wt%. 0.05% or 0.1% by weight, and upper limit is 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% % Or 100% by weight. In the present invention, the upper limit and the lower limit of the dry weight of Rahan fruit glycoside are any combination of the above values. However, the dose is not limited as long as it promotes healing of skin symptoms. Preferably it is 0.002 to 1 weight%.
本発明の医薬組成物は、単独または他の治療剤と組み合わせて投与され得る。組み合わせは、例えば、混合物として同時に；同時にまたは並行してだが別々に；あるいは経時的のいずれかで投与され得る。例えば、本発明の医薬組成物は、公知の局所塗布用の皮膚症状治癒促進剤と組み合わせて投与され得る。 The pharmaceutical composition of the present invention may be administered alone or in combination with other therapeutic agents. The combination can be administered, for example, either simultaneously as a mixture; simultaneously or concurrently but separately; or over time. For example, the pharmaceutical composition of the present invention can be administered in combination with a known skin symptom healing accelerator for topical application.
本発明の医薬組成物による処置の終了は、処置の対象である皮膚症状に特徴的な臨床症状の消滅によって判断され得る。 The end of treatment with the pharmaceutical composition of the present invention can be judged by the disappearance of clinical symptoms characteristic of the skin symptoms to be treated.
（食品組成物）
本発明の組成物は、甘味および創傷治癒促進作用を有する食品そのもの、または調味料のような添加物として利用され得る（このような組成物を食品組成物という）。本発明の食品組成物は、健康食品、栄養補助食品、および特別用途食品（特定保健用食品）として利用され得る。
(Food composition)
The composition of the present invention can be used as a food itself having a sweetness and wound healing promoting effect, or as an additive such as a seasoning (such a composition is referred to as a food composition). The food composition of the present invention can be used as a health food, a dietary supplement, and a special-purpose food (a food for specified health use).
本発明の組成物が食品である場合、当該組成物のうち、作用を有する羅漢果配糖体の乾燥重量は、代表的には、下限は０．００１重量％、０．００２重量％、０．００３重量％、０．００４重量％、０．００５重量％、０．０１重量％。０．０５重量％または０．１重量％であり、上限は１０重量％、２０重量％、３０重量％、４０重量％、５０重量％、６０重量％、７０重量％、８０重量％、９０重量％または１００重量％であり得る。本発明において、羅漢果配糖体の乾燥重量の上限および下限は、上述の値の任意の組み合わせである。しかしながら、皮膚症状の治癒を促進する限り、この用量には限定されない。 When the composition of the present invention is a food product, the dry weight of Rakan fruit glycoside having an action in the composition is typically 0.001% by weight, 0.002% by weight, 0.00% by weight. 003 wt%, 0.004 wt%, 0.005 wt%, 0.01 wt%. 0.05% or 0.1% by weight, and upper limit is 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% % Or 100% by weight. In the present invention, the upper limit and the lower limit of the dry weight of Rahan fruit glycoside are any combination of the above values. However, the dose is not limited as long as it promotes healing of skin symptoms.
本発明の食品組成物は、当該分野で通常使用される食品原料をさらに含み得る。食品原料の例としては、ラクトース、デキストロース、スクロース、ソルビトール、マンニトール、リンゴファイバー、大豆ファイバー、肉エキス、黒酢エキス、ゼラチン、コーンスターチ、蜂蜜、動植物油脂、多糖類、穀物、野菜、果菜、果物、肉、卵、乳製品、海藻などおよびそれらの加工品が挙げられる。本発明の組成物は、これらの食品原料を単独種または複数種含み得る。 The food composition of the present invention may further contain food ingredients that are usually used in the art. Examples of food ingredients include lactose, dextrose, sucrose, sorbitol, mannitol, apple fiber, soybean fiber, meat extract, black vinegar extract, gelatin, corn starch, honey, animal and vegetable oils, polysaccharides, grains, vegetables, fruit vegetables, fruits, Examples include meat, eggs, dairy products, seaweed, and processed products thereof. The composition of the present invention may contain one or more of these food ingredients.
本発明の食品組成物は、上記の医薬品の場合と同様に、上記の食品原料に加えて、潤沢剤、乳化剤、懸濁化剤、酸化防止剤、防腐剤、甘味剤および香味剤などの成分の１種以上をさらに含み得る。また、水溶性ビタミン類および油溶性ビタミン類などを含む他の成分をさらに含んでいてもよい。当業者は、羅漢果配糖体の作用を妨げることのない適切な成分を容易に選択し得る。 The food composition of the present invention is a component such as a lubricant, an emulsifier, a suspending agent, an antioxidant, an antiseptic, a sweetener, and a flavoring agent in addition to the above-mentioned food ingredients, as in the case of the above-mentioned pharmaceutical product. One or more of the following. Further, it may further contain other components including water-soluble vitamins and oil-soluble vitamins. A person skilled in the art can easily select an appropriate ingredient that does not interfere with the action of the Rahan fruit glycoside.
本発明の食品組成物は、当該分野で周知の方法によって製造される。例えば、作用を有する純粋な羅漢果配糖体を添加する工程を包含する方法によって製造してもよいし、作用を有する羅漢果配糖体を含有する組成物を添加する工程を包含する方法によって製造してもよい。 The food composition of the present invention is produced by a method well known in the art. For example, it may be produced by a method including a step of adding a pure Rakan fruit glycoside having an action, or may be produced by a method including a step of adding a composition containing an Rakha fruit glycoside having an action. May be.
本発明の食品組成物の形態は特に限定されない。本発明の食品組成物の形態の例としては、顆粒、錠菓、ゼリー、飴、飲料などが挙げられる。 The form of the food composition of the present invention is not particularly limited. Examples of the form of the food composition of the present invention include granules, tablet confectionery, jelly, rice cake, and beverage.
本発明の食品組成物は、必要に応じて摂取され、薬膳などのように毎日毎食摂取してもよいし、１日１回、１週間に１回、１ヶ月に１回のようなさらに長期の間隔をおいて摂取してもよい。好ましくは、１日３食摂取される。 The food composition of the present invention is ingested as necessary, and may be ingested every day like a medicine basket, or once a day, once a week, once a month, etc. It may be taken at long intervals. Preferably, three meals are taken per day.
本発明の食品組成物に用いられる羅漢果配糖体は、広い用量範囲にわたって有効である。従って、羅漢果配糖体の一日あたりの用量の下限は、３．０ｍｇ、４．０ｍｇ、５．０ｍｇ、６．０ｍｇ、７．０ｍｇ、８．０ｍｇ、９．０ｍｇまたは１０．０ｍｇ、２０．０ｍｇ、３０．０ｍｇ、４０．０ｍｇ、５０．０ｍｇである。羅漢果配糖体の一日あたりの用量の上限は、５．０ｇ、１０．０ｇ、１１．０ｇ、１２．０ｇ、１３．０ｇ、１４．０ｇ、１５．０ｇ、１６．０ｇ、１７．０ｇ、１８．０ｇまたは１９．０ｇである。本発明において、羅漢果配糖体の一日当たりの用量の上限および下限は、上述の値の任意の組み合わせである。しかしながら、皮膚症状の治癒を促進する限り、この用量には限定されない。この用量を、１回または数回に分けて服用するのが好ましいが、必ずしもこれに限定されない。実際の用量は、食品を摂取する対象の年齢、体重および症状の重篤度などを配慮した上で決定される。 The Rahan fruit glycoside used in the food composition of the present invention is effective over a wide dose range. Therefore, the lower limit of the daily dose of Rahan fruit glycoside is 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 7.0 mg, 8.0 mg, 9.0 mg or 10.0 mg, 20. 0 mg, 30.0 mg, 40.0 mg, and 50.0 mg. The upper limit of the daily dosage of Rahan fruit glycoside is 5.0 g, 10.0 g, 11.0 g, 12.0 g, 13.0 g, 14.0 g, 15.0 g, 16.0 g, 17.0 g, 18.0 g or 19.0 g. In the present invention, the upper limit and the lower limit of the daily dose of Rahan fruit glycoside are any combination of the above values. However, the dose is not limited as long as it promotes healing of skin symptoms. This dose is preferably taken once or divided into several doses, but is not necessarily limited thereto. The actual dose is determined in consideration of the age, weight, and severity of symptoms of the subject taking the food.
本明細書において引用された、科学文献、特許、特許出願などの参考文献は、その全体が、各々具体的に記載されたのと同じ程度に本明細書において参考として援用される。 References such as scientific literature, patents and patent applications cited herein are hereby incorporated by reference in their entirety to the same extent as if each was specifically described.
以上、本発明を、理解の容易のために好ましい実施形態を示して説明してきた。以下に、実施例に基づいて本発明を説明するが、上述の説明および以下の実施例は、例示の目的のみに提供され、本発明を限定する目的で提供したのではない。従って、本発明の範囲は、本明細書に具体的に記載された実施形態にも実施例にも限定されず、請求の範囲によってのみ限定される。 The present invention has been described with reference to the preferred embodiments for easy understanding. In the following, the present invention will be described based on examples, but the above description and the following examples are provided only for the purpose of illustration, not for the purpose of limiting the present invention. Accordingly, the scope of the present invention is not limited to the embodiments or examples specifically described in this specification, but is limited only by the scope of the claims.
以下、実施例により本発明を更に詳細に説明するが、本発明は以下の実施例のみに限定されるものではない。 EXAMPLES Hereinafter, although an Example demonstrates this invention further in detail, this invention is not limited only to a following example.
（調製実施例：羅漢果抽出物の調製）
羅漢果の未乾燥果実をメタノールで抽出し、メタノールエキスを得た。メタノールエキスを水と混合し、Ｎ−ヘキサンで脱脂した。脱脂されたメタノールエキスを、多孔性樹脂（ＤＩＡＩＯＮ ＨＰ−２０カラムクロマト、三菱化学製）にかけ、８０％メタノール、１００％メタノール、およびアセトンの順に溶出させ、粗配糖体画分である８０％メタノール画分を得た。
(Preparation Example: Preparation of Rahan fruit extract)
The undried fruit of Rakan fruit was extracted with methanol to obtain a methanol extract. Methanol extract was mixed with water and degreased with N-hexane. The defatted methanol extract is applied to a porous resin (DIAION HP-20 column chromatography, manufactured by Mitsubishi Chemical) and eluted in the order of 80% methanol, 100% methanol and acetone, and 80% methanol which is a crude glycoside fraction. A fraction was obtained.
（比較例１：滅菌精製水を経口摂取させたときの創傷治癒過程）
４週齢のＩＣＲマウス（雄性）に、背部に直径６ｍｍ大の円形の開放創を作成した。その創部にパラフィルムをあて、写し取った創部の境界線に沿ってパラフィルムを切り取り、その重量を測定した。面積既知のパラフィルムの重量を基準に、その創部の面積を算出した。これを、０日目の創部面積とした。
(Comparative example 1: wound healing process when sterilized purified water is orally ingested)
A 4-week-old ICR mouse (male) was created with a circular open wound with a diameter of 6 mm on the back. Parafilm was applied to the wound part, the parafilm was cut along the boundary line of the copied wound part, and the weight was measured. The area of the wound was calculated based on the weight of the known parafilm. This was defined as the wound area on the 0th day.
開放創作製後に、滅菌精製水の経口投与を開始した。１日あたり０．２ｍＬ、５日間投与を行った。その間、創部面積を上述の方法で毎日測定した。結果を以下の表１に示す。 After the creation of the open wound, oral administration of sterile purified water was started. Administration was performed at 0.2 mL per day for 5 days. Meanwhile, the wound area was measured daily by the method described above. The results are shown in Table 1 below.
比較例１の創部面積の測定結果を、表１に示す。 The measurement results of the wound area of Comparative Example 1 are shown in Table 1.
４週齢のＩＣＲマウス（雄性）に、背部に直径６ｍｍ大の円形の開放創を作成した。これを、０日目の創部面積とした。
A 4-week-old ICR mouse (male) was created with a circular open wound with a diameter of 6 mm on the back. This was defined as the wound area on the 0th day.
開放創作成後に、羅漢果抽出物（羅漢果抽出エキス）の経口投与を開始した。羅漢果抽出エキスとして、羅漢果配糖体濃度として７０重量％の羅漢果配糖体粉末試料を１日あたり９ｍｇ、又は４．５ｍｇとなるように０．２ｍＬの滅菌精製水に溶解させた。これを５日間経口投与した。その間、創部の面積を毎日測定した。 After the creation of the open wound, oral administration of Rahan fruit extract (Rakan fruit extract) was started. As an extract of Rahan fruit, 70% by weight of Rakan fruit glycoside powder sample was dissolved in 0.2 mL of sterilized purified water so as to be 9 mg or 4.5 mg per day. This was orally administered for 5 days. Meanwhile, the area of the wound was measured daily.
創部面積の測定結果を、表２に示す。 Table 2 shows the measurement results of the wound area.
比較例１（表１）の結果と実施例１（表２）の結果を、図１および図２にまとめた。対照群と比較すると羅漢果抽出エキスを経口投与したラットの創部面積は１日目で飛躍的に縮小し、統計学的な有意差も認められた（有意水準１％）。この結果から、本発明の組成物の投与により、創傷または潰瘍などの、皮膚の上皮組織における損傷における治癒過程の初期段階である炎症期（マクロファージの活性化、タンパク分解から、壊死組織の除去などが起こる）が速やかに、かつ効率的に経過したことが示唆された。この効果は２日目以降も持続され、創傷治癒が明らかに促進されていることが示された。また、４．５ｍｇ／ｄａｙの投与量においても同様の創傷治癒促進の傾向が認められた。５日目にも統計学的な有意差が認められた（有意水準５％）。 The results of Comparative Example 1 (Table 1) and Example 1 (Table 2) are summarized in FIG. 1 and FIG. Compared with the control group, the wound area of rats administered orally with Rakan extract was dramatically reduced on the first day, and a statistically significant difference was also observed (significance level 1%). From this result, the administration of the composition of the present invention, the inflammatory phase (removal of necrotic tissue from macrophage activation, proteolysis, etc.), which is the initial stage of the healing process in damage to epithelial tissues of the skin, such as wounds or ulcers, etc. It was suggested that this occurred quickly and efficiently. This effect persisted from day 2 onwards, indicating that wound healing was clearly promoted. Moreover, the same tendency of wound healing promotion was recognized also in the dosage of 4.5 mg / day. A statistically significant difference was also observed on the fifth day (significance level 5%).
（実施例２：種々の羅漢果抽出物の効果確認例）
本発明の羅漢果由来成分含有組成物は、モグロサイドＩＶ、モグロサイドＶ、シアメノサイドＩ、および１１−オキソ−モグロサイドＶからなる群より選択される少なくとも１種の羅漢果配糖体を含む。この配糖体の種類および組み合わせのパターンを変えることによって、種々の羅漢果抽出物を調製する。
(Example 2: Example of confirming effects of various rakan fruit extracts)
The Rakan fruit-derived component-containing composition of the present invention comprises at least one Rahan fruit glycoside selected from the group consisting of Mogroside IV, Mogroside V, Siamenoside I, and 11-oxo-mogroside V. By varying the types of glycosides and the pattern of combinations, various rahan fruit extracts are prepared.
本実施例ではまた、羅漢果配糖体として、モグロサイドＩＶ、モグロサイドＶ、シアメノサイドＩ、または１１−オキソ−モグロサイドＶのうち１種のみを含む組成物、羅漢果配糖体として、モグロサイドＩＶ、モグロサイドＶ、シアメノサイドＩ、または１１−オキソ−モグロサイドＶのうち２種を含む組成物、モグロサイドＩＶ、モグロサイドＶ、シアメノサイドＩ、または１１−オキソ−モグロサイドＶのうち３種を含む組成物、あるいはモグロサイドＩＶ、モグロサイドＶ、シアメノサイドＩ、または１１−オキソ−モグロサイドＶの４種全てを含む組成物を調製し、それらについて実施例１と同様の実験を行って、その皮膚の上皮組織における損傷の治癒促進効果を測定する。 In this Example, the composition containing only one of mogroside IV, mogroside V, siamenoside I, or 11-oxo-mogroside V is used as the rahan fruit glycoside, and mogroside IV, mogroside V, A composition comprising two of siamenoside I or 11-oxo-mogroside V, a composition comprising three of mogroside IV, mogroside V, siamenoside I or 11-oxo-mogroside V, or mogroside IV, mogroside V , Siamenoside I, or 11-oxo-mogroside V are prepared, and the same experiment as in Example 1 is performed to measure the effect of promoting the healing of damage in the epithelial tissue of the skin. .
本実施例ではまた、羅漢果果実から熱水抽出しただけの粗抽出ペーストエキス（羅漢果配糖体重量％として２％〜５％）、およびこのペーストエキスから羅漢果配糖体画分を濃縮したエキス粉末（羅漢果配糖体重量％として３０％）を調製し、それらについて実施例１と同様の実験を行って、その皮膚の上皮組織における損傷の治癒促進効果を測定する。 In the present example, a crude extract paste extract (2% to 5% by weight as Luhan fruit glycoside weight%) just extracted with hot water from Luhan fruit and extract powder obtained by concentrating the Luhan fruit glycoside fraction from this paste extract (30% as the Rakan fruit glycoside weight%) is prepared, and the same experiment as in Example 1 is performed on them to measure the effect of promoting the healing of damage in the epithelial tissue of the skin.
（実施例３：種々の量の羅漢果抽出物の効果確認例）
本実施例では、種々の量の羅漢果抽出物について、実施例１と同様の実験を行い、その創傷治癒促進効果を測定する。
(Example 3: Example of confirming the effect of various amounts of Rakan fruit extract)
In this example, the same experiment as in Example 1 is performed on various amounts of Rakan fruit extract, and the wound healing promoting effect is measured.
羅漢果抽出エキスとして、羅漢果配糖体濃度として７０重量％の羅漢果配糖体粉末試料を、実施例１において実験した量よりも多い量（すなわち、１日あたり９ｍｇよりも多い量、例えば、１３．５ｍｇ、１８ｍｇなど）、または実施例１において実験した量よりも少ない量（すなわち、１日あたり４．５ｍｇよりも少ない量、例えば、１ｍｇ、３ｍｇなど）となるように０．２ｍＬの滅菌精製水に溶解させた。これらの組成物を用いて、実施例１と同様の実験を行って、その皮膚の上皮組織における損傷の治癒促進効果を測定する。 As the Rakan fruit extract, an amount of Luhan fruit glycoside powder sample having a Luohan fruit glycoside concentration of 70% by weight is larger than the amount tested in Example 1 (that is, an amount larger than 9 mg per day, for example, 13. 5 mL, 18 mg, etc.) or 0.2 mL of sterile purified water so that it is less than the amount tested in Example 1 (ie, less than 4.5 mg per day, eg, 1 mg, 3 mg, etc.) Dissolved in. Using these compositions, the same experiment as in Example 1 is performed to measure the effect of promoting healing of damage in the epithelial tissue of the skin.
（実施例４：他の間接投与＜経鼻投与、経管投与または経腸投与＞例）
本実施例では、経口投与以外の間接投与による、本発明の組成物の創傷の治癒促進効果を測定する。
(Example 4: Other indirect administration <nasal administration, tube administration or enteral administration> example)
In this example, the wound healing promotion effect of the composition of the present invention by indirect administration other than oral administration is measured.
羅漢果抽出エキスとして、羅漢果配糖体濃度として７０重量％の羅漢果配糖体粉末試料を１日あたり９ｍｇ、又は４．５ｍｇとなるように０．２ｍＬの滅菌精製水に溶解する。これを５日間経鼻投与、経管投与または経腸投与する。その間、創部の面積を毎日測定し、実施例１において得られたデータと比較する。 As a rakan fruit extract, a 70% by weight rahan fruit glycoside powder sample is dissolved in 0.2 mL of sterilized purified water so as to be 9 mg or 4.5 mg per day. This is administered nasally, tube, or enterally for 5 days. Meanwhile, the wound area is measured daily and compared with the data obtained in Example 1.
（実施例５：羅漢果抽出物の製剤例）
本発明の医薬組成物の形態は、特に限定されない。本発明の医薬組成物の形態の例としては、錠剤、丸剤、粉剤、シロップ剤、乳濁剤、液剤、懸濁剤、ゼラチンカプセル剤などの形態；スプレー剤などの形態を挙げることができる。本実施例では、これらの製剤化の例を示す。
(Example 5: Formulation of Rahan fruit extract)
The form of the pharmaceutical composition of the present invention is not particularly limited. Examples of the form of the pharmaceutical composition of the present invention include forms such as tablets, pills, powders, syrups, emulsions, solutions, suspensions, gelatin capsules, and the like; sprays and the like. . In the present Example, the example of these formulation is shown.
処方例１
医薬品錠剤 （質量％）
１．羅漢果抽出物（羅漢果配糖体３０％含有） １．０％
２．乳 糖 ７８．０％
３．コーンスターチ ２０．０％
４．グアーガム １．０％
医薬品カプセル剤 （質量％）
１．羅漢果配糖体（羅漢果配糖体３０％含有） ６．７％
２．α化澱粉 ９３．３％
上記成分を十分混合後、カプセル（１５０ｍｇ／カプセル）に充填する。
Formulation Example 1
Pharmaceutical tablets (mass%)
1. Rahan fruit extract (containing 30% Rahan fruit glycoside) 1.0%
2. Lactose 78.0%
3. Cornstarch 20.0%
4). Guar gum 1.0%
Pharmaceutical capsules (mass%)
1. Rahan fruit glycoside (containing 30% Rahan fruit glycoside) 6.7%
2. Pregelatinized starch 93.3%
After sufficiently mixing the above ingredients, the capsules (150 mg / capsule) are filled.
（実施例６：羅漢果抽出物の食品製造例）
本発明の食品組成物の形態は特に限定されない。本発明の食品組成物の形態の例としては、顆粒、錠菓、ゼリー、飴、飲料などが挙げられる。本実施例では、これらの食品の製造例を示す。
(Example 6: Example of food production of Rakan fruit extract)
The form of the food composition of the present invention is not particularly limited. Examples of the form of the food composition of the present invention include granules, tablet confectionery, jelly, rice cake, and beverage. In this example, production examples of these foods are shown.
処方例１
酸乳飲料 重量％
１．ブドウ糖液糖 １０．０％
２．発酵乳 １０．０％
３．羅漢果抽出物（羅漢果配糖体３０％含有） ０．１％
４．５０％乳酸 ０．１％
５．カラメル色素 適量
６．香料 適量
７．水にて １００％
調合液を均質化（１５０ｋｇ／ｃｍ２）した後、９０℃、１０分間殺菌し、ホットパック充填する。
Formulation Example 1
Sour milk drink
1. Glucose liquid sugar 10.0%
2. Fermented milk 10.0%
3. Rahan fruit extract (containing 30% Rahan fruit glycoside) 0.1%
4.50% lactic acid 0.1%
5. Caramel color Perfume appropriate amount 7. 100% in water
The mixture is homogenized (150 kg / cm 2 ), sterilized at 90 ° C. for 10 minutes, and filled in a hot pack.
処方例２
グレープゼリー 重量％
１．グラニュー糖 １０．０％
２．ゼリー用ゲル化剤 １．０％
３．羅漢果抽出物（羅漢果配糖体３０％含有） ０．２％
４．クエン酸三ナトリウム ０．１％
５．乳酸カルシウム ０．０５％
６．濃縮グレープ果汁 ２．５％
７．クエン酸 ０．２％
８．香料 適量
水を攪拌しながら１〜４の粉体混合物を添加し、８０℃１０分間攪拌溶解する。５（乳酸カルシウム）は、予め熱湯溶解したのちに添加し、引き続き６〜８を添加する。全量補正し、容器に充填する。８５℃で３０分間殺菌する。
Formulation example 2
Grape jelly wt%
1. Granulated sugar 10.0%
2. Gelling agent for jelly 1.0%
3. Rahan fruit extract (containing 30% Rahan fruit glycoside) 0.2%
4). Trisodium citrate 0.1%
5. Calcium lactate 0.05%
6). Concentrated grape juice 2.5%
7). Citric acid 0.2%
8). Fragrance Add 1 to 4 powder mixture while stirring an appropriate amount of water, and dissolve by stirring at 80 ° C. for 10 minutes. 5 (calcium lactate) is added after dissolving in hot water in advance, followed by 6-8. Correct the total amount and fill the container. Sterilize at 85 ° C for 30 minutes.
以上のように、本発明の好ましい実施形態を用いて本発明を例示してきたが、本発明は、特許請求の範囲によってのみその範囲が解釈されるべきであることが理解される。本明細書において引用した特許、特許出願および文献は、その内容自体が具体的に本明細書に記載されているのと同様にその内容が本明細書に対する参考として援用されるべきである。 As mentioned above, although this invention has been illustrated using preferable embodiment of this invention, it is understood that the scope of this invention should be construed only by the claims. The patents, patent applications, and literature cited herein are to be incorporated by reference in their entirety, as if the contents themselves were specifically described herein.
本発明により、皮膚症状治癒に関わる生体の再生能を積極的に促進し、皮膚症状完治までの時間の短縮を達成し、且つ副作用の危険が有意に低減された安全性の高い組成物が提供され、医薬品製造、食品製造業において、利用価値が高いと考えられる。 The present invention provides a highly safe composition that actively promotes the regenerative ability of living bodies involved in healing skin symptoms, shortens the time to complete skin symptoms, and significantly reduces the risk of side effects. In the pharmaceutical manufacturing and food manufacturing industries, the utility value is considered high.
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| JP6814182B2 (en) * | 2018-09-10 | 2021-01-13 | アナリティコン ディスカバリー ゲーエムベーハー | A novel tripelten glycoside used as a sweetener or sweetener |
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