JP2021172640A - Autophagy activator - Google Patents
Autophagy activator Download PDFInfo
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- JP2021172640A JP2021172640A JP2020080580A JP2020080580A JP2021172640A JP 2021172640 A JP2021172640 A JP 2021172640A JP 2020080580 A JP2020080580 A JP 2020080580A JP 2020080580 A JP2020080580 A JP 2020080580A JP 2021172640 A JP2021172640 A JP 2021172640A
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- autophagy
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- activator
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Abstract
Description
本発明は、生体内でオートファジーを活性化できるオートファジー活性化剤に関する。 The present invention relates to an autophagy activator capable of activating autophagy in vivo.
オートファジーとは、細胞質の一部が隔離膜によって取り囲まれてオートファゴソームとよばれる膜構造を形成し、このオートファゴソームがリソソームと融合してオートリソソームとなって、老廃物や不要な蛋白質等を分解する細胞内分解機構である。近年、オートファジーが、生体において生理学的又は病理学的機能に重要な役割を担っており、オートファジー活性の低下が一因となっている疾患や症状が多数報告されている。このような疾患や症状としては、例えば、神経変性疾患、感染症、炎症性疾患、免疫疾患、腎疾患、呼吸器疾患、眼疾患、筋疾患、ミトコンドリア病、生活習慣病、皮膚老化、その他の各種疾患又は症状等がある。 In autophagy, a part of the cytoplasm is surrounded by an isolation membrane to form a membrane structure called autophagosome, and this autophagosome fuses with lysosome to become autophagosome, which produces waste products and unnecessary proteins. It is an intracellular degradation mechanism that degrades. In recent years, autophagy plays an important role in physiological or pathological functions in the living body, and many diseases and symptoms contributed by a decrease in autophagy activity have been reported. Such diseases and symptoms include, for example, neurodegenerative diseases, infectious diseases, inflammatory diseases, immune diseases, renal diseases, respiratory diseases, eye diseases, muscle diseases, mitochondrial diseases, lifestyle diseases, skin aging, and others. There are various diseases or symptoms.
そこで、従来、オートファジー活性の低下が一因となっている疾患や症状の予防又は治療のために、オートファジーを活性化する有効成分を配合した医薬や食品が種々開発されている。例えば、特許文献１には、メマンチン、クレマスチン及びそれらの塩をオートファジー誘導剤として使用できることが報告されている。特許文献２には、特定のピロロキノリンキノンをオートファジー誘導剤として使用できることが報告されている。特許文献３には、環状グルコオリゴ糖をオートファジー誘導剤として使用できることが報告されている。特許文献４には、梅肉エキスの疎水性有機溶媒抽出物又は梅肉エキスの中和処理物は、オートファジー誘導用飲食品として使用できることが開示されている。しかしながら、製剤処方の多様化、オートファジー活性化作用の更なる向上等に対応するために、オートファジーを活性化させる新たな有効成分の開発が望まれている。 Therefore, conventionally, various medicines and foods containing an active ingredient that activates autophagy have been developed for the prevention or treatment of diseases and symptoms that are caused by a decrease in autophagy activity. For example, Patent Document 1 reports that memantine, clemastine and salts thereof can be used as autophagy inducers. Patent Document 2 reports that a specific pyrroloquinoline quinone can be used as an autophagy inducer. Patent Document 3 reports that cyclic glucooligosaccharides can be used as autophagy inducers. Patent Document 4 discloses that the hydrophobic organic solvent extract of ume meat extract or the neutralized product of ume meat extract can be used as a food or drink for inducing autophagy. However, in order to cope with the diversification of pharmaceutical formulations and the further improvement of the autophagy activating action, it is desired to develop a new active ingredient that activates autophagy.
本発明の目的は、生体内でオートファジーを活性化できるオートファジー活性化剤を提供することである。 An object of the present invention is to provide an autophagy activator capable of activating autophagy in vivo.
本発明者は、前記課題を解決すべく鋭意検討を行ったところ、セージ、ウイキョウ、ソウハクヒ、チョウジ、ゲンチアナ、シャクヤク、及び／又は緑茶の抽出物には、優れたオートファジー活性化作用があり、オートファジー活性化剤の有効成分として使用できることを見出した。本発明は、かかる知見に基づいて、更に検討を重ねることにより完成したものである。 As a result of diligent studies to solve the above problems, the present inventor has found that the extracts of sage, fennel, sohakuhi, chouji, gentiana, gentian, sakuyaku, and / or green tea have an excellent autophagy activating effect. It has been found that it can be used as an active ingredient of an autophagy activator. The present invention has been completed by further studies based on such findings.
即ち、本発明は、下記に掲げる態様の発明を提供する。
項１． セージ、ウイキョウ、ソウハクヒ、チョウジ、ゲンチアナ、シャクヤク、及び緑茶よりなる群から選択される少なくとも１種の植物の抽出物を有効成分として含む、オートファジー活性化剤。
項２． 前記有効成分が、セージの葉の抽出物である、項１に記載のオートファジー活性化剤。
項３． 飲食品、医薬品、又は化粧料である、項１又は２に記載のオートファジー活性化剤。
That is, the present invention provides the inventions of the following aspects.
Item 1. An autophagy activator comprising an extract of at least one plant selected from the group consisting of sage, fennel, sohakuhi, chouji, gentiana, peony, and green tea as an active ingredient.
Item 2. Item 2. The autophagy activator according to Item 1, wherein the active ingredient is an extract of sage leaves.
Item 3. Item 2. The autophagy activator according to Item 1 or 2, which is a food or drink, a pharmaceutical product, or a cosmetic.
本発明のオートファジー活性化剤は、優れたオートファジーの活性化作用を有しており、更に飲食品、医薬品、化粧料等の様々な形態で提供できるので、オートファジーの活性低下が一因となって生じる疾患や症状を予防又は改善できる様々な製品の提供が可能になる。 The autophagy activator of the present invention has an excellent autophagy activating effect, and can be provided in various forms such as foods and drinks, pharmaceuticals, cosmetics, etc., which is partly due to the decrease in autophagy activity. It becomes possible to provide various products that can prevent or improve the diseases and symptoms that occur.
本発明のオートファジー活性化剤は、セージ、ウイキョウ、ソウハクヒ、チョウジ、ゲンチアナ、シャクヤク、及び緑茶よりなる群から選択される少なくとも１種の植物の抽出物を有効成分とすることを特徴とする。以下、本発明のオートファジー活性化剤について詳述する。 The autophagy activator of the present invention is characterized by containing an extract of at least one plant selected from the group consisting of sage, fennel, sohakuhi, chouji, gentiana, peony, and green tea as an active ingredient. Hereinafter, the autophagy activator of the present invention will be described in detail.
[有効成分]
セージとは、学名Ｓａｌｖｉａ ｏｆｆｉｃｉｎａｌｉsであり、シソ科アキギリ属の多年草または常緑低木である。本発明で使用されるセージ抽出物は、セージの葉、全草等の少なくとも葉を含む部位を抽出原料として抽出処理することにより得ることができる。
[Active ingredient]
Sage is a perennial or evergreen shrub of the genus Sage of the Labiatae family, with the scientific name Salvia officinalis. The sage extract used in the present invention can be obtained by performing an extraction treatment using a portion containing at least leaves such as sage leaves and whole plants as an extraction raw material.
ウイキョウとは、学名Ｆｏｅｎｉｃｕｌｕｍ ｖｕｌｇａｒｅであり、セリ科ウイキョウ属の多年生草本である。本発明で使用されるウイキョウ抽出物は、ウイキョウの果実、種等の部位（好ましくは果実）を抽出原料として抽出処理することにより得ることができる。 Fennels has the scientific name Foenicularum vulgare and is a perennial herb of the genus Fennels in the Umbelliferae family. The fennel extract used in the present invention can be obtained by performing an extraction treatment using fennel fruits, seeds and other parts (preferably fruits) as extraction raw materials.
ソウハクヒとは、マグワ（学名Ｍｏｒｕｓ ａｌｂａ）及びその他同属植物の根皮である。本発明で使用されるソウハクヒ抽出物は、ソウハクヒを抽出原料として抽出処理することにより得ることができる。 Morus alba (scientific name: Morus alba) and the root bark of other plants of the same genus. The Sohakuhi extract used in the present invention can be obtained by performing an extraction treatment using Sohakuhi as an extraction raw material.
チョウジとは、学名Ｓｙｚｙｇｉｕｍ ａｒｏｍａｔｉｃｕｍであり、フトモモ科の 常緑小高木である。本発明で使用されるチョウジ抽出物は、チョウジの蕾を抽出原料として抽出処理することにより得ることができる。 Clove is a scientific name, Syzygium aromaticum, and is an evergreen small tree of the Myrtaceae family. The clove extract used in the present invention can be obtained by performing an extraction treatment using clove buds as an extraction raw material.
ゲンチアナとは、学名Ｇｅｎｔｉａｎａ ｌｕｔｅａであり、リンドウ科の多年草である。本発明で使用されるゲンチアナ抽出物は、ゲンチアナの根、根茎等の部位（好ましくは根）を抽出原料として抽出処理することにより得ることができる。 Gentiana is a perennial plant of the Gentianaceae family with the scientific name Gentiana lutea. The gentiana extract used in the present invention can be obtained by performing an extraction treatment using a site (preferably root) of gentiana root, rhizome, etc. as an extraction raw material.
シャクヤクとは、学名Ｐａｅｏｎｉａ ａｌｂｉｆｌｏｒａであり、ボタン科の多年草である。本発明で使用されるシャクヤク抽出物は、シャクヤクの根を抽出原料として抽出処理することにより得ることができる。 Peony is the scientific name Paeonia albiflora and is a perennial plant of the Peony family. The peony extract used in the present invention can be obtained by performing an extraction treatment using peony root as an extraction raw material.
緑茶とは、チャノキ（学名Ｃａｍｅｌｌｉａ ｓｉｎｅｎｓｉｓ）の葉である。本発明で使用される緑茶抽出物は、緑茶を抽出原料として抽出処理することにより得ることができる。 Green tea is a leaf of tea plant (scientific name: Camellia sinensis). The green tea extract used in the present invention can be obtained by performing an extraction treatment using green tea as an extraction raw material.
本発明のオートファジー活性化剤は、有効成分として、セージ抽出物、ウイキョウ抽出物、ソウハクヒ抽出物、チョウジ抽出物、ゲンチアナ抽出物、シャクヤク抽出物、及び緑茶抽出物の中から１種の植物抽出物を選択して単独で使用してもよく、またこれらの中から２種以上の植物抽出物を組み合わせて使用してもよい。 The autophagy activator of the present invention contains one type of plant extract as an active ingredient from sage extract, uikyo extract, sohakuhi extract, chouji extract, gentiana extract, shakuyaku extract, and green tea extract. A product may be selected and used alone, or two or more kinds of plant extracts may be used in combination from these.
前記各植物抽出物を得るための抽出処理は、植物抽出物の製造に使用される一般的な抽出手法であればよい。また、前記各植物抽出物の抽出原料は、そのままの生の状態であってもよいが、必要に応じて、粉砕、切断、蒸熱、揉捻、乾燥、焙煎等の前処理に供されていてもよい。 The extraction process for obtaining each plant extract may be any general extraction method used for producing the plant extract. Further, the extraction raw material of each plant extract may be in a raw state as it is, but if necessary, it is subjected to pretreatment such as crushing, cutting, steaming, kneading, drying, roasting and the like. May be good.
抽出処理は、溶媒抽出処理、超臨界抽出処理、水蒸気蒸留処理等によって行うことができる。これらの中でも、好ましくは溶媒抽出処理が挙げられる。 The extraction treatment can be performed by a solvent extraction treatment, a supercritical extraction treatment, a steam distillation treatment or the like. Among these, solvent extraction treatment is preferable.
溶媒抽出処理に使用される抽出溶媒は、植物の種類に応じて適宜選択すればよいが、例えば、水；メタノール、エタノール、ｎ−プロパノール、イソプロパノール、ｎ−ブタノール等の炭素数１〜４の低級アルコール；プロピレングリコール、１，３−ブチレングリコール等の多価アルコール；これらの混合液等が挙げられる。より具体的には、セージ、ウイキョウ、ソウハクヒ、及びチョウジの場合であれば、抽出溶媒として、好ましくは、水、低級アルコール、及びこれらの混合液；より好ましくは水、エタノール、及びこれらの混合液；更に好ましくは水とエタノールの混合液が挙げられる。また、ゲンチアナ、シャクヤク、及び緑茶の場合であれば、抽出溶媒として、好ましくは、水、多価アルコール、及びこれらの混合液；より好ましくは水、１，３−ブチレングリコール、及びこれらの混合液；更に好ましくは水と１，３−ブチレングリコールの混合液が挙げられる。 The extraction solvent used for the solvent extraction treatment may be appropriately selected depending on the type of plant, and is, for example, water; lower grades having 1 to 4 carbon atoms such as methanol, ethanol, n-propanol, isopropanol, and n-butanol. Alcohols; polyhydric alcohols such as propylene glycol, 1,3-butylene glycol; and mixtures thereof. More specifically, in the case of sage, uikyo, sohakuhi, and chouji, the extraction solvent is preferably water, a lower alcohol, and a mixture thereof; more preferably water, ethanol, and a mixture thereof. More preferably, a mixed solution of water and ethanol can be mentioned. In the case of Gentiana, Shakyak, and Green Tea, the extraction solvent is preferably water, a polyhydric alcohol, and a mixture thereof; more preferably water, 1,3-butylene glycol, and a mixture thereof. More preferably, a mixed solution of water and 1,3-butylene glycol can be mentioned.
抽出溶媒として、水と低級アルコールの混合溶媒を使用する場合、当該混合溶媒における低級アルコールの含有量としては、例えば、１０〜９０容量％、好ましくは２０〜８０容量％、より好ましくは２０〜６０容量％、更に好ましくは２５〜５５容量％が挙げられる。また、抽出溶媒として、水と多価アルコールの混合溶媒を使用する場合、当該混合溶媒における多価アルコールの含有量としては、例えば、１０〜９０容量％、好ましくは２０〜８０容量％、より好ましくは３０〜７０容量％、更に好ましくは４０〜６０容量％が挙げられる。 When a mixed solvent of water and a lower alcohol is used as the extraction solvent, the content of the lower alcohol in the mixed solvent is, for example, 10 to 90% by volume, preferably 20 to 80% by volume, and more preferably 20 to 60% by volume. Percentage of volume, more preferably 25 to 55% by volume. When a mixed solvent of water and polyhydric alcohol is used as the extraction solvent, the content of the polyhydric alcohol in the mixed solvent is, for example, 10 to 90% by volume, preferably 20 to 80% by volume, more preferably. 30 to 70% by volume, more preferably 40 to 60% by volume.
溶媒抽出処理は、抽出溶媒中に各植物の抽出原料を浸漬又は還流させて行えばよい。抽出処理後に固液分離により固形物を除去することにより、前記各植物の抽出液が得られる。得られた抽出液は、そのまま液状エキスとして使用してもよいが、必要に応じて、一部又は全ての溶媒を除去して濃縮エキス又は乾燥エキスとして使用してもよい。 The solvent extraction treatment may be carried out by immersing or refluxing the extraction raw material of each plant in the extraction solvent. By removing the solid matter by solid-liquid separation after the extraction treatment, an extract of each of the plants can be obtained. The obtained extract may be used as a liquid extract as it is, or may be used as a concentrated extract or a dry extract by removing a part or all of the solvent, if necessary.
［剤型・形態］
本発明のオートファジー活性化剤の剤型については、特に限定されず、固体状、半固体状、又は液体状のいずれであってもよい。
[Dosage form / form]
The dosage form of the autophagy activator of the present invention is not particularly limited and may be solid, semi-solid, or liquid.
本発明のオートファジー活性化剤の適用形態については、経口、経皮、経腸、経静脈、経肺、皮下、経粘膜、筋肉内等のいずれの形態で適用してもよく、予防又は治療対象となる疾患や症状等に応じて適宜設定すればよい。 The application form of the autophagy activator of the present invention may be applied in any form such as oral, transdermal, enteral, enteral, parenteral, subcutaneous, transmucosal, intramuscular, etc., and may be applied for prevention or treatment. It may be set appropriately according to the target disease or symptom.
本発明のオートファジー活性化剤の形態として、具体的には、飲食品、医薬品、化粧料等が挙げられる。 Specific examples of the form of the autophagy activator of the present invention include foods and drinks, pharmaceuticals, cosmetics and the like.
本発明のオートファジー活性化剤を飲食品の形態にする場合（即ち、オートファジー活性化用の飲食品として提供する場合）、前記有効成分を、そのまま又は他の食品素材や添加成分と組み合わせて所望の形態に調製すればよい。飲食品としては、一般の飲食品の他、保健機能食品（特定保健用食品、栄養機能食品、機能性表示食品を含む）、病者用食品等の食品等が挙げられる。これらの飲食品の形態として、特に限定されないが、具体的には、茶飲料、栄養ドリンク、果汁飲料、炭酸飲料、乳酸飲料等の飲料；カプセル剤（ソフトカプセル剤、ハードカプセル剤）、錠剤、顆粒剤、粉剤、ゼリー剤、リポソーム製剤等のサプリメント；グミ、キャンディー、ゼリー等の嗜好品等が挙げられる。これらの飲食品の中でも、好ましくはサプリメントが挙げられる。 When the autophagy activator of the present invention is formed into a food or drink form (that is, when it is provided as a food or drink for autophagy activation), the active ingredient is used as it is or in combination with other food materials or additive components. It may be prepared in a desired form. Examples of foods and drinks include general foods and drinks, foods with health claims (including foods for specified health use, foods with nutritional claims, and foods with functional claims), foods for the sick, and the like. The form of these foods and drinks is not particularly limited, but specifically, beverages such as tea beverages, nutritional drinks, fruit juice beverages, carbonated beverages, and lactic acid beverages; capsules (soft capsules, hard capsules), tablets, and granules. , Powders, jellies, supplements such as liposome preparations; luxury drinks such as gummy, candy, and jelly. Among these foods and drinks, supplements are preferable.
本発明のオートファジー活性化剤を飲食品の形態にする場合、飲食品における前記有効成分の含有量については、飲食品の種類、１日当たりの有効成分の摂取量等に応じて適宜設定すればよいが、例えば、前記有効成分が乾燥重量換算で、０．０００１〜１００重量％、好ましくは０．００１〜９０重量％、より好ましくは０．００３〜８０重量％が挙げられる。 When the autophagy activator of the present invention is formed into a food or drink, the content of the active ingredient in the food or drink may be appropriately set according to the type of the food or drink, the daily intake of the active ingredient, or the like. However, for example, the active ingredient may be 0.0001 to 100% by weight, preferably 0.001 to 90% by weight, and more preferably 0.003 to 80% by weight in terms of dry weight.
本発明のオートファジー活性化剤を医薬品（医薬部外品を含む）の形態にする場合、前記有効成分を、そのまま又は他の添加剤等と組み合わせて所望の形態に調製すればよい。医薬品としては、具体的には、錠剤、丸剤、散剤、細粒剤、顆粒剤、カプセル剤（ハードカプセル及びソフトカプセルを含む）、トローチ剤、チュアブル剤、エキス剤（軟エキス剤、乾燥エキス剤等を含む）、ゼリー剤、シロップ剤、酒精剤、エリキシル剤、リポソーム製剤等の内服用医薬品；軟膏剤、クリーム剤、ローション剤、ゲル剤、噴霧剤、貼付剤、乳液剤、懸濁液剤、パップ剤、リニメント剤、エアゾール剤、軟膏剤、パック剤、吸入剤、坐剤等の外用医薬品；注射剤等が挙げられる。 When the autophagy activator of the present invention is in the form of a pharmaceutical product (including a quasi-drug), the active ingredient may be prepared as it is or in combination with other additives or the like to a desired form. Specific examples of pharmaceuticals include tablets, suppositories, powders, fine granules, granules, capsules (including hard capsules and soft capsules), troches, chewables, extracts (soft extracts, dry extracts, etc.). ), Jelly, syrup, alcohol, elixir, liposome preparation, etc.; ointments, creams, lotions, gels, sprays, patches, emulsions, suspensions, paps Examples include external pharmaceuticals such as agents, liniment agents, aerosol agents, ointments, packs, inhalants, suppositories; injections and the like.
本発明のオートファジー活性化剤を医薬品の形態にする場合（即ち、オートファジー活性化用の医薬品として提供する場合）、医薬品における前記有効成分の含有量については、医薬品の種類、１日当たりの有効成分の投与量等に応じて適宜設定すればよいが、例えば、内服用医薬品の場合であれば、前記有効成分が乾燥重量換算で、０．０００１〜１００重量％、好ましくは０．００１〜９０重量％、より好ましくは０．００３〜８０重量％が挙げられ、外用医薬品の場合であれば、前記有効成分が乾燥重量換算で、０．０００１〜５重量％、好ましくは０．００１〜２重量％、より好ましくは０．００３〜１重量％が挙げられる。 When the autophagy activator of the present invention is in the form of a drug (that is, when it is provided as a drug for activating autophagy), the content of the active ingredient in the drug is determined by the type of drug and the effect per day. It may be appropriately set according to the dose of the ingredient and the like. For example, in the case of an oral drug, the active ingredient is 0.0001 to 100% by weight, preferably 0.001 to 90% by weight in terms of dry weight. By weight%, more preferably 0.003 to 80% by weight, and in the case of an external drug, the active ingredient is 0.0001 to 5% by weight, preferably 0.001 to 2% by weight in terms of dry weight. %, More preferably 0.003 to 1% by weight.
本発明のオートファジー活性化剤を化粧料の製剤形態にする場合（即ち、オートファジー活性化用の化粧料として提供する場合）、前記有効成分を、そのまま又は他の添加剤等と組み合わせて所望の形態に調製すればよい。化粧料としては、具体的には、クリーム剤、ローション剤、ジェル剤、乳液剤、液剤、軟膏剤、パック剤等が挙げられる。 When the autophagy activator of the present invention is formed into a pharmaceutical formulation (that is, when it is provided as a cosmetic for autophagy activation), the active ingredient is desired as it is or in combination with other additives or the like. It may be prepared in the form of. Specific examples of cosmetics include creams, lotions, gels, emulsions, liquids, ointments, and facial masks.
本発明のオートファジー活性化剤を化粧料の形態にする場合、化粧料における前記有効成分の含有量については、化粧料の種類、１日当たりの有効成分の適用量等に応じて適宜設定すればよいが、例えば、前記有効成分が乾燥重量換算で、０．０００１〜５重量％、好ましくは０．００１〜２重量％、より好ましくは０．００３〜１重量％が挙げられる。 When the autophagy activator of the present invention is formed into a cosmetic form, the content of the active ingredient in the cosmetic may be appropriately set according to the type of cosmetic, the amount of the active ingredient applied per day, and the like. However, for example, the active ingredient may be 0.0001 to 5% by weight, preferably 0.001 to 2% by weight, and more preferably 0.003 to 1% by weight in terms of dry weight.
［用途・用量等］
本発明のオートファジー活性化剤は、生体内でオートファジーの活性を向上させる用途に使用される。
[Use, dose, etc.]
The autophagy activator of the present invention is used for improving the activity of autophagy in vivo.
生体内でオートファジーの活性を向上させることによりオートファジーの活性低下が一因となって生じる疾患や症状を予防又は改善できるので、本発明のオートファジー活性化剤は、当該疾患又は症状の予防又は改善剤として使用することができる。 By improving the activity of autophagy in vivo, it is possible to prevent or ameliorate a disease or symptom caused by a decrease in the activity of autophagy. Therefore, the autophagy activator of the present invention prevents the disease or symptom. Alternatively, it can be used as an improving agent.
オートファジー活性の低下が一因となって生じる疾患及び症状としては、例えば、神経変性疾患、感染症、炎症性疾患、免疫疾患、腎疾患、呼吸器疾患、眼疾患、筋疾患、ミトコンドリア病、生活習慣病、皮膚老化、その他の各種疾患又は症状等が挙げられる。 Diseases and symptoms caused by decreased autophagy activity include, for example, neurodegenerative diseases, infectious diseases, inflammatory diseases, immune diseases, renal diseases, respiratory diseases, eye diseases, muscle diseases, mitochondrial diseases, and the like. Lifestyle diseases, skin aging, various other diseases or symptoms, etc. can be mentioned.
当該疾患及び症状として、具体的には、筋委縮症、ミオパチー、アルツハイマー病、パーキンソン病（神経セロイドリポフスチン症、多系統萎縮症（ＭＳＡ）等を含む）、ハンチントン病、リー症候群、進行性核上性麻痺（ＰＳＰ）、大脳皮質基底核変性症（ＣＢＤ）、レビー小体型認知症（ＤＬＢ）、クロイツフェルト-ヤコブ病、特発性急速眼球運動睡眠行動障害等の神経変性疾患；オートファジーにより殺菌される病原体（例えば、Ａ群連鎖球菌、結核菌、黄色ブドウ球菌、赤痢菌等）の感染症；クローン病、膵炎、鼻副鼻腔炎等の炎症性疾患；グレーブス病、自己免疫性甲状腺炎、橋本病、１型糖尿病、重症筋無力症、グッドパスチャー病、全身性エリテマトーデス、全身性強皮症、乾癬、アトピー性皮膚炎、シェーグレン症候群等の免疫疾患；糸球体硬化症、腎不全等の腎疾患；嚢胞性線維症、喘息、気管支拡張症、慢性閉塞性肺疾患、特発性肺線維症等の呼吸器疾患；ドライアイ、加齢黄斑変性症等の眼疾患；筋肉減退、筋肉萎縮、悪液質、サルコペニア、筋ジストロフィー、ミオペニア等の筋疾患；糖尿病難聴症候群(ＤＡＤ)、レーベル遺伝性視神経萎縮症、ニューロパシー,運動失調,網膜色素変性症候群（ＮＡＲＰ）、ミトコンドリア神経胃腸管性脳症症候群（ＭＮＧＩＥ）、赤色ぼろ線維を伴うミオクローヌスてんかん（ＭＥＲＲＦ）、ミトコンドリア脳筋症・乳酸アシドーシス・脳卒中様発作症候群（ＭＥＬＡＳ）等のミトコンドリア病；２型糖尿病、動脈硬化、肝線維化症、肝硬変症、肝炎、アルコール性肝疾患、脂肪肝、非アルコール性脂肪肝炎、メタボリックシンドローム、高脂血症、肥満等の生活習慣病；メラニン蓄積、しみ、皺等の皮膚老化；脳腫脹、ライソゾーム病、ダウン症、心不全、貧血、疲労、睡眠不足、冷え性、便秘、筋肉低下、創傷治癒遅延等のその他の疾患及び症状等が挙げられる。 Specific examples of the disease and symptoms include muscle atrophy, myopathy, Alzheimer's disease, Parkinson's disease (including neuroseloid lipofustinosis, multiline atrophy (MSA), etc.), Huntington's disease, Lee's syndrome, and progressive nucleus. Neurodegenerative diseases such as superior paralysis (PSP), cerebral cortical basal nucleus degeneration (CBD), Levy body dementia (DLB), Kreuzfeld-Jakob disease, idiopathic rapid eye movement sleep behavior disorder; sterilized by autophagy Infectious diseases of pathogens (eg, group A streptococci, tuberculosis, yellow staphylococcus, diarrhea, etc.); inflammatory diseases such as Crohn's disease, pancreatitis, nasal sinusitis; Graves' disease, autoimmune thyroiditis, Immune diseases such as Hashimoto disease, type 1 diabetes, severe myasthenia, good pasture disease, systemic erythematosus, systemic strong skin disease, psoriasis, atopic dermatitis, Schegren syndrome; kidneys such as glomerulosclerosis and renal failure Diseases; Respiratory diseases such as cystic fibrosis, asthma, bronchial dilatation, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis; Eye diseases such as dry eye and age-related luteal degeneration; Muscle diseases such as fluid, sarcopenia, muscular dystrophy, and myopenia; diabetic hearing loss syndrome (DAD), label hereditary optic nerve atrophy, neuropathy, ataxia, retinal pigment degeneration syndrome (NARP), mitochondrial neurogastrointestinal encephalopathy syndrome (MNGIE) , Myokronus epilepsy with red rag fibers (MERRF), mitochondrial diseases such as mitochondrial encephalomyopathy, lactic acid acidosis, stroke-like attack syndrome (MELAS); type 2 diabetes, arteriosclerosis, liver fibrosis, liver cirrhosis, hepatitis, alcohol Lifestyle diseases such as sexual liver disease, fatty liver, non-alcoholic steatosis, metabolic syndrome, hyperlipidemia, obesity; skin aging such as melanin accumulation, stains and wrinkles; brain swelling, lysosome disease, down syndrome, heart failure, anemia Other diseases and symptoms such as fatigue, lack of sleep, coldness, constipation, muscle weakness, delayed wound healing and the like.
本発明のオートファジー活性化剤の適用量については、剤形、製剤形態、付与すべきオートファジー活性化作用の程度等に応じて適宜設定すればよい。 The applied amount of the autophagy activator of the present invention may be appropriately set according to the dosage form, the pharmaceutical form, the degree of autophagy activating action to be imparted, and the like.
例えば、本発明のオートファジー活性化剤が経口投与又は経口摂取される場合であれば、成人１日当たりの前記有効成分の乾燥重量換算で１〜５０００ｍｇ程度で、１日当たり１回、又は１日当たり複数回に分けて経口投与又は経口摂取すればよい。 For example, when the autophagy activator of the present invention is orally administered or orally ingested, the dry weight of the active ingredient per adult is about 1 to 5000 mg per day, once per day, or multiple times per day. It may be orally administered or orally ingested in divided doses.
また、例えば、本発明のオートファジー活性化剤が経皮適用される場合であれば、１回当たり、皮膚１ｃｍ2当たり、前記有効成分が乾燥重量換算で１〜５００００μｇ程度となる量で、１日１〜数回程度の頻度で経皮適用すればよい。 Further, for example, when the autophagy activator of the present invention is applied transdermally, the amount of the active ingredient is about 1 to 50,000 μg in terms of dry weight per 1 cm 2 of the skin. It may be applied transdermally once to several times a day.
以下に実施例を示して本発明をより具体的に説明するが、本発明はこれらに限定されるものではない。 Hereinafter, the present invention will be described in more detail with reference to Examples, but the present invention is not limited thereto.
なお、以下の試験で使用した抽出物の入手元等については、以下の通りである。以下の試験において、下記抽出物は、必要に応じて、濃縮、乾燥等を行った後に使用した。
・セージ抽出物：商品名「Ｐ．セージＥ」（一丸ファルコス株式会社）、セージの葉をエタノール（約４６容量％）と水の混合液で抽出処理した抽出物。
・ウイキョウ抽出物：商品名「Ｐ．ウイキョウＭＥー」（一丸ファルコス株式会社）、ウイキョウの果実をエタノール（約２６容量％）と水の混合液で抽出処理した抽出物。
・ソウハクヒ抽出物：商品名「Ｐ．ソウハクヒＥ」（一丸ファルコス株式会社）、ソウハクヒをエタノール（約４５容量％）と水の混合液で抽出処理した抽出物。
・チョウジ抽出物：商品名「Ｐ．チョウジ」（一丸ファルコス株式会社）、チョウジの蕾をエタノール（約４１容量％）と水の混合液で抽出処理した抽出物。
・ゲンチアナ抽出物：商品名「ゲンチアナ抽出液ＢＧ−Ｊ」（丸善製薬株式会社）、ゲンチアナの根を１，３−ブチレングリコール（約４９容量％）と水の混合液で抽出処理した抽出物。
・シャクヤク抽出物：商品名「シャクヤク抽出液ＢＧ−ＪＣ」（丸善製薬株式会社）、シャクヤクの根を１，３−ブチレングリコール（約４８容量％）と水の混合液で抽出処理した抽出物。
・緑茶抽出物：商品名「緑茶抽出液ＢＧ」（丸善製薬株式会社）、茶葉を１，３−ブチレングリコール（約５０容量％）と水の混合液で抽出処理した抽出物。
・アイセニア抽出物：商品名「アイセニアヴェールＥ」（一丸ファルコス株式会社）
・グレープフルーツ抽出物：商品名「Ｐ．グレープフルーツＥ」（一丸ファルコス株式会社）
・納豆抽出物：商品名「フィトコラージュＰＦＥ（Ｎ）」（一丸ファルコス株式会社）
・ローヤルゼリー抽出物：商品名「ローヤルゼリー抽出液」（丸善製薬株式会社）
・キンギンカ抽出物：商品名「キンギンカ抽出液−Ｊ」（丸善製薬株式会社）
・オリーブ葉抽出物：商品名「オリーブ葉抽出液ＢＧ」（丸善製薬株式会社）
・加水分解シルク：商品名「ゴールデンシルク抽出液ＢＧ３０」（丸善製薬株式会社）
・加水分解コンキオリン１：商品名「真珠たん白抽出液ＬＡ−Ｊ」（丸善製薬株式会社）
・加水分解コンキオリン２：商品名「真珠たん白抽出液ＢＧ−ＪＣ＜ＮＰ＞」（丸善製薬株式会社）
・ニンドウ抽出物：商品名「ニンドウ抽出液−Ｊ」（丸善製薬株式会社）
・パイナップル果実抽出物：商品名「パインセラＣ」（丸善製薬株式会社）
・ビワ抽出物：商品名「ビワ抽出液−Ｊ」（丸善製薬株式会社）
・ヘチマ抽出物：商品名「ヘチマ抽出液−ＪＣ」（丸善製薬株式会社）
・ベニバナ抽出物：商品名「ベニバナ抽出液」（丸善製薬株式会社）
・ペパーミント抽出物：商品名「ペパーミント抽出液ＢＧ」（丸善製薬株式会社）
・マロニエ抽出物：商品名「マロニエ抽出液ＢＧ−Ｊ」（丸善製薬株式会社）
・米糠抽出物：商品名「紫玄米ヌカ抽出液ＢＧ」（丸善製薬株式会社）
・レイシ抽出物：商品名「レイシ抽出液ＢＧ０２」（丸善製薬株式会社）
・ノニ果汁：商品名「和ｉｓｍ＜ノニ果汁＞」（丸善製薬株式会社）
・ユキノシタ抽出物：商品名「和ｉｓｍ＜ユキノシタ果汁＞」（丸善製薬株式会社）
・ワイルドタイム抽出物：商品名「ワイルドタイム抽出液ＢＧ」（丸善製薬株式会社）
The sources of the extracts used in the following tests are as follows. In the following tests, the following extracts were used after being concentrated, dried, etc., if necessary.
-Sage extract: An extract obtained by extracting and treating sage leaves with a mixture of ethanol (about 46% by volume) and water under the trade name "P. sage E" (Ichimaru Falcos Co., Ltd.).
-Fennel extract: An extract obtained by extracting the fruit of fennel under the trade name "P. fennel ME" (Ichimaru Falcos Co., Ltd.) with a mixed solution of ethanol (about 26% by volume) and water.
-Sohakuhi extract: An extract obtained by extracting Souhakuhi with a mixture of ethanol (about 45% by volume) and water under the trade name "P. Sohakuhi E" (Ichimaru Falcos Co., Ltd.).
-Clove extract: An extract obtained by extracting the clove buds under the trade name "P. Clove" (Ichimaru Falcos Co., Ltd.) with a mixture of ethanol (about 41% by volume) and water.
-Gentiana extract: An extract obtained by extracting the root of gentiana with a mixture of 1,3-butylene glycol (about 49% by volume) and water under the trade name "Gentiana extract BG-J" (Maruzen Pharmaceuticals Co., Ltd.).
-Peony extract: An extract obtained by extracting the roots of peony under the trade name "Peony extract BG-JC" (Maruzen Pharmaceuticals Co., Ltd.) with a mixture of 1,3-butylene glycol (about 48% by volume) and water.
-Green tea extract: An extract obtained by extracting tea leaves with a mixture of 1,3-butylene glycol (about 50% by volume) and water under the trade name "Green Tea Extract BG" (Maruzen Pharmaceuticals Co., Ltd.).
・ Aisenia extract : Product name "Aisenia veil E" (Ichimaru Falcos Co., Ltd.)
・ Grapefruit extract : Product name "P. Grapefruit E" (Ichimaru Falcos Co., Ltd.)
・ Natto extract : Product name "Phytocollage PFE (N)" (Ichimaru Falcos Co., Ltd.)
Royal jelly extract: trade name "royal jelly extract" (Maruzen Pharmaceuticals Co., Ltd.)
-Kinginka extract : Product name "Kinginka extract-J" (Maruzen Pharmaceuticals Co., Ltd.)
Olive leaf extract: the trade name of "olive leaf extract BG" (Maruzen Pharmaceuticals Co., Ltd.)
-Hydrolyzed silk : Product name "Golden Silk Extract BG30" (Maruzen Pharmaceuticals Co., Ltd.)
-Hydrolyzed conchiolin 1 : Product name "Pearl protein extract LA-J" (Maruzen Pharmaceuticals Co., Ltd.)
-Hydrolyzed conchiolin 2 : Brand name "Pearl protein extract BG-JC <NP>" (Maruzen Pharmaceuticals Co., Ltd.)
・ Honeysuckle extract : Product name “honeysuckle extract-J” (Maruzen Pharmaceuticals Co., Ltd.)
・ Pineapple fruit extract : Product name "Pinecella C" (Maruzen Pharmaceuticals Co., Ltd.)
- loquat extract: trade name "loquat extract -J" (Maruzen Pharmaceuticals Co., Ltd.)
・ Loofah extract : Product name "Luffa extract-JC" (Maruzen Pharmaceuticals Co., Ltd.)
・ Safflower extract : Product name "Safflower extract" (Maruzen Pharmaceuticals Co., Ltd.)
Peppermint extract: trade name "peppermint extract BG" (Maruzen Pharmaceuticals Co., Ltd.)
- horse chestnut extract: trade name "horse chestnut extract BG-J" (Maruzen Pharmaceuticals Co., Ltd.)
・Rice bran extract: Product name "Purple brown rice nuka extract BG" (Maruzen Pharmaceuticals Co., Ltd.)
- litchi extract: trade name "litchi extract BG02" (Maruzen Pharmaceuticals Co., Ltd.)
・ Noni juice : Product name "Wa ism <Noni juice>" (Maruzen Pharmaceuticals Co., Ltd.)
・ Yukinoshita extract : Product name "Wa ism <Yukinoshita juice>" (Maruzen Pharmaceuticals Co., Ltd.)
Wild thyme extract: trade name "wild thyme extract liquid BG" (Maruzen Pharmaceuticals Co., Ltd.)
試験例１：オートファジー活性の測定
表１に示す成分について、オートファジー活性化効果を測定した。具体的には、先ず、ＮＨＥＫ細胞（正常ヒト新生児表皮角化細胞、クラボウ株式会社）をＨｕＭｅｄｉａ-ＫＧ２培地（クラボウ株式会社）に懸濁させた液を、５×１０3ｃｅｌｌｓ／２５μＬ／ｗｅｌｌとなるように３８４ウェルプレートに播種して、３７℃で終夜培養した。次いで、培地を除去後、表１に示す成分を含むＨｕＭｅｄｉａ-ＫＧ２培地（以下、試験液）を各ウェルに２５μＬ添加して、３７℃で１８時間インキュベートした。その後、各ウェルの上清を除去し、ＰＢＳで１回洗浄した後に、ＣＹＴＯ−ＩＤ（登録商標）オートファジー検出キット（Ｅｎｚｏ Ｌｉｆｅ Ｓｃｉｅｎｃｅ，Ｉｎｃ）を用いて、オートファジー小胞を特異的に緑色に染色した。また、核をＤＡＰＩで青色に核染色した。また、ポジティブコントロールとして、前記試験液に代えて、ラパマイシンを０．４５７μｇ/ｍＬ含むＨｕＭｅｄｉａ-ＫＧ２培地を使用して前記と同条件で操作を行った。更に、ネガティブコントロールとして、前記試験液に代えて、ＨｕＭｅｄｉａ-ＫＧ２培地（添加成分なし）を使用して前記と同条件で操作を行った。
Test Example 1: Measurement of autophagy activity The autophagy activation effect was measured for the components shown in Table 1. Specifically, first, a solution in which NHEK cells (normal human neonatal epidermal keratinocytes, Kurabou Co., Ltd.) was suspended in HuMedia-KG2 medium (Kurabou Co., Ltd.) was subjected to 5 × 10 3 cells / 25 μL / well. The seeds were sown in 384-well plates so as to be, and cultured at 37 ° C. overnight. Then, after removing the medium, 25 μL of HuMedia-KG2 medium (hereinafter, test solution) containing the components shown in Table 1 was added to each well, and the mixture was incubated at 37 ° C. for 18 hours. Then, the supernatant of each well is removed, washed once with PBS, and then the autophagy vesicles are specifically greened using the CYTO-ID® autophagy detection kit (Enzo Life Science, Inc). Was stained. In addition, the nuclei were stained blue with DAPI. Further, as a positive control, the operation was carried out under the same conditions as described above using HuMedia-KG2 medium containing 0.457 μg / mL of rapamycin instead of the test solution. Further, as a negative control, HuMedia-KG2 medium (without additional components) was used instead of the test solution, and the operation was carried out under the same conditions as described above.
次いで、各ウェルの中心部分を蛍光顕微鏡で観察し、ImageJを用いて画像解析を行い、緑色（オートファジー小胞）の蛍光強度と青色（核）の蛍光強度をそれぞれ求めた。細胞数を標準化するために、緑色（オートファジー小胞）の蛍光強度を青色（核）の蛍光強度で除して、オートファジー活性値を求めた。ポジティブコントロールのオートファジー活性値を１、ネガティブコントロールのオートファジー活性値を０として、各試験液のオートファジー活性値の相対値を算出した。 Next, the central portion of each well was observed with a fluorescence microscope, and image analysis was performed using ImageJ to determine the fluorescence intensity of green (autophagy vesicles) and blue (nucleus), respectively. In order to standardize the number of cells, the fluorescence intensity of green (autophagy vesicles) was divided by the fluorescence intensity of blue (nucleus) to obtain the autophagy activity value. The relative value of the autophagy activity value of each test solution was calculated by setting the autophagy activity value of the positive control to 1 and the autophagy activity value of the negative control to 0.
結果を表１に示す。この結果、セージ抽出物、ウイキョウ抽出物、ソウハクヒ抽出物、チョウジ抽出物、ゲンチアナ抽出物、シャクヤク抽出物、及び緑茶抽出物は、オートファジー活性値の相対値が１を超えており、ラパマイシンを凌ぐ優れたオートファジー活性化作用があることが明らかとなった。 The results are shown in Table 1. As a result, the sage extract, uikyo extract, sohakuhi extract, chouji extract, gentiana extract, sakuyaku extract, and green tea extract have an autophagy activity value of more than 1 and surpass rapamycin. It was revealed that it has an excellent autophagy activating effect.
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