JP2011016792A - Uric acid level lowering composition - Google Patents

Uric acid level lowering composition Download PDF

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JP2011016792A
JP2011016792A JP2010131169A JP2010131169A JP2011016792A JP 2011016792 A JP2011016792 A JP 2011016792A JP 2010131169 A JP2010131169 A JP 2010131169A JP 2010131169 A JP2010131169 A JP 2010131169A JP 2011016792 A JP2011016792 A JP 2011016792A
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uric acid
acid level
ginseng
hyperuricemia
composition
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JP5550995B2 (en
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Kumiko Kitamura
久美子 北村
Hiroaki Kamibayashi
博明 上林
Hideaki Iwasaki
英明 岩崎
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Lion Corp
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Lion Corp
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Priority to KR1020167022095A priority patent/KR101717893B1/en
Priority to EP10839037.8A priority patent/EP2517711B1/en
Priority to CN201310455798.4A priority patent/CN103520179B/en
Priority to CN201080059382.5A priority patent/CN102665725B/en
Priority to PCT/JP2010/067058 priority patent/WO2011077800A1/en
Priority to KR1020127015321A priority patent/KR101661793B1/en
Priority to EP13005566.8A priority patent/EP2702996A1/en
Publication of JP2011016792A publication Critical patent/JP2011016792A/en
Priority to US13/527,729 priority patent/US20120258184A1/en
Priority to US13/738,234 priority patent/US8927033B2/en
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Abstract

PROBLEM TO BE SOLVED: To provide a uric acid level lowering composition having excellent hypouricemic action, easily and safely takable for a long time without causing side effects and contributing to prevention and amelioration of hyperuricemia.SOLUTION: The uric acid level lowering composition contains an active component comprising an acid-treated residue obtained by hydrolyzing a plant of genus Panax, family Araliaceae in the presence of an aqueous solution of a strong acid and a lower alcohol, adding water to the hydrolyzate and filtering the product. The plant of genus Panax, family Araliaceae is preferably Panax Noto ginseng.

Description

本発明は、ウコギ科トチバニンジン属植物に由来し、優れた尿酸値低下作用を有する尿酸値低下組成物に関する。   The present invention relates to a composition for lowering uric acid level, which is derived from a plant belonging to the genus Arionaceae and has an excellent uric acid level lowering action.

尿酸は、食物から摂取したプリン体より肝臓にてほぼ一定量産生され、産生量とほぼ同量が主に腎臓から尿中へ濾し取られて排泄されている。ところが、何らかの原因(例えば食生活、飲酒、ストレス、腎臓機能の低下、薬剤による影響、遺伝的要因など)で尿酸産生量と排泄量とのバランスが崩れると、体内の尿酸量が増え過ぎて高尿酸血症になることがある。体内の尿酸値が増え、血中尿酸値が7.0mg/dLを超えると高尿酸血症と判定される。高尿酸血症を長期間放置すると過剰な尿酸塩により関節や軟骨組織の周辺等に尿酸塩結晶が形成され痛風関節炎が誘発される。   Uric acid is produced in the liver from a purine body taken from food in an almost constant amount, and almost the same amount as the produced amount is mainly filtered out from the kidney into the urine and excreted. However, if the balance between uric acid production and excretion is lost due to some cause (for example, eating habits, alcohol consumption, stress, decreased kidney function, effects of drugs, genetic factors, etc.), the amount of uric acid in the body increases too much. May cause uricemia. When the uric acid level in the body increases and the blood uric acid level exceeds 7.0 mg / dL, hyperuricemia is determined. When hyperuricemia is left for a long period of time, excessive urate causes the formation of urate crystals in the vicinity of joints and cartilage tissues and induces gout arthritis.

日本国内において痛風の予備軍である高尿酸血症の患者は約500万人と推定され、高尿酸血症患者の若年化が進み、過去20年間で患者数は、2倍以上に増加している。
現在、高尿酸血症治療の医薬品が存在するものの、服用を中止すると再び高尿酸血症の状態に戻ってしまう。一方で、服用により発熱、発疹、肝障害、腎機能異常などの副作用が認められている。したがって、高尿酸血症の治療剤としては長期間安心して無理なく服用でき、副作用のないものが強く望まれている。
There are an estimated 5 million hyperuricemia patients who are gout reserves in Japan, and the number of hyperuricemia patients has become younger, and the number of patients has more than doubled over the past 20 years. Yes.
Currently, there are drugs for the treatment of hyperuricemia, but if you stop taking it, it will return to the state of hyperuricemia again. On the other hand, side effects such as fever, rash, liver damage and abnormal renal function have been observed. Therefore, a therapeutic agent for hyperuricemia is strongly desired that can be safely and comfortably taken for a long time and has no side effects.

このような状況から、副作用のない植物由来の尿酸値低下組成物等が種々検討されている。
例えば、ヤシ殻を原材料とした活性炭を有効成分とする尿酸値抑制剤が提案されている(特許文献1参照)。
また、イチョウ葉抽出物を有効成分とする尿酸値低下剤及びこれを含有する飲食品が提案されている(特許文献2参照)。
また、茶に由来する茶ポリフェノールを有効成分として含有する尿酸値低下剤が提案されている(特許文献3参照)。
また、ザクロ抽出物を有効成分とする、キサンチンオキシダーゼ阻害剤、血中尿酸値低下剤、高尿酸血症の予防または改善剤、及び、痛風の予防剤、並びに、これらの剤を含有する、飲食品、医薬品、または化粧品が提案されている(特許文献4参照)。
また、生体の代謝活動で生じた有害物や老廃物(尿酸等)などの体内の毒素に対する排泄促進を目的として、田七ニンジン、朝鮮ニンジン等の生薬を含有する体内浄化用組成物、それを用いた食品、入浴剤、化粧料、製剤及び有害金属排泄促進剤が提案されている(特許文献5参照)。
また、デンシチ(サンシチ)、オタネ人参等のうちの一種と、柳科植物を粉末状にした柳科植物物質とを混合させ、尿酸等の排出を増大促進させる柳混合物が提案されている(特許文献6参照)。
また、痛風等の症状に効能を付与することを目的として、朝鮮人参等の薬草を用いたサウナが提案されている(特許文献7参照)。
また、高脂血症患者に対して薬用人参を長期間投与し、血中尿酸値等、身体に与える影響が報告されている(非特許文献1参照)。
Under such circumstances, various plant-derived uric acid level lowering compositions and the like without side effects have been studied.
For example, a uric acid level inhibitor that uses activated carbon made from coconut shell as an active ingredient has been proposed (see Patent Document 1).
Moreover, the uric acid value reducing agent which uses a ginkgo biloba extract as an active ingredient, and the food-drinks containing this are proposed (refer patent document 2).
Moreover, the uric acid value lowering agent which contains the tea polyphenol derived from tea as an active ingredient is proposed (refer patent document 3).
In addition, a xanthine oxidase inhibitor, a blood uric acid level-lowering agent, a hyperuricemia preventing or improving agent, a gout preventing agent, and a food and drink containing these agents, comprising a pomegranate extract as an active ingredient Products, pharmaceuticals, and cosmetics have been proposed (see Patent Document 4).
In addition, for the purpose of promoting the excretion of toxins in the body, such as harmful substances and waste products (uric acid, etc.) generated by metabolic activities of the living body, a composition for purifying the body containing herbal medicines such as carrots and ginseng Foods, bathing agents, cosmetics, preparations and harmful metal excretion promoters used have been proposed (see Patent Document 5).
In addition, a willow mixture is proposed in which one of Densiti (Sanshichi), Panax ginseng, etc. is mixed with a willow plant material in the form of a powder of the willow plant, which promotes increased discharge of uric acid, etc. (patent) Reference 6).
In addition, a sauna using medicinal herbs such as ginseng has been proposed for the purpose of imparting efficacy to symptoms such as gout (see Patent Document 7).
In addition, it has been reported that ginseng is administered to hyperlipidemic patients for a long period of time and effects on the body such as blood uric acid level (see Non-Patent Document 1).

しかしながら、現在、高尿酸血症治療薬として用いられる医薬品に代わり、副作用がなく長期間安心して無理なく服用できる尿酸値低下組成物として、効果や有効性において満足できるものが存在しないというのが現状である。   However, at present, there are no uric acid level-reducing compositions that can be safely and comfortably taken for a long period of time instead of the drugs used as therapeutic drugs for hyperuricemia. It is.

特開2005−187405号公報JP 2005-187405 A 特開2002−370980号公報JP 2002-370980 A 特開2002−212085号公報Japanese Patent Laid-Open No. 2002-212085 特開2006−16340号公報JP 2006-16340 A 特開2007−153888号公報JP 2007-153888 A 特開平9−208479号公報JP-A-9-208479 特開平3−9752号公報JP-A-3-9752

Proc. Symp. WAKAN−YAKU 16,p.188(1983)Proc. Symp. WAKAN-YAKU 16, p. 188 (1983)

本発明は、前記従来における諸問題を解決し、以下の目的を達成することを課題とする。即ち、本発明は、優れた尿酸値低下作用を有し、副作用がなく長期間安心して無理なく服用でき、更に、高尿酸血症の予防及び改善に寄与する尿酸値低下組成物を提供することを目的とする。   An object of the present invention is to solve the conventional problems and achieve the following objects. That is, the present invention provides an uric acid level-lowering composition that has an excellent uric acid level-lowering action, can be safely and comfortably taken without any side effects, and contributes to prevention and improvement of hyperuricemia. With the goal.

前記課題を解決するための手段としては、以下の通りである。即ち、
<1> ウコギ科トチバニンジン属植物を強酸水溶液及び低級アルコールの存在下で加水分解処理後、加水濾過して得られる酸処理物残渣を有効成分として含有することを特徴とする尿酸値低下組成物である。
<2> ウコギ科トチバニンジン属植物が田七人参である前記<1>に記載の尿酸値低下組成物である。
<3> 血中尿酸値低下剤、高尿酸血症予防剤、高尿酸血症改善剤、痛風予防剤及び痛風改善剤に用いられる前記<1>から<2>のいずれかに記載の尿酸値低下組成物である。
Means for solving the problems are as follows. That is,
<1> A uric acid level-decreasing composition characterized by containing, as an active ingredient, an acid-treated product residue obtained by hydrolyzing a urchinaceae Tochibanin genus plant in the presence of a strong acid aqueous solution and a lower alcohol, followed by hydrofiltration. is there.
<2> The uric acid level-decreasing composition according to <1>, wherein the genus Araceae is a ginseng.
<3> The uric acid value according to any one of <1> to <2>, which is used for a blood uric acid level-lowering agent, a hyperuricemia preventing agent, a hyperuricemia improving agent, a gout preventing agent, and a gout improving agent A lowering composition.

本発明によれば、従来における前記諸問題を解決し、前記目的を達成することができ、本発明は、優れた尿酸値低下作用を有し、副作用がなく長期間安心して無理なく服用でき、更に、高尿酸血症の予防及び改善に寄与する尿酸値低下組成物を提供することができる。   According to the present invention, the conventional problems can be solved and the object can be achieved, the present invention has an excellent uric acid level lowering action, can be safely and comfortably taken for a long time without side effects, Furthermore, a uric acid level-reducing composition that contributes to prevention and improvement of hyperuricemia can be provided.

(尿酸値低下組成物)
本発明の尿酸値低下組成物は、ウコギ科トチバニンジン属植物を強酸水溶液及び低級アルコールの存在下で加水分解処理後、加水濾過して得られる酸処理物残渣を有効成分として含有してなり、必要に応じて、その他の成分を含むこととしてなる。
(Uric acid level lowering composition)
The uric acid level-reducing composition of the present invention comprises an acid-treated product residue obtained by hydrolyzing an Argyceae plant as belonging to the presence of a strong acid aqueous solution and a lower alcohol as an active ingredient. Depending on the case, other components are included.

<ウコギ科トチバニンジン属植物の酸処理物残渣>
前記ウコギ科トチバニンジン属植物としては、特に制限はなく、目的に応じて適宜選択することができ、例えば、田七人参(デンシチニンジン、別名:三七人参(サンシチニンジン))、御種人参(オタネニンジン、別名:朝鮮人参(チョウセンニンジン)、高麗人参(コウライニンジン))、トチバニンジン(別名:竹節人参(チクセツニンジン))、アメリカニンジン(別名:西洋人参(セイヨウニンジン)、西洋参(セイヨウジン))、ベトナムニンジン、ヒマラヤニンジン、相思子様人参(ソウシシヨウニンジン)、ホソバチクセツニンジン、狭葉仮人参(キョウヨウカニンジン、別名:竹根七(チクコンシチ))、羽葉三七(ウヨウサンシチ)、秀麗仮人参(シュウレイカニンジン、別名:竹節三七(チクセツサンシチ))、大葉三七(ダイヨウサンシチ)、峨眉三七(ガビサンシチ)、ビョウブサンシチニンジン(別名:托三七(タクサンシチ))、ミツバニンジン、ノサンシチニンジン(別名:姜状三七(キョウジョウサンシチ))等が挙げられる。これらの中でも、御種人参、田七人参が好ましく、特に、安定的に入手できる観点から田七人参がより好ましい。
<Resistance of acid-treated product of Arsiaceae plant>
The plant belonging to the genus Tocobanin is not particularly limited and may be appropriately selected depending on the intended purpose. , Aka: ginseng (carrot carrot), ginseng (carrot carrot)), tochiban carrot (aka: ginseng carrot), american carrot (aka: western ginseng, western ginseng)), Vietnamese carrots, Himalayan carrots, Ginseng-like carrots, Carrionaceae carrots, Nanaha carrots (Anthony carrots, also known as Chikukonshichi), Sansou Haba (Uyosanshichi), Shuryo Ginseng (Shureikainjin, also known as: Chikutsu Sansichi), Ohba 7 (Daiyo Sanshichi), Ehime Sanchichi (Gabisanshichi), Gyosan Sanchichininjin (aka: Tsukusanshichi), honeybee carrot, Nosanshichininjin (aka: Sanjou Shichichi) (etc.) Can be mentioned. Among these, the ginseng and the ginseng are preferred, and the ginseng is more preferred from the viewpoint of being stably available.

前記トチバニンジン属植物としては、天然から採取されたそのままの状態で用いてもよいが、その根や根茎に特に有効成分を多く含んでいるので、その根や根茎部分の部分や、これを粉砕した粉末を用いることが好ましい。これらの中でも、後述する酸処理を効率的に行う観点からは、粉末状のものが好ましい。   As the plant belonging to the genus Totibandin, it may be used as it is collected from nature, but since the roots and rhizomes contain a particularly large amount of active ingredients, the roots and rhizome parts, and this were crushed It is preferable to use a powder. Among these, a powdery one is preferable from the viewpoint of efficiently performing the acid treatment described later.

前記ウコギ科トチバニンジン属植物の酸処理物残渣は、前記ウコギ科トチバニンジン属植物を用いるよりも、優れた尿酸値低下作用を示す。
この理由は、前記ウコギ科トチバニンジン属植物を酸処理すると、植物体に含まれる薬効成分である配糖体(サポニン)から糖がはずれ、パナキサトリオール(PT)、パナキサジオール(PD)、プロトパナキサトリオール(PPT)、プロトパナキサジオール(PPD)等のサポゲニン(アグリコン体)が生成される。これらのサポゲニンが活性成分として、前記尿酸値低下作用を発揮するものと考えられる。
前記酸処理物残渣中の、前記サポゲニンの含有率としては、特に制限はなく、目的に応じて適宜選択することができるが、3質量%以上が好ましく、5質量%以上がより好ましく、10質量%以上が特に好ましい。
前記サポゲニンの含有量は、例えば、液体クロマトグラフィーなどで測定することができる。
The acid-treated product residue of the genus Tochibanin ginseng plant exhibits a superior uric acid level lowering effect than the use of the Uchigaceae Tochibanin ginseng plant.
The reason for this is that when the above-mentioned Araceae Tochibanin genus plant is acid-treated, the sugar is released from the glycoside (saponin), which is a medicinal component contained in the plant body, and panaxatriol (PT), panaxadiol (PD), proto Sapogenins (aglycone bodies) such as panaxatriol (PPT) and protopanaxadiol (PPD) are produced. These sapogenins are considered to exhibit the uric acid level lowering action as an active ingredient.
There is no restriction | limiting in particular as content rate of the said sapogenin in the said acid-processed residue, Although it can select suitably according to the objective, 3 mass% or more is preferable, 5 mass% or more is more preferable, 10 mass % Or more is particularly preferable.
The content of the sapogenin can be measured by, for example, liquid chromatography.

前記尿酸値低下組成物における前記酸処理物残渣の含有量としては、特に制限はなく、目的に応じて適宜選択することができる。また、前記尿酸値低下剤組成物は、前記酸処理物そのものであってもよい。   There is no restriction | limiting in particular as content of the said acid-processed residue in the said uric acid value fall composition, According to the objective, it can select suitably. Further, the uric acid level reducing agent composition may be the acid-treated product itself.

<その他の成分>
前記その他の成分としては、特に制限はなく、本発明の効果を損なわない範囲で、目的に応じて適宜選択することができる。
前記尿酸値低下組成物における前記その他の成分の含有量としても、特に制限はなく、目的に応じて適宜選択することができる。
<Other ingredients>
There is no restriction | limiting in particular as said other component, In the range which does not impair the effect of this invention, it can select suitably according to the objective.
There is no restriction | limiting in particular also as content of the said other component in the said uric acid value fall composition, According to the objective, it can select suitably.

<製造方法>
前記ウコギ科トチバニンジン属植物の酸処理物残渣は、上記の通り、前記ウコギ科トチバニンジン属植物を強酸水溶液及び低級アルコールの存在下で加水分解処理後、加水濾過して得られる。
特に、前記酸処理物残渣を効率的に得る観点から、以下の製造方法により製造することが好ましい。
<Manufacturing method>
As described above, the residue of the acid-treated product of the genus Tochibanin genus plant is obtained by subjecting the genus Tochibanin genus plant to hydrolysis treatment in the presence of a strong acid aqueous solution and a lower alcohol, followed by hydrofiltration.
In particular, from the viewpoint of efficiently obtaining the acid-treated product residue, it is preferably produced by the following production method.

即ち、前記酸処理物残渣は、前記ウコギ科トチバニンジン属植物を所定の濃度の強酸水溶液及び低級アルコールの存在下で加水分解処理し(加水分解処理工程)、得られた加水分解処理後の液を中和後(中和工程)、加水濾過し(加水濾過工程)、濾別された残渣を乾燥する(乾燥工程)。
以下、前記好ましい製造方法について、詳細に説明をする。
That is, the acid-treated product residue is obtained by hydrolyzing the arginaceae plant in the presence of a strong acid aqueous solution having a predetermined concentration and a lower alcohol (hydrolysis treatment step), and the resulting hydrolyzed solution is obtained. After neutralization (neutralization step), it is subjected to hydrofiltration (hydrofiltration step), and the residue separated by filtration is dried (drying step).
Hereinafter, the preferable manufacturing method will be described in detail.

<<加水分解処理工程>>
前記加水分解処理工程では、前記ウコギ科トチバニンジン属植物に所定の濃度の強酸水溶液及び低級アルコールの存在下で前記ウコギ科トチバニンジン属植物を加水分解し、前記酸処理物を生成させる。
<< Hydrolysis treatment process >>
In the hydrolysis treatment step, the Argyceae Tochibanin ginseng plant is hydrolyzed in the presence of a strong acid aqueous solution and a lower alcohol at a predetermined concentration to produce the acid-treated product.

前記強酸水溶液としては、強酸を含む水溶液であれば、特に制限はなく、目的に応じて適宜選択することができるが、これらの中でも、塩酸、リン酸、硫酸、硝酸等の無機酸を含む水溶液が好ましく、塩酸を含む水溶液が特に好適である。前記強酸水溶液における酸の濃度は、0.01mol/L〜4mol/Lであり、これらの中でも、0.5mol/L〜3mol/Lであることが好ましい。
前記酸の濃度が、0.01mol/L未満であると、加水分解が不十分で効率よく前記酸処理物が生成されないという問題が生じ、4mol/Lを超えると、加水分解が進み過ぎたり、コスト的に不利であるという問題が生じる。一方、前記酸の濃度が、前記好ましい範囲内であると、十分な加水分解により、効率よく酸処理物が得られる点で、有利である。
The strong acid aqueous solution is not particularly limited as long as it is an aqueous solution containing a strong acid, and can be appropriately selected according to the purpose. Among these, an aqueous solution containing an inorganic acid such as hydrochloric acid, phosphoric acid, sulfuric acid, nitric acid, etc. An aqueous solution containing hydrochloric acid is particularly preferable. The acid concentration in the strong acid aqueous solution is 0.01 mol / L to 4 mol / L, and among these, 0.5 mol / L to 3 mol / L is preferable.
When the concentration of the acid is less than 0.01 mol / L, there is a problem that hydrolysis is insufficient and the acid-treated product is not efficiently generated. When the acid concentration exceeds 4 mol / L, hydrolysis proceeds excessively, There is a problem that it is disadvantageous in terms of cost. On the other hand, when the acid concentration is within the preferable range, it is advantageous in that an acid-treated product can be obtained efficiently by sufficient hydrolysis.

前記強酸水溶液は、前記ウコギ科トチバニンジン属植物に対して、2倍容量〜20倍容量を使用することが好ましい。
前記強酸水溶液の使用量が、前記ウコギ科トチバニンジン属植物に対して、2倍容量未満であると、前記ウコギ科トチバニンジン属植物が十分に浸らず加水分解処理が不十分になること等があり、20倍容量を超えると、コスト的に不利になること等がある。
It is preferable that the strong acid aqueous solution is used in a volume of 2 to 20 times the volume of the genus Tochibaninjin.
When the amount of the strong acid aqueous solution used is less than 2 times the volume of the genus Tochibanin ginseng plant, the Uchigaceae Tochibanin ginseng plant may not be sufficiently immersed and the hydrolysis treatment may be insufficient. If the capacity exceeds 20 times, it may be disadvantageous in terms of cost.

<<<低級アルコールの使用>>>
前記加水分解処理は、低級アルコールの存在下で行う。前記低級アルコールを使用することにより、前記ウコギ科トチバニンジン属植物と、前記強酸水溶液との親和性を向上させ、効率よく加水分解を進めることが可能となる。また、前記低級アルコールを使用することにより、得られる酸処理物残渣の味や取扱い性を高めることができる点でも、有利である。
前記低級アルコールとしては、特に制限はなく、目的に応じて適宜選択することができるが、これらの中でも、メタノール、エタノール、プロパノールが好ましく、安全性の点からエタノールが特に好適である。
なお、本明細書において、低級アルコールとは、炭素数が1〜4のアルコール化合物を示す。
<<< Use of lower alcohol >>>
The hydrolysis treatment is performed in the presence of a lower alcohol. By using the lower alcohol, it is possible to improve the affinity between the Argiaceae Tochibanin genus plant and the strong acid aqueous solution, and to proceed the hydrolysis efficiently. Further, the use of the lower alcohol is also advantageous in that the taste and handleability of the resulting acid-treated residue can be improved.
The lower alcohol is not particularly limited and may be appropriately selected depending on the intended purpose. Among these, methanol, ethanol and propanol are preferable, and ethanol is particularly preferable from the viewpoint of safety.
In addition, in this specification, a lower alcohol shows a C1-C4 alcohol compound.

前記低級アルコールの使用量としては、特に制限はないが、加水分解液総量に対して、1容量%〜80容量%であることが好ましく、10容量%〜50容量%であることがより好ましく、20容量%〜40容量%であることが特に好ましい。
前記低級アルコールの使用量が、前記加水分解液総量に対して、1容量%未満であると、効率よく酸処理物が得られないこと等があり、80容量%を超えると、効率よく前記酸処理物が得られないことや、コスト的に不利になること等がある。一方、前記低級アルコールの使用量が、前記特に好ましい範囲内であると、効率よく酸処理物が得られる点で、有利である。なお、前記「加水分解液総量」とは、前記強酸水溶液、及び、前記低級アルコールを含めた全反応液量のことをいう。
Although there is no restriction | limiting in particular as the usage-amount of the said lower alcohol, It is preferable that it is 1 volume%-80 volume% with respect to the total amount of a hydrolysis liquid, It is more preferable that it is 10 volume%-50 volume%, It is particularly preferably 20% by volume to 40% by volume.
If the amount of the lower alcohol used is less than 1% by volume relative to the total amount of the hydrolyzed solution, an acid-treated product may not be obtained efficiently. If the amount used exceeds 80% by volume, the acid is efficiently obtained. There are cases in which a processed product cannot be obtained and the cost becomes disadvantageous. On the other hand, when the amount of the lower alcohol used is within the particularly preferred range, it is advantageous in that an acid-treated product can be obtained efficiently. The “total amount of hydrolyzed liquid” refers to the total amount of the reaction liquid including the strong acid aqueous solution and the lower alcohol.

前記強酸水溶液、及び、前記低級アルコールを含めた全反応液量(加水分解液総量)としては、特に制限はないが、前記ウコギ科トチバニンジン属植物に対し、2倍容量〜20倍容量とすることが好ましい。
全反応液量が、前記ウコギ科トチバニンジン属植物に対して、2倍容量未満であると、十分に浸らず加水分解処理が不十分になること等があり、20倍容量を超えると、コスト的に不利になること等がある。
Although there is no restriction | limiting in particular as total reaction liquid quantity (hydrolysis liquid total amount) including the said strong acid aqueous solution and the said lower alcohol, It shall be 2 times capacity-20 times capacity with respect to the said Araceae Tochibanin genus plant. Is preferred.
If the total amount of the reaction solution is less than 2 times the volume of the genus Tochibanin genus, the hydrolysis treatment may be insufficient due to insufficient immersion, and if it exceeds 20 times the cost, May be disadvantageous.

前記加水分解処理における処理温度としては、特に制限はないが、60℃〜100℃が好ましく、70℃〜90℃がより好ましい。
前記処理温度が、60℃未満であると、加水分解が不十分で効率よく前記酸処理物が生成されないこと等があり、100℃を超えると、特殊な製造設備が必要となり、コスト的に不利になること等がある。一方、前記処理温度が、前記より好ましい範囲内であると、効率よく前記酸処理物が得られる点で、有利である。
Although there is no restriction | limiting in particular as processing temperature in the said hydrolysis process, 60 to 100 degreeC is preferable and 70 to 90 degreeC is more preferable.
If the treatment temperature is less than 60 ° C, hydrolysis may be insufficient and the acid-treated product may not be produced efficiently. If the treatment temperature exceeds 100 ° C, special production equipment is required, which is disadvantageous in terms of cost. There are things to become. On the other hand, when the treatment temperature is within the more preferable range, it is advantageous in that the acid-treated product can be obtained efficiently.

また、前記加水分解処理における処理時間としては、特に制限はないが、30分〜24時間が好ましく、2時間〜8時間がより好ましい。
前記処理時間が、30分未満であると、加水分解が不十分で効率よく酸処理物が得られないこと等があり、24時間を超えると、反応が進みすぎたり、コスト的に不利になること等がある。一方、前記処理時間が、前記より好ましい範囲内であると、効率よく前記酸処理物が得られる点で、有利である。
The treatment time in the hydrolysis treatment is not particularly limited, but is preferably 30 minutes to 24 hours, and more preferably 2 hours to 8 hours.
If the treatment time is less than 30 minutes, hydrolysis may be insufficient and an acid-treated product may not be obtained efficiently. If the treatment time exceeds 24 hours, the reaction proceeds excessively or the cost is disadvantageous. There are things. On the other hand, when the treatment time is within the more preferable range, it is advantageous in that the acid-treated product can be obtained efficiently.

<<中和工程>>
前記中和工程では、前記加水分解処理後、得られた加水分解処理後の液を中和する。
前記中和は、特に制限はなく、公知の手法により行うことができ、例えば、前記加水分解処理後の液に、水酸化ナトリウム、水酸化カリウム等の強塩基水溶液を適宜加えることにより、行うことができる。なお、前記中和後のpHは、5〜8とすることが好ましい。
<< Neutralization process >>
In the neutralization step, the obtained hydrolyzed solution is neutralized after the hydrolysis treatment.
The neutralization is not particularly limited and can be performed by a known method. For example, the neutralization is performed by appropriately adding a strong base aqueous solution such as sodium hydroxide or potassium hydroxide to the liquid after the hydrolysis treatment. Can do. In addition, it is preferable that the pH after the said neutralization shall be 5-8.

<<加水濾過工程>>
前記濾過工程では、前記中和工程後の加水分解処理後の液を加水濾過し、濾液と残渣とに濾別する。
前記加水濾過は、特に制限はなく、公知の手法により行うことができる。なお、濾過後は、更に塩がなくなるまで水洗を繰り返してもよい。
<< Hydrofiltration process >>
In the filtration step, the hydrolyzed liquid after the neutralization step is hydrofiltered and separated into a filtrate and a residue.
The hydrofiltration is not particularly limited and can be performed by a known method. After filtration, washing with water may be repeated until there is no more salt.

<<<加水濾過>>>
前記低級アルコールを使用することから、濾過前に、前記酸処理物残渣への残留を促す目的で、水を加えて加水分解処理後の液中の低級アルコール濃度を下げる。
この場合に加水分解処理後の液中の低級アルコール濃度は低ければ低いほどよく、したがって添加する水は多いほどよいが、加水分解処理後の液中の低級アルコール濃度が50容量%以下となるように添加することが好ましく、30容量%以下となるように添加することがより好ましく、10容量%以下となるように添加することが特に好ましい。
前記加水分解処理後の液中の低級アルコール濃度が、50容量%を超えたまま濾過に供すると、得られた前記酸処理物が低級アルコールに溶解して濾液として排出される点で不利となる。一方、前記加水分解処理後の液中の低級アルコール濃度を、特に好ましい範囲内とすると、より効率よく前記酸処理物残渣が得られる点で、有利である。
<<< Hydrofiltration >>>
Since the lower alcohol is used, water is added to lower the concentration of the lower alcohol in the solution after the hydrolysis treatment for the purpose of promoting the residue in the acid-treated product residue before filtration.
In this case, the lower alcohol concentration in the liquid after the hydrolysis treatment is better as it is lower. Therefore, the more water is added, the lower alcohol concentration in the liquid after the hydrolysis treatment is 50% by volume or less. It is preferable to add to 30% by volume, more preferably 30% by volume or less, and particularly preferably 10% by volume or less.
When the lower alcohol concentration in the liquid after the hydrolysis treatment is subjected to filtration while exceeding 50% by volume, it is disadvantageous in that the obtained acid-treated product is dissolved in the lower alcohol and discharged as a filtrate. . On the other hand, when the concentration of the lower alcohol in the liquid after the hydrolysis treatment is within a particularly preferable range, it is advantageous in that the acid-treated product residue can be obtained more efficiently.

<<乾燥工程>>
前記乾燥工程では、前記加水濾過工程後の濾別された残渣を乾燥し、精製された前記酸処理物残渣を得る。
前記乾燥は、特に制限はなく、公知の手法により行うことができ、例えば、凍結乾燥、通風乾燥、加熱乾燥、減圧乾燥など通常の方法が利用できる。
<< Drying process >>
In the drying step, the residue separated by filtration after the hydrofiltration step is dried to obtain the purified acid-treated product residue.
There is no restriction | limiting in particular in the said drying, It can perform by a well-known method, For example, normal methods, such as freeze drying, ventilation drying, heat drying, and reduced pressure drying, can be utilized.

<摂取>
前記尿酸値低下組成物の摂取方法、摂取量、摂取回数、摂取時期、及び摂取対象としては、特に制限はなく、目的に応じて適宜選択することができる。
前記摂取方法としては、特に制限はなく、目的に応じて適宜選択することができるが、経口で摂取する方法が、容易に摂取できるため継続しやすい点で好ましい。
前記摂取量としては、特に制限はなく、摂取対象個体の年齢、体重、体質、症状、他の成分を有効成分とする医薬の投与の有無など、様々な要因を考慮して適宜選択することができるが、1日あたりの摂取量が、少なくとも1mg以上であることが好ましく、10mg〜1,000mgがより好ましく、20mg〜500mgが更に好ましく、30mg〜300mgが特に好ましい。
前記摂取回数としては、特に制限はなく、目的に応じて適宜選択することができるが、1日1回が、利便性が良い点で好ましい。また、長期間継続摂取することが好ましい。
前記摂取対象となる動物種としては、ヒトに対して好適に適用されるものであるが、その作用効果が奏される限り、ヒト以外の動物(例えば、マウス、ラット、ハムスター、トリ、イヌ、ネコ、ヒツジ、ヤギ、ウシ、ブタ、サルなど)に対して適用することもできる。前記尿酸値低下組成物は、前記摂取対象がヒトである場合、尿酸値が7.0mg/dLを超える高尿酸血症のヒトに対して、特に優れた尿酸値低下作用を示す点で有利である。
<Ingestion>
There is no restriction | limiting in particular as an ingestion method of the said uric acid value fall composition, ingestion amount, ingestion frequency, ingestion time, and ingestion object, According to the objective, it can select suitably.
There is no restriction | limiting in particular as said ingestion method, Although it can select suitably according to the objective, The method of ingesting orally is preferable at the point which is easy to continue since it can ingest easily.
The intake amount is not particularly limited and may be appropriately selected in consideration of various factors such as the age, weight, constitution, symptom, and presence / absence of administration of a drug containing another component as an active ingredient. However, the daily intake is preferably at least 1 mg, more preferably 10 mg to 1,000 mg, still more preferably 20 mg to 500 mg, and particularly preferably 30 mg to 300 mg.
There is no restriction | limiting in particular as said frequency | count of ingestion, Although it can select suitably according to the objective, Once a day is preferable at the point with the convenience. Moreover, it is preferable to ingest continuously for a long time.
The animal species to be ingested are those that are suitably applied to humans, but as long as their effects are exerted, animals other than humans (eg, mice, rats, hamsters, birds, dogs, Cat, sheep, goat, cow, pig, monkey, etc.). The uric acid level-lowering composition is advantageous in that it has a particularly excellent uric acid level-lowering effect on a human with hyperuricemia whose uric acid level exceeds 7.0 mg / dL when the ingestion target is a human. is there.

<用途>
前記尿酸値低下組成物は、例えば、医薬品、医薬部外品、一般食品、健康食品や健康飲料、保健機能食品、食品添加剤、飼料、飼料用添加剤など様々な用途に使用することができ、その際の形態としては、乾燥粉末として提供することもできるし、液剤、錠剤、散剤、顆粒、糖衣錠、カプセル、懸濁液、乳剤、アンプル剤、注射剤、その他任意の形態に調製して提供することもできる。
<Application>
The uric acid level-lowering composition can be used for various applications such as pharmaceuticals, quasi drugs, general foods, health foods and health drinks, health functional foods, food additives, feeds, feed additives, and the like. As a form at that time, it can be provided as a dry powder, or it can be prepared as a liquid, tablet, powder, granule, dragee, capsule, suspension, emulsion, ampoule, injection, or any other form. It can also be provided.

前記尿酸値低下組成物としては、製剤化により血中尿酸値低下剤、高尿酸血症予防剤、高尿酸血症改善剤、痛風予防剤及び痛風改善剤等の治療剤として用いることができる。
前記製剤化の方法としては、特に制限はなく、目的に応じて適宜選択することができ、例えば、公知の製剤技術により行なうことができ、製剤中には適当な添加物も加えることができる。
The uric acid level lowering composition can be used as a therapeutic agent such as a blood uric acid level lowering agent, a hyperuricemia preventing agent, a hyperuricemia improving agent, a gout preventing agent and a gout improving agent by formulation.
There is no restriction | limiting in particular as the method of the said formulation, According to the objective, it can select suitably, For example, it can carry out by a well-known formulation technique, A suitable additive can also be added in a formulation.

以下、実施例を挙げて本発明をより詳細に説明するが、本発明は該実施例に何ら限定されるものではない。   EXAMPLES Hereinafter, although an Example is given and this invention is demonstrated in detail, this invention is not limited to this Example at all.

<尿酸値低下組成物の調製>
(実施例1)
田七人参粉末300gを、塩酸(35.0質量%〜37.0質量%:和光純薬工業(株)製)0.48L、及び蒸留水1.52L、並びに99.5%エタノール(和光純薬工業(株)製)1Lを加え、6時間、80℃の温度条件で攪拌、加熱を行った。
続いて、得られた反応液に5M水酸化ナトリウム水溶液を加えpH7.0に調整した後、12.5Lの蒸留水を加え、その後溶液を濾過し、濾液と残渣に濾別した。
得られた残渣を凍結乾燥して、田七人参酸処理物残渣からなる実施例1の尿酸値低下組成物52.0gを得た(収率17.3%)。
<Preparation of uric acid level lowering composition>
Example 1
300 g of ginseng powder is added to 0.48 L of hydrochloric acid (35.0 mass% to 37.0 mass%: manufactured by Wako Pure Chemical Industries, Ltd.), 1.52 L of distilled water, and 99.5% ethanol (Wako Pure). 1 L of Yakuhin Kogyo Co., Ltd. was added, and the mixture was stirred and heated at 80 ° C. for 6 hours.
Subsequently, 5M aqueous sodium hydroxide solution was added to the resulting reaction solution to adjust the pH to 7.0, 12.5 L of distilled water was added, the solution was then filtered, and the filtrate and the residue were separated by filtration.
The obtained residue was lyophilized to obtain 52.0 g of a uric acid value-reducing composition of Example 1 consisting of a residue of a processed ginseng acid residue (yield 17.3%).

(比較例1)
実施例1に用いた田七人参粉末と同じ田七人参粉末を比較例1の尿酸値低下組成物として用いた。
(Comparative Example 1)
The same ginseng powder as the ginseng powder used in Example 1 was used as the uric acid value-reducing composition of Comparative Example 1.

<尿酸値低下効果の試験(I)>
−試験方法−
成人20名の血中尿酸値を測定し、尿酸値が平均的となるように二群に分け、一方に比較例1の尿酸値低下組成物(田七人参粉末)1.0gを封入したカプセル、他方に実施例1の尿酸値低下組成物(田七人参酸処理物残渣)173mg(田七人参粉末1.0gに相当)を封入したカプセルを空腹状態で午前中に一度摂取させ、これを2週間継続させた。
<Test of uric acid level lowering effect (I)>
-Test method-
The blood uric acid level of 20 adults was measured and divided into two groups so that the uric acid level would be average. One capsule encapsulating 1.0 g of the uric acid level lowering composition (Tanachi ginseng powder) of Comparative Example 1 On the other hand, a capsule encapsulating 173 mg (corresponding to 1.0 g of ginseng powder) of the uric acid level-reducing composition of Example 1 was ingested once in the morning on an empty stomach, Continued for 2 weeks.

−試験結果−
下記表1から理解されるように、比較例1の尿酸値低下組成物を用いた田七人参粉末摂取群においては、摂取前と、2週間摂取後とで、2週間摂取後の方が、0.2mg/dLの分だけ尿酸値が低下するのにとどまった。これに対し、実施例1の尿酸値低下組成物を用いた田七人参酸処理物残渣の摂取群においては、摂取前と、2週間摂取後とで、2週間摂取後の方が、0.66mg/dL低下し、尿酸値の大幅な低下が見られた。
2週間摂取後の田七人参粉末摂取群の尿酸値低下値と、田七人参酸処理残渣摂取群の尿酸値低下値について、スチューデントt検定を用いて統計解析を行ったところ、危険率P=0.02となり、田七人参酸処理残渣摂取群の尿酸値低下に統計的に有意な差が認められた。
-Test results-
As understood from Table 1 below, in the Group 7 ginseng powder ingestion group using the uric acid level lowering composition of Comparative Example 1, before ingestion and after ingestion for 2 weeks, after ingestion for 2 weeks, The uric acid level only decreased by 0.2 mg / dL. On the other hand, in the ingestion group of the processed ginseng acid residue using the uric acid level-lowering composition of Example 1, before the ingestion and after the ingestion for 2 weeks, the one after the ingestion for 2 weeks was 0. It decreased by 66 mg / dL, and a significant decrease in uric acid level was observed.
A statistical analysis was performed on the uric acid level decrease in the group of ginseng powder after 2 weeks intake and the uric acid level decrease in the group of ginseng treated residues using the Student t test. It was 0.02, and a statistically significant difference was observed in the decrease in uric acid level in the group of the seven ginseng treated residues.

Figure 2011016792
Figure 2011016792

<高尿酸血症予防及び改善の試験>
−試験方法−
尿酸値低下効果の評価において、実施例1の尿酸値低下組成物を用いた田七人参酸処理物残渣の摂取被験者に対して、更に、下記(1)、(2)の様に群分けを行い、その群ごとに下記に示す方法で尿酸値の測定を行った。
(1)4週摂取群(被験者11〜15)
この群では、前記尿酸値低下効果の試験(2週間継続摂取)に引き続いて、更に、2週間摂取し、合計4週間に亘り、実施例1における尿酸値低下組成物を継続して摂取した。
(2)中断後2週群(被験者16〜20)
この群では、前記尿酸値低下効果の試験(2週間継続摂取)で、摂取を中断し、その後2週間継続して実施例1における尿酸値低下組成物を摂取しないようにした。
<Test for prevention and improvement of hyperuricemia>
-Test method-
In the evaluation of the uric acid level lowering effect, for the subjects ingesting the residue of processed ginseng acid using the uric acid level lowering composition of Example 1, further grouping as shown in the following (1), (2) The uric acid level was measured for each group by the method shown below.
(1) 4-week intake group (Subjects 11-15)
In this group, following the above-described test for uric acid level lowering effect (continuous intake for 2 weeks), the uric acid level lowering composition in Example 1 was continuously ingested for a further 4 weeks.
(2) 2 weeks after interruption (subjects 16-20)
In this group, in the test for the effect of lowering uric acid level (continuous intake for 2 weeks), the intake was interrupted and then continued for 2 weeks so that the uric acid level-lowering composition in Example 1 was not taken.

−試験結果−
前記(1)4週摂取群と、前記(2)中断後2週群とにおける各被験者に対し、試験終了後の尿酸値を測定した。その結果を下記表2に示す。
下記表2から理解されるように、前記(1)4週摂取群においては、前記(2)中断後2週群と比較して、有意に尿酸値が低い値を示した。
即ち、前記(2)中断後2週群では、摂取開始後2週間経過時と試験終了時(摂取を中断して2週間経過時)とを比較して、低い尿酸値状態が維持されないが(尿酸値が平均0.6mg/dLの上昇)、前記(1)4週摂取群では、摂取開始後2週間経過時と試験終了時(摂取開始後4週間経過時)とを比較して、低い尿酸値状態が維持される(尿酸値が平均0.18mg/dL低下)ことが確認された。
なお、4週間摂取群における摂取開始2週間後と試験終了時(摂取開始4週間後)とを比較した尿酸値の差と、中断後2週群における摂取開始2週間後と試験終了時(摂取を中断して2週間経過時)とを比較した尿酸値の差について、スチューデントt検定を用いて統計解析を行ったところ、危険率P=0.05となり、尿酸値低下効果に統計的に有意な差が認められた。
このように、実施例1における尿酸値低下組成物を継続して摂取し続けると、尿酸値の上昇を抑制することができ、また尿酸値低下組成物の摂取を中断すると尿酸値は上昇するため、本発明の尿酸値低下組成物は、高尿酸血症の予防及び改善に寄与することができると推察される。
-Test results-
The uric acid level after completion of the test was measured for each subject in the (1) 4-week intake group and the (2) 2-week post-interruption group. The results are shown in Table 2 below.
As can be seen from Table 2 below, the (1) 4-week intake group showed a significantly lower uric acid value than the (2) 2-week post-interruption group.
That is, in the group of 2 weeks after the interruption (2), a low uric acid level state is not maintained when comparing 2 weeks after the start of intake and at the end of the test (2 weeks after stopping the intake) ( (Increased uric acid level of 0.6 mg / dL on average), (1) In the 4-week intake group, compared to 2 weeks after the start of intake and at the end of the test (4 weeks after the start of intake), low It was confirmed that the uric acid level state was maintained (the uric acid level decreased by 0.18 mg / dL on average).
The difference in uric acid levels compared between 2 weeks after the start of intake in the 4-week intake group and at the end of the study (4 weeks after start of intake), and 2 weeks after the start of intake in the group after 2 weeks and at the end of the test (intake) The statistical analysis of the difference in uric acid value compared to 2 weeks after the interruption was performed using Student's t-test, the risk rate was P = 0.05, which was statistically significant in the uric acid value lowering effect The difference was recognized.
As described above, if the uric acid value-lowering composition in Example 1 is continuously ingested, an increase in the uric acid value can be suppressed, and if the uric acid value-lowering composition is interrupted, the uric acid value increases. It is speculated that the uric acid level-lowering composition of the present invention can contribute to prevention and improvement of hyperuricemia.

Figure 2011016792
Figure 2011016792

<尿酸値低下効果の試験(II)>
高尿酸血症の判断指標である血中尿酸値が7.0mg/dLを超える血中尿酸値を持つ成人(高尿酸血症群)と、血中尿酸値が7.0mg/dL以下の成人(正常尿酸値群)とを被験者とした尿酸値低下効果の試験を実施した。
<Test of uric acid level lowering effect (II)>
Adults (blood hyperuricemia group) who have a blood uric acid level that is more than 7.0 mg / dL, an index for determining hyperuricemia, and adults whose blood uric acid level is 7.0 mg / dL or less A test of the effect of lowering uric acid levels was carried out using (normal uric acid level group) as subjects.

(実施例2:高用量剤の調製)
実施例1で得られた田七人参酸処理物残渣を用いて、田七人参酸処理物を180mg配合した結晶セルロース1.0gをカプセルに封入し、実施例2における尿酸値低下組成物(以下、「高用量剤」と称することがある。)を調製した。
(Example 2: Preparation of high dose)
Using the rice ginseng acid processed product residue obtained in Example 1, 1.0 g of crystalline cellulose containing 180 mg of the ginseng acid processed product was encapsulated in a capsule, and the uric acid value-reducing composition in Example 2 (hereinafter referred to as the uric acid value-reduced composition) , Sometimes referred to as “high dose”).

(実施例3:低用量剤の調製)
実施例1で得られた田七人参酸処理物残渣を用いて、田七人参酸処理物を45mg配合した結晶セルロース1.0gをカプセルに封入し、実施例3における尿酸値低下組成物(以下、「低用量剤」と称することがある。)を調製した。
(Example 3: Preparation of low dose)
Using the rice ginseng acid processed product residue obtained in Example 1, 1.0 g of crystalline cellulose containing 45 mg of the ginseng acid processed product was encapsulated in a capsule, and the uric acid value-reducing composition in Example 3 (hereinafter referred to as “the uric acid value reduced composition”) , Sometimes referred to as “low dose”).

(比較例2:プラセボ剤の調製)
実施例1で得られた田七人参酸処理物残渣を配合しない結晶セルロース1.0gをカプセルに封入したこと以外は、実施例2ならびに実施例3と同様にして、比較例2における尿酸値低下組成物(以下、「プラセボ剤」と称することがある。)を調製した。
(Comparative Example 2: Preparation of placebo)
The decrease in uric acid level in Comparative Example 2 was performed in the same manner as in Example 2 and Example 3, except that 1.0 g of crystalline cellulose not containing the residue of the processed ginseng acid product obtained in Example 1 was encapsulated. A composition (hereinafter sometimes referred to as “placebo”) was prepared.

−試験方法−
高尿酸血症の判断指標である血中尿酸値が7.0mg/dLを超える血中尿酸値を持つ成人12名(高尿酸血症群:被験者59〜70)と、血中尿酸値が7.0mg/dL以下の成人38名(正常尿酸値群:被験者21〜58)とを被験者とし、高尿酸血症群、並びに、正常尿酸値群のそれぞれに対して血中尿酸値を測定し、尿酸値が平均的になるように三群に分け、プラセボ群(被験者21〜33、59〜63)、低用量群(被験者46〜58、68〜70)、高用量群(被験者34〜45、64〜67)の三群を設定した。プラセボ群には比較例2の尿酸低下組成物、低用量群には実施例3の尿酸低下組成物、高用量群には実施例2の尿酸低下組成物を空腹状態で午前中に一度摂取させ、これを12週間継続させた。
-Test method-
Twelve adults (blood hyperuremia group: subjects 59 to 70) with blood uric acid levels that are more than 7.0 mg / dL, which are indicators of hyperuricemia, and blood uric acid levels of 7 0.0 38 mg / dL or less adults (normal uric acid level group: subjects 21 to 58) were subjects, and the blood uric acid level was measured for each of the hyperuricemia group and the normal uric acid level group, The uric acid level is divided into three groups so that the uric acid level becomes average, a placebo group (subjects 21-33, 59-63), a low dose group (subjects 46-58, 68-70), a high dose group (subjects 34-45, Three groups of 64 to 67) were set. In the placebo group, the uric acid lowering composition of Comparative Example 2 was ingested, in the low dose group, the uric acid lowering composition of Example 3, and in the high dose group, the uric acid lowering composition of Example 2 was ingested once in the morning on an empty stomach. This was continued for 12 weeks.

−試験結果−
正常尿酸値群の結果を下記表3に、高尿酸血症群の結果を下記表4に示す。
表3から理解されるように、血中尿酸値が7.0mg/dL以下の正常尿酸値群においては、摂取前と摂取12週間後とでは、血中尿酸値に対し大きな変動は見られなかった。
一方、表4から理解されるように、血中尿酸値が7.0mg/dLを超える高尿酸血症群においては、プラセボ群について、摂取前と摂取12週間後とでは、摂取12週間後の方が血中尿酸値は0.36mg/dLの上昇が見られた。これに対し、実施例3の尿酸値低下組成物を摂取した低用量群においては、摂取前と摂取12週間後とでは、摂取12週間後の方が、血中尿酸値は0.47mg/dLの低下が見られ、また測定結果について、スチューデントt検定を用いて解析を行ったところ、危険率P=0.10となり、緩和な尿酸値低下効果が見られた。更に実施例2の尿酸値低下組成物を摂取した高用量群においては、摂取前と摂取12週間後とでは、摂取12週間後の方が、血中尿酸値は0.6mg/dLの低下が見られ、また、測定結果についてスチューデントt検定を用いて解析を行ったところ、危険率P=0.04となり、尿酸値低下効果において、統計的に有意な差が認められた。
なお、全ての群において12週間の摂取期間中、被験者には何ら副作用は認められず、摂取に際して被験者の抵抗感もなかった。これらの結果より、本試験組成物は安全かつ無理なく継続的に摂取することができ、特に血中尿酸値が高値を示す者に対して効果的に尿酸値を低下させ得ることが判明した。
-Test results-
The results of the normal uric acid value group are shown in Table 3 below, and the results of the hyperuricemia group are shown in Table 4 below.
As can be seen from Table 3, in the normal uric acid level group with a blood uric acid level of 7.0 mg / dL or less, there was no significant change in the blood uric acid level before and after 12 weeks of ingestion. It was.
On the other hand, as can be seen from Table 4, in the hyperuricemia group in which the blood uric acid level exceeded 7.0 mg / dL, the placebo group was 12 weeks after ingestion before and 12 weeks after ingestion. The blood uric acid level increased by 0.36 mg / dL. In contrast, in the low-dose group ingesting the uric acid level-lowering composition of Example 3, the blood uric acid level was 0.47 mg / dL before ingestion and 12 weeks after ingestion, 12 weeks after ingestion. When the measurement results were analyzed using the Student t test, the risk factor P was 0.10, and a moderate uric acid value lowering effect was observed. Furthermore, in the high-dose group ingesting the uric acid level-lowering composition of Example 2, the blood uric acid level decreased by 0.6 mg / dL before ingestion and after 12 weeks of ingestion after 12 weeks of ingestion. In addition, when the measurement results were analyzed using the student t test, the risk factor P = 0.04, and a statistically significant difference was observed in the uric acid level lowering effect.
In all groups, no adverse effects were observed in the subjects during the intake period of 12 weeks, and the subjects did not feel any resistance during intake. From these results, it was found that this test composition can be safely and continuously ingested, and can effectively reduce the uric acid level particularly for those who have high blood uric acid levels.

Figure 2011016792
Figure 2011016792

Figure 2011016792
Figure 2011016792

本発明の尿酸値低下組成物は、血中の尿酸値を低下させるとともに、副作用がなく長期
間安心して無理なく服用でき、更に、高尿酸血症の予防及び改善に寄与することから、血
中尿酸値低下剤、高尿酸血症予防剤、高尿酸血症改善剤、痛風予防剤、痛風改善剤として好適に利用することができる。
The uric acid level-lowering composition of the present invention lowers the uric acid level in the blood, can be safely and comfortably taken for a long time without side effects, and further contributes to the prevention and improvement of hyperuricemia. It can be suitably used as a uric acid level lowering agent, a hyperuricemia preventing agent, a hyperuricemia improving agent, a gout preventing agent, and a gout improving agent.

Claims (3)

ウコギ科トチバニンジン属植物を強酸水溶液及び低級アルコールの存在下で加水分解処理後、加水濾過して得られる酸処理物残渣を有効成分として含有することを特徴とする尿酸値低下組成物。   A composition for reducing uric acid level, which comprises, as an active ingredient, an acid-treated product residue obtained by hydrolyzing a Urugiaceae plant belonging to the genus Tochibaninjin in the presence of a strong acid aqueous solution and a lower alcohol, followed by hydrofiltration. ウコギ科トチバニンジン属植物が田七人参である請求項1に記載の尿酸値低下組成物。   The uric acid level-decreasing composition according to claim 1, wherein the Arionaceae Tochibaninjin plant is a ginseng. 血中尿酸値低下剤、高尿酸血症予防剤、高尿酸血症改善剤、痛風予防剤及び痛風改善剤に用いられる請求項1から2のいずれかに記載の尿酸値低下組成物。   The uric acid level lowering composition according to any one of claims 1 to 2, which is used for a blood uric acid level lowering agent, a hyperuricemia preventing agent, a hyperuricemia improving agent, a gout preventing agent and a gout improving agent.
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