JP2018090552A - Arthralgia improver - Google Patents

Arthralgia improver Download PDF

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JP2018090552A
JP2018090552A JP2016237617A JP2016237617A JP2018090552A JP 2018090552 A JP2018090552 A JP 2018090552A JP 2016237617 A JP2016237617 A JP 2016237617A JP 2016237617 A JP2016237617 A JP 2016237617A JP 2018090552 A JP2018090552 A JP 2018090552A
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denatured
collagen
joint pain
proteoglycan
improving
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嘉文 濱口
Yoshifumi Hamaguchi
嘉文 濱口
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Wellvernus Co Ltd
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Wellvernus Co Ltd
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Priority to JP2022150450A priority patent/JP7485470B2/en
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  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Abstract

PROBLEM TO BE SOLVED: To provide an arthralgia improver having high efficacy.SOLUTION: An arthralgia improver contains as active ingredients nondenaturing proteoglycan and nondenaturing collagen of 3:10-7:10 in mass ratio.SELECTED DRAWING: Figure 7

Description

本発明は、関節痛改善剤に関する。   The present invention relates to an agent for improving arthralgia.

関節痛や高齢者で問題となる膝関節の変形による関節症などは日常生活の質に重大な影響を与えている。従来、このような症状を緩和するためにステロイド剤や非ステロイド剤が広く用いられていたが、過剰な免疫抑制作用による副作用が懸念されている。   Joint pain and arthropathy caused by knee deformation, which is a problem in the elderly, have a significant impact on the quality of daily life. Conventionally, steroids and non-steroids have been widely used to relieve such symptoms, but there are concerns about side effects due to excessive immunosuppressive action.

ところで、コンドロイチン、ビタミンＢ１類、Ｎ−アセチルグルコサミン（ＮＡＧ）、グルコサミンなど、関節痛を改善する作用を有する物質は種々報告されている（特許文献１、２）。   By the way, various substances having an action to improve joint pain such as chondroitin, vitamin B1 class, N-acetylglucosamine (NAG), and glucosamine have been reported (Patent Documents 1 and 2).

そして、プロテオグリカンによる関節痛改善効果についても報告されている。プロテオグリカンによる関節痛改善効果として、膝関節痛改善効果や腰痛改善効果が知られている（特許文献３、４）。   And the joint pain improvement effect by proteoglycan has also been reported. As a joint pain improving effect by proteoglycan, a knee joint pain improving effect and a low back pain improving effect are known (Patent Documents 3 and 4).

プロテオグリカンは関節痛改善効果以外にも、運動器系の正常化、機能低下予防・回復・改善と、美容系における皮膚のたるみ、弾力、しわ、色素沈着の予防・回復・改善、角質の正常化などの効果が知られている（特許文献３）。   In addition to the joint pain improvement effect, proteoglycan normalizes the musculoskeletal system, prevents / recovers / improves functional deterioration, prevents / restores / improves skin sagging, elasticity, wrinkles, and pigmentation in the beauty system, and normalizes keratin Such effects are known (Patent Document 3).

さらに、分子量の大きい非変性プロテオグリカンに炎症性腸疾患、皮膚バリア機能などの改善に高い効果があることも報告されている（特許文献５、６）。また、非変性プロテオグリカンが皮膚繊維芽細胞増殖活性やヒアルロン酸結合活性を有することも報告されている（特許文献５、６）。   Furthermore, it has also been reported that non-denatured proteoglycans having a large molecular weight are highly effective in improving inflammatory bowel disease, skin barrier function, etc. (Patent Documents 5 and 6). It has also been reported that non-denatured proteoglycans have skin fibroblast proliferation activity and hyaluronic acid binding activity (Patent Documents 5 and 6).

また、コラーゲンを含む治療剤が関節痛を改善する効果を有することも報告されている（特許文献７、８）。   It has also been reported that therapeutic agents containing collagen have an effect of improving joint pain (Patent Documents 7 and 8).

特開２０１５−２０９５９号公報Japanese Patent Laying-Open No. 2015-20959 特開２０１５−１８０６８７号公報Japanese Patent Laying-Open No. 2015-180687 特開２０１６−１３８０６０号公報Japanese Patent Laid-Open No. 2006-138060 特開２０１５−１３８４５号公報Japanese Patent Application Laid-Open No. 2015-13845 特開２０１１−２１９４４９号公報JP 2011-219449 A 特開２０１６−１２８４６７号公報Japanese Patent Laid-Open No. 2006-128467 特開２００３−１５５２５０号公報JP 2003-155250 A 特開２０１４−１１４２３２号公報JP 2014-114232 A

このように、関節痛を改善する作用を有する物質は複数種報告されているが、それらの組み合わせについての研究はほとんどされていない。   As described above, a plurality of types of substances having an action of improving joint pain have been reported, but few studies have been made on combinations thereof.

中でも、プロテオグリカンの作用についてはその作用機序が明らかでないことから、プロテオグリカンと他の関節痛を改善する作用を有する物質の相互作用による有用性についてはほとんど知られていない。   Among them, since the mechanism of action of proteoglycan is not clear, little is known about the usefulness of the interaction between proteoglycan and other substances having an action to improve joint pain.

上記事情に鑑みなされた本発明は、プロテオグリカンと他の関節痛を改善する作用を有する物質の相互作用による有用性を見出すことを課題とする。加えて、その配合比を検討することで、関節痛の痛みの緩和に極めて効果の高い関節痛改善剤、関節痛改善用組成物あるいは食品を提供することを本発明の課題とする。   This invention made | formed in view of the said situation makes it a subject to find the usefulness by interaction of the substance which has the effect | action which improves the proteoglycan and other joint pain. In addition, an object of the present invention is to provide a joint pain ameliorating agent, a composition for improving joint pain, or a food that is extremely effective in alleviating joint pain by examining the blending ratio.

本発明者らは上記課題を解決するために鋭意研究に励んだ結果、非変性プロテオグリカンと非変性コラーゲンを特定の質量比で含む関節痛改善用剤が高い関節痛改善効果を有することを見出し、本発明を完成させた。   As a result of diligent research to solve the above problems, the present inventors have found that a joint pain improving agent containing a non-modified proteoglycan and a non-modified collagen at a specific mass ratio has a high joint pain improving effect, The present invention has been completed.

すなわち、本発明の関節痛改善剤は非変性プロテオグリカンと非変性コラーゲンを有効成分として含む関節痛改善剤であって、非変性プロテオグリカンと非変性コラーゲンを３：１０〜７：１０の質量比で含むことを特徴とする。
本発明の関節痛改善剤は非変性プロテオグリカン及び非変性コラーゲンを特定の質量比で含むため、高い関節痛改善効果を奏する。 That is, the joint pain improving agent of the present invention is a joint pain improving agent containing non-denatured proteoglycan and non-denatured collagen as active ingredients, and comprises non-denatured proteoglycan and non-denatured collagen in a mass ratio of 3:10 to 7:10. It is characterized by that.
Since the joint pain improving agent of the present invention contains non-denatured proteoglycan and non-denatured collagen at a specific mass ratio, it exhibits a high joint pain improving effect.

本発明の好ましい形態では、前記非変性プロテオグリカンは９０万Ｄａ以上の平均分子量を有する。   In a preferred form of the invention, the unmodified proteoglycan has an average molecular weight of 900,000 Da or more.

本発明の関節痛改善剤には、あらゆる非変性コラーゲンを使用することができる。中でも、非変性II型コラーゲンを用いる形態とすることが好ましい。このような形態によれば、より高い関節痛改善効果を奏する。   Any non-denatured collagen can be used for the joint pain improving agent of the present invention. Among these, a form using non-denatured type II collagen is preferable. According to such a form, a higher joint pain improving effect is exhibited.

また本発明は、前記関節痛改善用剤を有効成分として含む関節痛改善用組成物にも関する。   The present invention also relates to a composition for improving joint pain comprising the above-mentioned agent for improving joint pain as an active ingredient.

本発明の好ましい形態では、前記関節痛改善用組成物は食品組成物である。   In a preferred form of the present invention, the composition for improving joint pain is a food composition.

本発明の関節痛改善剤及び関節痛改善用組成物は関節痛、及び関節症を軽減させる作用に優れる。   The joint pain improving agent and the joint pain improving composition of the present invention are excellent in the action of reducing joint pain and arthropathy.

実施例に記載のVAS試験による、非変性プロテオグリカンと非変性コラーゲンの質量比と「安静時の左膝の痛み」改善効果の関係を示すグラフである。It is a graph which shows the relationship between the mass ratio of a non-denatured proteoglycan and a non-denatured collagen, and the improvement effect of "the pain of the left knee at rest" by the VAS test as described in an Example. 実施例に記載のVAS試験による、非変性プロテオグリカンと非変性コラーゲンの質量比と「安静時の右膝の痛み」改善効果の関係を示すグラフである。It is a graph which shows the relationship between the mass ratio of a non-denatured proteoglycan and a non-denatured collagen, and the improvement effect of "the pain of the right knee at rest" by the VAS test as described in an Example. 実施例に記載のVAS試験による、非変性プロテオグリカンと非変性コラーゲンの質量比と「通常歩行時の左膝の痛み」改善効果の関係を示すグラフである。It is a graph which shows the relationship between the mass ratio of a non-denatured proteoglycan and a non-denatured collagen, and the improvement effect of "the pain of the left knee at the time of normal walking" by the VAS test as described in an Example. 実施例に記載のVAS試験による、非変性プロテオグリカンと非変性コラーゲンの質量比と「通常歩行時の右膝の痛み」改善効果の関係を示すグラフである。It is a graph which shows the relationship between the mass ratio of a non-denatured proteoglycan and a non-denatured collagen, and the improvement effect of "the pain of the right knee at the time of normal walking" by the VAS test as described in an Example. 実施例に記載のVAS試験による、非変性プロテオグリカンと非変性コラーゲンの質量比と「階段昇降時の左膝の痛み」改善効果の関係を示すグラフである。It is a graph which shows the relationship between the mass ratio of a non-denatured proteoglycan and a non-denatured collagen, and the "left knee pain at the time of stair climbing" improvement effect by the VAS test as described in an Example. 実施例に記載のVAS試験による、非変性プロテオグリカンと非変性コラーゲンの質量比と「階段昇降時の右膝の痛み」改善効果の関係を示すグラフである。It is a graph which shows the relationship between the mass ratio of a non-denatured proteoglycan and a non-denatured collagen, and the improvement effect of "the pain of the right knee at the time of stair climbing" by the VAS test as described in an Example. 実施例に記載のVAS試験による、非変性プロテオグリカンと非変性コラーゲンの質量比と関節痛改善効果の「総合評価」の関係を示すグラフである。It is a graph which shows the relationship of the "total evaluation" of the mass ratio of non-denatured proteoglycan and non-denatured collagen, and the joint pain improvement effect by the VAS test as described in an Example.

本発明の関節痛改善剤は、非変性プロテオグリカン及び非変性コラーゲンを有効成分として含む。   The joint pain improving agent of the present invention contains non-denatured proteoglycan and non-denatured collagen as active ingredients.

非変性プロテオグリカンとは、その起源となる生物中のプロテオグリカンの分子量を実質的に保持したまま製剤化に利用できる状態としたプロテオグリカンである。   Non-denatured proteoglycans are proteoglycans that can be used for formulation while substantially maintaining the molecular weight of the proteoglycans in the organism from which they are derived.

なお、非変性プロテオグリカンの分子量の組成が必ずしもその起源となる生物中のプロテオグリカンの分子量の組成と同一である必要はなく、製剤化に利用できる状態としたプロテオグリカンがその起源となる生物中のプロテオグリカンの分子量の組成と同じ特徴を有していれば、本発明の関節痛改善剤に含まれるプロテオグリカンは「非変性プロテオグリカン」といえる。   It should be noted that the molecular weight composition of non-denatured proteoglycan is not necessarily the same as the molecular weight composition of proteoglycan in the organism from which it originates, and the proteoglycan in the organism from which the proteoglycan made available for formulation can be used. Proteoglycans contained in the joint pain ameliorating agent of the present invention can be said to be “non-denatured proteoglycans” if they have the same characteristics as the molecular weight composition.

また、非変性プロテオグリカンとは、抽出又は製剤化の過程で変性処理に施されていないプロテオグリカンでもある。   Non-denatured proteoglycans are also proteoglycans that have not been subjected to denaturation treatment in the process of extraction or formulation.

本発明において「変性処理」とは、積極的にプロテオグリカンを変性させる操作をすることを意味する。すなわち、プロテオグリカンを実質的に分解又は破壊せずに抽出又は製剤化の操作をすること、及びプロテオグリカンが経時変化によって自然に変性することは、「変性処理」に含まない。   In the present invention, “denaturation treatment” means an operation of actively denaturing proteoglycans. That is, the operation of extraction or formulation without substantially decomposing or destroying proteoglycan and the natural denaturation of proteoglycan over time are not included in the “denaturation treatment”.

なお、本発明の関節痛改善剤の製造工程において、変性したプロテオグリカンが生じていたとしても、主たるプロテオグリカンがその起源となる生物中のプロテオグリカンの分子量の組成の範囲内であれば、本発明の関節痛改善剤に含まれるプロテオグリカンは「非変性プロテオグリカン」といえる。具体的には例えば、本発明の関節痛改善剤に含まれるプロテオグリカンの８０質量％以上、好ましくは９０質量％以上、より好ましくは９９質量％以上が起源となる生物中のプロテオグリカンの分子量の組成の範囲内のプロテオグリカンであれば、本発明の関節痛改善剤に含まれるプロテオグリカンは非変性プロテオグリカンであると評価できる。   Even if a modified proteoglycan is produced in the production process of the joint pain ameliorating agent of the present invention, the joint of the present invention can be used as long as the main proteoglycan is within the range of the molecular weight composition of the proteoglycan in the organism from which it originated. Proteoglycans contained in pain ameliorating agents can be said to be “non-denatured proteoglycans”. Specifically, for example, the composition of the molecular weight of the proteoglycan in the organism originated from 80% by mass or more, preferably 90% by mass or more, more preferably 99% by mass or more of the proteoglycan contained in the joint pain improving agent of the present invention. If the proteoglycan is within the range, the proteoglycan contained in the joint pain ameliorating agent of the present invention can be evaluated as a non-denatured proteoglycan.

また、本発明の関節痛改善剤に含まれる非変性プロテオグリカンは、その起源に特に制限はなく、例えば、サケの鼻軟骨組織、エイの軟骨組織、サメの軟骨組織等の魚類由来の軟骨組織、ニワトリ等の軟骨組織等の鳥類の軟骨組織、さらにはウシの喉軟骨や気管支軟骨、クジラの軟骨等の哺乳動物由来の軟骨組織から抽出した非変性プロテオグリカンを挙げることができる。   The origin of the non-denatured proteoglycan contained in the joint pain ameliorating agent of the present invention is not particularly limited. For example, fish-derived cartilage tissue such as salmon nasal cartilage tissue, ray cartilage tissue, shark cartilage tissue, Non-denatured proteoglycans extracted from avian cartilage tissues such as chicken cartilage tissues, and from mammalian cartilage tissues such as bovine throat cartilage, bronchial cartilage, and whale cartilage.

中でも、非変性プロテオグリカンは、サケの鼻軟骨組織、サメの軟骨組織、ニワトリ等の軟骨組織のうち１種又は２種以上の生物の組織から抽出されたものであることが好ましい。また、非変性プロテオグリカンは、サケの鼻軟骨組織から抽出されたものであることがさらに好ましい。   Among them, the non-denatured proteoglycan is preferably extracted from the tissue of one or more organisms of cartilage tissues such as salmon nasal cartilage tissue, shark cartilage tissue and chicken. The non-denatured proteoglycan is more preferably extracted from salmon nasal cartilage tissue.

なお、非変性プロテオグリカンを天然物から調製する場合には、その調製方法はプロテオグリカンを変性させないものであれば特に限定されるものではないが、例えば、サケ鼻軟骨を原料としてアルカリ溶液を用いて抽出、調製する方法や、過酢酸を含む溶液に浸漬させ、浸漬後の溶液を回収する方法を選択することができる。   In the case where non-modified proteoglycan is prepared from a natural product, the preparation method is not particularly limited as long as it does not denature the proteoglycan. For example, salmon nasal cartilage is used as a raw material and extracted using an alkaline solution. The method of preparing and the method of immersing in the solution containing peracetic acid and recovering the solution after immersion can be selected.

非変性プロテオグリカンは市販されている医薬品原料又は食品原料であってもよい。   The unmodified proteoglycan may be a commercially available pharmaceutical raw material or food raw material.

そして、本発明の関節痛改善剤には、平均分子量が好ましくは９０万Ｄａ以上、より好ましくは１２０万Ｄａ以上、さらに好ましくは１５０万Ｄａ以上である非変性プロテオグリカンを用いることが好ましい。   In the joint pain ameliorating agent of the present invention, it is preferable to use a non-modified proteoglycan having an average molecular weight of preferably 900,000 Da or more, more preferably 1,200,000 Da or more, and further preferably 1,500,000 Da or more.

なお、非変性プロテオグリカンの平均分子量を算出する方法は、製品中のプロテオグリカンの分子量の組成から分子量の平均を算出することのできる方法であれば特に制限はなく、例えば、高速液体クロマトグラフィ装置を用いた定量分析により平均分子量の算出する方法、ＥＬＩＳＡ法を用いて定量した後に電気泳動処理に施し平均分子量の算出する方法、を挙げることができる。   The method for calculating the average molecular weight of the non-denatured proteoglycan is not particularly limited as long as the average molecular weight can be calculated from the composition of the molecular weight of the proteoglycan in the product. For example, a high performance liquid chromatography apparatus was used. Examples thereof include a method for calculating an average molecular weight by quantitative analysis, and a method for calculating an average molecular weight by performing electrophoresis treatment after quantification using an ELISA method.

また、非変性コラーゲンとは、その起源となる生物中のコラーゲンの分子量を実質的に保持したまま製剤化に利用できる状態としたコラーゲンである。   Non-denatured collagen is collagen that can be used for formulation while substantially maintaining the molecular weight of the collagen in the organism that is the origin.

なお、非変性コラーゲンの分子量の組成が必ずしもその起源となる生物中のコラーゲンの分子量の組成と同一である必要はなく、製剤化に利用できる状態としたコラーゲンがその起源となる生物中のコラーゲンの分子量の組成と同じ特徴を有していれば、本発明の関節痛改善剤に含まれるコラーゲンは「非変性コラーゲン」といえる。   Note that the molecular weight composition of non-denatured collagen does not necessarily have to be the same as the molecular weight composition of the collagen in the organism from which it originates, and the collagen in a state where it can be used for formulation is the source of the collagen in the organism from which it originates. If it has the same characteristics as the composition of molecular weight, the collagen contained in the joint pain improving agent of the present invention can be said to be “non-denatured collagen”.

また、非変性コラーゲンとは、抽出又は製剤化の過程で変性処理に施されていないコラーゲンでもある。   Non-denatured collagen is collagen that has not been subjected to denaturation treatment in the process of extraction or formulation.

なお、本発明において、「変性処理」とは、積極的にコラーゲンを変性させる操作をすることを意味する。すなわち、コラーゲンを実質的に分解又は破壊せずに抽出または製剤化の操作をすること、及びコラーゲンが経時変化によって自然に変性することは、「変性処理」に含まない。   In the present invention, “denaturation treatment” means an operation of actively denaturing collagen. That is, the operation of extraction or formulation without substantially degrading or destroying the collagen and the natural denaturation of the collagen over time are not included in the “denaturation treatment”.

なお、本発明の関節痛改善剤の製造工程において、変性したコラーゲンが生じていたとしても、主たるコラーゲンがその起源となる生物中のコラーゲンの分子量の組成の範囲内であれば、本発明の関節痛改善剤に含まれるコラーゲンは「非変性コラーゲン」といえる。具体的には例えば、本発明の関節痛改善剤に含まれるコラーゲンの８０質量％以上、好ましくは９０質量％以上、より好ましくは９９質量％以上が起源となる生物中のコラーゲンの分子量の組成の範囲内のコラーゲンであれば、本発明の関節痛改善剤に含まれるコラーゲンは非変性コラーゲンであると評価できる。   In the process for producing the joint pain improving agent of the present invention, even if denatured collagen is produced, the joint of the present invention is not limited as long as the main collagen is within the range of the molecular weight composition of the collagen in the organism from which it originated. Collagen contained in the pain ameliorating agent can be said to be “non-denatured collagen”. Specifically, for example, the composition of the molecular weight of collagen in an organism originating from 80% by mass or more, preferably 90% by mass or more, more preferably 99% by mass or more of the collagen contained in the joint pain improving agent of the present invention. If the collagen is within the range, it can be evaluated that the collagen contained in the joint pain ameliorating agent of the present invention is non-denatured collagen.

また、本発明の関節痛改善剤に含まれる非変性コラーゲンは、その起源に特に制限はなく、例えば、サケの鼻軟骨組織、エイの軟骨組織、サメの軟骨組織等の魚類由来の軟骨組織、ニワトリ等の軟骨組織等の鳥類の軟骨組織、さらにはウシの喉軟骨や気管支軟骨、クジラの軟骨等の哺乳動物由来の軟骨組織から抽出した非変性コラーゲンを挙げることができる。   The origin of the non-denatured collagen contained in the joint pain ameliorating agent of the present invention is not particularly limited. For example, fish-derived cartilage tissues such as salmon nasal cartilage tissue, ray cartilage tissue, shark cartilage tissue, Non-denatured collagen extracted from avian cartilage tissues such as chicken cartilage tissues and further from cartilage tissues derived from mammals such as bovine throat cartilage, bronchial cartilage and whale cartilage.

中でも、非変性コラーゲンは、サケの鼻軟骨組織、サメの軟骨組織、ニワトリ等の軟骨組織のうち１種又は２種以上の生物の組織から抽出されたものであることが好ましい。また、非変性コラーゲンは、サケの鼻軟骨組織から抽出されたものであることがさらに好ましい。   Among these, non-denatured collagen is preferably extracted from tissue of one or more organisms among cartilage tissues such as salmon nasal cartilage tissue, shark cartilage tissue, and chicken. The non-denatured collagen is more preferably extracted from salmon nasal cartilage tissue.

なお、非変性コラーゲンを天然物から調製する場合には、その調製方法はコラーゲンを変性させないものであれば特に限定されるものではなく、常法により天然物から調製する方法を採用することができる。   In the case of preparing non-denatured collagen from a natural product, the preparation method is not particularly limited as long as it does not denature the collagen, and a method of preparing from a natural product by a conventional method can be adopted. .

なお、非変性コラーゲンは市販されている医薬品原料又は食品原料であってもよい。   The non-denatured collagen may be a commercially available pharmaceutical material or food material.

また、非変性コラーゲンは、非変性II型コラーゲンであることが好ましい。
本発明の関節痛改善剤に含まれる非変性コラーゲンが非変性II型コラーゲンであることで、より高い関節痛改善効果を発揮する。 The non-denatured collagen is preferably non-denatured type II collagen.
When the non-denatured collagen contained in the joint pain ameliorating agent of the present invention is non-denatured type II collagen, a higher joint pain improving effect is exhibited.

そして、本発明の関節痛改善剤には、平均分子量が好ましくは３０万Ｄａ〜４０万Ｄａである非変性コラーゲンを用いることが好ましい。   And it is preferable to use the undenatured collagen whose average molecular weight becomes like this. Preferably it is 300,000 Da to 400,000 Da for the joint pain improving agent of this invention.

なお、非変性コラーゲンの平均分子量を算出する方法は、製品中のコラーゲンの分子量の組成から分子量の平均を算出することのできる方法であれば特に制限はなく、例えば、高速液体クロマトグラフィ装置を用いた定量分析により平均分子量の算出する方法、ＥＬＩＳＡ法を用いて定量した後に電気泳動処理に施し平均分子量の算出する方法、を挙げることができる。   The method for calculating the average molecular weight of non-denatured collagen is not particularly limited as long as the average molecular weight can be calculated from the composition of the molecular weight of collagen in the product. For example, a high performance liquid chromatography apparatus was used. Examples thereof include a method for calculating an average molecular weight by quantitative analysis, and a method for calculating an average molecular weight by performing electrophoresis treatment after quantification using an ELISA method.

そして、本発明の関節痛改善剤は非変性プロテオグリカンと非変性コラーゲンを好ましくは３：１０〜７：１０、より好ましくは４：１０〜６：１０さらに好ましくは４．５：１０〜５．５：１０の質量比で含む。   The arthralgia improving agent of the present invention is preferably non-denatured proteoglycan and non-denatured collagen, preferably 3:10 to 7:10, more preferably 4:10 to 6:10, and even more preferably 4.5: 10 to 5.5. : It is included at a mass ratio of 10.

また、本発明は、上記の関節痛改善用剤を有効成分として含む、関節痛改善用組成物にも関する。
本組成物は、食品組成物、医薬組成物の形態とすることができる。また、本発明の関節痛改善剤は経口用組成物の形態とすることが好ましい。 The present invention also relates to a composition for improving joint pain comprising the above-mentioned agent for improving joint pain as an active ingredient.
The present composition can be in the form of a food composition or a pharmaceutical composition. Further, the joint pain improving agent of the present invention is preferably in the form of an oral composition.

食品組成物としては、菓子やパン、麺などの一般食品、ドリンク製剤、カプセル剤や錠剤の形態をとる健康増進の目的を有する食品群（例えば、特定保健用食品、栄養機能食品等）が例示できる。医薬組成物としては、顆粒剤、粉末剤、カプセル剤や、錠剤の形態をとる経口投与医薬品等が例示できる。特に好ましくは食品組成物としての形態である。   Examples of food compositions include general foods such as confectionery, bread, and noodles, drink preparations, food groups with the purpose of promoting health in the form of capsules and tablets (for example, foods for specified health use, nutritional functional foods, etc.) it can. Examples of the pharmaceutical composition include granules, powders, capsules, orally-administered drugs in the form of tablets. Particularly preferred is a form as a food composition.

またこれらの食品組成物及び医薬組成物は、許容される任意成分を含有することができる。このような任意成分としては、食品組成物であれば、塩、砂糖、グルタミン酸ナトリウム、イノシン酸ナトリウム、酢等の調味成分、着色成分、フレーバー等の矯臭成分、増粘剤、乳化・分散剤、保存料、安定剤、各種ビタミン類等が好適に例示でき、健康増進の目的を有する食品群や医薬組成物であれば、キャッツクロー抽出物、セイヨウシロヤナギ抽出物、ボスウェリアセラタ樹脂抽出物等の植物由来成分、結晶セルロース、乳糖等の賦形剤、アラビヤガムやヒドロキシプロピルセルロース等の結合剤、クロスカルメロースナトリウム、デンプン等の崩壊剤、ステアリン酸マグネシウム、ステアリン酸カルシウム、微粒酸化ケイ素等の滑沢剤、矯味、矯臭剤、着色剤、ビタミンB1、ビタミンB6、ビタミンD3、ビタミンB12、抽出ビタミンEなどの各種ビタミン類等が好ましく例示できる。これらを常法に従って処理することにより、本発明の組成物を製造することができる。   Moreover, these food compositions and pharmaceutical compositions can contain acceptable optional ingredients. As such optional ingredients, if it is a food composition, seasoning ingredients such as salt, sugar, sodium glutamate, sodium inosinate, vinegar, coloring ingredients, flavoring ingredients such as flavors, thickeners, emulsifying / dispersing agents, Preservatives, stabilizers, various vitamins and the like can be suitably exemplified, and plants such as cat's claw extract, white willow extract, boswellia serrata resin extract can be used as long as they are food groups and pharmaceutical compositions with the purpose of promoting health. Origin components, excipients such as crystalline cellulose, lactose, binders such as arabic gum and hydroxypropyl cellulose, disintegrants such as croscarmellose sodium and starch, lubricants such as magnesium stearate, calcium stearate, fine silicon oxide, Flavoring, flavoring, coloring, vitamin B1, vitamin B6, vitamin D3, vitamin B12, extracted vitamin E, etc. These various vitamins can be preferably exemplified. By treating these according to a conventional method, the composition of the present invention can be produced.

本発明の関節痛改善用組成物における非変性プロテオグリカンと非変性コラーゲンの総含有量は、０．０５〜９０質量％、より好ましくは０．５〜３０質量％、さらに好ましくは５〜１０質量％、さらに好ましくは７〜８質量％とすることができる。   The total content of non-denatured proteoglycan and non-denatured collagen in the composition for improving joint pain of the present invention is 0.05 to 90% by mass, more preferably 0.5 to 30% by mass, and still more preferably 5 to 10% by mass. More preferably, it can be 7-8 mass%.

本発明の関節痛改善用組成物全量に対し、プロテオグリカンは、０．０２〜３０質量％、より好ましくは、０．２〜１０質量％、さらに好ましくは、１〜５質量％含有することが好ましい。これは、下限以上であれば本発明の関節痛改善剤が有する関節痛の改善効果がより高く発揮され、上限以下であれば関節痛の改善効果がより効率よく発揮されるためである。   Proteoglycan is contained in an amount of 0.02 to 30% by mass, more preferably 0.2 to 10% by mass, and still more preferably 1 to 5% by mass with respect to the total amount of the composition for improving joint pain of the present invention. . This is because the joint pain improving effect of the joint pain ameliorating agent of the present invention is exhibited to a higher degree if it is at least the lower limit, and the joint pain improving effect is more efficiently exhibited if it is below the upper limit.

また、本発明の関節痛改善用組成物全量に対し、コラーゲンは、０．０４〜６０質量％、より好ましくは、０．４〜２０質量％、さらに好ましくは、２〜１０質量％含有することが好ましい。これは、下限以上であれば本発明の関節痛改善剤が有する関節痛の改善効果がより高く発揮され、上限以下であれば関節痛の改善効果がより効率よく発揮されるためである。   Further, collagen is contained in an amount of 0.04 to 60% by mass, more preferably 0.4 to 20% by mass, and still more preferably 2 to 10% by mass with respect to the total amount of the composition for improving joint pain of the present invention. Is preferred. This is because the joint pain improving effect of the joint pain ameliorating agent of the present invention is exhibited to a higher degree if it is at least the lower limit, and the joint pain improving effect is more efficiently exhibited if it is below the upper limit.

また本発明の関節痛改善用組成物は、関節痛改善用組成物中の有効成分である非変性プロテオグリカンと非変性コラーゲンを１日あたり１〜１５ｍｇを１回又は数回に分けて摂取する形態とすることが好ましい。   The composition for improving joint pain of the present invention is a form in which 1 to 15 mg of non-modified proteoglycan and non-modified collagen, which are active ingredients in the composition for improving joint pain, are taken once or in several divided doses per day. It is preferable that

以下、本発明を実施例により具体的に説明する。   Hereinafter, the present invention will be specifically described by way of examples.

実施例では、非変性プロテオグリカンと非変性コラーゲンの質量比と関節痛改善効果の相関関係を調べた。   In the examples, the correlation between the mass ratio of non-denatured proteoglycan and non-denatured collagen and the joint pain improving effect was examined.

１．被験者
被験者は、１ヵ月以上持続して軽度の膝関節痛等を有し、変形性膝関節症にて通院及び投薬を受けていない４０歳以上７５歳未満の成人男女各２５名、合計５０名を対象とした。 1. Subjects: 25 adults aged 40 to under 75 years of age who have mild knee pain, etc. who have sustained mild knee pain, etc. and have not undergone hospitalization or medication for osteoarthritis, a total of 50 Targeted.

２．製品の製造
生の鮭から鼻軟骨を摘出し冷凍保存したものに、アルカリ抽出溶媒を加え、得た中間生成物を遠心分離機により非変性プロテオグリカン及び非変性II型コラーゲンに分離した。
その後、不純物を除去するフィルタ処理行い、その後、スプレードライ工程をすることにより非変性プロテオグリカン粉末及び非変性II型コラーゲン粉末を得た。 2. Manufacture of the product The nasal cartilage was extracted from raw salmon and stored frozen, and an alkali extraction solvent was added, and the obtained intermediate product was separated into non-denatured proteoglycan and non-denatured type II collagen by a centrifuge.
Then, the filter process which removes an impurity was performed, and the non-denaturing proteoglycan powder and the non-denaturing type II collagen powder were obtained by performing a spray-drying process after that.

この非変性プロテオグリカン粉末及び非変性II型コラーゲン粉末に結晶セルロース、ステアリン酸Ca、微粒酸化ケイ素等の賦形剤を加え、造粒し、得られた顆粒をカプセル加工することで１錠あたり２００ｍｇのカプセル型の製品１〜４を製造した。   By adding excipients such as crystalline cellulose, calcium stearate, and fine silicon oxide to the non-modified proteoglycan powder and non-modified type II collagen powder, granulation is performed, and the resulting granules are processed into capsules to give 200 mg per tablet. Capsule-type products 1 to 4 were produced.

製品１〜４（１錠 ２００ｍｇ）に含まれる非変性プロテオグリカンと非変性II型コラーゲン（計１５ｍｇ）の成分組成を表１に示した。
なお、製品Ｐは非変性プロテオグリカンと非変性II型コラーゲンを含まないプラセボ製品（１錠 ２００ｍｇ）である。 Table 1 shows the component composition of non-denatured proteoglycan and non-denatured type II collagen (total 15 mg) contained in the products 1 to 4 (one tablet 200 mg).
Product P is a placebo product (one tablet 200 mg) that does not contain non-denatured proteoglycan and non-denatured type II collagen.

なお、製品中の非変性プロテオグリカンについては高速液体クロマトグラフィ装置（島津製作所、カラムTSK-GEL G4000PWXL）を用いて定量を行った。また、製品中の非変性プロテオグリカンを示すピークの定量値から、製品中の非変性プロテオグリカンの平均分子量が９０万Ｄａ以上であることを確認した。   The non-denatured proteoglycan in the product was quantified using a high performance liquid chromatography apparatus (Shimadzu Corporation, column TSK-GEL G4000PWXL). Moreover, from the quantitative value of the peak indicating the non-modified proteoglycan in the product, it was confirmed that the average molecular weight of the non-modified proteoglycan in the product was 900,000 Da or more.

また、製品中の非変性II型コラーゲンについてはＥＬＩＳＡ法を用いて定量を行った。さらに、別途アガロース電気泳動処理に施し、製品中のコラーゲンの分子量が非変性II型コラーゲンの分子量である３０万Ｄａ〜４０万Ｄａの範囲内にあることを確認した。   In addition, non-denatured type II collagen in the product was quantified using the ELISA method. Further, it was separately subjected to an agarose electrophoresis treatment, and it was confirmed that the molecular weight of collagen in the product was in the range of 300,000 Da to 400,000 Da, which is the molecular weight of non-denatured type II collagen.

３．検査方法
被験者を男女各５名計１０名を１群として５つの被験者群に分け、各被験者群は製品１〜４、製品Ｐのいずれか一種類を１日１回、就寝前に１錠ずつ、コップ１杯の水とともに摂取した。 3. Examination method The test subject is divided into 5 test subject groups, each consisting of 5 men and women of 10 people, and each test subject group is one of products 1-4 or product P once a day, one tablet before going to bed. Ingested with a glass of water.

（自覚症状アンケート調査）
膝の関節痛評価方法は、Visual analogue scale（以下、VAS）による膝の痛みの程度に関して、試験開始時の痛みを最高得点部分（１００％）とし、最低得点部分（０％）を「全く痛くない」に設定し、「安静時の左膝の痛み」、「安静時の右膝の痛み」、「通常歩行時の左膝の痛み」、「通常歩行時の右膝の痛み」、「階段昇降時の左膝の痛み」、「階段昇降時の右膝の痛み」、「総合評価」の7項目についてアンケート調査を実施し、試験製品摂取の影響を観察した。 (Subjective questionnaire survey)
Regarding the knee joint pain evaluation method, regarding the degree of knee pain according to the visual analogue scale (hereinafter referred to as VAS), the pain at the start of the test was defined as the highest score portion (100%), and the lowest score portion (0%) as “no pain at all”. Set to “No”, “Pain in the left knee during rest”, “Pain in the right knee during rest”, “Pain in the left knee during normal walking”, “Pain in the right knee during normal walking”, “Stairs” A questionnaire survey was conducted on seven items: pain in the left knee during ascending / descending, pain in the right knee during ascending / descending stairs, and comprehensive evaluation, and the effects of test product intake were observed.

４．結果
結果を図１〜７に示す。
製品１を摂取した被験者群は６週経過時において、他の製品を摂取した被験者群と比較して関節痛の顕著な改善が認められた。製品２、３を摂取した被験者群は６週経過時において、他の製品を摂取した被験者群と比較して関節痛の有意な改善が認められた。また、製品２、３は同程度の関節痛改善効果を有していることが認められる。 4). Results The results are shown in FIGS.
The group of subjects who took the product 1 showed a marked improvement in joint pain at the end of 6 weeks compared with the group of subjects who took other products. The group of subjects who took the products 2 and 3 showed a significant improvement in joint pain at the end of 6 weeks compared with the group of subjects who took other products. Moreover, it is recognized that the products 2 and 3 have the same joint pain improving effect.

５．考察
以上の結果により、非変性プロテオグリカンと非変性II型コラーゲンとを特定の質量比で含む本発明の関節痛改善剤は、優れた膝関節痛改善効果を有する。特に、非変性プロテオグリカンと非変性II型コラーゲンを５：１０の質量比で含む製品（製品１）は優れた膝関節痛改善効果を有していた。さらに製品１は長期間投与し続けても効果が薄れないという効果の反復継続性を有していた。 5. Discussion Based on the above results, the joint pain improving agent of the present invention containing non-denatured proteoglycan and non-denatured type II collagen at a specific mass ratio has an excellent knee joint pain improving effect. In particular, a product (product 1) containing non-denatured proteoglycan and non-denatured type II collagen at a mass ratio of 5:10 had an excellent knee joint pain improving effect. Furthermore, product 1 had a repeated continuity of effect that the effect did not fade even if it was administered for a long time.

また、非変性プロテオグリカンと非変性II型コラーゲンを６：１０の質量比で含む製品（製品２）、４：１０の質量比で含む製品（製品３）の関節痛改善効果が同等であるという結果から、製品１の関節痛改善効果を極大として、非変性プロテオグリカンと非変性II型コラーゲンを一定の範囲の割合で含む関節痛改善剤にも有意な関節痛改善効果があるといえる。すなわち、非変性プロテオグリカンと非変性II型コラーゲンを３：１０〜７：１０の質量比で含む関節痛改善剤にも有意な関節痛改善効果が望める。   In addition, the effect of improving joint pain of a product (product 2) containing non-denatured proteoglycan and non-denatured type II collagen in a mass ratio of 6:10 (product 2) and a product containing a mass ratio of 4:10 (product 3) is equivalent. Therefore, it can be said that the joint pain improving agent containing the non-denatured proteoglycan and the non-denatured type II collagen in a certain range ratio has a significant joint pain improving effect, with the joint pain improving effect of the product 1 being maximized. That is, a significant joint pain improving effect can be expected from a joint pain improving agent containing non-modified proteoglycan and non-modified type II collagen in a mass ratio of 3:10 to 7:10.

本発明はサプリメントに応用できる。

The present invention can be applied to supplements.

Claims (5)

非変性プロテオグリカン及び非変性コラーゲンを有効成分として含む、関節痛改善剤であって、
非変性プロテオグリカンと非変性コラーゲンを３：１０〜７：１０の質量比で含むことを特徴とする、関節痛改善剤。 A joint pain ameliorating agent comprising non-denatured proteoglycan and non-denatured collagen as active ingredients,
An arthralgia improving agent comprising non-denatured proteoglycan and non-denatured collagen in a mass ratio of 3:10 to 7:10. 前記非変性プロテオグリカンが、９０万Ｄａ以上の平均分子量を有する、請求項１に記載の関節痛改善剤。   The joint pain improving agent according to claim 1, wherein the non-denatured proteoglycan has an average molecular weight of 900,000 Da or more. 前記非変性コラーゲンが非変性II型コラーゲンである、請求項１又は２に記載の関節痛改善剤。   The joint pain improving agent according to claim 1 or 2, wherein the non-denatured collagen is non-denatured type II collagen. 請求項１〜３の何れか１項記載の関節痛改善剤を有効成分として含む、関節痛改善用組成物。   The composition for joint pain improvement containing the joint pain improving agent of any one of Claims 1-3 as an active ingredient. 食品組成物である請求項４に記載の関節痛改善用組成物。

The composition for improving joint pain according to claim 4, which is a food composition.

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