JP2019043871A - Agent for reducing in-blood urine acid values and composition for reducing in-blood urine acid values - Google Patents
Agent for reducing in-blood urine acid values and composition for reducing in-blood urine acid values Download PDFInfo
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- JP2019043871A JP2019043871A JP2017167299A JP2017167299A JP2019043871A JP 2019043871 A JP2019043871 A JP 2019043871A JP 2017167299 A JP2017167299 A JP 2017167299A JP 2017167299 A JP2017167299 A JP 2017167299A JP 2019043871 A JP2019043871 A JP 2019043871A
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- Prior art keywords
- whey protein
- uric acid
- protein hydrolyzate
- reducing
- blood uric
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- 239000005720 sucrose Substances 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000012353 t test Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 235000019640 taste Nutrition 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 229940126585 therapeutic drug Drugs 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 239000012588 trypsin Substances 0.000 description 1
- 239000012991 xanthate Substances 0.000 description 1
- 229940075420 xanthine Drugs 0.000 description 1
- 239000003064 xanthine oxidase inhibitor Substances 0.000 description 1
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
本技術は、ホエイタンパク質加水分解物を有効成分とする、血中尿酸値低減剤、血中尿酸値低減用医薬組成物、及び血中尿酸値低減用飲食品組成物に関する。 The present technology relates to a blood uric acid level reducing agent, a blood uric acid level reducing pharmaceutical composition, and a blood uric acid level reducing food and drink composition containing a whey protein hydrolyzate as an active ingredient.
尿酸は、ヒトにおいて、核酸や生体内のエネルギー源であるＡＴＰ、又は飲食品に由来するプリン体の代謝による最終産物であり、体内で生成された最終産物の尿酸は、おもに腎臓から排泄される。尿酸の生成から排泄までの経路に種々の要因が作用し、尿酸の生成が過剰になったり、排泄量が低下したりすると、血中の尿酸値が高まることで高尿酸血症が生じる。この要因としては、肥満、過食、飲酒、過度な運動（無酸素運動）、ストレス等が知られている。さらに、高尿酸血症が長期間持続して、尿酸が結晶化して関節や腎臓に析出することで痛風が発症する。
近年の食生活等の生活習慣の変化から、我が国においては、痛風患者が増加傾向であり、さらに、痛風予備軍とされる高尿酸血症の患者数も増加している。
In humans, uric acid is an end product of metabolism of purine derived from nucleic acid and in vivo energy source, or food and drink in human, and uric acid of the end product produced in the body is mainly excreted from the kidney . When various factors act on the pathway from the production of uric acid to the excretion and the production of uric acid becomes excessive or the amount of excretion decreases, hyperuricemia is caused by the increase of the level of uric acid in blood. Obesity, overeating, alcohol consumption, excessive exercise (anaerobic exercise), stress, etc. are known as this factor. Furthermore, hyperuricemia lasts for a long time, and uric acid crystallizes and precipitates on joints and kidneys, causing gout.
In recent years, gout patients tend to increase in Japan due to changes in lifestyle habits such as eating habits in recent years, and the number of hyperuricemia patients considered to be a gout reserve force is also increasing.
痛風の治療は、痛風発作の治療と高尿酸血症の治療に分けられる。痛風発作の治療は、非ステロイド抗炎症薬を中心とする薬物治療で、高尿酸血症の治療には、生活習慣の改善と尿酸降下薬による薬物治療があり、高尿酸血症の程度や合併病態により治療が施される。痛風や高尿酸血症には、高血圧、脂質異常症、糖尿病、耐糖能異常等の合併病態がみられることが多い（非特許文献１）。 The treatment of gout is divided into the treatment of gout and the treatment of hyperuricemia. Treatment of gout attacks is drug treatment centering on non-steroidal anti-inflammatory drug, treatment of hyperuricemia includes lifestyle improvement and drug treatment with uric acid lowering drug, degree of hyperuricemia and merger Treatment is given by the condition. In gout and hyperuricemia, combined disease states such as hypertension, dyslipidemia, diabetes, glucose intolerance and the like are often found (Non-patent Document 1).
現在の高尿酸血症の薬物治療においては、キサンチンから尿酸に生成するキサンチンオキシダーゼという酵素を阻害することにより尿酸の産生を抑制するという系統と、尿酸の再取り込みを抑制することにより尿酸の排出を促進する系統があり、これら系統の薬剤の使用により血中尿酸値を低下させる方法が用いられる。現在使用されている治療薬として、アロプリノールやフェブキソスタット等の尿酸産生抑制薬、又はベンズブロマロンやプロベネシド等の尿酸排出促進薬が知られている。
しかし、薬剤にはメリットの他にそれぞれ特有の副作用が存在するため、新たな治療薬の開発が望まれると共に、さらに安心して投与できるものが望まれている。
例えば、特許文献１には、オールスパイス（フトモモ科Pimenta dioica Merrillの果実）の抽出物から単離したピメントールを有効成分として含有するキサンチンオキシダーゼ阻害剤が開示されている。
また、特許文献２には、米胚乳よりアルカリで抽出後に酸で沈殿させたタンパク質を乾燥させたものを有効成分とする血清尿酸低下剤が開示されている。
また、特許文献３には、チーズをリパーゼ及びプロテアーゼで処理したチーズ酵素分解物を有効成分とする血中尿酸値低下剤が開示されている。
In the current drug treatment of hyperuricemia, phylic acid is suppressed by inhibiting xanthate production by inhibiting an enzyme called xanthine oxidase that is generated from xanthine to uric acid, and uric acid excretion is suppressed by suppressing uric acid reuptake. There are strains that promote, and methods of lowering blood uric acid levels by using drugs of these strains are used. As therapeutic agents currently used, uric acid production inhibitors such as allopurinol and febuxostat, or uric acid excretion promoters such as benzbromarone and probenecid are known.
However, since each drug has its own unique side effects as well as merits, development of a new therapeutic drug is desired, and one that can be administered more safely is desired.
For example, Patent Document 1 discloses a xanthine oxidase inhibitor containing pimenthol isolated from an extract of allspice (fruit of Pimenta dioica Merrill) as an active ingredient.
Further, Patent Document 2 discloses a serum uric acid-lowering agent which contains, as an active ingredient, a protein obtained by extracting an acid from rice endosperm with alkali followed by drying with an acid.
In addition, Patent Document 3 discloses a blood uric acid level-lowering agent containing, as an active ingredient, a cheese enzyme degradation product obtained by treating cheese with a lipase and a protease.
血中の尿酸値を急に下げるとそれまで関節に蓄積されてきた尿酸の結晶が一気に溶け出して痛風発作を引き起こすことがあり、高尿酸血症の治療において、血中尿酸値を短期的に下げるのではなく、長期間かけて徐々に低下させて目標値を長期間維持する必要がある。このため、安心して長期間摂取できる血中尿酸値低減作用を有する物質が望まれている。
そこで、本技術は、安心して長期間摂取することができる血中尿酸値低減剤を提供することを主な目的とする。
If the uric acid level in the blood drops sharply, crystals of uric acid accumulated in the joint may dissolve at once, causing a gout attack. In treating hyperuricemia, the blood uric acid level may be shortened in a short time. It is necessary to gradually reduce the target value over a long period of time to maintain the target value for a long period of time rather than lowering it. For this reason, a substance having a blood uric acid level reducing action that can be safely taken for a long time is desired.
Therefore, the present technology has as its main object to provide a blood uric acid level reducing agent that can be taken safely and for a long time.
本発明者等が研究を進めた結果、種々の成分を含むホエイタンパク質を加水分解し、ペプチド（長鎖〜短鎖）及び遊離アミノ酸等といった分解物を含む混合物であるホエイタンパク質の加水分解物をヒトに数ヶ月摂取させた場合に、血中の尿酸値が摂取前よりも大幅に低減できた。よって、本技術は、安心して長期間摂取できるホエイタンパク質加水分解物が血中尿酸値の低減作用を有することを見出し、本発明を完成させた。 As a result of research conducted by the present inventors, it is possible to hydrolyze whey protein containing various components, and hydrolysate whey protein which is a mixture containing degradation products such as peptides (long chain to short chain) and free amino acids, etc. When humans were ingested for several months, blood uric acid levels were significantly reduced compared to before intake. Therefore, the present technology has found that whey protein hydrolyzate which can be safely ingested for a long period of time has an effect of reducing blood uric acid levels, and completed the present invention.
すなわち、本技術は、ホエイタンパク質加水分解物を有効成分とする血中尿酸値低減剤である。
また、本技術は、ホエイタンパク質加水分解物を有効成分とする血中尿酸値低減用医薬組成物である。前記組成物は、高尿酸血症の予防及び／又は治療のために用いられるものであってもよい。
また、本技術は、ホエイタンパク質加水分解物を有効成分とする血中尿酸値低減用飲食品組成物である。
That is, the present technology is a blood uric acid level reducing agent containing whey protein hydrolyzate as an active ingredient.
In addition, the present technology is a pharmaceutical composition for blood uric acid level reduction, which comprises whey protein hydrolyzate as an active ingredient. The composition may be used for the prevention and / or treatment of hyperuricemia.
Further, the present technology is a food and drink composition for blood uric acid level reduction, which comprises whey protein hydrolyzate as an active ingredient.
本技術によれば、安心して長期間摂取することができる血中尿酸値低減剤を提供することができる。
なお、ここに記載された効果は、必ずしも限定されるものではなく、本技術中に記載されたいずれかの効果であってもよい。
According to the present technology, it is possible to provide a blood uric acid level reducing agent which can be safely taken for a long time.
In addition, the effect described here is not necessarily limited and may be any effect described in the present technology.
次に、本発明の好ましい実施形態について説明する。ただし、本発明は以下の好ましい実施形態に限定されず、本発明の範囲内で自由に変更することができるものである。尚、本明細書において百分率は特に断りのない限り質量による表示である。 Next, preferred embodiments of the present invention will be described. However, the present invention is not limited to the following preferred embodiments, and can be freely modified within the scope of the present invention. In the present specification, percentages are indicated by mass unless otherwise specified.
本技術は、ホエイタンパク質加水分解物を有効成分とする血中尿酸値低減剤又は血中尿酸値低減用組成物であり、好適には医薬又は飲食品に用いることができる。本技術は、痛風患者、高尿酸血症患者又はその予備軍に対して用いることができ、またこれら疾患又は症状の予防又は治療のために用いることができる。 The present technology is a blood uric acid level reducing agent or a blood uric acid level reducing agent containing whey protein hydrolyzate as an active ingredient, and can be suitably used for medicine or food and drink. The present technology can be used for gout patients, hyperuricemia patients or their backup arm, and can be used for the prevention or treatment of these diseases or conditions.
［１］ホエイタンパク質加水分解物及びその製造方法
本技術に使用するホエイタンパク質加水分解物は、乳由来のホエイタンパク質を加水分解して得られるものである。ホエイタンパク質には種々の成分が含まれており、本技術の加水分解物は、これらが加水分解されたものである。
当該加水分解は、タンパク質加水分解酵素、酸及びアルカリ等から選択される１種又は組み合わせが挙げられる。
前記ホエイタンパク質としては、例えば、市販品又は牛乳、脱脂乳等から公知の方法により分離されたホエイ（たとえば、ホエイ粉末、脱塩ホエイ粉末等）、分離精製したホエイタンパク質濃縮物（ＷＰＣ）、ホエイタンパク質単離物（ＷＰＩ）及びこれらの任意の割合の混合物が挙げられる。
本技術において、牛乳由来のホエイタンパク質を用いることが好ましく、さらにホエイタンパク質のうち、ホエイタンパク質濃縮物（ＷＰＣ）が好適である。
前記牛乳由来のホエイタンパク質の組成として、一般的に、α−ラクトアルブミン１５〜２５％、β−ラクトグロブリン５０〜６５％、ウシ血清アルブミン５〜１０％、ラクトフェリン等が含まれていることが知られている。かかるタンパク質の組成は、ホエイタンパク質濃縮物（ＷＰＣ）及びホエイタンパク質単離物（ＷＰＩ）でも同様である。
[1] Whey protein hydrolyzate and method for producing the same Whey protein hydrolyzate used in the present technology is obtained by hydrolyzing whey protein derived from milk. Whey protein contains various components, and the hydrolyzate of the present technology is a hydrolyzate of these.
The hydrolysis includes one or a combination selected from proteolytic enzymes, acids, alkalis and the like.
As the whey protein, for example, whey (eg, whey powder, desalted whey powder, etc.) separated by a known method from commercial products or milk, skimmed milk etc., separated / purified whey protein concentrate (WPC), whey Protein isolates (WPI) and mixtures of any of these may be mentioned.
In the present technology, it is preferable to use whey protein derived from milk, and furthermore, among whey proteins, whey protein concentrate (WPC) is suitable.
It is known that the composition of the milk protein derived from milk generally contains 15 to 25% of α-lactalbumin, 50 to 65% of β-lactoglobulin, 5 to 10% of bovine serum albumin, lactoferrin and the like. It is done. The composition of such proteins is similar for whey protein concentrate (WPC) and whey protein isolate (WPI).
前記ホエイタンパク質加水分解物は、タンパク質加水分解酵素により加水分解されたホエイタンパク質加水分解物（以下、「ホエイタンパク質酵素分解物」ともいう）であることが好ましい。当該ホエイタンパク質酵素分解物は、前記ホエイタンパク質をタンパク質加水分解酵素によって加水分解して製造されることが好ましい。
前記ホエイタンパク質酵素分解物の製造方法としては、以下が例示されるが、これに限定されるものではない。
具体的には、まず、原料であるホエイタンパク質を水又は温湯に分散し、溶解してホエイタンパク質溶液を調製する。
前記ホエイタンパク質溶液の濃度には制限はないが、通常、タンパク質濃度として、２〜２０％程度、好ましくは５〜１５％の濃度範囲に設定することが効率性及び操作性の点から好ましい。溶解濃度２％以上の場合に、製造上の効率が良くなり、溶解濃度２０％以下の場合に、分解効率の低下、加熱処理時の焦付き、冷却時の粘度上昇等が生じる恐れを抑制することができるので望ましい。
The whey protein hydrolyzate is preferably whey protein hydrolyzate hydrolyzed by a proteolytic enzyme (hereinafter, also referred to as "whey protein enzyme degradation product"). The whey protein enzyme degradation product is preferably produced by hydrolyzing the whey protein with a proteolytic enzyme.
Although the following is illustrated as a manufacturing method of the said whey protein enzyme degradation product, it is not limited to this.
Specifically, first, whey protein which is a raw material is dispersed in water or warm water and dissolved to prepare a whey protein solution.
Although the concentration of the whey protein solution is not limited, it is usually preferable to set the concentration of protein as about 2 to 20%, preferably 5 to 15%, from the viewpoint of efficiency and operability. When the dissolution concentration is 2% or more, the manufacturing efficiency is improved, and when the dissolution concentration is 20% or less, the possibility of reduction in decomposition efficiency, sticking during heat treatment, viscosity increase during cooling, etc. is suppressed. It is desirable because it can be done.
前記ホエイタンパク質溶液は、本技術で使用するタンパク質加水分解酵素の至適ｐＨの範囲になるように、酸又はアルカリの溶液を用いて、ｐＨ調整することが好ましい。前記ホエイタンパク質溶液のｐＨは、加水分解前にｐＨ６．５以上１０．０以下に調整することが望ましい。
なお、加水分解前の処理工程として、ｐＨ調整前若しくは後、又はその両方で加熱処理、イオン交換処理等を適宜追加して実施することもできる。
It is preferable to adjust the pH of the whey protein solution using an acid or alkali solution so as to be in the range of the optimum pH of the proteolytic enzyme used in the present technology. It is desirable to adjust the pH of the whey protein solution to pH 6.5 or more and 10.0 or less before hydrolysis.
In addition, as a treatment process before hydrolysis, a heat treatment, an ion exchange treatment, etc. can be appropriately added and carried out before or after pH adjustment or both.
適宜ｐＨ調整されたホエイタンパク質溶液に、タンパク質加水分解酵素を添加して加水分解を行う。
本技術に使用するホエイタンパク質加水分解物の製造に用いられるタンパク質加水分解酵素は、特に制限されないが、好ましくはプロテアーゼであり、より好ましくはエンドプロテアーゼであり、必要に応じてエキソプロテアーゼを組み合わせて使用しても良い。なお、本技術に使用する酵素は、１種類を又は異なる酵素を複数種類組み合わせて使用することも可能である。
本技術に使用するエンドプロテア−ゼとしては、例えば、ビオプラーゼ（長瀬生化学工業社製）、プロチンＳＤ−ＡＹ１０（天野エンザイム社製）、プロチンＮＹ１００（天野エンザイム社製）、プロテアーゼＮアマノ（天野エンザイム社製）、ニュートラーゼ（ノボ・ノルディスク社製）、アルカラーゼ（ノボ・ノルディスク社製）、トリプシン（ノボ・ノルディスク社製）、キモトリプシン（ノボ・ノルディスク社製）、パパイン（天野エンザイム社製）、及びブロメライン（天野エンザイム社製）等の市販品を例示することができる。
また、本技術に使用するエキソプロテアーゼとしては、例えば、プロテアーゼＡアマノ（天野エンザイム社製）、スミチームＬＰ５０Ｄ（新日本科学工業社製）、及びフレーバーザイム（ノボ・ノルディスク社製）等の市販品を例示することができる。
The hydrolysis is carried out by adding a protein hydrolyzing enzyme to the whey protein solution appropriately adjusted in pH.
The protein hydrolyzing enzyme used for producing whey protein hydrolyzate used in the present technology is not particularly limited, but is preferably a protease, more preferably an endoprotease, and optionally using an exoprotease in combination You may. In addition, it is also possible to use the enzyme used for this technique in combination of one type or multiple types of different enzymes.
Examples of endoproteases used in the present technology include bioplase (made by Nagase Seikagaku Kogyo Co., Ltd.), Protin SD-AY10 (made by Amano Enzyme Co., Ltd.), Protin NY100 (made by Amano Enzyme Co., Ltd.), Protease N Amano (Amano Enzyme) Company), Neutrase (Novo Nordisk), Alcalase (Novo Nordisk), trypsin (Novo Nordisk), chymotrypsin (Novo Nordisk), papain (Amano Enzyme) Commercially available products such as those produced in Japan and Bromelain (manufactured by Amano Enzyme Co., Ltd.) can be exemplified.
Moreover, as an exoprotease used for this technique, commercial products, such as protease A Amano (made by Amano Enzyme Co., Ltd.), Sumiteam LP50D (made by Shin Nippon Kagaku Kogyo Co., Ltd.), and flavorzyme (made by Novo Nordisk Co., Ltd.) Can be illustrated.
タンパク質加水分解酵素が添加されたホエイタンパク質溶液は、所定の処理条件に調整して加水分解されることが望ましい。具体的には、使用する酵素の至適温度で所定時間保温して加水分解されることが望ましい。
前記至適温度としては、好ましくは３０〜６０℃、より好ましくは４０〜５５℃であり、また、処理時間としては、好ましくは２〜２４時間、より好ましくは３〜１２時間である。ホエイタンパク質溶液は、このような温度帯にて一定時間保温されて酵素加水分解されることが望ましい。さらに、このときのホエイタンパク質溶液のｐＨは、好ましくはｐＨ６以上１１以下、より好ましくは６．５以上１０以下、さらに好ましくは７以上９以下に調整されることが望ましい。
前記酵素は同時又は適宜の間隔で添加することができ、固定化酵素を使用することもできる。また、酵素の至適ｐＨを維持するため、加水分解中に溶液のｐＨを適宜調整することもできる。
It is desirable that the whey protein solution to which the protein hydrolyzing enzyme is added be adjusted to predetermined processing conditions and hydrolyzed. Specifically, it is desirable that the hydrolysis be carried out by incubating for a predetermined time at the optimum temperature of the enzyme to be used.
The optimum temperature is preferably 30 to 60 ° C., more preferably 40 to 55 ° C., and the treatment time is preferably 2 to 24 hours, more preferably 3 to 12 hours. It is desirable that the whey protein solution is maintained in such a temperature zone for a certain period of time to be enzymatically hydrolyzed. Furthermore, it is desirable that the pH of the whey protein solution at this time is adjusted to preferably pH 6 or more and 11 or less, more preferably 6.5 or more and 10 or less, and still more preferably 7 or more and 9 or less.
The enzymes can be added simultaneously or at appropriate intervals, and immobilized enzymes can also be used. In addition, the pH of the solution can be appropriately adjusted during hydrolysis to maintain the optimum pH of the enzyme.
なお、ホエイタンパク質溶液をバッチ処理により加水分解した場合には、常法により加水分解溶液を加熱処理し、酵素を失活させる。加熱温度と保持時間は使用した酵素の熱安定性を配慮し、十分に失活できる条件を適宜設定することが好ましい。加熱処理後は、常法により冷却し、そのまま又は必要に応じて濃縮し、乾燥し、粉末製品を得ることもできる。 When the whey protein solution is hydrolyzed by batch treatment, the hydrolysis solution is heat-treated by a conventional method to inactivate the enzyme. The heating temperature and the holding time are preferably set appropriately under conditions that allow sufficient inactivation, in consideration of the thermal stability of the enzyme used. After the heat treatment, it can be cooled by a conventional method, concentrated as it is or as required, and dried to obtain a powder product.
［２］ホエイタンパク質加水分解物の理化学的性質
前記ホエイタンパク質加水分解物は、以下１）〜３）（好適には以下の１）〜６））の理化学的性質を有するように、［１］に記載した方法により適宜調整され、製造されることが可能である。
１）ホエイタンパク質加水分解物の平均分子鎖長が２〜１０である。
２）ホエイタンパク質加水分解物の分子量５，０００から１０，０００ダルトンの画分が全ホエイタンパク質加水分解物の８％以下である。
３）ホエイタンパク質加水分解物の全アミノ酸量に対する遊離アミノ酸量が１０％以下である。
４）１０質量％ホエイタンパク質加水分解物溶液における５４０ｎｍの透過率が９５％以上である。
５）５質量％ホエイタンパク質加水分解物溶液がｐＨ４〜７で１２０℃、１０分間加熱処理した際に沈殿を生じない。
６）５質量％ホエイタンパク質加水分解物溶液が０．０２５ｍｏｌ／Ｌ塩化カルシウムの存在下、ｐＨ３〜５で８５℃、１０分間加熱処理してもゲル化しない。
[2] Physicochemical properties of whey protein hydrolyzate The whey protein hydrolyzate has the physicochemical properties of 1) to 3) below (preferably 1) to 6) below, [1] It can be suitably adjusted and manufactured by the method described in.
1) The average molecular chain length of whey protein hydrolyzate is 2-10.
2) The fraction with a molecular weight of 5,000 to 10,000 daltons of whey protein hydrolyzate is 8% or less of the total whey protein hydrolyzate.
3) The amount of free amino acids is 10% or less with respect to the total amount of amino acids of whey protein hydrolyzate.
4) The transmittance at 540 nm in the 10% by mass whey protein hydrolyzate solution is 95% or more.
5) When the 5% by mass whey protein hydrolyzate solution is heat treated at 120 ° C. for 10 minutes at pH 4 to 7, no precipitation occurs.
6) The 5% by mass whey protein hydrolyzate solution does not gelate even when heat-treated at 85 ° C. for 10 minutes at pH 3-5 in the presence of 0.025 mol / L calcium chloride.
本技術に用いられるホエイタンパク質加水分解物の平均分子鎖長は、２〜１０であることが好ましく、３〜５であることがより好ましい。
本技術における平均分子鎖長は、ＴＮＢＳ法（非特許文献２：日本栄養・食糧学会誌、Ｖｏｌ．４７、Ｎｏ．３、１９５−２０１（１９９４）；「３）平均ペプチド鎖長測定法ＴＮＢＳ法」参照）により測定することが可能である。
The average molecular chain length of the whey protein hydrolyzate used in the present technology is preferably 2 to 10, and more preferably 3 to 5.
The average molecular chain length in this technology is the TNBS method (Non Patent Literature 2: Journal of Japan Nutrition and Food Society, Vol. 47, No. 3, 195-201 (1994); “3) Average peptide chain length measurement method TNBS method It is possible to measure by
前記ホエイタンパク質加水分解物のうち、分子量５，０００〜１０，０００ダルトンの画分は、全ホエイタンパク質加水分解物の８％以下の割合であることが好ましく、５％以下であることがより好ましく、２％以下であることがさらに好ましい。
なお、ホエイタンパク質加水分解物の分子量は、以下の＜分子量分布の測定＞により測定することが可能である。
＜分子量分布の測定＞
高速液体クロマトグラフィーにより分子量分布を測定する（宇井信生ら編、「タンパク質・ペプチドの高速液体クロマトグラフィー」、化学増刊第１０２号、第２４１頁、株式会社化学同人、１９８４年）。
具体的には、ポリハイドロキシエチル・アスパルタミド・カラム［Ｐｏｌｙ Ｈｙｄｒｏｘｙｅｔｈｙｌ Ａｓｐａｒｔａｍｉｄｅ Ｃｏｌｕｍｎ：ポリ・エル・シー（Ｐｏｌｙ ＬＣ社製）。直径４．６ｍｍ及び長さ２２０ｍｍ］を用い、２０ｍＭ塩化ナトリウム、５０ｍＭギ酸により溶出速度０．５ｍＬ／ｍｉｎで溶出する。
検出はＵＶ検出器（島津製作所社製）を用い、データ解析はＧＰＣ分析システム（島津製作所社製）を使用する。
〔各分子量画分の割合（％）〕＝〔分子量分布における各分子量範囲の面積／分子量分布におけるホエイタンパク質加水分解物の全面積（全エリア）〕。
Among the whey protein hydrolysates, the fraction having a molecular weight of 5,000 to 10,000 daltons is preferably 8% or less of all whey protein hydrolysates, and more preferably 5% or less More preferably, it is 2% or less.
The molecular weight of whey protein hydrolyzate can be measured by the following <Measurement of molecular weight distribution>.
<Measurement of molecular weight distribution>
The molecular weight distribution is measured by high performance liquid chromatography (Ui Nobuo et al., Ed., "High Performance Liquid Chromatography of Proteins and Peptides", Chemical Supplement, No. 102, page 241, Dojin Co., Ltd., 1984).
Specifically, a polyhydroxy ethyl aspartamide column (Poly Hydroxy Ethyl Aspartamide Column: manufactured by Poly LC). Elution is carried out with 20 mM sodium chloride, 50 mM formic acid at a dissolution rate of 0.5 mL / min using a diameter of 4.6 mm and a length of 220 mm].
For detection, a UV detector (manufactured by Shimadzu Corporation) is used, and for data analysis, a GPC analysis system (manufactured by Shimadzu Corporation) is used.
[Proportion of each molecular weight fraction (%)] = [Area of each molecular weight range in molecular weight distribution / total area of whey protein hydrolyzate in molecular weight distribution (total area)].
前記ホエイタンパク質加水分解物の全アミノ酸量に対する遊離アミノ酸量は、１０％以下であることが好ましく、８％以下であることがより好ましく、６％以下であることがさらに好ましい。
前記ホエイタンパク質加水分解物において、全アミノ酸量に対する遊離アミノ酸量が前記の範囲であることにより、アミノ酸特有の風味がほとんど確認されない点で優れている。そのため、本技術に用いられるホエイタンパク質加水分解物は、他の飲食品と混合することなしに単独で摂取した場合でも、良好な風味を呈する。
なお、本技術に用いられるホエイタンパク質加水分解物に含まれる遊離アミノ酸量は、遊離アミノ酸の質量合計の割合（％）＝（全遊離アミノ酸の質量／全アミノ酸の質量）×１００（特許文献４：特開２０１７−３１１０５号公報記載の＜アミノ酸遊離率の算定方法＞参照）により測定することが可能である。
The amount of free amino acids relative to the total amount of amino acids of the whey protein hydrolyzate is preferably 10% or less, more preferably 8% or less, and still more preferably 6% or less.
In the whey protein hydrolyzate, the free amino acid amount relative to the total amino acid amount is in the above-mentioned range, so that it is excellent in that the taste characteristic of the amino acid is hardly confirmed. Therefore, the whey protein hydrolyzate used in the present technology exhibits a good flavor even when taken alone without being mixed with other food and drink.
The amount of free amino acids contained in whey protein hydrolyzate used in the present technology is the ratio of the total mass of free amino acids (%) = (mass of all free amino acids / mass of total amino acids) × 100 (Patent Document 4) It can be measured according to <Method of calculating amino acid release rate> described in JP-A-2017-31105.
本技術に用いられるホエイタンパク質加水分解物は、１０質量％ホエイタンパク質加水分解物溶液における５４０ｎｍの透過率が９５％以上であることが好ましく、９７％以上であることがより好ましい。当該１０質量％ホエイタンパク質加水分解物溶液は、粉末化したホエイタンパク質加水分解物を１０質量％（質量／体積）水溶液になるように水に溶解したものである。
本技術は１０質量％ホエイタンパク質加水分解物溶液における５４０ｎｍの透過率が前記範囲であることにより、溶液状態が透明であるため、食品や医薬品等の幅広い製品への応用が可能である点で優れている。
In the whey protein hydrolyzate used in the present technology, the transmittance at 540 nm in a 10% by mass whey protein hydrolyzate solution is preferably 95% or more, and more preferably 97% or more. The 10% by mass whey protein hydrolyzate solution is obtained by dissolving powdered whey protein hydrolyzate in water so as to be a 10% by mass (mass / volume) aqueous solution.
This technology is excellent in that it can be applied to a wide range of products such as food and medicine because the solution state is transparent by the transmittance of 540 nm in the 10% by mass whey protein hydrolyzate solution being in the above range. ing.
本技術に用いられるホエイタンパク質加水分解物は、５質量％ホエイタンパク質加水分解物溶液（ｐＨ４〜７調整済み）を１２０℃、１０分間加熱処理した際に沈殿を生じないことが好ましい。
また、本技術に用いられるホエイタンパク質加水分解物は、０．０２５ｍｏｌ／Ｌになるように塩化カルシウムを添加した後、ｐＨ３〜５に調整し、５質量％水溶液になるようにしてから、８５℃、１０分間加熱処理してもゲル化しないことが好ましい。
なお、当該５質量％ホエイタンパク質加水分解物溶液は、粉末化したホエイタンパク質加水分解物を５質量％（質量／体積）水溶液になるように調製したものである。
It is preferable that the whey protein hydrolyzate used for this technique does not produce a precipitate, when a 5 mass% whey protein hydrolyzate solution (pH 4-7 adjusted) is heat-processed for 10 minutes at 120 degreeC.
In addition, whey protein hydrolyzate used in the present technology is adjusted to pH 3 to 5 after adding calcium chloride to 0.025 mol / L and adjusted to a 5% by mass aqueous solution, then 85 ° C. It is preferable that no gelation occurs even after heat treatment for 10 minutes.
In addition, the said 5 mass% whey protein hydrolyzate solution is prepared so that the powdered whey protein hydrolyzate may be 5 mass% (mass / volume) aqueous solution.
［３］本技術のホエイタンパク質加水分解物の用途（血中尿酸値低減剤等）
本技術のホエイタンパク質加水分解物は、後記〔実施例〕に示すように、血中の尿酸値を低下する作用を有するため、血中尿酸値の上昇を有効に抑制させることができ、また、効率的に高尿酸血症又は痛風の予防又は治療に使用することが可能である。
したがって、本技術のホエイタンパク質加水分解物は、有効成分として血中尿酸値低減剤又は血中尿酸値低減用組成物に含有させることができ、また医薬品、飲食品、飼料等の種々の用途に使用できる。本技術のホエイタンパク質加水分解物は、分解物自体を単独としてそのまま用いることが可能であり、又は生理的若しくは薬剤学的に許容される通常の担体若しくは希釈剤と共に混合して用いることもできる。また、本技術のホエイタンパク質加水分解物は、これら各種製剤又は各種組成物等の製造のために使用することができる。
また、本技術に用いられるホエイタンパク質加水分解物は、水に溶けやすいので加工安定性に優れており、苦みが少なく、風味が良好で、またホエイタンパク質は経験則的に安全性も高いので、安心して継続して長期間摂取することができる。よって、本技術のホエイタンパク質加水分解物によれば、優れた血中尿酸値の低下作用を有し、風味が良好で飲みやすい経口摂取用の製剤又は組成物を提供することができる。
[3] Applications of whey protein hydrolyzate of the present technology (blood uric acid level reducing agents, etc.)
The whey protein hydrolyzate according to the present technology has an action to lower the level of uric acid in blood as described later (Examples), so that it is possible to effectively suppress an increase in the level of uric acid in blood. It can be used efficiently for the prevention or treatment of hyperuricemia or gout.
Therefore, the whey protein hydrolyzate of the present technology can be contained as an active ingredient in a blood uric acid level reducing agent or a composition for reducing blood uric acid level, and also for various uses such as pharmaceuticals, foods and drinks It can be used. The whey protein hydrolyzate according to the present technology can be used alone as the degradation product itself, or can be used as a mixture with a physiologically or pharmaceutically acceptable common carrier or diluent. In addition, the whey protein hydrolyzate of the present technology can be used for producing these various preparations or various compositions and the like.
In addition, whey protein hydrolyzate used in the present technology is easily soluble in water, so it is excellent in processing stability, has a low bitterness, good flavor, and whey protein has high safety as a rule of thumb, You can take it safely and continuously for a long time. Therefore, according to the whey protein hydrolyzate of the present technology, it is possible to provide a preparation or composition for oral intake which has an excellent blood uric acid level lowering action, is excellent in flavor, and is easy to drink.
本技術の血中尿酸値低減剤又は血中尿酸値低減用組成物に含まれるホエイタンパク質加水分解物の量は、特に制限されないが、他成分を含む場合、５〜９０％が好ましく、１０〜８０％がより好ましく、２０〜７０％がさらに好ましい。 The amount of whey protein hydrolyzate contained in the blood uric acid level reducing agent or blood uric acid level reducing composition of the present technology is not particularly limited, but if it contains other components, 5 to 90% is preferable, 10 to 10%. 80% is more preferable, and 20 to 70% is further preferable.
本技術の血中尿酸値低減剤又は血中尿酸値低減用組成物におけるホエイタンパク質加水分解物の割合は、摂取者が１回当たりに摂取する血中尿酸値低減剤又は血中尿酸値低減用組成物の量と、ホエイタンパク質加水分解物の量に応じて決定すればよい。
なお、１回当たりのホエイタンパク質加水分解物の量は、摂取者の性別、年齢、状態、患者であれば疾患の重篤度などに応じて適宜決定すればよいが、例えば、２〜５０ｇ／日とすることが好ましく、２〜２０ｇ／日とすることがより好ましく、５〜２０ｇ／日とすることがさらにより好ましい。体重１ｋｇ当たりの換算量としては、０．０１〜１ｇ／ｋｇ体重／日とすることが好ましく、０．０５〜０．５ｇ／ｋｇ体重／日とすることがより好ましい。
また、血中尿酸値低減剤又は血中尿酸値低減用組成物の１日当たりの摂取回数は特に制限されず、１日当たりのホエイタンパク質加水分解物の摂取量に応じて適宜決定することが可能である。
本技術の血中尿酸値低減剤又は血中尿酸値低減用組成物は、ある程度の期間、恒常的に摂取することが好ましい。摂取期間としては、６週間以上が好ましく、１２週間以上がより好ましく、１８週間以上がさらに好ましい。
The ratio of whey protein hydrolyzate in the blood uric acid level reducing agent or composition for blood uric acid level reduction of the present technology is for the blood uric acid level reducing agent or blood uric acid level reduction consumed by the user per dose It may be determined according to the amount of composition and the amount of whey protein hydrolyzate.
The amount of whey protein hydrolyzate per injection may be appropriately determined according to the sex, age, condition of the user, and the patient depending on the severity of the disease, etc. It is preferable to set it as a day, it is more preferable to set it as 2-20 g / day, and it is still more preferable to set it as 5-20 g / day. The conversion amount per kg body weight is preferably 0.01 to 1 g / kg body weight / day, and more preferably 0.05 to 0.5 g / kg body weight / day.
In addition, the number of daily intakes of the blood uric acid level reducing agent or the blood uric acid level reducing composition is not particularly limited, and can be appropriately determined according to the daily intake of whey protein hydrolyzate. is there.
The blood uric acid level reducing agent or the blood uric acid level reducing composition of the present technology is preferably consumed constantly for a certain period of time. The intake period is preferably 6 weeks or more, more preferably 12 weeks or more, and still more preferably 18 weeks or more.
なお、本技術のホエイタンパク質加水分解物は、適用対象であるヒト若しくは非ヒト動物（好適には霊長類）に使用してもよく、ヒト及びペットが好ましく、より好ましくはヒトである。
さらに、適用対象は、痛風患者、高尿酸血症患者又はその予備軍であるのが好適であるが、尿酸値７ｍｇ／ｄＬ超が高尿酸血症の目安となる。本技術は、安全性が高いので、高尿酸血症となっていないヒトに対して予防的に適用することが可能であり、例えば〔表１〕に示すように、尿酸が正常値のヒト、尿酸値が５ｍｇ／ｄＬ以上で正常なヒトにも適用可能である。さらに、尿酸排泄機能が低下し易く、かつ尿酸が体内に蓄積し高濃度になり易い、中高年（４０歳以上）が好適である。
In addition, the whey protein hydrolyzate of this technique may be used for the human or non-human animal (suitably primate) which is application object, a human and a pet are preferable, and a human is more preferable.
Furthermore, although the subject of application is preferably a gout patient, a hyperuricemia patient or a preparatory arm thereof, a uric acid value of 7 mg / dL or more is an indicator of hyperuricemia. Since this technology is highly safe, it can be applied prophylactically to humans who do not develop hyperuricemia, for example, as shown in [Table 1], humans with normal values of uric acid, The present invention is also applicable to normal human with uric acid level of 5 mg / dL or more. Furthermore, middle-aged and elderly people (40 years of age or older), in which the uric acid excretion function is likely to be reduced and uric acid is easily accumulated in the body and become high concentration, are preferable.
また、本技術は、治療目的使用であっても、非治療目的使用であってもよい。
「非治療目的」とは、医療行為、すなわち、治療による人体への処置行為を含まない概念である。例えば、健康増進、生活習慣病予防等が挙げられる。
「予防」とは、適用対象における疾患若しくは症状の発症の防止や遅延、又は適用対象の疾患若しくは症状の危険性の低下をいう。
Also, the technology may be for therapeutic or non-therapeutic use.
"Non-therapeutic purpose" is a concept that does not include medical practice, that is, treatment of the human body by treatment. For example, health promotion, lifestyle-related disease prevention, etc. are mentioned.
"Prevention" refers to preventing or delaying the onset of a disease or condition in a subject of application, or reducing the risk of a disease or condition of interest.
［４］医薬組成物
本技術に用いられるホエイタンパク質加水分解物は、血中尿酸値を低減させる作用を有するため、痛風又は高尿酸血症の予防又は治療に有効な医薬組成物として利用することができる。さらに、本技術の医薬組成物の有効成分であるホエイタンパク質加水分解物は、食経験が豊富であるため安全性が高く、高血圧、脂質異常症、糖尿病又は耐糖能異常等の合併病態を伴っている痛風患者又は高尿酸血症患者にも好適に使用することができる。また、本技術に用いられるホエイタンパク質加水分解物は、原料であるホエイタンパク質にプリン体が少ないか存在しないこともあり、痛風患者又は高尿酸血症患者、当該予備軍が安心して摂取することができる。
かかる医薬組成物に含まれるホエイタンパク質加水分解物の量は、特に制限されないが、他成分を含む場合、５〜９０％が好ましく、１０〜８０％がより好ましく、２０〜７０％がさらに好ましい。
[4] Pharmaceutical composition Since whey protein hydrolyzate used in the present technology has an action to reduce blood uric acid level, it is used as a pharmaceutical composition effective for the prevention or treatment of gout or hyperuricemia. Can. Furthermore, whey protein hydrolyzate, which is an active ingredient of the pharmaceutical composition of the present technology, is highly safe because it has abundant eating experience, and is accompanied by combined pathologies such as hypertension, dyslipidemia, diabetes or glucose intolerance. It can also be suitably used for gout patients or hyperuricemia patients. In addition, the whey protein hydrolyzate used in the present technology may have little or no purine in the whey protein that is the raw material, and it can be safely consumed by the gout patient or hyperuricemia patient, and the preparatory force. it can.
The amount of whey protein hydrolyzate contained in such a pharmaceutical composition is not particularly limited, but when including other components, 5 to 90% is preferable, 10 to 80% is more preferable, and 20 to 70% is more preferable.
当該医薬組成物の投与量は、特に限定されず年齢、性別、症状の程度等に応じて決定されるが、有効成分としてのホエイタンパク質加水分解物の量として、２〜５０ｇ／日とすることが好ましく、５〜２０ｇ／日とすることがより好ましい。体重１ｋｇ当たりの換算量としては、０．０１〜１ｇ／ｋｇ体重／日とすることが好ましく、０．０５〜０．５ｇ／ｋｇ体重／日とすることがより好ましい。また、１日の投与量を複数回に分けてもよく、１日１回から３回に分けることが好ましいが、２回に分けることがより好ましい。
本技術の医薬組成物は、ある程度の期間、恒常的に摂取することが好ましい。摂取期間としては、６週間以上が好ましく、１２週間以上がより好ましく、１８週間以上がさらに好ましい。
The dose of the pharmaceutical composition is not particularly limited and is determined according to the age, sex, degree of symptoms, etc., but the amount of whey protein hydrolyzate as an active ingredient is 2 to 50 g / day. Is preferred, and 5 to 20 g / day is more preferred. The conversion amount per kg body weight is preferably 0.01 to 1 g / kg body weight / day, and more preferably 0.05 to 0.5 g / kg body weight / day. In addition, the daily dose may be divided into a plurality of times, and it is preferable to divide into 1 to 3 times a day, but it is more preferable to divide into 2 times.
The pharmaceutical composition of the present technology is preferably taken constantly for a certain period of time. The intake period is preferably 6 weeks or more, more preferably 12 weeks or more, and still more preferably 18 weeks or more.
投与経路は、例えば経口投与、腹腔内投与、静脈内投与、筋肉内投与、経粘膜投与、鼻腔内投与、直腸内投与等が挙げられる。このうち、経口投与（経口摂取）が好ましい。
なお、投与対象は、通常、ヒトであることが好ましいが、ヒト以外の哺乳動物、例えばイヌ、ネコ等のペット動物、ウシ、ヒツジ、ブタ等の家畜も含むものとする。
The administration route includes, for example, oral administration, intraperitoneal administration, intravenous administration, intramuscular administration, transmucosal administration, intranasal administration, intrarectal administration and the like. Among these, oral administration (oral intake) is preferred.
The subject of administration is usually preferably human, but it also includes mammals other than human, for example, pet animals such as dogs and cats, and domestic animals such as cows, sheep and pigs.
投与形態（又は製剤）としては、固体製剤及び液体製剤のいずれの形態でもよく、例えば、錠剤、丸剤、カプセル剤、散剤、顆粒剤、溶液剤、注射剤、粉末剤、噴霧製剤等が挙げられる。 The administration form (or preparation) may be any form of solid preparation and liquid preparation, and examples thereof include tablets, pills, capsules, powders, granules, solutions, injections, powders, spray preparations and the like. Be
本技術の医薬組成物は、製薬上許容可能な担体を含んでいてもよい。かかる担体には、賦形剤又は希釈剤が含まれ、例えば、デキストラン類、サッカロース、ラクトース、マルトース、キシロース、トレハロース、マンニトール、ソルビトール、ゼラチン、カルボキシメチルセルロース、カルボキエチルセルロース、ヒドロキシプロピルメチルセルロース、アラビアガム、グアーガム、トラガカント、アクリル酸コポリマー、エタノール、生理食塩水、リンゲル液等が挙げられる。 Pharmaceutical compositions of the present technology may comprise a pharmaceutically acceptable carrier. Such carriers include excipients or diluents, for example dextrans, sucrose, lactose, maltose, xylose, trehalose, mannitol, sorbitol, gelatin, carboxymethylcellulose, carboxymethylcellulose, hydroxypropyl methylcellulose, gum arabic, guar gum Tragacanth, acrylic acid copolymer, ethanol, physiological saline, Ringer's solution and the like.
前記担体に加えて、必要に応じて防腐剤、安定化剤、結合剤、ｐＨ調節剤、緩衝剤、増粘剤、ゲル化剤、抗酸化剤等の添加剤を加えることができる。これらの添加剤は、製薬の際に使用されるものが好ましい。 In addition to the above-mentioned carrier, additives such as preservatives, stabilizers, binders, pH adjusters, buffers, thickeners, gelling agents, antioxidants and the like can be added if necessary. These additives are preferably those used in pharmaceuticals.
本技術のホエイタンパク質加水分解物を有効成分として含む医薬組成物を製造する際は、製剤技術分野において慣用の方法、例えば、日本薬局方に記載の方法あるいはそれに準じる方法に従って製造することができる。 When producing a pharmaceutical composition containing the whey protein hydrolyzate of the present technology as an active ingredient, it can be produced according to a conventional method in the field of formulation technology, for example, a method described in Japanese Pharmacopoeia or a method according thereto.
本技術に係る痛風又は高尿酸血症のための予防又は治療用医薬組成物は、他の医薬品と組み合わせて使用してもよい。 組み合わせて使用する医薬品は、本技術の痛風又は高尿酸血症のための予防又は治療用医薬組成物の投与と同時に、投与前に、あるいは投与後のいずれかの時点で投与することができる。その投与量は特に限定されないが、市販の医薬品である場合、医薬メーカーによって指示される投与量であることが好ましい。 The pharmaceutical composition for preventing or treating gout or hyperuricemia according to the present technology may be used in combination with other pharmaceutical agents. The pharmaceutical agents used in combination may be administered simultaneously with, prior to, or after administration of the pharmaceutical composition for preventing or treating gout or hyperuricemia of the present technology. The dosage is not particularly limited, but in the case of a commercially available drug, it is preferably a dosage indicated by a pharmaceutical manufacturer.
［５］飲食品組成物
本技術に用いられるホエイタンパク質加水分解物は、飲食品や飼料等に添加して飲食品組成物として用いることができる。本技術に用いられるホエイタンパク質加水分解物は、血中の尿酸値を低下する作用に基づいて、飲食品に由来する血中尿酸値の上昇を有効に抑制することができる。
例えば、本技術に用いられるホエイタンパク質加水分解物は、小麦粉製品、即席食品、農産加工品、水産加工品、畜産加工品、乳・乳製品、油脂類、基礎調味料、複合調味料・食品類、冷凍食品、菓子類、飲料、これら以外の市販食品や、錠菓、流動食、飼料（ペット用を含む）等に添加して用いることができる。飲食品の形態は、液状、ペースト状、固体、粉末等の形態を問わず用いることができる。
かかる飲食品組成物に含まれるホエイタンパク質加水分解物の量は、特に制限されないが、他成分を含む場合、５〜９０％が好ましく、１０〜８０％がより好ましく、２０〜７０％がさらに好ましい。
[5] Food and Beverage Composition The whey protein hydrolyzate used in the present technology can be added to food and drink, feed and the like to be used as a food and drink composition. The whey protein hydrolyzate used in the present technology can effectively suppress the increase in blood uric acid level derived from food and drink based on the action of lowering the uric acid level in blood.
For example, whey protein hydrolyzate used in the present technology includes wheat flour products, instant foods, processed agricultural products, processed fish products, processed livestock products, milk and dairy products, oils and fats, basic seasonings, combined seasonings and foods It can be added to frozen foods, confectioneries, beverages, commercial foods other than these, tablets, liquid foods, feeds (including for pets), and the like. The form of the food and drink may be any form such as liquid, paste, solid, powder and the like.
The amount of whey protein hydrolyzate contained in the food and drink composition is not particularly limited, but when including other components, 5 to 90% is preferable, 10 to 80% is more preferable, and 20 to 70% is more preferable. .
本技術の飲食品組成物の摂取量は、特に限定されないが、有効成分としてのホエイタンパク質加水分解物の量として、２〜５０ｇ／日とすることが好ましく、２〜２０ｇ／日とすることがより好ましく、５〜２０ｇ／日とすることがさらにより好ましい。体重１ｋｇ当たりの換算量としては、０．０１〜１ｇ／ｋｇ体重／日とすることが好ましく、０．０５〜０．５ｇ／ｋｇ体重／日とすることがより好ましい。また、１日の摂取量を複数回に分けてもよく、１日１回から３回に分けることが好ましいが、２回に分けることがより好ましい。
本技術の飲食品組成物は、ある程度の期間、恒常的に摂取することが好ましい。摂取期間としては、６週間以上が好ましく、１２週間以上がより好ましく、１８週間以上がさらに好ましい。
The intake amount of the food and drink composition of the present technology is not particularly limited, but the amount of whey protein hydrolyzate as an active ingredient is preferably 2 to 50 g / day, and may be 2 to 20 g / day. It is more preferable to use 5 to 20 g / day. The conversion amount per kg body weight is preferably 0.01 to 1 g / kg body weight / day, and more preferably 0.05 to 0.5 g / kg body weight / day. In addition, the daily intake may be divided into a plurality of times, and it is preferable to divide into 1 to 3 times a day, but it is more preferable to divide into 2 times.
The food and drink composition of the present technology is preferably consumed constantly for a certain period of time. The intake period is preferably 6 weeks or more, more preferably 12 weeks or more, and still more preferably 18 weeks or more.
本技術の飲食品組成物は、血中尿酸値低減等の保健用途が表示された飲食品として提供・販売されることが可能である。かかる表示としては、例えば、「尿酸値が気になる方へ」、「尿酸値が高めの方へ」、「尿酸値の上昇を抑えます」又は「プリン体が気になる方へ」等と表示することが挙げられる。 The food and drink composition of the present technology can be provided and sold as food and drink on which health uses such as blood uric acid level reduction are displayed. As such a display, for example, "to those who are concerned about uric acid levels", "to those who are high in uric acid levels", "to suppress the rise of uric acid levels" or "to those who are concerned about purine bodies" It can be mentioned that it is displayed.
「表示」行為には、需要者に対して前記用途を知らしめるための全ての行為が含まれ、前記用途を想起・類推させうるような表現であれば、表示の目的、表示の内容、表示する対象物・媒体等の如何に拘わらず、全て本発明の「表示」行為に該当する。 "Display" acts include all acts to inform consumers of the application, and if it is an expression that can recall or analogize the application, the purpose of the display, the content of the display, the display Regardless of the target object, medium, etc., they all fall under the "display" action of the present invention.
また、「表示」は、需要者が上記用途を直接的に認識できるような表現により行われることが好ましい。具体的には、飲食品に係る商品又は商品の包装に前記用途を記載したものを譲渡し、引き渡し、譲渡若しくは引き渡しのために展示し、輸入する行為、商品に関する広告、価格表若しくは取引書類に上記用途を記載して展示し、若しくは頒布し、又はこれらを内容とする情報に上記用途を記載して電磁気的（インターネット等）方法により提供する行為等が挙げられる。 Moreover, it is preferable that "display" is performed by the expression which a consumer can recognize the said application directly. Specifically, the goods or goods packaging pertaining to food and drink are transferred to those which describe the use, and displayed for delivery, transfer or delivery, and the act of importing, advertisement for goods, price list or transaction documents The above-mentioned use is described and displayed, or it distributes, or the above-mentioned use is described in the information which makes these contents, and the action etc. which are provided by an electromagnetic (Internet etc.) method etc. are mentioned.
一方、表示内容としては、行政等によって認可された表示（例えば、行政が定める各種制度に基づいて認可を受け、そのような認可に基づいた態様で行う表示等）であることが好ましい。また、そのような表示内容を、包装、容器、カタログ、パンフレット、ＰＯＰ等の販売現場における宣伝材、その他の書類等へ付することが好ましい。 On the other hand, it is preferable that the display content is a display approved by the administration or the like (for example, a display etc. which is approved on the basis of various systems defined by the administration and performed in a mode based on such authorization). In addition, it is preferable to attach such display contents to advertising materials at sales sites such as packaging, containers, catalogs, brochures, POPs, and other documents.
また、「表示」には、健康食品、機能性食品、経腸栄養食品、特別用途食品、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、医薬用部外品等としての表示も挙げられる。この中でも特に、消費者庁によって認可される表示、例えば、特定保健用食品、栄養機能食品、若しくは機能性表示食品に係る制度、又はこれらに類似する制度にて認可される表示等が挙げられる。具体的には、特定保健用食品としての表示、条件付き特定保健用食品としての表示、身体の構造や機能に影響を与える旨の表示、疾病リスク減少表示、科学的根拠に基づいた機能性の表示等を挙げることができ、より具体的には、健康増進法に規定する特別用途表示の許可等に関する内閣府令（平成二十一年八月三十一日内閣府令第五十七号）に定められた特定保健用食品としての表示（特に保健の用途の表示）及びこれに類する表示が典型的な例である。 In addition, as "indication", as health food, functional food, enteral nutrition food, special purpose food, health functional food, food for specified health, nutritional functional food, functional display food, quasi-drugs etc. There is also a display. Among these, the indication approved by the consumer agency, for example, the indication approved by the system concerning the food for specified health, the nutritive function food, or the functional indication food, or the system similar thereto is mentioned. Specifically, labeling as food for specific health, labeling as food for conditional health, labeling indicating that the structure or function of the body is affected, disease risk reduction labeling, functionality based on scientific evidence The Cabinet Office Ordinance on the Permitting of Special Use Indications Specified in the Health Promotion Act (August 31, 2011 Cabinet Office Ordinance No. 57) Indications as food for specified health use (especially indications of health use) and similar indications specified in the above are typical examples.
このように、本技術は、飲食品、飲食品組成物、機能性食品、医薬品、飼料等の幅広い分野に使用することができる。 Thus, the present technology can be used in a wide range of fields such as food and drink, food and drink composition, functional food, medicine, feed and the like.
また、本技術は、以下の構成を採用することも可能である。
〔１〕 ホエイタンパク質加水分解物を有効成分として含有する血中尿酸値低減剤又は血中尿酸値低減用組成物。
〔２〕 前記組成物は、好適には医薬組成物又は飲食品組成物である、前記〔１〕記載の血中尿酸値低減剤又は血中尿酸値低減用組成物。
〔３〕 前記組成物は、高尿酸血症の予防又は治療である、前記〔１〕又は〔２〕記載の血中尿酸値低減剤又は血中尿酸値低減用組成物。
In addition, the present technology can also adopt the following configuration.
[1] A blood uric acid level reducing agent or a composition for reducing blood uric acid level, comprising whey protein hydrolyzate as an active ingredient.
[2] The composition for reducing blood uric acid levels or the composition for reducing blood uric acid levels according to [1], wherein the composition is preferably a pharmaceutical composition or a food and drink composition.
[3] The composition for reducing blood uric acid levels or the composition for reducing blood uric acid levels according to the above [1] or [2], which is the prevention or treatment of hyperuricemia.
〔４〕 前記ホエイタンパク質が、牛乳由来のホエイタンパク質濃縮物（ＷＰＣ）である、前記〔１〕〜〔３〕の何れか１記載の血中尿酸値低減剤又は血中尿酸値低減用組成物。好適には、前記ホエイタンパク質濃縮物が、α−ラクトアルブミン１５〜２５％、β−ラクトグロブリン５０〜６５％、ウシ血清アルブミン５〜１０％を含むものである。 [4] The blood uric acid level reducing agent or the composition for reducing blood uric acid level according to any one of the above [1] to [3], wherein the whey protein is milk protein-derived whey protein concentrate (WPC) . Preferably, the whey protein concentrate comprises 15 to 25% α-lactalbumin, 50 to 65% β-lactoglobulin, and 5 to 10% bovine serum albumin.
〔５〕 前記ホエイタンパク質加水分解物が、タンパク質酵素分解物である、前記〔１〕〜〔４〕の何れか１記載血中尿酸値低減剤又は血中尿酸値低減用組成物。好適には、前記酵素が、エンド型プロテアーゼである。
〔６〕 前記酵素分解物の処理条件が、３０〜６０℃で、及び／又は、２〜２４時間で、及び／又はｐＨ６〜１１で、行うことである、前記〔１〕〜〔５〕の何れか１記載の血中尿酸値低減剤又は血中尿酸値低減用組成物。
[5] The blood uric acid level reducing agent or the composition for reducing blood uric acid levels according to any one of the above [1] to [4], wherein the whey protein hydrolyzate is a protein enzyme degradation product. Preferably, the enzyme is an endoprotease.
[6] The treatment conditions of the enzyme degradation product are to perform at 30 to 60 ° C., and / or for 2 to 24 hours, and / or at pH 6 to 11, in the above [1] to [5] The blood uric acid level reducing agent or the composition for blood uric acid level reduction according to any one of the present inventions.
〔７〕 前記酵素分解物は、少なくとも以下１）〜３）の理化学的性質（好適には１）〜６）の理化学的性質）を有するように調整されたものである、前記〔１〕〜〔３〕の何れか１記載の血中尿酸値低減剤又は血中尿酸値低減用組成物。
１）ホエイタンパク質加水分解物の平均分子鎖長が２〜１０である。
２）ホエイタンパク質加水分解物の分子量５，０００から１０，０００ダルトンの画分が全ホエイタンパク質加水分解物の８％以下である。
３）ホエイタンパク質加水分解物の全アミノ酸量に対する遊離アミノ酸量が１０％以下である。
４）１０質量％ホエイタンパク質加水分解物溶液における５４０ｎｍの透過率が９５％以上である。
５）５質量％ホエイタンパク質加水分解物溶液がｐＨ４〜７で１２０℃、１０分間加熱処理した際に沈殿を生じない。
６）５質量％ホエイタンパク質加水分解物溶液が０．０２５ｍｏｌ／Ｌ塩化カルシウムの存在下、ｐＨ３〜５で８５℃、１０分間加熱処理してもゲル化しない。
[7] The enzyme degradation product is at least one of the following 1) to 3) physicochemical properties (preferably 1) to 6) physicochemical properties): The blood uric acid level reducing agent or the composition for reducing blood uric acid level according to any one of [3].
1) The average molecular chain length of whey protein hydrolyzate is 2-10.
2) The fraction with a molecular weight of 5,000 to 10,000 daltons of whey protein hydrolyzate is 8% or less of the total whey protein hydrolyzate.
3) The amount of free amino acids is 10% or less with respect to the total amount of amino acids of whey protein hydrolyzate.
4) The transmittance at 540 nm in the 10% by mass whey protein hydrolyzate solution is 95% or more.
5) When the 5% by mass whey protein hydrolyzate solution is heat treated at 120 ° C. for 10 minutes at pH 4 to 7, no precipitation occurs.
6) The 5% by mass whey protein hydrolyzate solution does not gelate even when heat-treated at 85 ° C. for 10 minutes at pH 3-5 in the presence of 0.025 mol / L calcium chloride.
〔８〕 前記血中尿酸値低減剤又は血中尿酸値低減用組成物は、経口摂取用である、前記〔１〕〜〔７〕の何れか１記載の血中尿酸値低減剤又は血中尿酸値低減用組成物。
〔９〕 前記ホエイタンパク質分解物を２〜５０ｇ／１日摂取させる、及び／又は少なくとも６週間継続摂取させる、前記〔１〕〜〔８〕の何れか１記載の血中尿酸値低減剤又は血中尿酸値低減用組成物。
〔１０〕 前記〔１〕〜〔７〕の何れか１記載のホエイタンパク質加水分解物を有効成分として投与若しくは摂取する、又は、当該ホエイタンパク質加水分解物を使用する、痛風又は高尿酸血症の予防又は治療方法。
〔１１〕 血中尿酸値低減のための、又は高尿酸血症の予防又は治療のための、前記〔１〕〜〔７〕の何れか１記載のホエイタンパク質加水分解物。
〔１２〕 血中尿酸値低減剤又は血中尿酸値低減用組成物を製造するための、前記〔１〕〜〔７〕の何れか１記載のホエイタンパク質加水分解物の使用。
[8] The blood uric acid level reducing agent or the composition for reducing blood uric acid level according to any one of the above [1] to [7], which is for oral intake. Composition for reducing uric acid level.
[9] The blood uric acid level reducing agent or the blood according to any one of the above [1] to [8], wherein the whey protein hydrolyzate is ingested 2 to 50 g / day and / or continuously consumed for at least 6 weeks. Composition for reducing middle uric acid level.
[10] Gout or hyperuricemia using the whey protein hydrolyzate according to any one of the above [1] to [7] as an active ingredient, or using the whey protein hydrolyzate Methods of prevention or treatment.
[11] The whey protein hydrolyzate according to any one of the above [1] to [7] for reducing blood uric acid levels, or for preventing or treating hyperuricemia.
[12] Use of the whey protein hydrolyzate according to any one of the above [1] to [7] for producing a blood uric acid level reducing agent or a composition for reducing blood uric acid level.
以下に実施例を用いて本発明をさらに詳しく説明するが、本発明はこれら実施例に限定されるものではない。 EXAMPLES The present invention will be described in more detail using the following examples, but the present invention is not limited to these examples.
［試験例１］
（１）試験サンプルの調製
市販のＷＰＣ（ホエイタンパク質濃縮物、Ｍｉｌｅｉ８０（ミライ社製））を１０％の濃度で水に溶解し、水酸化ナトリウムを添加して溶液のｐＨを８．０に調整して、ホエイ水溶液を調製した。このホエイ水溶液に、たんぱく質１ｇ当たりプロテアーゼＮアマノ（天野エンザイム社製）を５，０００単位添加し、ｐＨ８．０において、５０℃で７時間分解した。次いで、９０℃で１０分間加熱して酵素を失活させ、噴霧乾燥機により粉末化し、ホエイ加水分解物の乾燥品を得た。
このようにして製造したホエイタンパク質加水分解物の乾燥品を５ｇずつ個包装に充填した。
なお、市販のＷＰＣ（ホエイタンパク質濃縮物、Ｍｉｌｅｉ８０（ミライ社製））を使用した。一般的に、ＷＰＣ（ホエイタンパク質濃縮物）には、α−ラクトアルブミン１５〜２５％、β−ラクトグロブリン５０〜６５％、ウシ血清アルブミン５〜１０％、ラクトフェリン等が含まれている。
[Test Example 1]
(1) Preparation of test sample A commercially available WPC (whey protein concentrate, Milei 80 (manufactured by Mirai)) is dissolved in water at a concentration of 10%, and sodium hydroxide is added to adjust the pH of the solution to 8.0. Then, whey aqueous solution was prepared. To this aqueous whey solution, 5,000 units of protease N Amano (manufactured by Amano Enzyme Inc.) were added per 1 g of protein, and the mixture was decomposed at pH 8.0 at 50 ° C. for 7 hours. Then, the enzyme was inactivated by heating at 90 ° C. for 10 minutes, and powdered with a spray dryer to obtain a dried whey hydrolyzate.
5 g of the dried product of whey protein hydrolyzate produced in this way was packed into individual packages.
A commercially available WPC (whey protein concentrate, Milei 80 (manufactured by Mirai)) was used. In general, WPC (whey protein concentrate) contains 15 to 25% of α-lactalbumin, 50 to 65% of β-lactoglobulin, 5 to 10% of bovine serum albumin, lactoferrin and the like.
また、試験例１のホエイタンパク質酵素分解物の理化学的性質は、以下のとおりであった。
１）ホエイタンパク質加水分解物の平均分子鎖長が３〜５であった。平均分子鎖長は、ＴＮＢＳ法（非特許文献２；「３）平均ペプチド鎖長測定法ＴＮＢＳ法」参照）により測定した。
２）ホエイタンパク質加水分解物の分子量５，０００〜１０，０００ダルトンの画分が全ホエイタンパク質加水分解物の２％以下であった。画分中の割合は上述した＜分子量分布の測定＞に記載の方法にて測定した。
３）ホエイタンパク質加水分解物の全アミノ酸量に対する遊離アミノ酸量が６％以下であった。ホエイタンパク質加水分解物に含まれる遊離アミノ酸量は、（特許文献４；＜アミノ酸遊離率の算定方法＞参照）により測定した。
４）１０質量％ホエイタンパク質加水分解物溶液における透過率は、分光光度計（Ｕ−２０００、日立製作所製：５４０ｎｍ）にて測定したが、１０質量％ホエイタンパク質加水分解物溶液における５４０ｎｍの透過率が９７％以上であった。
５）５質量％ホエイタンパク質加水分解物溶液（ｐＨ４〜７）を１２０℃、１０分間加熱処理した際に、目視により沈殿の有無を確認したが、沈殿は生じなかった。
６）５質量％ホエイタンパク質加水分解物溶液が０．０２５ｍｏｌ／Ｌ塩化カルシウムの存在下、ｐＨ３〜５で８５℃、１０分間加熱処理した際に、目視によりゲル化の有無を確認したが、ゲル化は生じていなかった。
The physicochemical properties of the whey protein enzyme degradation product of Test Example 1 were as follows.
1) The average molecular chain length of whey protein hydrolyzate was 3-5. The average molecular chain length was measured by the TNBS method (see Non-Patent Document 2; “3. Average peptide chain length measurement method TNBS method”).
2) The fraction with a molecular weight of 5,000 to 10,000 daltons of whey protein hydrolyzate was not more than 2% of the total whey protein hydrolyzate. The proportion in the fraction was measured by the method described in <Measurement of molecular weight distribution> described above.
3) The amount of free amino acids relative to the total amount of amino acids of whey protein hydrolyzate was 6% or less. The amount of free amino acids contained in whey protein hydrolyzate was measured by (see Patent Document 4; <Method for calculating amino acid release rate>).
4) The transmittance of the 10% by mass whey protein hydrolyzate solution was measured with a spectrophotometer (U-2000, manufactured by Hitachi, Ltd .: 540 nm), but the transmittance of 540 nm with the 10% by mass whey protein hydrolyzate solution was measured Was 97% or more.
5) When 5% by mass whey protein hydrolyzate solution (pH 4 to 7) was heat-treated at 120 ° C. for 10 minutes, the presence or absence of precipitation was visually confirmed, but no precipitation occurred.
6) When the 5% by mass whey protein hydrolyzate solution was heat-treated at 85 ° C. for 10 minutes at pH 3 to 5 in the presence of 0.025 mol / L calcium chloride, the presence or absence of gelation was visually confirmed. No conversion had occurred.
（２）投与試験
平均年齢約６５歳の高齢者６８名を被験者とし、該被験者を、前記試験例１のホエイタンパク質加水分解物を摂取する試験群３４名と、対照品を摂取する対照群３４名とに分けた。
試験群には、前記「（１）試験サンプルの調製」にて調製した前記ホエイタンパク質加水分解物の乾燥品１包５ｇを１００ｍＬの飲用水に溶解したものを１日に２回１２週間継続摂取させた。一方、対照群には、１包当りデキストリン（松谷化学工業株式会社製）５ｇ含むサンプルを１００ｍＬの飲用水に溶解したものを対照品として、１日に２回１２週間継続摂取させた。
各サンプルの摂取前（０週）と最後の摂取終了後（１２週）に、被験者から採血し血中尿酸値を測定した。また、サンプルの摂取前（０週）と摂取終了後（１２週）との血中尿酸値について、ｔ検定により統計学的有意差を検証した。
(2) Administration test The subjects were 68 elderly subjects with an average age of about 65 years, and the subjects were 34 test groups receiving the whey protein hydrolyzate of Test Example 1 and a control group receiving a control product. It was divided into names.
In the test group, a solution obtained by dissolving 5 g of the dried product of the whey protein hydrolyzate prepared in “(1) Preparation of test sample” in 100 mL of drinking water twice daily for 12 weeks I did. On the other hand, the control group was continuously ingested twice a day for 12 weeks as a control product in which a sample containing 5 g of dextrin (manufactured by Matsutani Chemical Industry Co., Ltd.) per package was dissolved in 100 mL of drinking water.
Before taking (Week 0) and after the last taking (Week 12) of each sample, the subject was bled and blood uric acid levels were measured. In addition, statistically significant differences were verified by t-test for blood uric acid levels before (0 week) and after (12 week) ingestion of the sample.
（３）結果
各群における被験者の血中尿酸値は、下表のとおりとなった。ホエイタンパク質加水分解物を摂取した試験群では、試験前に比較して尿酸値（平均値）が０．３ｍｇ／ｄＬ以上低下した。一方、ホエイタンパク質加水分解物を摂取しなかった対照群では、試験前に比較して尿酸値（平均値）が約０．２ｍｇ／ｄＬ増加した。
(3) Results The blood uric acid levels of the subjects in each group were as shown in the table below. In the test group ingested whey protein hydrolyzate, the uric acid value (average value) decreased by 0.3 mg / dL or more compared to before the test. On the other hand, in the control group which did not take whey protein hydrolyzate, the uric acid value (average value) increased by about 0.2 mg / dL as compared to before the test.
この結果から、本技術のホエイタンパク質加水分解物を１２週間以上の長期間にわたり摂取することにより血中尿酸値が有意に低減することがわかった。すなわち、本技術のホエイタンパク質加水分解物は、有効成分として含有させる血中尿酸値低減剤として使用することができ、また血中の尿酸値を低下させることにより、プリン体の含量が高い飲食品等の摂取に伴う血中尿酸値の上昇を抑制する用途等に利用することができる。また、本技術のホエイタンパク質加水分解物は、高尿酸血症又は痛風の予防又は治療等に有効に利用することができる。 From this result, it was found that blood uric acid levels are significantly reduced by taking the whey protein hydrolyzate of the present technology for a long period of 12 weeks or more. That is, the whey protein hydrolyzate of the present technology can be used as a blood uric acid level reducing agent to be contained as an active ingredient, and a food and drink having a high content of purine by lowering the uric acid level in blood. It can be used for the purpose of suppressing an increase in blood uric acid level accompanying intake of food. In addition, the whey protein hydrolyzate of the present technology can be effectively used for the prevention or treatment of hyperuricemia or gout.
すなわち、本技術のホエイタンパク質加水分解物は、血中尿酸値の低下作用を有するため、飲食品に由来する血中尿酸値の上昇を有効に抑制することが可能であり、また、痛風又は高尿酸血症の予防又は治療に有効である。また、本技術に用いられるホエイタンパク質加水分解物は、加工安定性に優れており、苦みが少なく、風味が良好で安心して継続摂取することができる。したがって、本技術によれば、優れた血中尿酸値の低下作用を有し、風味が良好で飲みやすい血中尿酸値低減剤、血中尿酸値低減用医薬組成物又は血中尿酸値低減用飲食品組成物を提供することができる。 That is, since the whey protein hydrolyzate of the present technology has a lowering action on blood uric acid levels, it is possible to effectively suppress the increase in blood uric acid levels derived from food and drink, and gout or high It is effective for the prevention or treatment of uricemia. In addition, the whey protein hydrolyzate used in the present technology is excellent in processing stability, less bitter, has a good flavor, and can be continuously ingested with confidence. Therefore, according to the present technology, a blood uric acid level reducing agent having an excellent blood uric acid level lowering action, having a good flavor and being easy to drink, a pharmaceutical composition for blood uric acid level reduction or for blood uric acid level reduction A food and drink composition can be provided.
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| JP2004155751A (en) * | 2002-03-13 | 2004-06-03 | Meiji Milk Prod Co Ltd | Peptide useful for oral immunonutritional therapy in bioinvasion |
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