JP5632162B2 - 経口組成物 - Google Patents
経口組成物 Download PDFInfo
- Publication number
- JP5632162B2 JP5632162B2 JP2009516367A JP2009516367A JP5632162B2 JP 5632162 B2 JP5632162 B2 JP 5632162B2 JP 2009516367 A JP2009516367 A JP 2009516367A JP 2009516367 A JP2009516367 A JP 2009516367A JP 5632162 B2 JP5632162 B2 JP 5632162B2
- Authority
- JP
- Japan
- Prior art keywords
- hydroxyproline
- oral composition
- collagen
- gelatin
- weight
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Nutrition Science (AREA)
- Pharmacology & Pharmacy (AREA)
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- General Health & Medical Sciences (AREA)
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Description
コラーゲンは繊維状や膜状の構造体を形成し、第一義的な機能としては、組織の構造維持、支持、結合、補強などを担っており、皮膚、骨、腱、靱帯、角膜、血管などに多く存在する。これらの組織の老化に伴い引き起こされる、しわやたるみ、骨粗鬆症などは、組織コラーゲンの減少、変性などが大きな要因であると考えられている。実際、長期間の日光暴露により組織コラーゲンが顕著に減少する(非特許文献2参照)、加齢に伴う生体成分の新陳代謝の低下は、コラーゲンの新陳代謝の低下が引き金となって進行する(非特許文献3参照)との報告もある。
コラーゲンの新陳代謝を高める方法としては、コラーゲン分解物によるコラーゲンの合成促進作用が知られている(特許文献1〜4参照)。
また、ヒドロキシプロリンには、培養ヒト繊維芽細胞に対するコラーゲン合成促進作用、外用によるしわ形成の抑制または改善作用が知られている(特許文献5参照)。
しかし、コラーゲン含有飲食品は、数グラムオーダーで摂取しないと体感が得られにくいと考えられている上、摂取形態によっては臭いや味の点で摂取しにくいという問題があり、コラーゲンの摂取量を抑えられる新たな方法が望まれている。
「生化学辞典 第1版」、東京化学同人、1984年、p.480 「加齢と皮膚」、清至書院、1986年、p.35 「老化のメカニズムと制御」、アイピーシー、1993年、p.151 「生化学データブックI」、日本生化学学会、1981年、p.1667
(1)コラーゲンもしくはゼラチンまたはその分解物を含有する組成物にヒドロキシプロリンまたはその塩を添加してなる経口組成物。
(2)コラーゲンもしくはゼラチンまたはその分解物を含有する組成物にヒドロキシプロリンを添加してなる経口組成物であって、該経口組成物を加水分解して得られるアミノ酸に含まれるアラニンとヒドロキシプロリンとの重量比が1:1.5〜150である経口組成物。
(3)コラーゲンもしくはゼラチンまたはその分解物、およびヒドロキシプロリンまたはその塩を含有する経口組成物であって、該経口組成物を加水分解して得られるアミノ酸に含まれるアラニンとヒドロキシプロリンとの重量比が1:1.5〜150である経口組成物。
(4)コラーゲンもしくはゼラチンまたはその分解物を含有する組成物にヒドロキシプロリンを添加することを特徴とする経口組成物の製造方法。
(5)経口組成物を加水分解して得られるアミノ酸に含まれるアラニンとヒドロキシプロリンとの重量比が1:1.5〜150となるように、ヒドロキシプロリンを添加する上記(4)の製造方法。
コラーゲンとしては、コラーゲンP、マリンジェンS−06(PF)(以上、新田ゼラチン社製)等、市販のものを用いてもよい。また、ゼラチンとしては、フィッシュゼラチン(イクオスシリーズ)、豚由来ゼラチン(APHシリーズ)(以上、新田ゼラチン社製)等、市販のものを用いてもよい。
加水分解酵素としては、中性プロテアーゼ、アルカリ性プロテアーゼ、酸性プロテアーゼ等があげられる。加水分解酵素としては、例えば「プロテアーゼp−3」(アマノエンザイム製、アルカリ性プロテアーゼ)等、市販のものを用いてもよい。
コラーゲンもしくはゼラチンまたはその分解物の分子量は、通常は400〜30万、好ましくは500〜10万であるが、500〜15000のものが好適に用いられる。
具体的なヒドロキシプロリンとしては、シス−4−ヒドロキシ−L−プロリン、シス−4−ヒドロキシ−D−プロリン、シス−3−ヒドロキシ−L−プロリン、シス−3−ヒドロキシ−D−プロリン、トランス−4−ヒドロキシ−L−プロリン、トランス−4−ヒドロキシ−D−プロリン、トランス−3−ヒドロキシ−L−プロリンおよびトランス−3−ヒドロキシ−D−プロリンがあげられるが、トランス−4−ヒドロキシ−L−プロリンが好ましい。
トランス−4−ヒドロキシ−L−プロリンは、アミコラトプシス(Amycolatopsis)属またはダクチロスポランジウム(Dactylosporangium)属より単離したプロリン4位水酸化酵素(特開平7−313179)を用いて製造することができる。また、シス−3−ヒドロキシ−L−プロリンは、ストレプトマイセス(Streptomyces)属より単離したプロリン3位水酸化酵素(特開平7−322885)を用いて製造することができる(バイオインダストリー, 14巻, 31号, 1997年)。
酸付加塩としては、塩酸塩、硫酸塩、硝酸塩、リン酸塩等の無機酸塩、酢酸塩、マレイン酸塩、フマル酸塩、リンゴ酸塩、乳酸塩、α−ケトグルタル酸塩、グルコン酸塩、カプリル酸塩、オロット酸等の有機酸塩があげられる。
アンモニウム塩としては、アンモニウム、テトラメチルアンモニウム等の塩があげられる。
有機アミン付加塩としては、モルホリン、ピペリジン等の塩があげられる。
本発明の経口組成物を加水分解してアミノ酸を遊離させた場合のアラニンとヒドロキシプロリンとの重量比は、特に限定はないが、1:1.5〜150が好ましく、1:2.5〜100がさらに好ましく、1:3.5〜60が特に好ましい。
経口組成物を加水分解して得られるアラニンとヒドロキシプロリンの重量は、例えば経口組成物を上記方法により加水分解し、減圧条件下で乾固物を得た後、例えば全自動アミノ酸の溶離液に溶解し、全自動アミノ酸分析機(日本電子社製 JLC−500/V)により測定することができる。
本発明の経口組成物は、例えば該経口組成物を加水分解してアミノ酸を遊離させた場合に、遊離したアラニンとヒドロキシプロリンとの重量比が1:1.5〜150、好ましくは1:2.5〜100、さらに好ましくは1:3.5〜60となるように、コラーゲンもしくはゼラチンまたはその分解物を含有する組成物にヒドロキシプロリンまたはその塩を添加することにより製造することができる。
本発明の経口組成物は、例えば医薬、飲食品または食品添加剤として用いることができる(以下、それぞれ本発明の医薬、飲食品または食品添加剤ともいう)。
本発明の経口組成物を製剤化する際には、賦形剤、結合剤、崩壊剤、滑沢剤、分散剤、懸濁剤、乳化剤、希釈剤、緩衝剤、抗酸化剤、細菌抑制剤等の添加剤を用いることができる。製剤の剤形としては、錠剤、散剤、顆粒剤、乳剤、シロップ剤、カプセル剤等があげられる。
本発明の飲食品は、本発明の食品添加剤を添加する以外は、一般的な飲食品の製造方法を用いることにより、加工、製造することができる。
本発明の飲食品は、コラーゲン合成促進用の健康食品、機能性食品、栄養補助食品、特定保健用食品等の飲食品として用いることができる。
なお、本発明の経口組成物は、ヒトだけでなく、ヒト以外の動物(以下、非ヒト動物と略す)に対しても使用することができる。
非ヒト動物に投与する場合の投与量は、動物の年齢、種類等に応じて異なるが、経口組成物を加水分解して遊離したヒロドキシプロリンの重量として、体重1kg1日当たり、通常2〜600mg、好ましくは2〜360mg、より好ましくは2〜180mgを投与する。1日1回または数回に分けて投与する。投与期間は、特に限定はないが、通常は1日間〜1年間、好ましくは1週間〜3か月間である。
試験例1
F344/DuCrlCrljラット(オス、8週齢、日本チャールス・リバー社より購入)を用いた。飼育は温度23℃、湿度55%の環境下で行い、飼料はCE−2(日本クレア)を用いて、飲料水とともに自由摂取させた。一群6匹とし、体重で差がないように群分けを行ない、各投与群のラットに試料液として以下の組成物または精製水を、1日1回、12日間連続で経口投与した。
試験例2
F344/DuCrlCrlj ラット(オス、7週齢、日本チャールス・リバー社より購入)を用い、試験例1と同様の投与試験を、1群4匹で行なった。
各試料液中のコラーゲンペプチドおよびL−ヒドロキシプロリンの含有量、ならびに各試験液中のL−アラニンとL−ヒドロキシプロリンとの重量比を表3に示す。
投与試験を開始して13日目に、ペントバルビタール腹腔内投与麻酔下で腹部を剃毛した後、腹部皮膚を採取し、6M塩酸で110℃、18時間処理後、試験例1と同様の方法で可溶性コラーゲンおよび不溶性コラーゲン中のL−ヒドロキシプロリン量を測定し、コラーゲン合成能の指標とした。値は平均値±標準偏差で表した。
試験例3
年齢25〜60歳の健常人11名を、試験群(6名)および対照群(5名)の2群に分け、ダブルブラインドで4週間の摂取試験を行った。被験物質は毎日夕食後にハードカプセル形態で2錠ずつ、水と共に飲用させた。被験物質の配合を表5に示す。
試験例4
実施例5で得られた飲料および比較例1で得られた飲料について、2名で官能評価を実施したところ、実施例5で得られた飲料は「飲みやすい」との結果が得られたのに対して、比較例1で得られた飲料は「コラーゲン独特の臭いがしてやや飲みにくい」との結果が得られた。
実施例2で得られる錠剤を粉砕、製粒し、篩別して20−50メッシュの顆粒剤を得る。
Claims (2)
- コラーゲンもしくはゼラチン、または分子量が400〜30万であるそれらの分解物を含有する組成物にヒドロキシプロリンまたはその塩を添加してなるコラーゲンの合成促進用または顔の乾燥改善用経口組成物であって、該経口組成物を加水分解してアミノ酸を遊離させた場合のアラニンとヒドロキシプロリンとの重量比が1:3.5〜60であり、成人に対する1日あたりの摂取量が該経口組成物を加水分解して遊離したヒドロキシプロリンの重量として0.1〜1gである経口組成物。
- コラーゲンもしくはゼラチン、または分子量が400〜30万であるそれらの分解物、およびヒドロキシプロリンまたはその塩を含有するコラーゲンの合成促進用または顔の乾燥改善用経口組成物であって、該経口組成物を加水分解して得られるアミノ酸に含まれるアラニンとヒドロキシプロリンとの重量比が1:3.5〜60であり、成人に対する1日あたりの摂取量が該経口組成物を加水分解して遊離したヒドロキシプロリンの重量として0.1〜1gである経口組成物。
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