JP2019515685A - 皮膚用組成物 - Google Patents
皮膚用組成物 Download PDFInfo
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- JP2019515685A JP2019515685A JP2019505283A JP2019505283A JP2019515685A JP 2019515685 A JP2019515685 A JP 2019515685A JP 2019505283 A JP2019505283 A JP 2019505283A JP 2019505283 A JP2019505283 A JP 2019505283A JP 2019515685 A JP2019515685 A JP 2019515685A
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Abstract
Description
従来法に従ってカプセルを調製した。
カプセル毎に含まれるもの
ω−3脂肪酸 572.00 mg
ヒアルロン酸* 6.50 mg
デルマタン硫酸* 1.34 mg
ヌクレオチド 300.00 mg
酸化亜鉛 13.88 mg
ω−6脂肪酸 75.00 mg
*ヒアルロン酸およびデルマタン硫酸を、10mgのDermial(ヒアルロン酸とデルマタン硫酸とを含む)で代用することがある。
従来法に従ってカプセルを調製した。
カプセル毎に含まれるもの
ω−3脂肪酸 572.00 mg
ヒアルロン酸* 6.50 mg
デルマタン硫酸* 1.34 mg
ヌクレオチド 300.00 mg
酸化亜鉛 13.88 mg
ω−6脂肪酸 75.00 mg
ビタミンE 18.00 mg
*ヒアルロン酸およびデルマタン硫酸を、10mgの Dermial(ヒアルロン酸とデルマタン硫酸とを含む)で代用することがある。
線維芽細胞は、ケラチン生成細胞と共に、真皮および表皮の主細胞である。その移動と増殖は再上皮化過程に関与し、皮膚バリアが変調する、また、病変自体により、または痒みのため掻きむしることで患者に損傷が表れる皮膚病変において、非常に重要である。この実験の狙いは、ω−3脂肪酸とヒアルロン酸とデルマタン硫酸とヌクレオチドを含む、本発明の組成物の、ヒト皮膚線維芽細胞の増殖に対する刺激活性を測定し、これを、ω−3脂肪酸とヒアルロン酸とデルマタン硫酸とを含む組成物と比較することであった。2つの組成物を、0.156mg/mLの同じ最終濃度で比較した。
増殖中の線維芽細胞内におけるDNA合成の際のブロモデオキシウリジン(BrdU)の取り込みを測定し、増殖の程度を定量した。
図1に示すように、本発明の組成物(O−3+HA+DS+N)は、0.156mg/mLの用量において、48時間後、ベースライン対照と比べて、線維芽細胞の増殖に対して統計的に有意な刺激作用を示した(p=0.0297)。詳細には、増殖率が40.70%増加した。しかし、0.156mg/mLの同じ用量において、ω−3脂肪酸とヒアルロン酸とデルマタン硫酸とを含むが、ヌクレオチドを含まない組成物(O−3+HA+DS)は、効果を示さなかった(線維芽細胞の増殖を刺激する傾向は見られたが、ベースライン対照と比べて、統計的に有意ではなかった)。図1は、2つの組成物の間に統計的有意差がある(p=0.0263)ことも示している。
この試験の狙いは、ω−3脂肪酸とヒアルロン酸とデルマタン硫酸とヌクレオチドとZnOとを含む、本発明の組成物の、ヒト皮膚線維芽細胞の増殖に対する刺激活性を測定し、これを、ω−3脂肪酸とヒアルロン酸とデルマタン硫酸とを含む組成物と比較することであった。2つの組成物を、0.078mg/mLの同じ最終濃度で比較した。
実施例3で使用したものと同じ手順を適用したが、この場合では、培養物を、0.078mg/mLの最終濃度に調製した被験組成物に24時間曝露した。
図2に示すように、0.078mg/mLの用量において、24時間後、本発明の組成物(O−3+HA+DS+N+ZnO)と、ω−3脂肪酸とヒアルロン酸とデルマタン硫酸とを含む(O−3+HA+DS)がヌクレオチドまたは酸化亜鉛を含まない組成物との間に、統計的有意差(p=0.0001)があった。
この試験の狙いのひとつは、創傷閉鎖に関するin vitro試験により、5成分を含む本発明の組成物の治癒活性を測定し、これを、3成分(ω−3脂肪酸とヒアルロン酸とデルマタン硫酸)しか含まない組成物と比較することであった。もうひとつの狙いは、5成分(ω−3脂肪酸とヒアルロン酸とデルマタン硫酸とヌクレオチドと酸化亜鉛)を含む本発明の組成物が、相乗効果を持つかどうかを調べることであった。
ヒト皮膚線維芽細胞(HDF)を使用し、これを、表面積1.99cm2の、24ウェルのディッシュ中、7×104細胞/ウェルの密度で培養した。滅菌したプラスチックチップを用いて、細胞の単一層の表面に約2mm幅の直線を引き、細胞のない部分を作った。その後すぐに、化合物または組成物を、次の濃度で、培養物に適用した。
・ω−3脂肪酸(O−3):0.156 mg/mL
・ヒアルロン酸(HA):0.0017 mg/mL
・デルマタン硫酸(DS):0.0004 mg/mL
・ヌクレオチド(N):0.0818 mg/mL
・酸化亜鉛(ZnO):0.0027 mg/mL
・3成分組成物:0.156mg/mLのO−3+0.0017mg/mLのHA+0.0004mg/mLのDS (O−3:HA:DSの質量比は、100:1.09:0.25)
・本発明の4成分組成物:0.156mg/mLのO−3+0.0017mg/mLのHA+0.0004mg/mLのDS+0.0818mg/mLのN (O−3:HA:DS:Nの質量比は、100:1.09:0.25:52.43)
・本発明の5成分組成物:0.156mg/mLのO−3+0.0017mg/mLのHA+0.0004mg/mLのDS+0.0818mg/mLのN+0.0027mg/mLのZnO (O−3:HA:DS:N:ZnOの質量比は、100:1.09:0.25:52.43:1.73)
図3は、本発明の組成物、O−3+HA+DS+N+ZnOに相乗効果があることを示している。ヌクレオチドとZnOと3成分組成物(O−3+HA+DS)との組み合わせは、個別の成分それぞれを合わせたものより大きな相乗的治癒効果を示した。
Claims (17)
- ヒアルロン酸と、デルマタン硫酸と、少なくとも1つのω−3脂肪酸と、少なくとも1つのヌクレオチドとを含む組成物。
- 前記ω−3脂肪酸と前記ヒアルロン酸とが、100:0.50から100:5の間の、ω−3脂肪酸:ヒアルロン酸質量比で存在することを特徴とする、請求項1に記載の組成物。
- 前記ω−3脂肪酸と前記デルマタン硫酸とが、100:0.10から100:2の間の、ω−3脂肪酸:デルマタン硫酸質量比で存在することを特徴とする、請求項1または請求項2に記載の組成物。
- 前記ω−3脂肪酸と前記ヌクレオチドとが、100:20から100:200の間の、ω−3脂肪酸:ヌクレオチド質量比で存在することを特徴とする、請求項1から請求項3のいずれか1項に記載の組成物。
- 亜鉛化合物を更に含むことを特徴とする、請求項1から請求項4のいずれか1項に記載の組成物。
- 前記亜鉛化合物が、酸化亜鉛であることを特徴とする、請求項5に記載の組成物。
- 前記ω−3脂肪酸と前記酸化亜鉛とが、100:1から100:10の間の、ω−3脂肪酸:酸化亜鉛質量比で存在することを特徴とする、請求項6に記載の組成物。
- 少なくとも1つのω−6脂肪酸を更に含むことを特徴とする、請求項1から請求項7のいずれか1項に記載の組成物。
- 前記ω−3脂肪酸が、エイコサペンタエン酸、ドコサヘキサエン酸、α−リノレン酸、ステアリドン酸、エイコサテトラエン酸、ヘンエイコサペンタエン酸、ドコサペンタエン酸、およびこれらの混合物から成る群より選ばれることを特徴とする、請求項1から請求項8のいずれか1項に記載の組成物。
- 前記ω−6脂肪酸が、γ−リノレン酸、リノール酸、およびこれらの混合物から成る群より選ばれることを特徴とする、請求項8または請求項9に記載の組成物。
- 前記ヌクレオチドが、酵母から得たものであることを特徴とする、請求項1から請求項10のいずれか1項に記載の組成物。
- 請求項1から請求項11のいずれか1項において記載された組成物と、少なくとも1つの栄養添加物とを含む、補助食品、機能性食品、または医療食。
- 請求項1から請求項11のいずれか1項において記載された組成物と、少なくとも1つの薬学的に許容される賦形剤とを含む医薬組成物。
- 薬剤または医療食として使用するための、請求項1から請求項11のいずれか1項において記載された組成物。
- 哺乳動物における、アトピー性皮膚炎、アレルギー性皮膚炎、毛包虫症、乾癬、創傷、潰瘍、および熱傷から成る群より選ばれる、皮膚疾患または損傷の治療または予防に使用するための、請求項1から請求項11のいずれか1項において記載された組成物。
- 哺乳動物における、皮膚炎もしくは毛包虫症の際もしくはその後の皮膚の健常性(integrity)の回復、乾癬病巣の予防もしくは逆転(reversing)、皮膚の潤い(hydration)と柔軟性の増進、創傷もしくは潰瘍の形成予防、または、創傷、潰瘍、もしくは熱傷の治癒品質の向上に使用するための、請求項1から請求項11のいずれか1項において記載された組成物を含む医療食。
- 哺乳動物における、皮膚炎もしくは毛包虫症の際もしくはその後の皮膚の健常性の回復、乾癬病巣の予防もしくは逆転、皮膚の潤いと柔軟性の増進、創傷もしくは潰瘍の形成予防、または、創傷、潰瘍、もしくは熱傷の治癒品質の向上のための、補助食品、機能性食品、または医療食としての、請求項1から請求項11のいずれか1項において記載された組成物の使用。
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