JP2023529202A - ペンタペプチドを有効成分として含むアレルギー性疾患又はかゆみの予防、改善又は治療用組成物 - Google Patents
ペンタペプチドを有効成分として含むアレルギー性疾患又はかゆみの予防、改善又は治療用組成物 Download PDFInfo
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Abstract
Description
新規のペンタペプチドの合成及び物性の確認
1-1.ペンタペプチドの合成
配列番号1で記載されるアミノ酸配列から構成される新規のペプチド配列「KFLIK」は、公知の方法を用いて製造した。分子量測定器を用いて前記配列番号1のアミノ酸配列を含むペプチドの分子量を測定した結果、その分子量が647.4Daに該当することを確認した。
配列番号1のアミノ酸配列から構成された本発明のペプチドを1000ppmの濃度で滅菌蒸溜水に溶かし、45℃で7日、14日、28日、60日、75日間保管した後、HPLC分析を行った。
本発明のペプチドを1000ppmの濃度で滅菌蒸溜水に溶かし、121℃で15分、30分間加温した後、HPLC分析を行った。
肥満細胞におけるペンタペプチド処理による脱顆粒抑制の効果
本発明のペンタペプチドによるアレルギー性炎症反応抑制の効果及びアトピー皮膚炎改善の効果を確認するため、肥満細胞(rat basophilic leukemia cell line、RBL-2H3)を用いて脱顆粒(degranulation)の程度を確認した。
% release=(experimental β-hexosaminidase release-spontaneous β-hexosaminidase release)/total cellular β-hexosaminidase × 100
肥満細胞におけるペンタペプチド処理による炎症関連サイトカインの発現抑制の効果
本発明のペンタペプチドによるアレルギー性炎症反応抑制の効果及びアトピー皮膚炎改善の効果を確認するため、肥満細胞(rat basophilic leukemia cell line,RBL-2H3)を用いて炎症関連サイトカインの発現の様相を確認した。
脾臓細胞におけるペンタペプチド処理による炎症関連サイトカインの発現抑制の効果
本発明のペンタペプチドによるアレルギー性炎症反応抑制の効果及びアトピー皮膚炎改善の効果を確認するため、マウスの脾臓細胞を用いて炎症関連サイトカインの発現の様相を確認した。
臨床試験を介したアトピー皮膚炎改善の効果
アトピー皮膚炎患者21名を対象として、乾燥症によるかゆみの緩和に対する人体効能評価を実施した。乾燥症病変部位を試験部位とし、製品の使用前、製品使用2週後、製品使用4週後の患部に対して機器測定を進めた。
ペンタペプチドによるアトピー皮膚症状改善の効果を確認するため、実施例1で合成した本発明のペンタペプチドが2000ppm含まれるようにセラムとクリームを製造した。
[図5a]に示したように、本発明のペンタペプチド含有セラム及びクリームを用いる場合、統計的に有意な病変部位の皮膚水分改善の効能を示すものと確認された(使用2週、4週;P<0.05)。
[図5b]に示したように、本発明のペンタペプチドを含有したセラムとクリームを用いた場合、統計的に有意な病変部位の経皮水分損失改善の効能を示した[経皮水分損失変化率(%)=(after-before)/before*100]。
[図5c]に示したように、かゆみ改善の効果においても、本発明のペンタペプチドを含有したセラムとクリームを用いた場合、塗布前に比べて2週、4週後、統計的に有意にかゆみ指数が改善されるものと確認された。
Claims (13)
- 配列番号1のアミノ酸配列から構成されるペンタペプチドを有効成分として含む、アレルギー性疾患の予防又は治療用薬学的組成物。
- 前記アレルギー性疾患は、浮腫、過敏症(anaphylaxis)、アレルギー性鼻炎(allergic rhinitis)、喘息(asthma)、アレルギー性結膜炎(allergic conjunctivitis)、アレルギー性皮膚炎(allergic dermatitis)、接触性皮膚炎、蕁麻疹、掻痒症、昆虫アレルギー、食品アレルギー及び薬品アレルギーよりなる群から選択される1つ以上を含むものである、請求項1に記載の薬学的組成物。
- 前記アレルギー性皮膚炎は、アトピー皮膚炎である、請求項2に記載の薬学的組成物。
- 前記ペンタペプチドは、i)IL-4、IL-13、TNF-α、IL-1β、IL-6又はIL-8の発現を抑制し、ii)β-ヘキソサミニダーゼの放出を抑制するものである、請求項1に記載の薬学的組成物。
- 前記薬学的組成物は、薬剤学的に許容される担体、賦形剤又は希釈剤をさらに含むものである、請求項1に記載の薬学的組成物。
- 前記薬学的組成物は、経口用製剤、注射用製剤又は外用剤の形態に剤形化されるものである、請求項1に記載の薬学的組成物。
- 前記外用剤は、クリーム、ゲル、軟膏、乳化液、懸濁液、噴霧剤及び経皮伝達性パッチ剤よりなる群から選択されるいずれか1つ以上のものである、請求項5に記載の薬学的組成物。
- 配列番号1のアミノ酸配列から構成されるペンタペプチドを有効成分として含む、アレルギー性疾患の予防又は改善用化粧料組成物。
- 前記アレルギー性疾患は、アレルギー性皮膚炎、接触性皮膚炎、蕁麻疹、掻痒症、乾癬及び湿疹よりなる群から選択される1つ以上を含むものである、請求項8に記載の化粧料組成物。
- 前記アレルギー性皮膚炎は、アトピー皮膚炎である、請求項8に記載の化粧料組成物。
- 前記化粧料組成物は、化粧品学的に許容される担体、賦形剤又は希釈剤をさらに含むものである、請求項8に記載の化粧料組成物。
- 前記化粧料組成物は、スキン、ローション、クリーム、エッセンス、乳液、ゲル、ハンドクリーム、リップスティック、クレンジングフォーム、クレンジングクリーム、クレンジングウォーター、噴霧剤、シャンプー、リンス、トリートメント、ボディクレンザー、石鹸、パック、マッサージ剤、フェイスパウダー、コンパクト、ファンデーション、ツーウェイケーキ、及びメーキャップベースよりなる群から選択されるいずれか1つ以上の剤形に製造されるものである、請求項8に記載の化粧料組成物。
- 配列番号1のアミノ酸配列から構成されるペンタペプチドを有効成分として含む、かゆみ(itching)の予防又は改善用組成物。
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KR10-2020-0071658 | 2020-06-12 | ||
PCT/KR2021/007322 WO2021251788A1 (ko) | 2020-06-12 | 2021-06-11 | 펜타펩타이드를 유효성분으로 포함하는 알러지성 질환 또는 가려움증의 예방, 개선 또는 치료용 조성물 |
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DESIREE LUDWIG: "Measurement of mast cell and basophil activation in vitro as means for investigation of drug hyperse", THESIS OF THE DEGREE OF MASTER OF PHILOSOPHY, UNIVERSITY OF SOUTHAMPTON FACULTYOF MEDICINE, JPN6023051933, 2015, ISSN: 0005222505 * |
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EP4166156A4 (en) | 2023-05-17 |
CN115697370A (zh) | 2023-02-03 |
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