JP5302632B2 - 植物抽出物を含有するアトピー性皮膚炎の予防及び治療用経口組成物 - Google Patents
植物抽出物を含有するアトピー性皮膚炎の予防及び治療用経口組成物 Download PDFInfo
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- JP5302632B2 JP5302632B2 JP2008288600A JP2008288600A JP5302632B2 JP 5302632 B2 JP5302632 B2 JP 5302632B2 JP 2008288600 A JP2008288600 A JP 2008288600A JP 2008288600 A JP2008288600 A JP 2008288600A JP 5302632 B2 JP5302632 B2 JP 5302632B2
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Description
本発明から得られた4種の植物に対する抽出方法を整理すると下記のようである。
楡根皮抽出物の製法
楡根皮(Ulmus davidiana var.)、すなわち、陰乾したニレの根の皮を粉砕機で細切してその体積に対して2〜200倍、望ましくは10〜30倍の有機溶媒を加えて、10〜50℃で1〜10日間、望ましくは2〜5日間抽出して濾過したした後、減圧濃縮して乾燥する工程によって製造することができる。このとき、抽出溶媒としてはエタノール及びメタノール、ジクロロメタンなどを用いることができ、40〜90%のエタノール水溶液が望ましい。
決明子(Cassia obtusifolia)を粉砕した後、その体積に対して2〜200倍、望ましくは10〜30倍の有機溶媒を加えて、10〜30℃で1〜10日間、望ましくは2〜5日間抽出して濾過した後、減圧濃縮して乾燥する工程によって製造することができる。ここで、抽出溶媒としては、エタノール及びメタノール、ジクロロメタンなどを用いることができ、40〜90%のエタノール水溶液が望ましい。
蒲公英(Taraxacum platycarpum)を粉砕した後、その体積に対して2〜200倍、望ましくは10〜30倍の有機溶媒を加えて、10〜30℃で1〜10日間、望ましくは2〜5日間抽出して濾過した後、減圧濃縮して乾燥する工程によって製造することができる。ここで、抽出溶媒としては、エタノール及びメタノール、ジクロロメタンなどを用いることができ、40〜90%のエタノール水溶液が望ましい。
スモモ(Prunus salicina)の核を除去して4等分して50℃以下の熱風乾燥または凍結乾燥した後、その体積に対して2〜200倍、望ましくは10〜30倍の有機溶媒を加えて、10〜30℃で1〜10日間、望ましくは2〜5日間抽出して濾過した後、減圧濃縮して乾燥する工程で製造することができる。ここで、抽出溶媒としては、エタノール及びメタノール、ジクロロメタンなどを用いることができ、40〜90%のエタノール水溶液が望ましい。
β−ヘキソサミニダーゼ(β−hexosaminidase)は、ヒト肥満細胞(human mast cell line−1(HMC−1))中の顆粒内にヒスタミン(histamine)のように存在する炎症前駆物質である。抗原が、肥満細胞(mast cell)の細胞膜の表面に存在するFc受容体と結合しているIgE抗体との間に架橋結合(cross liking)を形成すると、細胞膜が活性化され、酵素反応を経て短時間に脱顆粒されてβ−ヘキソサミニダーゼとヒスタミンが分泌される。ヒスタミンは、肥満細胞内に低い濃度で存在し、その測定には多数の段階を経るため、分析偏差が大きい。そのため、比較的誤差が少なく、安定的に測定されるβ−ヘキソサミニダーゼアッセイ(β−hexosaminidase assay)を用いた。
β−ヘキソサミニダーゼ(β−hexosaminidase)の分泌量は、下記の数式(1)を用いて求めた。
その結果を図1に示す。
外部抗原に対する反応としてヒト肥満細胞(human mast cell)の脱顆粒によるβ−ヘキソサミニダーゼとヒスタミンの分泌を抑制して、皮膚疾患に有用な4種の植物抽出物、即ち、楡根皮及び決明子、蒲公英、スモモ抽出物などをそれぞれ同一の成分割合に混合して天然物製剤(AF−343)を完成した。AF−343を用いてβ−ヘキソサミニダーゼ分泌抑制能を測定した結果、各植物の抽出物を単独に用いるよりも優れた効果を示した(図2)。即ち、1μg/mlのレベルにおいても95%レベルの有意差が認められ、処理濃度が増加するほど脱顆粒抑制効果が強く現れた。
多くのアトピー性皮膚炎患者において、免疫過敏の反応として血清IgE値が増加していて、IgEの生成を増幅させるIL−6などのサイトカインを分泌することが知られている。よって、実施例3で、脱顆粒を抑制する効能が明らかになったAF−343を用いて免疫活性にかかわるサイトカインの分泌量を確認した。
アトピー性皮膚炎誘発モデルとしてよく知られている6週齢の雄のマウスNC/Ngaを用いて7日間、実験環境に適応させるため飼育した後、4週間の実験を行った。無処理群とアトピー性皮膚炎の誘発物質処理群、及びアトピー性皮膚炎誘発物質処理群にAF−343を1.667mg/kg/day(体重60kgである場合1日0.1g)、16.67mg/kg/day,166.7mg/kg/day経口投与した実験群に区分して実験した。
図12は、4週間試験飼育したNC/Ngaマウスの血清を採取してアトピー性皮膚炎の誘発にかかわるIgEの濃度を測定した結果である。即ち、アトピー性皮膚炎誘発物質のみを処理したPC群に比べて、アトピー性皮膚炎誘発物質で処理しAF−343を1.667mg/kg/dayずつ経口投与した場合、95%の有意差レベルでIgEの低下効果が示され、16.67mg/kg/day以上では、アトピー性皮膚炎誘発物質を処理しない正常群のIgEの濃度とは差があるものの、99%のレベルでPC群に比べて有意差のあるIgEの分泌を抑制することが示された。
アトピー性皮膚炎の一般人30名を対象として、4週間、AF−343を500mg/day投与した後、その治療効果を確認した質問の結果である(図13)。質問の番号は下記の内容で、7点尺度法を用いて、最も深刻な場合7点、全然そうでない場合1点にして評価した。
2.花粉の飛ぶ季節には他の季節に比べて痒いかあるいは赤くなる程度がどれくらいですか。
3.腕の内側や首しわなど折られる部分に汗が出ると、痒いかあるいは赤くなる程度はどれくらいですか。
4.皮膚が乾燥しており、特に皮膚が更に乾燥した場合、痒いですか。
5.平素に患部の痒みの程度はどれくらいですか。
6.皮膚を掻いた後、痒いかあるいは赤く腫れる程度がどれくらいですか。
7.皮膚を掻いた後、掻いた部位に炎症が生じる程度どれくらいですか。
8.皮膚を掻いた後、掻いた部位に角質が生じる程度どれくらいですか。
9.寝ているとき、患部を掻いて血が出るか、あるいは痒みで目が覚めたことがありますか。
10.ほこりの多い日に外出した後、患部の痒みや炎症が更にひどくなりますか。
楡根皮及び決明子、蒲公英、スモモ抽出物 2g
乳糖 1g
前記の成分を混合し、包装用袋に充填して散剤を製造する。
楡根皮及び決明子、蒲公英、スモモ抽出物 100mg
乳糖 100mg
トウモロコシでんぷん 100mg
ステアリン酸マグネシウム 2mg
前記の成分を混合した後、通常の錠剤の製造方法によって打錠して錠剤を製造する。
楡根皮及び決明子、蒲公英、スモモ抽出物 100mg
乳糖 100mg
トウモロコシでんぷん 100mg
ステアリン酸マグネシウム 2mg
前記の成分を混合した後、通常のカプセルの剤製造方法によってゼラチンカプセルに充填してカプセル剤を製造する。
玄米40%、麦30%、はと麦20%、アルファ米粉10%を焙煎した後、粉砕機で粒度60メッシュの穀類粉末を作る。
黒豆40%、黒ゴマ30%、エゴマ30%を焙煎した後、粉砕機で粒度60メッシュの種実類粉末を作る。
前記製造した穀類75%、種実類20%、及び楡根皮及び決明子、蒲公英、スモモ抽出物の乾燥粉末5%を配合した後、顆粒化して禅食を製造する。
ガムベース20%、砂糖76%、香料1.5%、及び水2%と本発明の楡根皮及び決明子、蒲公英、スモモ抽出物0.5%を配合して通常の方法でチューインガムを製造する。
砂糖60%、水あめ39%、及び香料0.5%と本発明の楡根皮及び決明子、蒲公英、スモモ抽出物0.5%を配合して通常の方法でキャンディを製造する。
薄力粉25%、中力粉23%、精白糖6%、食塩1%、パームショートニング13%、ミルクフレーバ0.1%、脱脂粉乳3%、全粉乳7%、及び水16.9%と本発明の楡根皮及び決明子、蒲公英、スモモ抽出物5%を配合して通常の方法でビスケットを製造する。
蜂蜜5重量%、果糖3%、塩酸リボフラビンナトリウム0.0001%、塩酸ピリドキシン0.0001%、及び水86.9998%と本発明の楡根皮及び決明子、蒲公英、スモモ抽出物5%を配合して通常の方法で健康飲料を製造する。
オクタコサノール粉末15%、乳糖加水分解粉末15%、分離大豆たんぱく粉末15%、キトオリゴ糖15%、酵母抽出物粉末10%、ビタミンミネラル混合製材10%、ステアリン酸マグネシウム4.6%、二酸化チタニウム0.2%、及びグリセリン脂肪酸エステル0.2%と本発明の楡根皮及び決明子、蒲公英、スモモ抽出物20%を配合して通常の方法で錠剤型健康機能食品を製造する。
Claims (6)
- 楡根皮、決明子、蒲公英、及びスモモ抽出物をそれぞれ同一の成分割合で含み、
1日の摂取量が500mg以上であることを特徴とするアトピー性皮膚炎の予防及び治療用経口組成物。 - 散剤、錠剤またはカプセル剤とする請求項1に記載のアトピー性皮膚炎の予防及び治療用経口組成物。
- 前記各抽出物は、抽出液を乾燥させた粉末状態であることを特徴とする請求項1又は請求項2に記載のアトピー性皮膚炎の予防及び治療用経口組成物。
- 楡根皮、決明子、蒲公英、及びスモモにそれぞれ10〜30倍の有機溶媒を加え、
前記有機溶媒が加えられたそれぞれの楡根皮、決明子、蒲公英、及びスモモを10℃〜30℃で2〜5日間抽出して濾過し、
前記濾過後の結果物を減圧して濃縮し、
前記減圧濃縮の結果物を乾燥し、それぞれ同一の成分割合で混合する、ことを含むアトピー性皮膚炎の予防及び治療用経口組成物の製造方法。 - 前記有機溶媒は、40〜90%のエタノール水溶液であることを特徴とする請求項4に記載のアトピー性皮膚炎の予防及び経口治療用組成物の製造方法。
- 賦形剤を添加して凍結乾燥する、または、噴霧乾燥して、前記減圧濃縮の結果物を乾燥する請求項3または4に記載のアトピー性皮膚炎の予防及び治療用経口組成物の製造方法。
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