JP2012507505A - 医薬として使用するための脂肪酸 - Google Patents
医薬として使用するための脂肪酸 Download PDFInfo
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- JP2012507505A JP2012507505A JP2011533936A JP2011533936A JP2012507505A JP 2012507505 A JP2012507505 A JP 2012507505A JP 2011533936 A JP2011533936 A JP 2011533936A JP 2011533936 A JP2011533936 A JP 2011533936A JP 2012507505 A JP2012507505 A JP 2012507505A
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- Prior art keywords
- acid
- fatty acids
- oil
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- fatty acid
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Abstract
【選択図】なし
Description
から選択される動物源から誘導される海産動物油が挙げられる。上記のものなどの油は、加水分解によって直ちに遊離脂肪酸へと変換される。
魚油からの脂肪酸混合物の調製:脂肪酸混合物を、水性媒体中での加水分解後の魚油(魚肝油など、例えばタラ肝油)から抽出する。水酸化ナトリウム(130グラム)を1.0リットルのエタノールおよび1.5リットルの精製水の混合物の中に溶解する。次いで1000グラムのタラ肝油を加え、この混合物を還流下、85℃で8時間加熱する。5℃まで冷却した後、800mLの6M塩酸を加え、油相を水溶液から分離する。次いでこの油を50℃の800mlの精製水で4回洗浄し、最後に真空下で、室温で乾燥する。この抽出物およびこの抽出物を調製するために使用したタラ肝油の脂肪酸組成をガスクロマトグラフィによって決定する。この抽出物の相対的脂肪酸組成は、未加水分解の油の組成とほぼ同じである(表4)。
座薬を融合方法により調製した。白ろう(Apifil Gattefosse、フランス;50グラム)、ジベヘン酸グリセロール(Compritol 888、Gattefosse;19グラム)および硬質脂肪(Suppocire NA 0、Gattefosse;530グラム)を融解させ、約75℃で混合し、50℃まで冷却した。次いでトコフェロール抗酸化物質混合物(Coviox T70、Cognis、ドイツ;1グラム)、タラ肝油(100グラム)および上記脂肪酸抽出物(300グラム)を加え、十分に混合し45℃に冷却した後、この混合物を座薬金型(2.2ml)の中へと注ぎ込み、室温で冷却した。10%および20%脂肪酸抽出物を含有する座薬、ならびにタラ肝油(100グラム)または脂肪酸抽出物(300グラム)のいずれかを含有する座薬(この場合、さらなる量のSuppocire NA 0で他の成分を置き換えた)を、同じ方法によって調製した。
軟膏剤を融合方法により調製した。蜜ろう(Apifil、Gattefosse;49グラム)、ジステアリン酸グリセリル(Precirol ATO、Gattefosse;20グラム)およびワセリン(白色の軟パラフィン 欧州薬局方(Ph.Eur);330グラム)を、65〜75℃の水浴の上で一緒に融解させた。50℃へ冷却後、タラ肝油(300グラム)、脂肪酸抽出物(300グラム)およびトコフェロール抗酸化物質混合物(Coviox T70、Cognis;1グラム)をこの基剤に加えた。次いで、室温まで冷却後、この軟膏剤を30mlのアルミニウムチューブに充填した。
二重盲検試験を30人の健常な志願者に対して行った。1日目に、参加者は肛門検査を受け、当該活性成分(30% オメガ富化された脂肪酸混合物を含有する座薬および軟膏剤、表2および実施例2および実施例3を参照)を投与される研究グループ、ならびに2週間の全研究期間の間、プラセボ(魚肝油および当該脂肪酸混合物を含まない同一の座薬および軟膏剤)を投与される対照群に無作為化された。研究グループは3人の男性および12人の女性からなり、平均年齢は46歳であった。対照群は、6人の男性および9人の女性からなり、平均年齢は43歳であった。参加者は、1日2回直腸に上記座薬を投与され、かつ肛門周囲領域に上記軟膏剤を塗布され、第1週後に肛門検査とともに臨床検査を受け、その際に紅斑、炎症、出血またはヒリヒリした感じのいずれかの徴候を記録した。第2週の後、志願者は最終検査を受けた。また参加者は、1週間および2週間後、管理検査の間の自分の便通に対する当該座薬の効果についての質問表に答えた。
5人の健常な志願者がこの研究に参加した。1日目に、この志願者らは、10% オメガ富化された魚肝油および30% オメガ富化された脂肪酸混合物を含有する1つの座薬(表2および実施例2を参照)を直腸に投与され、7日目に、志願者らは、魚肝油(40%)のみを含有するが遊離脂肪酸を含有しない同一の座薬を投与された。上記魚肝油および上記脂肪酸混合物を含有する座薬は、便通を促進し、すべての参加者で排便を引き起こしたが、他方で魚肝油のみを含有する座薬は排便を引き起こさなかった。
10グラムのγ−シクロデキストリン、3グラムのカルボキシメチルセルロースナトリウム(分子量90,000Da)および0.02グラムの塩化ベンザルコニウムをガラスのビーカーの中で秤量することにより、遊離脂肪酸を含有する乾燥粉末を調製し、純水を90mlまで加えた。次いで9グラムのタラ肝油および1グラムの遊離脂肪酸混合物(実施例1)を、この溶液に加えた。十分に混合した後、生成したエマルションを凍結乾燥し、乾燥した錯体粉末を形成した。次いで98.5グラムのこの錯体粉末を0.5グラムの二酸化ケイ素および1グラムのステアリン酸マグネシウムと混合し、錠剤(直径15mm、重量0.75グラム)を直接圧縮によって調製した。
γ−シクロデキストリン(ガンマ−シクロデキストリン;15グラム)を85mlの水に溶解し、15グラムの脂肪酸混合物(実施例1)をこの溶液(pH 7.4)に加えた。十分に混合した後、生成したエマルションを凍結乾燥し、乾燥した錯体粉末を形成した。
96穴細胞培養プレート(Nunc、デンマーク)の中のCV−1細胞(アフリカミドリザルの腎臓細胞株)の単分子層を使用して、ウイルス感染価を決定した。細胞培養培地は、10% ウシ胎仔血清(FBS)を加えたイーグル最小必須培地(MEM)であり、維持培地(MM)は2% FBSを加えたMEMであった。タラ肝油由来の脂肪酸抽出物、脂肪酸抽出物(実施例1)または脂肪酸抽出物/γ−シクロデキストリン錯体(実施例7)を、1分間ボルテックスにかけることにより、所望の濃度(0.5%および1.0%)までMMの中に溶解した。MMの中での抽出物の希釈物を単純ヘルペスウイルス1型(HSV−1)の原液と4:1の比で混合し、室温で10分間インキュベーションした。次いでこの混合物の中でのウイルス感染力を、CV−1単分子層を含むウェルの中への、MMの中での10倍希釈物の接種によって直ちに滴定した。1ウェルあたり100μL、および1つの希釈物あたり4つのウェルで行った。この細胞培養プレートを、5% CO2空気中で、37℃で5日間インキュベーションした。次いでウイルス感染価を読み取り、100μLあたりのlog10 CCID50(50%細胞培養感染量)として表した。脂肪酸抽出物との混合物における力価を、HSV−1がMMの中で4:1に希釈された対照混合物の力価から差し引いた。その差、すなわち力価の減少、を抗ウイルス活性の尺度として使用した(表5を参照)。
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Claims (34)
- 排便を誘発するために、直腸および/または大腸に投与するための医薬品剤形であって、前記剤形は活性成分として1以上の脂肪酸を含む、医薬品剤形。
- 前記1以上の脂肪酸は、遊離脂肪酸、脂肪酸エチルエステルおよび脂肪酸モノグリセリドから選択される形態にある、請求項1に記載の医薬品剤形。
- 前記1以上の脂肪酸はC4〜C36の範囲の炭素鎖長を有する1以上の飽和または不飽和の脂肪酸を含む、請求項1に記載の医薬品剤形。
- 前記1以上の脂肪酸は、少なくとも約20重量%の不飽和脂肪酸および少なくとも約5重量%の多価不飽和脂肪酸を含む脂肪酸の混合物を含む、請求項1に記載の医薬品剤形。
- 前記脂肪酸の混合物は、サフラワー油、トウモロコシ油、アーモンド油、ゴマ油、大豆油、アマニ油、菜種油、ブドウ種子油、ヒマワリ油、小麦胚芽油、大麻油、およびいずれかのこれらの混合物からなる群から選択される植物油から誘導される脂肪酸を含む、請求項4に記載の医薬品剤形。
- 前記脂肪酸の混合物は海洋生物由来の脂肪酸を含む、請求項4に記載の医薬品剤形。
- 前記脂肪酸の混合物は、タラ肝油、マグロ油を含めた魚肝油;ニシン、カラフトシシャモ、サバ、メンハーデン、イワシ、カタクチイワシ、アジ、アオギス、およびマグロ由来の肉または粉末を含めた魚肉または魚粉;プランクトン生物、イカおよび軟体動物、ならびにいずれかのこれらの混合物から選択される動物源から誘導される海産動物油からなる群から選択される海洋生物物質から誘導される、請求項6に記載の医薬品剤形。
- 座薬、軟膏剤、クリーム、ローション剤、ペースト、ゲル、および浣腸投与用製剤から選択される形態にある、請求項1に記載の医薬品剤形。
- 50〜2000mgの範囲、好ましくは100〜750mgの範囲の脂肪酸を含む、請求項8に記載の医薬品剤形。
- 座薬の形態にあり、約5重量%〜75重量%の範囲の脂肪酸、好ましくは約5重量%〜50重量%の範囲の脂肪酸を含む、請求項8に記載の医薬品剤形。
- 10〜50重量%の範囲の脂肪酸を含み、かつ5〜25重量%の範囲のトリアシルグリセリド油をさらに含む、請求項1に記載の医薬品剤形。
- シクロデキストリンをさらに含む、請求項1に記載の医薬品剤形。
- 排便のプロセスを促進および/または惹起する方法であって、直腸粘膜にある多モード侵害受容器を刺激するために、前記直腸および/または腸管に、1以上の脂肪酸を投与することを含む、方法。
- 前記1以上の脂肪酸脂肪酸は、遊離脂肪酸、脂肪酸エチルエステルおよび脂肪酸モノグリセリドから選択される形態にある、請求項13に記載の方法。
- 50〜2000mgの範囲の脂肪酸を投与することを含む、請求項13に記載の方法。
- 前記1以上の脂肪酸は、座薬、軟膏剤および浣腸投与用製剤から選択される形態で投与される、請求項13に記載の方法。
- 前記1以上の脂肪酸は、タラ肝油、マグロ油を含めた魚肝油;ニシン、カラフトシシャモ、サバ、メンハーデン、イワシ、カタクチイワシ、アジ、アオギス、およびマグロ由来の肉または粉末を含めた魚肉または魚粉;プランクトン生物、イカおよび軟体動物から選択される動物源から誘導される海産動物油からなる群から選択される海洋生物物質から誘導される、請求項13に記載の方法。
- 前記1以上の脂肪酸は、5〜25重量%の範囲のトリアシルグリセリド油をさらに含む座薬の中で調合される、請求項16に記載の方法。
- 排便のプロセスを誘発するための医薬として使用するための脂肪酸。
- 遊離脂肪酸、脂肪酸エチルエステルおよび脂肪酸モノグリセリドから選択される形態にある、請求項19に記載の脂肪酸。
- C4〜C36の範囲、好ましくは8〜24の範囲の鎖長を有する飽和または不飽和の脂肪酸である、請求項19に記載の脂肪酸。
- ヘキサン酸、ヘプタン酸、オクタン酸、ノナン酸、カプリン酸、ウンデシレン酸、ラウリン酸、トリデシル酸、ミリスチン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、cis−バクセン酸、オレイン酸、エライジン酸、ガドレイン酸、ゴンド酸、セトレイン酸、リノール酸、α−リノール酸、γ−リノール酸、リノレン酸、アラキドン酸、ステアリドン酸、モロクチン酸、ゴンド酸、エルカ酸、エイコサジエン酸、エイコサトリエン酸、エイコサテトラエン酸、エイコサペンタエン酸、セトレイン酸、ドコサペンタエン酸、ドコサヘキサエン酸およびいずれかのこれらの混合物からなる群から選択される、請求項19に記載の脂肪酸。
- 20重量%超の不飽和脂肪酸および5重量%超の多価不飽和脂肪酸を含む脂肪酸の混合物の形態にある、請求項19に記載の脂肪酸。
- 直腸および/または腸管下部への投与のための医薬として使用するための、請求項19に記載の脂肪酸。
- 前記医薬は、座薬、軟膏剤および浣腸投与用製剤から選択される形態にある、請求項24に記載の脂肪酸。
- 便通を促進および/または惹起するための、痔、細菌感染症、単純ヘルペスウイルス感染を含めたウイルス感染症、および炎症の処置のための、ならびに裂肛および肛門周囲掻痒症に対する処置のための、活性成分として約5〜75重量%の範囲の1以上の脂肪酸を含む、座薬、軟膏剤、クリーム、ローション剤、ペースト、および浣腸投与用製剤からなる群から選択される形態にある医薬品剤形。
- 遊離脂肪酸への魚油グリセリドの加水分解によって魚油から誘導される脂肪酸混合物を含む、請求項26に記載の医薬品剤形。
- 前記1以上の脂肪酸は遊離脂肪酸の形態にある、請求項26に記載の医薬品剤形。
- 5〜25重量%の範囲のトリアシルグリセリド油をさらに含む、請求項28に記載の医薬品剤形。
- 約5〜75重量%の範囲の1以上の脂肪酸を活性成分として含む医薬品剤形であって、前記脂肪酸はシクロデキストリンとの錯体として調合されている、医薬品剤形。
- 前記脂肪酸は遊離脂肪酸の形態にある、請求項30に記載の医薬品剤形。
- 前記シクロデキストリンは、α−シクロデキストリン、β−シクロデキストリン、およびγ−シクロデキストリンからなる群から選択される、請求項30に記載の医薬品剤形。
- 前記脂肪酸およびシクロデキストリンは粉末形態で与えられる、請求項30に記載の医薬品剤形。
- 錠剤およびカプセル剤からなる群から選択される形態にある、請求項30に記載の医薬品剤形。
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Also Published As
Publication number | Publication date |
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PT2349250T (pt) | 2017-07-25 |
AU2009309237B2 (en) | 2016-02-25 |
EP2349250A1 (en) | 2011-08-03 |
PL2349250T3 (pl) | 2017-09-29 |
EP2349250A4 (en) | 2012-05-23 |
CA2742227A1 (en) | 2010-05-06 |
EP2349250B1 (en) | 2017-04-19 |
US20130137771A1 (en) | 2013-05-30 |
WO2010049954A1 (en) | 2010-05-06 |
CN102245176B (zh) | 2015-05-27 |
AU2009309237A1 (en) | 2011-06-23 |
US20100113387A1 (en) | 2010-05-06 |
NZ593186A (en) | 2013-02-22 |
ES2633726T3 (es) | 2017-09-25 |
ZA201104036B (en) | 2012-03-28 |
US8372425B2 (en) | 2013-02-12 |
CN102245176A (zh) | 2011-11-16 |
JP6113954B2 (ja) | 2017-04-12 |
DK2349250T3 (en) | 2017-07-03 |
US9072714B2 (en) | 2015-07-07 |
CA2742227C (en) | 2017-01-24 |
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