JP2020504144A - 胃炎または消化性潰瘍予防または治療用組成物 - Google Patents
胃炎または消化性潰瘍予防または治療用組成物 Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract
Description
a)肉桂を非極性溶媒に浸漬して前処理する段階;
b)前記段階a)から非極性溶媒を除去する段階;および
c)前記段階b)から得られた肉桂を極性溶媒で抽出する段階。
本発明による肉桂前処理抽出物を以下の通り製造した。具体的に、肉桂生薬にエチルアセテート2倍数を加えて室温で1時間以上浸漬攪拌した。エチルアセテート除去し水で肉桂生薬を洗浄した後、水8倍数加えて約90℃付近で5時間抽出する(2回反復)。抽出物をろ過、減圧濃縮、真空乾燥または噴霧乾燥して肉桂エチルアセテート前処理水抽出物を製造した(抽出物収得:15〜20→1)。
本発明による肉桂前処理抽出物との比較のために、以下の通り肉桂溶媒抽出物と肉桂ブタノール前処理抽出物、および市販製剤としてラニチジン、レバミピドおよび艾葉抽出物を準備した。
1)肉桂エタノール抽出物
肉桂生薬にエタノール8倍を加えて約90℃付近で5時間抽出した(2回反復)。抽出物をろ過、減圧濃縮、真空乾燥または噴霧乾燥して肉桂エタノール抽出物として使用した(抽出物収得:25→1)。
2)肉桂水抽出物
前記肉桂エタノール抽出物と同様な方法で抽出物を製造し、抽出溶媒のみを水に変えて製造した(抽出物収得:11〜13→1)。
3)肉桂ブタノール前処理水抽出物
前記実施例1と同様な方法で抽出物を製造し、前処理溶媒のみをブタノールに変えて製造した。
ラニチジン、レバミピドおよび艾葉抽出物は市販される製剤の主成分のみ使用した。
前記実施例1および比較例1〜6の胃潰瘍抑制率を確認するために以下のような方法によって試験した。
試験動物は特定病原体部材(SPF)ラット雄7週齢を順応期間(7日)を経て平均体重ができるだけ均一に分布するように無作為法で群当り10匹ずつ分配した。投与経路は前記実施例1および比較例1〜6の物質をそれぞれ経口投与で単回投与し、投与液量は投与当日測定した体重を基準にして10mL/Kgに算出して投与した。試験物質および対照薬物投与48時間前から全ての動物を絶食した後、それぞれの試験物質および対照薬物を経口投与し、投与30分ごとに予め調剤しておいたインドメタシン(Indomethacin)を80mg/kgの容量で経口投与した。インドメタシン(Indomethacin)投与5時間目にジエチルエーテル(diethyl ether)で麻酔した後、胃を摘出して胃粘膜面をデジタルカメラで撮影した。損傷された部位の面積はImageJソフトウェア(NIH、Bethesda、MD)を用いて分析した。胃潰瘍指数は下記のような数式1によって測定した。その結果は下記表2、図1および2に示した。
胃潰瘍指数(%)=(損傷面積/全体面積)×100
前記実施例1および比較例1〜6の胃粘液量改善効果を確認するために次のような方法によって試験した。
試験動物は特定病原体不在(SPF)ラット雄7週齢を順応期間(7日)を経て平均体重ができるだけ均一に分布するように無作為法で群当り10匹ずつ分配した。試験物質および対照薬物は投与48時間前から全ての動物を絶食した後に経口投与し、投与30分後インドメタシン(Indomethacin)80mg/kgを経口投与した。インドメタシン(Indomethacin)投与7時間後、ジエチルエーテル(diethyl ether)で麻酔して後大静脈から採血した後、胃を摘出し、大彎部に沿って切開し裏返して腺胃部粘膜面を外部に露出させて冷たい0.25Mスクロース(sucrose)溶液で腺胃部を洗浄した。0.1%w/vアルシアンブルー(alcian blue)8GX溶液15mLに2時間浸した後、0.25Mスクロース(sucrose)溶液15mLで二回洗浄して(各15分ずつ)過量の染色剤を除去した。胃粘液と結合された試薬を抽出するために胃組織を0.5MのMgCl2溶液15mLに2時間浸して30分間隔で1分ずつ間欠的に振とう(shaking)を行った。抽出液を同量のジエチルエーテル(diethyl ether)と混合して振とう(shaking)した後、3,500rpmで10分間遠心分離して上澄液に対して605nmで吸光度を測定した。0.1%w/vアルシアンブルー(alcian blue)8GX溶液を0.25Mスクロース(sucrose)溶液で希釈して標準溶液を作って標準曲線を製作し、測定された吸光度値を胃粘膜と結合されたアルシアンブルー(alcian blue)の量に換算してその結果を表3に示した。
血清内PGE2が増加する場合、胃粘膜血流と上皮細胞の修復機序が維持され、胃粘膜の細胞が保存される作用を示すので、PGE2の向上した改善は胃炎または胃潰瘍治療に影響を与える。このようなPGE2の改善において、本発明による前記実施例1および比較例2、5〜6の効果を確認するために試験例2から採血した血液をPGE2 ELISA Kitの生産者が提供するプロトコル(protocol)によって血清分離後、サンプリング(sampling)処理を実施した後に分析し、その結果を下記表4に示した。
前記実施例1に対する容量別胃潰瘍試験を実験例1と同様な方法によって試験して表5に示した。
また、比較例2(既存(または通常)の肉桂水抽出物)は150mg/kgで誘導群に比して69.6%の抑制率を示したことは、本発明の実施例1の7mg/kgの容量と類似した効果を示すことであるので、約21倍容量を減らしても同一な効力を示すことが分かる。
本発明による肉桂前処理抽出物の成分および含量を分析するために実施例1の肉桂抽出物を桂皮酸、桂皮アルデヒド、2−メトキシ桂皮アルデヒド標準品を用いて下記のような条件下でHPLC含量分析を実施した。
1)カラム:Kromasil 100−5 C18(4.6mm×150mm、5.0μm)またはこれと同等なカラム
2)検出器:紫外部吸光光度計(測定波長:280nm)
3)流量:約0.7mL/分
4)注入量:10μL
5)移動相:アセトニトリル(0.2%トリフルオロ酢酸)/精製水
その結果を表6に示した。
Claims (19)
- 肉桂の非極性溶媒前処理および極性溶媒抽出物を含む胃炎または消化性潰瘍予防または治療用薬学的組成物。
- 前記消化性潰瘍は、胃潰瘍または十二指腸潰瘍である、請求項1に記載の薬学的組成物。
- 前記非極性溶媒は、エチルアセテートである、請求項1に記載の薬学的組成物。
- 前記極性溶媒は、水である、請求項1に記載の薬学的組成物。
- 前記薬学的組成物は、前記肉桂前処理抽出物の1日投与量が9.7〜2,919mgになるように前記抽出物を含むことを特徴とする、一回または数回分割投与用の、請求項1に記載の薬学的組成物。
- 前記肉桂前処理抽出物の収得量は、15〜20→1(原生薬15〜20Kgを投入時、最終抽出乾燥エキスは1Kg得られることを意味する)である、請求項1に記載の薬学的組成物。
- 肉桂の非極性溶媒前処理および極性溶媒抽出物を含む胃炎または消化性潰瘍予防または改善用食品組成物。
- 前記消化性潰瘍は、胃潰瘍または十二指腸潰瘍である、請求項7に記載の食品組成物。
- 前記非極性溶媒は、エチルアセテートである、請求項7に記載の食品組成物。
- 前記極性溶媒は、水である、請求項7に記載の食品組成物。
- 前記肉桂前処理抽出物は、前記肉桂前処理抽出物の1日投与量が9.7〜2,919mgになるように前記抽出物を含むことを特徴とする、一回または数回分割投与用である、請求項7に記載の食品組成物。
- 前記組成物は、健康機能食品、健康補助食品または機能性食品である、請求項1に記載の食品組成物。
- a)肉桂を非極性溶媒に浸漬して前処理する段階;
b)前記段階a)から非極性溶媒を除去する段階;および
c)前記段階b)から得られた肉桂を極性溶媒で抽出する段階
を含む、肉桂非極性溶媒前処理および極性溶媒抽出物の製造方法。 - 前記段階a)の非極性溶媒は、エチルアセテートである、請求項13に記載の製造方法。
- 前記段階a)は、肉桂生薬に対して1倍〜3倍数重量の非極性溶媒に肉桂を浸漬させて、20〜35℃で30分〜3時間攪拌して行う、請求項13に記載の製造方法。
- 前記段階c)で使用される極性溶媒は水である、請求項13に記載の製造方法。
- 前記段階c)は、段階b)で得られた肉桂を、肉桂生薬に対して6倍数〜10倍数の極性溶媒を使用して80〜100℃で2時間〜6時間抽出して行う、請求項13に記載の製造方法。
- 前記段階c)で製造した抽出物の乾燥収得量は、15〜20→1(原生薬15〜20Kgを投入時、最終抽出乾燥エキスは1Kg得られることを意味する)である、請求項13に記載の製造方法。
- 肉桂の非極性溶媒前処理および極性溶媒抽出物を含む組成物を投与する段階を含む、胃炎または消化性潰瘍の予防、改善または治療方法。
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EP3569240A4 (en) | 2020-06-17 |
US20240082337A1 (en) | 2024-03-14 |
EP3569240A1 (en) | 2019-11-20 |
JP6980791B2 (ja) | 2021-12-15 |
WO2018131780A1 (ko) | 2018-07-19 |
US20200061142A1 (en) | 2020-02-27 |
CN110167570B (zh) | 2024-02-20 |
US11918618B2 (en) | 2024-03-05 |
KR102247702B1 (ko) | 2021-05-03 |
KR20180082921A (ko) | 2018-07-19 |
US20220054571A1 (en) | 2022-02-24 |
CN110167570A (zh) | 2019-08-23 |
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