JP2018538233A - 口腔止血及び創傷保護フィルム - Google Patents
口腔止血及び創傷保護フィルム Download PDFInfo
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- JP2018538233A JP2018538233A JP2017533518A JP2017533518A JP2018538233A JP 2018538233 A JP2018538233 A JP 2018538233A JP 2017533518 A JP2017533518 A JP 2017533518A JP 2017533518 A JP2017533518 A JP 2017533518A JP 2018538233 A JP2018538233 A JP 2018538233A
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Abstract
【選択図】 図1
Description
界面活性剤、オイルおよび可塑剤のいずれか1つ以上、親水性高分子、および崩壊剤を備えて創傷部位に付着して微細な出血を遅延または防止する粘着層と、
水不溶性高分子を含み、前記粘着層上に位置して口腔内で舌、唾液または食べ物から上記粘着層を保護する支持体層と、を含み、
上記崩壊剤は、血液と反応の時に溶解放出され、粘着層内に微細なチャンネルを形成するを特徴的する口腔止血及び創傷保護フィルムに関する。
上記オイルとしては、シリコンオイル、液体パラフィン、ロジンワックス液、大豆油、オリーブ油、ゴマ油、カストルオイル、脂溶性ビタミン、脂溶性ビタミンアセテートなどが使用されることができる。上記オイルは、可塑剤としての役割も遂行可能である。
上記粘着層は、上記成分を溶媒に溶解させた後乾燥して形成することができる。上記溶媒は、水、メタノール、エタノール、アセトン、イソプロパノール、エチルアセテートなどを使用することができ、好ましくは、水を使用する。
下記表1と表2に示した成分を利用して粘着層溶液と支持体層溶液を製造した。まず、粘着層溶液を剥離層上に塗布した後、乾燥させて粘着層フィルムを製造した。続いて、支持体層溶液を付着層フィルム上に塗布して乾燥させた。このように製造された二層のフィルムを所定の大きさに切断した。
実施例1〜3と比較例1で製造した口腔止血及び創傷保護フィルム(以下、止血フィルム)を溶出率実験試料として使用した。大韓藥典の一般試験法中の溶出試験第2法(パドル法)に従った。具体的には、溶出液は900Ml(pH6.8液)、温度は37±0.5℃、パドルの回転速度は50rpmにして溶出した。実験を開始して10分間隔で溶出液を取り始めて5分から1時間まで評価した。溶出された物質としては、Blue#1色素を使用し、放出程度を5段階に分けて肉眼で評価し、その結果を表3に示した。
実施例4〜6及び比較例2、4で製造した口腔止血及び創傷保護フィルム(以下、止血フィルム)で創傷治癒程度を評価した。Male Sprague−Dawley rats(16 to 18 weeks old)72個を3つの群に分けて、標準飼育ケースに保存した。5%isofluraneとketaminehydrochlorideそしてxylaizneを使用し、局所的にはlidocaineを活用して麻酔させた。外科的創傷(Surgical defects)を5mmにtrephine burを活用した。calvarial defect procedureで傷を作った部位に実験群と対照群を処置し、縫合した後、4、8週間後傷の治癒の程度を比較して表4に示した。
上記実施例4〜6及び比較例1〜3で製造した口腔止血及び創傷保護フィルム(以下、止血フィルム)で止血防止程度を評価し表5に示した。評価方法として吸収率(ASTM D570)を応用した。止血フィルムを10×10(mm)のサイズにして、メッシュの中に閉じ込める。スプレー容器に生理食塩水(Nomal saline 0.9% 水溶液)を充填し、メッシュ内の止血フィルムに10回噴射する。その後、不織布に上げ、余分の水分を除去する。そして、約10gの重量で1分間圧縮、圧迫して表面的に結ばれている水分を除去する。メッシュの重量を引いた残りの試料重量を求め、下式によって吸水性を測定した。粘着層内部の精製水の含有量に応じて血液や膿瘍の吸収をより迅速に反応させることができるかどうかを評価した。
A(吸収率)=(Wa−Wo)/Wo*100
A:吸収率Wo:吸収前初期フィルム重量 Wa:噴射後のフィルム重量
上記実施例5,6、および比較例2〜4で製造した口腔止血及び創傷保護フィルム(以下、止血フィルム)で使用性を評価し表6に示した。使用性は、口腔内に付着時、快適度による満足感として判断した。30人の対象にし評価を行った。
20:支持体層 本考案のブロック
Claims (7)
- 界面活性剤、オイル及び可塑剤のいずれか1つ以上、親水性高分子、および崩壊剤を備えて、創傷部位に付着して微細な出血を遅延または防止する粘着層;及び
水不溶性高分子を含み、前記粘着層上に位置して口腔内で舌、唾液または食べ物から上記粘着層を保護する支持体層を含み、
上記崩壊剤は、血液と反応する時溶解放出され、粘着層内に微細なチャンネルを形成することを特徴的する口腔止血及び創傷保護フィルム。 - 前記崩壊剤は、グリコール、グリセリン、ソルビトールまたはPEG、ラクトース、ステアリン酸マグネシウム、結晶性セルロース及びクロスポビドンの中から選択されるいずれか1つ以上であることを特徴とする請求項1に記載の口腔止血及び創傷保護フィルム。
- 前記粘着層は、親水性高分子100重量部に対して、
上記界面活性剤、オイルまたは可塑剤を0.1〜60重量部;及び
上記崩壊剤を0.1〜30重量部含むこと特徴的する請求項1に記載の口腔止血及び創傷保護フィルム。 - 前記粘着層は、0.1〜30重量%の水をを含み、部分膨張(swollen)状態で口腔粘膜に付着されていることを特徴的する請求項1に記載の口腔止血及び創傷保護フィルム。
- 前記粘着層は、上記親水性高分子100重量部に対して、0.1〜30重量部の親油性軟化剤を含み、
口腔内で上記粘着層が消失されることによって、上記軟化剤が上記支持体層に浸透して、上記支持体層を軟化させ、上記軟化された支持体層が唾液によってゆっくり消失されることを特徴的する請求項1に記載の口腔止血及び創傷保護フィルム。 - 前記軟化剤は、トリエチルシトレート、ジブチルセバケート、アセチルトリエチルシートレート、及びトリアセチンの中から選択されたいずれか1つであることを特徴的する請求項5に記載の口腔止血及び創傷保護フィルム。
- 前記フィルムは、上記親水性高分子100重量部に対して、薬物0.01〜20重量部を含み、薬物は抗炎症、口腔疾患溶剤、抗ヒスタミン剤、ホルモン剤、高血圧治療薬、抗生物質または気管支拡張剤であることを特徴的する請求項1に記載の口腔止血及び創傷保護フィルム。
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Also Published As
Publication number | Publication date |
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JP6941839B2 (ja) | 2021-09-29 |
CN107106512A (zh) | 2017-08-29 |
KR101901660B1 (ko) | 2018-09-28 |
CA3044944C (en) | 2021-06-22 |
EP3381448A1 (en) | 2018-10-03 |
US10582915B2 (en) | 2020-03-10 |
US20170296157A1 (en) | 2017-10-19 |
KR20170061588A (ko) | 2017-06-05 |
CA3044944A1 (en) | 2017-06-01 |
EP3381448A4 (en) | 2019-07-24 |
PH12017501527A1 (en) | 2018-02-05 |
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