JP4703283B2 - 創傷被覆材およびその製造方法 - Google Patents
創傷被覆材およびその製造方法 Download PDFInfo
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- JP4703283B2 JP4703283B2 JP2005179617A JP2005179617A JP4703283B2 JP 4703283 B2 JP4703283 B2 JP 4703283B2 JP 2005179617 A JP2005179617 A JP 2005179617A JP 2005179617 A JP2005179617 A JP 2005179617A JP 4703283 B2 JP4703283 B2 JP 4703283B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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Description
本発明の創傷被覆材は、クマザサエキスを有効成分として配合しているものであるが、本発明に係るクマザサエキスに使用するクマザサおよびその抽出方法は、特に制限されるものではない。抽出方法に関しては、植物から抽出物を得る際に用いられる通常の方法により行うことができる。例えば、クマザサを抽出溶媒と共に浸漬または加熱還流した後、濾過し、得られた抽出液をそのまま、またはこれを濃縮して得ることができる。なお、濃縮または乾燥させた抽出物を、再度溶媒に溶解させて用いることもできる。抽出溶媒としては、通常、抽出に用いられる溶媒であれば任意に用いることができ、例えば、水またはメタノール、エタノール、アセトン、酢酸エチル、1,3−ブチレングリコール、プロピレングリコール等の有機溶媒が挙げられ、それらから任意に選ばれる1種、または任意に組み合わせた2種以上を使用することができる。抽出の条件は特に限定されるものではない。
創傷被覆材の作製
星製薬(株)製の熱水抽出法により抽出されたクマザサエキスを使用し、含有率が50質量%、25質量%、12.5質量%となるようにクマザサエキスおよびキトサン(粘度:800〜1,500cps、脱アセチル化度:75〜90mol%)を混合した。次に、2%(v/v)酢酸溶液を加えゲル化させ、ゲル化後、30分間減圧して脱気を行い、テフロン(登録商標)製の型に流し込み乾燥を行った。乾燥方法は、一晩凍結乾燥を行う方法と室温で2日間乾燥させる方法の2種類を用いた。以下、凍結乾燥を行い作製した膜を「FD膜(フリーズドライ膜)」と、自然乾燥を行い作製した膜を「ND膜(ナチュラルドライ膜)」と称する。
実施例に用いた凍傷モデルラットの作成は以下のように行った。まず7週齢のWistar系雄性ラット1頭に対し、0.12mlのペントバルビタールナトリウムを生理食塩水で0.5mlに希釈したものを腹腔内投与して麻酔後、背部肩甲骨の下中心線から右1.5cmの部分を中心として直径1.5cm円状に皮膚を取り除いた。次に、ドライアイス−アセトンを全体に満たして冷やしておいた真鍮管(厚さ1.5mm、底面直径1.5cm)を家庭用ポリエチレンフィルムにはさんで3分間、露出した組織面に押し当てた。処置後一晩は、医療用不織布ガーゼのみを当ててテーピングで固定し保護した。凍傷作成24時間後に創傷面を生理食塩水で洗浄し、2cm×2cmにカットした製剤またはガーゼを創傷面に適用した。
(1)製剤の付着性
各群の膜を創傷からはがす際に用いた生理食塩水の量から膜の付着性を20日間にわたり測定した。付着性の測定は、創傷面に付着した製剤またはガーゼに0.05mlずつ水をシリンジで滴下し、力を加えることなく軽くピンセットで持ち上げた程度で製剤およびガーゼが付着面から剥離する水分量を測定し、下記基準に基づき評価した。得られた結果を表1に示す。また、水分量(ml)を表2に示す。
+++:0.3ml以上の水分を必要とする
++:創傷面の中心だけ付着している
+:膜が浮いている
−:乾いている
N.D.:創傷面が完治したため測定不能
創傷に対する製剤およびガーゼの付着面積、剥離前の製剤の色の変化、剥離後の付着面側の製剤の色の変化を24時間ごとに目視で観察し、下記基準により評価した。得られた結果を表3に示す。また、製剤の色の変化を表4に示す。なお、適用前の製剤の色は全て茶色である。
+++:剥離前時点で製剤が黒色に変化
++:剥離後の付着面の色が茶褐色
+:剥離後の創傷面側が滲出液で若干濡れている
−:乾いている
N.D.:創傷面が完治したため測定不能
下記式
面積比=(観察時の創傷面の直径×短径)/(製剤適用時の創傷面の直径×短径)
を用い、創傷面の面積比を20日間にわたり計測し治癒状態の改善を観察した。その結果を図1に示す。
(4)製剤の吸水量および強度
PBS(リン酸塩緩衝液、pH7.4)に4.0cm×0.5cmの短冊状にカットした膜を入れて37℃で9日間インキュベートし、1日おきに取り出し、膜強度および吸水量を測定した。膜強度として各試料の引っ張り強度を測定し、吸水量として質量変化を測定した。測定には不動工業(株)のRHEOMETER(NRM‐2002D・D)を温度20℃、湿度40%から50%の条件下で使用した。膜強度の結果を図2に、吸水量の結果を図3に示す。
可塑剤として、分子量200および1000のポリエチレングリコールを用い、配合比(PEG:キトサン)を9:21または1:29とし、上記と同様の方法によりクマザサエキスの含有率がキトサンに対して50%の製剤を作製した。また、コントロールとして、PEGを配合していない製剤も併せて作製した。得られた製剤の変形に必要とする力を測定することで、可塑性を評価した。具体的には、それぞれの製剤を40mm×20mmの柵状とし、製剤の片方半分を台の上に乗せて端を台に固定し、台から出ているもう片方半分の製剤の端に錘を負荷して、台の端に固定した半分と台から出ているもう半分が直角になった時点、すなわち地面と製剤が垂直になった時点の錘の質量を比較した。負荷する錘が軽いほど可塑性が高いことを示す。それぞれの製剤において4回試験を行い、それぞれの平均値を下記表5に示す。なお、表中の数値はgである。
Claims (7)
- キトサンおよびクマザサ抽出物を含む混合液をゲル化させ、得られたゲルを乾燥してなることを特徴とする褥瘡被覆材。
- 前記クマザサ抽出物の含有率が6〜60質量%である請求項1記載の褥瘡被覆材。
- シート状である請求項1または2記載の褥瘡被覆材。
- ポリエチレングリコールが配合されている請求項1〜3のうちいずれか一項記載の褥瘡被覆材。
- 請求項1〜4のうちいずれか一項記載の褥瘡被覆材の製造方法であって、前記キトサンおよび前記クマザサ抽出物を含む混合溶液をゲル化させ、得られたゲルを乾燥させることを特徴とする褥瘡被覆材の製造方法。
- 前記混合溶液に酢酸水溶液を添加することにより前記ゲルを得る請求項5記載の褥瘡被覆材の製造方法。
- 前記乾燥が自然乾燥または凍結乾燥である請求項5または6記載の褥瘡被覆材の製造方法。
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