TW201639600A - 親水性聚氨酯、親水性聚氨酯發泡體及其製得的溼式創傷敷料 - Google Patents
親水性聚氨酯、親水性聚氨酯發泡體及其製得的溼式創傷敷料 Download PDFInfo
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- polyether polyol
- wound
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 18
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Classifications
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- A61F13/01008—
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive plasters or dressings
- A61F13/0203—Adhesive plasters or dressings having a fluid handling member
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- A—HUMAN NECESSITIES
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- A61M35/00—Devices for applying media, e.g. remedies, on the human body
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G18/00—Polymeric products of isocyanates or isothiocyanates
- C08G18/06—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen
- C08G18/28—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen characterised by the compounds used containing active hydrogen
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- C08G18/4009—Two or more macromolecular compounds not provided for in one single group of groups C08G18/42 - C08G18/64
- C08G18/4081—Mixtures of compounds of group C08G18/64 with other macromolecular compounds
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G18/00—Polymeric products of isocyanates or isothiocyanates
- C08G18/06—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen
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- C—CHEMISTRY; METALLURGY
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- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G18/00—Polymeric products of isocyanates or isothiocyanates
- C08G18/06—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen
- C08G18/28—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen characterised by the compounds used containing active hydrogen
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Abstract
一種親水性聚氨酯,其是使第一聚醚多元醇與多異氰酸酯反應,接著與第二聚醚多元醇及透明質酸反應而得的星狀嵌段聚氨酯,該第一聚醚多元醇含有至少三個末端羥基。本發明另提供一種親水性聚氨酯發泡體,其是使如上所述的親水性聚氨酯及一發泡組分發泡而得,且其孔洞為非連續式的封閉孔洞。本發明另提供一種溼式創傷敷料,包含一片狀吸收層,該片狀吸收層的材質是如上所述的親水性聚氨酯或親水性聚氨酯發泡體。本發明溼式創傷敷料兼具保持傷口溼潤並促進傷口癒合以及能有效吸收傷口滲液的親水性。
Description
本發明是有關於一種聚氨酯,特別是指一種親水性聚氨酯、親水性聚氨酯發泡體及其製得的溼式創傷敷料。
由於保健意識的提升,對於外科手術後的傷口照護備受重視,因此,能避免感染並保護傷口的各式創傷敷料相繼被開發。
為了進一步促進傷口癒合,通常會在敷料基材中混摻或在表面塗佈上能促進傷口癒合的有效成分(例如:海藻酸鹽、透明質酸或其鹽、次五倍子酸鉍等等),然而,混摻或塗佈不僅需要額外的加工製程,且這些額外添加的有效成分容易耗損流失而需要頻繁更換敷料(約在5至7天內),亦可能因有效成分被敷料基材吸收而降低敷料對於傷口滲液的吸收效果,對於傷口癒合的幫助有限。
因此,本發明之第一目的,即在提供一種親水性聚氨酯,可覆蓋於傷口做為創傷敷料,兼具保持傷口溼
潤並促進傷口癒合以及能有效吸收傷口滲液的親水性。
於是,本發明親水性聚氨酯第一聚醚多元醇與多異氰酸酯反應,接著與第二聚醚多元醇及透明質酸反應而得的星狀(star)嵌段(block)聚氨酯,其中,該第一聚醚多元醇含有至少三個末端羥基。
本發明之第二目的,即在提供一種親水性聚氨酯發泡體,其是使如上所述的親水性聚氨酯及一發泡組分發泡而得,且該親水性聚氨酯發泡體的孔洞為非連續式的封閉孔洞。
本發明之第三目的,即在提供一種溼式創傷敷料,包含一片狀吸收層,該片狀吸收層的材質是如上所述的親水性聚氨酯或親水性聚氨酯發泡體。
本發明之功效在於:藉由聚醚多元醇、多異氰酸酯及透明質酸反應而得的星狀嵌段聚氨酯,可製得能有效促進傷口癒合且能吸收傷口滲液的溼式創傷敷料。
以下將就本發明內容進行詳細說明:該星狀嵌段聚氨酯的星狀結構可使得聚氨酯具有較大的比表面積,以利於增進該親水性聚氨酯的吸水特性。
較佳地,該透明質酸的重量平均分子量範圍為500,000~2,500,000。重量平均分子量高於2,500,000的透明質酸較不利於促進傷口癒合。在本發明的具體實施例中,該透明質酸的重量平均分子量為1,000,000。
較佳地,以該第一聚醚多元醇、該多異氰酸酯
、該第二聚醚多元醇及該透明質酸的總合為100mol%,該透明質酸的含量範圍為0.001~20mol%。更佳地,該透明質酸的含量範圍為0.001~10mol%。
較佳地,該多異氰酸酯是脂肪族多異氰酸酯,以避免選自芳香族化合物可能具有的毒性風險。更佳地,該脂肪族多異氰酸酯是選自於1,6-己二異氰酸酯(hexamcthylene diisocyanate,HDI)、伸甲基二環己基二異氰酸酯(methylene dicyclohexyl diisocyanate,H12MDI)、異佛酮二異氰酸酯(isophorone diisocyanate,IPDI)或其組合。在本發明的具體實施例中,該多異氰酸酯是1,6-己二異氰酸酯。
較佳地,該第一聚醚多元醇為聚(丙二醇)三醇(PPG triol)
較佳地,該第二聚醚多元醇為聚乙二醇(PEG)。
在本發明的具體實施例中,該親水性聚氨酯是由聚(丙二醇)三醇與該多異氰酸酯反應延伸成星狀預聚物後,再與聚乙二醇及透明質酸進行交聯反應而得的星狀嵌段聚氨酯。
較佳地,該聚乙二醇的重量平均分子量範圍為1,000~6,000。若該聚乙二醇的重量平均分子量小於1,000,會經由代謝產生生物毒性;若該聚乙二醇的重量平均分子量大於6,000,會因黏度過高而使交聯反應的操作產生困難,但若是添加溶劑以降低黏度進行操作,則可能導致溶
劑殘留於敷料上而有細胞毒性的風險。
該親水性聚氨酯發泡體的孔洞為非連續式的封閉孔洞,以避免新生組織在傷口癒合的過程中生長進入其中的風險,減小移除時可能導致的傷害。
較佳地,該發泡組分包括發泡劑、水、界面活性劑、多胺及催化劑。該多胺是用以增加親水性聚氨酯的機械強度,更佳地,該多胺是選自於1,2-乙二胺、1,4-丁二胺、1,6-己二胺、三伸乙四胺(triethylenetetramine,TETA)或聚醚胺(polyetheramine)。該聚醚胺可選自但不限於Huntsman公司生產的JEFFAMINE®。該催化劑是用以催化過量的多異氰酸酯與水反應產生二氧化碳,更佳地,該催化劑可選自於異辛酸鋅、三伸乙二胺(TEDA,DABCO)、二甲基環己胺(DMCHA)、二甲基乙醇胺(DMEA)、三乙胺(TEA)、1,8-二吖雙環[5.4.0]十一-7-烯(DBU)或五甲基二伸乙三胺(pentamethyldiethylenetriamine,PMDETA)。
較佳地,本發明溼式創傷敷料還包含一背襯,該片狀吸收層是固著於該背襯上,以供黏貼於傷口周圍的皮膚上。更佳地,為了保持該背襯的黏性,本發明溼式創傷敷料還包含一離型紙,覆蓋於該片狀吸收層及該背襯上,以供在使用前撕下。
1‧‧‧片狀吸收層
21‧‧‧背襯
22‧‧‧離型紙
本發明之其他的特徵及功效,將於參照圖式的實施方式中清楚地呈現,其中:圖1是一立體示意圖,說明本發明的親水性聚氨酯或
親水性聚氨酯發泡體;及圖2是一立體示意圖,說明本發明的溼式創傷敷料。
在本發明被詳細描述之前,應當注意在以下的說明內容中,類似的元件是以相同的編號來表示。
本發明將就以下實施例來作進一步說明,但應瞭解的是,該等實施例僅為例示說明之用,而不應被解釋為本發明實施之限制。
<實施例1>星狀親水性聚氨酯PU1
將1mol PPG6000 triol(重量平均分子量為6,000)與3mol HDI混合,在80℃下反應1小時得到星狀預聚物後,再加入1mol PEG1000(重量平均分子量為1,000)、1.5mol PEG2000(重量平均分子量為2,000)及0.5mol透明質酸(重量平均分子量為1,000,000),在80℃下進行交聯反應6小時,得到星狀親水性聚氨酯PU1。
<實施例2>星狀親水性聚氨酯PU2
將0.5mol PPG6000 triol與2.5mol HDI混合,在80℃下反應1小時得到星狀預聚物後,再加入0.85mol PEG1000、0.85mol PEG2000及0.1mol透明質酸(重量平均分子量為1,000,000),在80℃下進行交聯反應6小時,得到星狀親水性聚氨酯PU2。
<應用例1>溼式創傷敷料DR1
參閱圖1,將實施例1的星狀親水性聚氨酯PU1與1mol HDI混合攪拌後塗佈於一離型膜上,在120℃下加
熱1小時,得到如圖1的片狀吸收層1,即為溼式創傷敷料DR1。
<應用例2>溼式創傷敷料DR2
參閱圖1及圖2,將0.1mol碳酸氫鈉(發泡劑)、0.4mol水、0.5mol聚二甲矽氧烷-聚氧化烯共聚物(界面活性劑)、0.1mol乙二胺及0.1mol異辛酸鋅(催化劑,購自於台灣錫生金化學工業股份有限公司,型號為TMG620)混合得到一發泡組分,接著將實施例2的星狀親水性聚氨酯PU2與該發泡組分快速攪拌混合,發泡成形後得到親水性聚氨酯發泡體,且該親水性聚氨酯發泡體的孔洞為非連續式的封閉孔洞。將該親水性聚氨酯發泡體裁切成適當大小的片狀吸收層1,並將其固著黏貼於一具有黏性的背襯21上,再將一離型紙22,覆蓋於該片狀吸收層1及該背襯21上,得到應用例2的溼式創傷敷料DR2。
<比較應用例1>創傷敷料CDR1
比較應用例1的創傷敷料CDR1為一般紗布。
<比較應用例2>創傷敷料CDR2
比較應用例2的創傷敷料CDR2為3M公司市售的柔軟傷口敷料3662A,其與傷口接觸的材質為不織布。
<比較應用例3>溼式創傷敷料CDR3
比較應用例3的溼式創傷敷料CDR3為AMED公司市售的水膠傷口敷料HERADERM®,其與傷口接觸的材質為2-羥乙基甲基丙烯酸甲酯(HEMA)。
<傷口癒合測試>
A.實驗動物:
下面實驗中所使用的S.D.大鼠是雄性Sprague-Dawley(S.D.)大鼠(8週大,體重約為200g)。所有的實驗動物被飼養於一個光照與黑暗各為12小時、室溫維持在22℃以及相對濕度維持在42%的獨立空調的動物房內,而且水分與飼料被充分地供給。在實驗之前,給予動物至少2週的期間去適應環境。有關實驗動物的飼養環境、處理以及一切實驗程序均符合國家衛生研究院(National Institutes of Health,NIH)的實驗動物飼養管理及使用規範(Guide for the Care and Use of Laboratory Animals)。
B.生物纖維敷料的滅菌(sterilization):
將在上面應用例1、2及比較應用例1中所得到的創傷敷料DR1、DR2及CDR1以珈瑪射線(γ-ray)(劑量為40kGy)予以滅菌,繼而將之拿來進行下面的實驗。
C.皮膚傷口(skin wound)的形成:
將S.D.大鼠的背側部分(dorsal part)進行剃毛(shaving),然後以碘酒(tincture of iodine)以及70%酒精予以消毒(disinfected)。之後,使用手術刀(surgical knife)於S.D.大鼠的背部的左側切出具有一約為2cm×2cm的面積大小以及一約為2~3mm的深度的皮膚傷口。
D.敷料的施用:
S.D.大鼠被隨機地分成2個實驗組以及3個對照組(亦即,實驗組1、2及對照組1~3)(每組n=3),其中
各組的S.D.大鼠是依照上面第C項中所述的方法來形成皮膚傷口。接著,實驗組1及2的S.D.大鼠的皮膚傷口分別被施用以依據上面第B項所製得之經滅菌的溼式創傷敷料DR1及DR2,而對照組1、2以及3的S.D.大鼠的皮膚傷口分別被施用以依據上面第B項所製得之經滅菌的創傷敷料CDR1、比較應用例2的創傷敷料CDR2及比較應用例3的創傷敷料CDR3。實驗被進行總共歷時7天,在施用敷料之後的第1、3、5以及7天之時,分別對各組S.D.大鼠的傷口面積進行測量,結果如下表1所示。
由上表1可以得知,在施用敷料後第1至7天,實驗組1及2的S.D.大鼠的皮膚傷口的面積皆有明顯縮小,其中,實驗組2的S.D.大鼠的皮膚傷口在施用敷料後第7天已近乎完全癒合,而對照組1至3的S.D.大鼠的皮膚傷口的面積縮小速度則明顯較緩慢,顯示實驗組1及2的溼式創傷敷料DR1及DR2對於傷口癒合具有較對照組1~3的紗布或市售敷料創傷敷料CDR1~CDR3更為顯著的幫
助。
綜上所述,本發明親水性聚氨酯及親水性聚氨酯發泡體藉由聚醚多元醇、多異氰酸酯及透明質酸反應而得的星狀嵌段聚氨酯,可製得能有效促進傷口癒合且能吸收傷口滲液的溼式創傷敷料,且本發明親水性聚氨酯發泡體的封閉孔洞能避免移除時可能導致的傷害。此外,本發明溼式創傷敷料的原料中不含可能具有毒性的單體或交聯劑,故確實能達成本發明之目的。
惟以上所述者,僅為本發明之實施例而已,當不能以此限定本發明實施之範圍,凡是依本發明申請專利範圍及專利說明書內容所作之簡單的等效變化與修飾,皆仍屬本發明專利涵蓋之範圍內。
1‧‧‧片狀吸收層
21‧‧‧背襯
22‧‧‧離型紙
Claims (10)
- 一種親水性聚氨酯,其是使第一聚醚多元醇與多異氰酸酯反應,接著與第二聚醚多元醇及透明質酸反應而得的星狀嵌段聚氨酯,其中,該第一聚醚多元醇含有至少三個末端羥基。
- 如請求項1所述的親水性聚氨酯,其中,該透明質酸的重量平均分子量範圍為500,000~2,500,000。
- 如請求項1所述的親水性聚氨酯,其中,以該第一聚醚多元醇、該多異氰酸酯、該第二聚醚多元醇及該透明質酸的總合為100mol%,該透明質酸的含量範圍為0.001~20mol%。
- 如請求項1所述的親水性聚氨酯,其中,該多異氰酸酯是脂肪族多異氰酸酯。
- 如請求項1所述的親水性聚氨酯,其中,該第一聚醚多元醇為聚(丙二醇)三醇。
- 如請求項1所述的親水性聚氨酯,其中,該第二聚醚多元醇為聚乙二醇。
- 如請求項6所述的親水性聚氨酯,其中,該聚乙二醇的重量平均分子量範圍為1,000~6,000。
- 一種親水性聚氨酯發泡體,其是使如請求項1所述的親水性聚氨酯及一發泡組分發泡而得,且該親水性聚氨酯發泡體的孔洞為非連續式的封閉孔洞。
- 如請求項8所述的親水性聚氨酯發泡體,其中,該發泡組分包括發泡劑、水、界面活性劑、多胺及催化劑。
- 一種溼式創傷敷料,包含一片狀吸收層,該片狀吸收層的材質是如請求項1所述的親水性聚氨酯或如請求項8所述的親水性聚氨酯發泡體。
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