200817468 九、發明說明： 【發明所屬之技術領域】 本發明疋有關於-種創傷敷#，且特別是有關於一種 具有生物可降解性及促癒效果之創傷敷材。 【先前技術】 近年來，生醫材料的研發皆著重在提高基材的生物活 性（bi〇1〇gical function)、生物可降解性（biodegradable)、生 &可吸收性及無細胞毒性上，除此之外，對於傷口之促癒 效果、無痛治療等特性也是選擇材料的重點。膠原蛋白、 明膠、幾丁聚醣、海藻酸鹽等材料皆由於具有部分上述生 醫材料所需之特性，因此為開發新式敷料時常用的成分。 幾丁質在自然界中是含量僅次於纖維素的多醣類，其 來源豐富，廣泛存在於動植物中。幾丁質經過高溫、高濃 度酸鹼溶液進行去乙醯反應（deacetylati〇nM^，即可得到幾 丁聚醣（ChitG_)。幾丁聚醣所製成之天然高分子物質，與 J &物，細胞冑良好組織互溶性’不會造成排斥現象，且幾 • +無毒性，又可被生物分解’具有良好之生物活性功能。 • =外，幾丁聚醣對細菌、酵母菌以及真菌類都有部分或完 - 纟的抑g效果，可作為抗菌材料。因此，近年來幾丁聚賭 在生醫材料上的應用十分廣泛。 然而，由於幾丁聚醣薄膜的降解速率過快、_度過 大曰’因而使得以幾丁聚醣薄膜製成的敷料有使用週期短的 問題。而為了要克服這個缺點，通常會加入交聯劑來改善 5 200817468 以達到控制藥物釋放速率的目的。目前—般顧化學交聯 劑，例如戊一駿’來形成幾丁聚酿的接連結構。化學交聯 劑常會對細胞產生毒性，有時甚至會導致強烈且持續性的 免疫反應，由於生醫敷材必須料皮膚或植人傷Π，故必 須更慎重考慮到其生物安全性的問題。 因此，以幾丁聚酶為基材之敷料，需要開發出更具細 胞女王性的4 丁聚醣交聯劑，來提高幾丁聚醣薄膜的使用 Ο 週期，並搭配適當的促癒劑，才能發揮幾丁聚醣之生物活 1*生力月b it到無母性、無排斥現象、具有良好組織互溶性 且有促癒效果的敷材。 【發明内容】 因此本發明—方面就是在提供—種㈣子素交聯幾 丁聚醣薄膜，用以取代傳統化學交聯劑具有細胞毒性，容 易引發不良免疫反應的問題。 丁 另—方面是在提供—種含有綠梔子素交聯幾 布、並$膜之創傷敷材，m豆蛋白纖維不織布作為基 改盖傳=巾藥白芨溶液，具有生物降解性及促癒效果， 1::統系丁聚膽薄膜膨满度高、使用週期短、更換時容 易導致傷口二次傷害之缺點。 聚二據膜本發明之上述目的，提出-種綠梔子素交聯幾丁 的OCH-其’係由幾丁聚醣的一期3+基團與綠振子素 例，綠振ίΓ合之交聯結構所構成。依照本發明之實施 〃子素交聯幾丁聚醣薄膜中的幾丁聚醣含量為15〇 6 200817468 PPm左右，綠振子素的含量為15ppm以下，綠振子素盘 邊丁聚齬的交聯度為55%。依照本發明之另_實施例，綠 梔子素交聯幾丁聚醣薄膜中可更包含一治療劑，例如消、炎 劑、殺菌劑、止痛劑、止血劑或上述之任意組合。綠振子 素交聯幾丁聚醣薄膜可附著於一基布上，例如不織布或合 成皮基布。 ^ 根據本發明之另—目的，提出—種具有生物安全性 &傷敷材’ 3有大豆蛋白纖維不織布、附著於大豆蛋白 •纖維不織布上之綠梔子素交聯幾丁聚醣薄膜。其中，綠振 2素係為-種無毒性天然的交㈣，用以取代傳統化學性 交聯劑’具有更佳之生物安全性。依照本發明之一實施 例，此綠梔子素交聯幾丁聚醣薄膜甲可更包含一治療劑， 例如消炎劑、殺菌劑、止痛劑、止血劑或上述之任意組合。 根據本發明之又—目的，提出—種具有生物可降解 性之創傷敷材，含有大豆蛋白纖維不織布、附著於大豆蛋 白纖維不織布上之綠梔子素交聯幾丁聚醣薄膜以及白复 ' 錢。依照本發明之實施例，添加於綠梔子素交聯幾丁聚 醣薄膜令之白芨溶液的濃度為6〇〜8〇ppm，用以達到創傷 ^ 促癒效果。 - A 了使本發明之構成特徵、操作方法、目的及優點更 加合易了解’故於下文中配合圖示及文字敘述，說明本發 明之實施例。 【實施方式】 200817468 請參照第1A圖及第1B圖，係繪示本發明之實施例的 一種具有生物可降解性之創傷敷材結構示意圖。創傷敷材 100係由一基布110及一綠梔子素交聯幾丁聚醣薄膜12〇 所組成，綠梔子素交聯幾丁聚醣薄膜120附著於基布110。 其中，基布110可為不織布或合成皮基布。依照本發 明之一實施例，基布11 〇可為一大豆蛋白纖維不織布，其 纖維本身主要是由大豆蛋白質所纽成。大豆蛋白纖維屬於 再生植物蛋白纖維類，可透過化學、生物化學的方法，從 榨掉油脂的大豆豆渣中提取球狀蛋白質，再經過添加功能 性助劑，改變蛋白質空間結構，經濕法紡絲而成。 大豆蛋白纖維是一種易生物降解的纖維，其纖維既具 有天然蠶絲的優良特性，又具有合成纖維的機械性能。此 外，大豆蛋白纖維與人體皮膚親和性佳，且含有多種人體 所必需的氨基酸，具有良好的保健作用，十分適合作為敷 材之基布。 綠梔子素交聯幾丁聚醣薄膜120係由幾丁聚醣 的-NH3+基團與綠梔子素的—OCH;-基團結合之交聯結構所 構成。依照本發明之一實施例，綠梔子素交聯幾丁聚醣薄 膜120中的幾丁聚醣含量為15〇ppm左右，綠梔子素的含 里為15 ppm以下，綠梔子素與幾丁聚醣的交聯度為 5 5 /〇。其中’綠振子素係作為幾丁聚之交聯劑，用以處 理幾丁聚醣以形成交聯結構，可提高幾丁聚醣抵抗免疫系 統及酵素的攻擊的能力，延長幾丁聚醣的使用週期。 綠梔子素是由中藥梔子的果實萃取純化出來的一種 8 200817468 天然父聯劑’在傳統中藥上，梔子的果實及其衍生物也常 被用來治療肝病及各種免疫性疾病。由於綠梔子素在天然 食用色素及傳統中藥上的應用已有相當長的歷史，因此其 所引起的生物毒性應比一些常用的化學交聯劑要來得低。 依照本發明之另一實施例，綠梔子素交聯幾丁聚醣薄 膜120中可更包含一治療劑，例如消炎劑、殺菌劑、止痛 劑、止血劑或上述之任意組合。 依照本發明之又一實施例，綠梔子素交聯幾丁聚醣薄 膜中更包含一白芨溶液，濃度可為6〇〜8〇 ρρηι。白复 (Bletillae Tuber)為一種能止血、抗菌、收斂、生肌消腫的 中樂匕被廣泛的應用於治肺胃出血、鐘金、外傷手術出 血、肺結核、燙傷、皮膚皺裂、潰瘍傷口等病例。 實例一 廋素交聯幾丁聚醣蜱瞪 將幾丁聚粉末（去乙醯度85%)溶於1 %醋酸溶液 中，再將1 wt%醋酸溶液加入幾丁聚醣粉末加熱至約6〇 π 攪拌，以配製成3 wt%的幾丁聚醣溶液。接著，再以水浴 法加熱幾丁聚醣溶液至70。(：左右，然後加入20%綠梔子 素溶液，與幾丁聚醣溶液進行交聯反應，然後將交聯後的 溶液倒入模具中，於室溫下自然風乾脫膜後，於_80〇c的冰 相中冷)東天，並次置1N的氮氧化納1小時中和醋酸， 再經過冷束乾燥處理後，得到綠梔子素交聯幾丁聚醣 (Genipin cross-linked Chitosan; GC)薄膜。 9 200817468 依照本發明之一實施例，綠梔子素交聯幾丁聚醣薄膜 中可更包含一治療劑，例如消炎劑、殺菌劑、止痛劑、止 血劑或上述之任意组合。 依照本發明之另一實施例，綠梔子素交聯幾丁聚酶薄 膜可附著於一基布上，其中，基布之材質可為不織布或合 成皮基布。 σ 請參照第2圖，為綠梔子素交聯幾丁聚醣薄膜與[ΑΝ 細胞貼附測試之結果。L-929細胞株係購自食品所生物資 源保存及研究中心。培養過程為先將細胞株放於回溫槽回 溫，再加入培養基，於3rc、5%c〇2之培養箱裡培養。 將綠梔子素交聯幾丁聚醣薄膜剪裁成直徑2〇毫米之圓面 積大小’利用70%酒精浸泡過夜消毒後，以pbs沖洗3次 後進行細胞貼附。 將約5000個細胞（L-929)小心的灑在綠梔子素交聯幾 丁聚薄膜上’並加入培養基蓋過材料。培養6小時後以 戊二搭固定，將已貼附細胞的材料用PBS清洗3次，每次 清洗時需浸泡5-10分鐘，清洗後以2%戊二醛固定48小 時，再分別以30、50、70、80、90、95、100%酒精溶液 各浸泡15分鐘，以進行脫水。脫水後將試片取出以臨界 點乾燥機（HCP_2 Critical Point Dryer，HITACHI，Japan)進 行臨界點乾燥將酒精去除，再以鍍金機（E_1010，HITACHI， Japan)鍍膜，然後以s_3〇〇〇N掃描式電子顯微鏡進行細胞 生長及貼附情形的觀察及攝影。 由第2圖（A)中可以明顯的看到l-929細胞與綠梔子素 200817468 又聯4丁聚醣薄膜在經過6小時的時間後大量貼附的情 形，違是因為綠梔子素交聯幾丁聚醣薄膜中含有少許未交 聯的幾丁聚醣吸附蛋白質使得細胞貼附增生所致。 而第2圖（B)中可更清楚看到細胞貼附的情形，細胞偽 足伸出固定於薄膜上，並向四周延伸與其他細胞相連結。 由以上結果顯示，本發明之綠梔子素交聯幾丁聚醣薄膜具 有良好的生物適應性。 實例二 基盡生物可降解性之創傷&材 依照實例一所述之方法，配製3 wt%的幾丁聚醣溶 液，並加入20 wt。/。的白芨溶液均勻攪拌後，再加入綠梔子 素溶液進行父聯。接著將添加白芨溶液及交聯劑的幾丁聚 醣溶液倒入模具中，並將剪裁好的大豆蛋白纖維不織布覆 蓋在溶液上方，在室溫下放置一天使幾丁聚醣與綠梔子素 交聯完全後，再進行冷凍乾燥以製成GCB敷材，並使用 UV燈照射一段時間滅菌。 請參照第3圖，為本發明一實施例的綠梔子素交聯幾 丁聚醣薄膜結合大豆纖維不織布之表面型態照片。由第3 圖中可以清楚看見大豆纖維可被薄膜排拒在外，無法進入 薄膜内與薄膜結合。綠梔子素的添加可使幾丁聚醣薄膜薄 膜與大豆纖維的親合性下降，而不會與大豆纖維不織布緊 密的結合，藉此可改善傷口在更換敷材時造成撕裂的二次 傷害。 11 200817468 接下來，再利用動物植入模式來進行材料的體内評 估，可了解本發明之創傷敷材的生物適應性與材料在生物 體被吸收以及新生皮膚組織癒合的情況。創傷癒合可以藉 由觀察沿切割邊緣向生長之肉芽組織形成與上~皮再生^ 發展加以評估，取創傷部位的組織作切片，以h&e染色， 在顯微鏡下觀察組織與細胞的變化。 請參照第4圖，為本發明之創傷敷材敷材植入老鼠皮 膚一週後的組織切片圖。實驗使用400-500克重之雄天竺 鼠，以注射性麻醉藥麻醉後，將背部毛髮剃除，露出的皮 膚經優蛾消毒，擦拭乾淨。首先在背部中央晝出一 4χ4平 方公分面積之區域，分別放入綠梔子素交聯幾丁聚醣薄膜 ，合大豆纖維不織布之敷材（GCS)及添加白芨之綠梔子素 父聯幾丁聚醣薄膜並結合大豆纖維不織布之敷 對照組則選用市面上使用之敷材，空白組利用優碟消毒後 以紗布包紮於一周後觀察創傷部位細胞再生的情形。 纟第4圖⑷中顯示空白組在-週後有許多的間葉細 ) 胞及被活化的纖維母細胞正在生長。相較於第4圖（B)中顯 示GCS敷材在使用-週後，組織中有些許的發炎反應並可 、 卩清楚的看到已生成了成熟的纖維母細胞，更發現了纖維200817468 IX. DESCRIPTION OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates to a wound dressing, and in particular to a wound dressing having biodegradability and a healing effect. [Prior Art] In recent years, research and development of biomedical materials have focused on improving the biological activity (bi〇1〇gical function), biodegradability, bioaccumulation, and non-cytotoxicity of substrates. In addition, the characteristics of the healing effect and painless treatment of the wound are also the focus of the selection of materials. Collagen, gelatin, chitosan, alginate and other materials are commonly used ingredients for the development of new dressings due to the properties required for some of the above-mentioned biomedical materials. Chitin is a polysaccharide that is second only to cellulose in nature. It is rich in sources and is widely found in animals and plants. Chitin is subjected to deacetylation reaction (deacetylati〇nM^) through high-temperature, high-concentration acid-base solution to obtain chitosan (ChitG_), a natural high molecular substance made of chitosan, and J & Substance, cell 胄 good tissue miscibility 'does not cause rejection, and a few + no toxicity, but also biodegradable' has a good biological activity. • =, chitosan against bacteria, yeast and fungi The class has partial or complete - 纟 抑 g effect, can be used as an antibacterial material. Therefore, in recent years, the use of gambling gambling on biomedical materials is very extensive. However, due to the rapid degradation rate of chitosan film, _ Oversized 因而' thus makes dressings made of chitosan film have a short life cycle. In order to overcome this shortcoming, a crosslinking agent is usually added to improve 5 200817468 to achieve the purpose of controlling the drug release rate. At present, chemical cross-linking agents, such as Wu Yijun, are used to form a continuous structure of chitosan. Chemical cross-linking agents are often toxic to cells, and sometimes even cause strong and sustained immunity. Should, because raw materials must be skin or implant scars, it is necessary to consider the biosafety issues more carefully. Therefore, dressings based on chitinase need to develop more cell queens. 4 chitosan cross-linking agent to improve the use cycle of chitosan film, and with appropriate pro-healing agent, can play the biological activity of chitosan 1* vitality month b it to no motherhood, no Repellent phenomenon, a material having good tissue miscibility and having a healing effect. SUMMARY OF THE INVENTION Accordingly, the present invention provides a cross-linked chitosan film to replace a conventional chemical crosslinking agent. It has the problem of cytotoxicity and easy to cause adverse immune reaction. Ding another aspect is to provide a kind of wound dressing containing a mixture of green scorpion and a film of m-bean protein fiber as a base change cover = The whitening solution of the towel has biodegradability and promoting effect. 1:: The film has a high degree of fullness, a short service life, and is liable to cause secondary damage to the wound when replaced. The above purpose is proposed - OCH of a green scorpion cross-linked chitin - which is composed of a first-phase 3+ group of chitosan and a cross-linked structure of a green vibrator and a green vibrating. According to the practice of the present invention The content of chitosan in the hazelnut cross-linked chitosan film is about 15〇6 200817468 PPm, the content of green vibrin is less than 15ppm, and the degree of cross-linking of green vibrin is about 55%. According to another embodiment of the present invention, the green scorpion-crosslinked chitosan film may further comprise a therapeutic agent such as an anti-inflammatory agent, a bactericide, an analgesic agent, a hemostatic agent or any combination thereof. The cross-linked chitosan film can be attached to a base fabric, such as a non-woven fabric or a synthetic leather base fabric. ^ According to another object of the present invention, a biosafety & The fiber is not woven, and the green scorpion protein attached to the soy protein fiber non-woven fabric cross-links the chitosan film. Among them, the green vibration 2 is a non-toxic natural cross (4), which is used to replace the traditional chemical crosslinker' to have better biosafety. According to an embodiment of the present invention, the green scorpion-crosslinked chitosan film may further comprise a therapeutic agent such as an anti-inflammatory agent, a bactericide, an analgesic, a hemostatic agent or any combination thereof. According to still another object of the present invention, a biodegradable wound dressing comprising a soy protein fiber non-woven fabric, a green scorpion-crosslinked chitosan film attached to a soybean protein fiber non-woven fabric, and a white complex are proposed. money. According to an embodiment of the present invention, the concentration of the white peony solution added to the green scorpion-crosslinked chitosan film is 6 〇 8 8 ppm to achieve the wound healing effect. The present invention has been described with reference to the drawings and the written description of the present invention. [Embodiment] 200817468 Referring to Figs. 1A and 1B, a schematic view showing the structure of a biodegradable wound dressing according to an embodiment of the present invention is shown. The wound dressing 100 is composed of a base fabric 110 and a green hazelnut cross-linked chitosan film 12, and the green scorpion-crosslinked chitosan film 120 is attached to the base fabric 110. The base fabric 110 may be a non-woven fabric or a synthetic leather base fabric. In accordance with an embodiment of the present invention, the base fabric 11 can be a soy protein fiber nonwoven fabric, the fibers themselves being primarily made up of soy protein. Soybean protein fiber belongs to the regenerative plant protein fiber. It can extract globular protein from soy bean dregs with oil and fat by chemical and biochemical methods. After adding functional additives, it changes the spatial structure of protein and is wet-spun. Made. Soy protein fiber is a kind of biodegradable fiber. Its fiber has both the excellent characteristics of natural silk and the mechanical properties of synthetic fiber. In addition, soy protein fiber has good affinity with human skin and contains a variety of amino acids necessary for human body, and has a good health care effect, and is very suitable as a base fabric for dressing. The green scorpion-crosslinked chitosan film 120 is composed of a crosslinked structure in which a -NH3+ group of chitosan binds to a -OCH;- group of scorpionin. According to an embodiment of the present invention, the chitosan content in the green scorpion-crosslinked chitosan film 120 is about 15 〇ppm, and the content of the scorpion scorpion is 15 ppm or less. The degree of crosslinking of chitosan is 5 5 /〇. Among them, 'Green Muscle" is used as a cross-linking agent for chitosan to treat chitosan to form a cross-linked structure, which can improve the ability of chitosan to resist the attack of immune system and enzymes, and prolong the chitosan. Use period. Green scorpion is a kind of extract extracted from the fruit of Chinese wolfberry. 8 200817468 Natural parent-linking agent 'In traditional Chinese medicine, the fruit and its derivatives of medlar are also often used to treat liver diseases and various immune diseases. Since scorpion scorpion has a long history of application in natural food coloring and traditional Chinese medicine, its biological toxicity should be lower than that of some commonly used chemical cross-linking agents. According to another embodiment of the present invention, the green scorpion-crosslinked chitosan film 120 may further comprise a therapeutic agent such as an anti-inflammatory agent, a bactericide, an analgesic, a hemostatic agent or any combination thereof. According to still another embodiment of the present invention, the green scorpion-crosslinked chitosan film further comprises a chalk solution having a concentration of 6 〇 8 8 ρρηι. Bletillae Tuber is a kind of Zhongle 能 which can stop bleeding, antibacterial, astringent and myogenic swelling. It is widely used in the treatment of lung and stomach hemorrhage, Zhong Jin, traumatic bleeding, tuberculosis, burns, skin wrinkles and ulcer wounds. Wait for the case. Example - Alizarin cross-linked chitosan 蜱瞪 Chitin poly powder (85% deacetylated) in 1% acetic acid solution, and then added 1 wt% acetic acid solution to chitosan powder heated to about 6 〇π was stirred to prepare a 3 wt% solution of chitosan. Next, the chitosan solution was heated to 70 by a water bath method. (: Left and right, then add 20% green scorpion solution, cross-link reaction with chitosan solution, then pour the cross-linked solution into the mold, and then air dry at room temperature to remove the film, at _80 The ice phase of 〇c is cold in the east, and the nitrogen is oxidized in 1N for 1 hour to neutralize the acetic acid, and after cold-drying treatment, the green scorpion cross-linked chitosan is obtained. ; GC) film. 9 200817468 In accordance with an embodiment of the present invention, the green scorpion-crosslinked chitosan film may further comprise a therapeutic agent, such as an anti-inflammatory agent, a bactericide, an analgesic, a hemostatic agent, or any combination thereof. According to another embodiment of the present invention, the green scorpion-crosslinked chitinase film may be attached to a base fabric, wherein the base fabric may be a non-woven fabric or a synthetic leather-based fabric. σ Refer to Figure 2 for the cross-linked chitosan film of scorpion scorpion and the results of the [ΑΝ cell attachment test. The L-929 cell line was purchased from the Bioresource Conservation and Research Center of the Food Institute. In the culture process, the cell line was first placed in a warming bath, and then added to the medium, and cultured in an incubator of 3rc and 5% c〇2. The green scorpion-crosslinked chitosan film was cut into a circular area of 2 mm in diameter, and the cells were immersed in 70% alcohol overnight, and washed with pbs for 3 times for cell attachment. Approximately 5000 cells (L-929) were carefully sprinkled onto the green hazelnut cross-linked polybutylene film' and the medium was added to cover the material. After 6 hours of incubation, the cells were fixed with glutarylene, and the cells to which the cells were attached were washed 3 times with PBS, soaked for 5-10 minutes each time after washing, and fixed with 2% glutaraldehyde for 48 hours after washing, and then 30 times respectively. 50, 70, 80, 90, 95, 100% alcohol solution was soaked for 15 minutes each for dehydration. After dehydration, the test piece was taken out and subjected to critical point drying by a critical point dryer (HCP_2 Critical Point Dryer, HITACHI, Japan) to remove the alcohol, and then coated with a gold plating machine (E_1010, HITACHI, Japan), and then scanned with s_3〇〇〇N. Electron microscopy for observation and photography of cell growth and attachment. It can be clearly seen from Fig. 2(A) that the l-929 cells and the green scorpionin 200817468 and the 4-butanose film are attached in a large amount after 6 hours, which is because the green scorpionin The cross-linked chitosan film contains a small amount of uncrosslinked chitosan adsorbing protein to cause cell attachment proliferation. In Fig. 2(B), the cell attachment is more clearly seen. The cell pseudopods extend and are fixed to the membrane and extend to the periphery to connect with other cells. From the above results, it was revealed that the green scorpion-crosslinked chitosan film of the present invention has good biocompatibility. Example 2 Wounds and Materials Based on Biodegradability A 3 wt% solution of chitosan was prepared according to the method described in Example 1, and 20 wt was added. /. After the white peony solution was uniformly stirred, the scorpion scorpion solution was added to carry out the parental association. Then, the chitosan solution with the white peony solution and the cross-linking agent is poured into the mold, and the cut soybean protein fiber non-woven fabric is covered on the solution, and left for one day at room temperature to make chitosan and scorpion scorpion. After the crosslinking was completed, lyophilization was carried out to prepare a GCB cast material, which was sterilized by irradiation with a UV lamp for a period of time. Referring to Fig. 3, a surface type photograph of a green scorpion-crosslinked chitosan film combined with a soybean fiber nonwoven fabric according to an embodiment of the present invention. It can be clearly seen from Fig. 3 that the soybean fiber can be rejected by the film and cannot enter the film to bond with the film. The addition of scorpionin can reduce the affinity of the chitosan film film to the soybean fiber without being tightly combined with the soybean fiber non-woven fabric, thereby improving the second time that the wound is torn when the dressing is changed. hurt. 11 200817468 Next, using the animal implantation model for in vivo evaluation of the material, the biocompatibility of the wound dressing of the present invention and the absorption of the material in the living body and the healing of the new skin tissue can be understood. Wound healing can be evaluated by observing the development of granulation tissue along the cutting edge and the development of the epithelial regeneration. The tissue of the wound site is sliced and stained with h&e, and the changes of tissue and cells are observed under a microscope. Referring to Fig. 4, a tissue section of the wound dressing of the present invention implanted in a mouse skin one week later. The experiment used 400-500 g of the male scorpion, and after anesthesia with an injectable anesthetic, the back hair was shaved, and the exposed skin was disinfected by a moth and wiped clean. First, in the center of the back, a area of 4 4 square centimeters is placed, and the green hazelnut cross-linked chitosan film, the soy fiber non-woven fabric (GCS) and the white scorpion green scorpion parent coupler are added. The control group of the butanose film combined with the soybean fiber non-woven fabric was selected from the market. The blank group was sterilized with a special dish and wrapped with gauze for one week to observe the cell regeneration of the wound site.纟 Figure 4 (4) shows that the blank group has many mesenchymal cells after -week and the activated fibroblasts are growing. Compared with Fig. 4(B), it is shown that after the use of GCS dressing, there is a slight inflammatory reaction in the tissue, and it can be clearly seen that mature fibroblasts have been formed, and fibers have been found.
* 母細胞增生所需的膠原蛋白。而第4圖（C)中則顯示GCB 敷材在使用-週後已生成了成熟的纖維母細胞，且纖維母 細胞呈一有方向性的整齊排列。 由此結果顯示，本發明之GCS、GCB敷材能夠有效的 促進傷口的癒合，尤其是GCB敷材’因為添加中藥白芨更 12 200817468 在傷口癒合的初期縮短發炎反應的時間，使組織快速生成 並整齊排列。 再參照第5圖，為本發明之創傷敷材敷材植入老鼠皮 膚兩週後的組織切片圖。由第5圖(A)中顯示空白組在兩週 -後組織的發炎反應仍可清楚的被看到，而第5圖（B)中顯示 GCS敷材在使用兩週後，組織中已無發炎反應並可以清楚 的看到表皮粒層、棘皮細胞層、基底層，這顯示表皮結構 〇 6生長的非常完整’並且在第5圖⑻中更可看見脂肪組織 的存在。而第5圖（C)中顯示GCB敷材在使用兩週後和⑽ 敷材情況相似，表皮結構已經生長的很完整。由上述結果 顯示，本發明之GCS、GCB敷材在使用兩週後相對於空白 組傷口的癒合已非常的完整。 第6圖為對照組敷材植入老鼠皮膚兩週後的組織切片 圖。顯示使用對照組敷材兩週後’組織間的纖維母細胞均 已生長成熟並且整齊的排列，但是仍有部份的發炎反應。 c t造成此現象是因為對照組敷材在進行更換時，不易撕除 而造成傷口的二次傷害，並且會將已生成的表皮結構 所致。 氟 由上述本發明較佳實施例可知，應用本發明具有下列 、 優點。 首先本發明以天然父聯劑綠梔子素取代傳統化學交 聯劑，形成綠梔子素交聯幾丁聚醣薄膜，不但無毒性且可 提供優良的交聯度，大幅改善幾丁聚醣使用週期短的缺 點，使幾丁聚醣具備之良好的生物相容性、無毒性、且具 13 200817468 有加速傷口癒合的特色得以發揮。 再者，本發明<實施例揭露一種以大豆蛋白纖維作為 敷材之基布，搭配本發明之綠振子素交聯幾丁聚酶薄膜， 利用大且纖維本身之生物降解性，及可媳美合成纖維的機 械性咸，製成柔#、透氣、無毒性且具有抗菌消炎的敷材， 可提供更好的生物適應性及使用舒適性。除此之外，由於 綠栀子素可可降低大豆纖維與幾丁聚醣薄膜的親和力，因 此不會過度緊密的黏附，反而能有效克服敷材更換時所導 致傷口的二次傷害。 此外，本發明之實施例更揭露一種以大豆蛋白纖維為 ，布Y搭配本發明之綠梔子素交聯幾丁聚醣薄膜並添加中 樂白芨溶液之敷材，利用白芨具有之止血、抗菌、收敛、 生肌消腫的藥理作用，可更有效的加速傷口癒合。 因此，本發明之可降解性創傷敷材，能完全符合傷口 癒合的臨床應用，不但無毒性且具有高生物相容性，更使 傷口能在乾淨舒適的環境下快速的癒合，達到使用週期 長、具生物安全性及促癒效果佳的優點。 以上所示之實施例中的特定時間、濃度、尺寸等數 據，僅是幫助讀者了解本發明的原理及提供技術上之概 念，並非用以限定本發明。 雖然本發明已以實施例揭露如上，然其並非用以限定 本發明，任何熟習此技藝者，在不脫離本發明之精神和範 圍内，當可作各種之更動與潤飾，因此本發明之保護範圍 當視後附之申請專利範圍所界定者為準。 200817468 【圖式簡單說明】 為讓本發明之上述和其他目的、特徵、優點與實施例 能更明顯易懂，所附圖式之詳細說明如下·· 第1A圖〜第1B圖為本發明之實施例的一種具有生物 可降解性之創傷敷材結構示意圖。 第2圖為綠梔子素交聯幾丁聚醣薄膜與L-929細胞貼 附測試之結果。 苐3圖為本發明一實施例的綠梔子素交聯幾丁聚醣薄 膜結合大豆纖維不織布之表面型態照片。 第4圖為本發明之創傷敷材敷材植入老鼠皮膚一週後 的組織切片圖。 第5圖為本發明之創傷敷材敷材植入老鼠皮膚兩週後 的組織切片圖。 第6圖為對照組敷材植入老鼠皮膚兩週後的組織切片 【主要元件符號說明】 100 :創傷敷材 110 :基布 120 :綠梔子素交聯幾丁聚醣薄膜 15* Collagen required for mother cell proliferation. In Fig. 4(C), it is shown that the mature fibroblasts have been produced after the GCB dressing has been used for weeks, and the fibroblasts are arranged in a directional alignment. The results show that the GCS and GCB dressings of the present invention can effectively promote the healing of wounds, especially the GCB dressings, because the addition of the traditional Chinese medicine Baiji 12 200817468 shortens the time of the inflammatory reaction in the early stage of wound healing, so that the tissue is rapidly formed and Neatly arranged. Referring again to Fig. 5, a tissue section of the wound dressing of the present invention after two weeks of implantation into a mouse skin is shown. It can be clearly seen from the inflammatory reaction of the blank group in the two-week-post posterior group shown in Fig. 5(A), and the figure 5(B) shows that the GCS dressing has no tissue in the tissue after two weeks of use. The inflammatory response and the epidermal granule layer, the echinoderma cell layer, and the basal layer can be clearly seen, which shows that the epidermal structure 〇6 grows very intact' and the presence of adipose tissue is more visible in Fig. 5 (8). Figure 5 (C) shows that the GCB dressing is similar to the (10) dressing after two weeks of use, and the epidermal structure has grown very intact. From the above results, it was revealed that the healing of the GCS and GCB dressings of the present invention relative to the blank group wound after two weeks of use was very complete. Figure 6 is a tissue section of the control group after two weeks of implantation into the skin of the mouse. It was shown that after two weeks of use of the control material, the fibroblasts between the tissues had matured and arranged neatly, but there was still some inflammatory reaction. This phenomenon is caused by the fact that the control material is not easily removed when it is replaced, causing secondary damage to the wound and will result from the resulting epidermal structure. Fluorine As apparent from the above-described preferred embodiments of the present invention, the application of the present invention has the following advantages. Firstly, the invention replaces the traditional chemical cross-linking agent with the natural parent-linked agent, scorpion scorpion, to form a green scorpion-crosslinked chitosan film, which is not only non-toxic and can provide excellent cross-linking degree, and greatly improves chitosan. The short-term use of shortcomings makes chitosan have good biocompatibility, non-toxicity, and has the characteristics of accelerated wound healing in 13 200817468. Furthermore, the present invention discloses a base fabric using soy protein fiber as a veneer, in combination with the green vibrin cross-linked chitin polymer film of the present invention, which utilizes the biodegradability of the fiber itself and can be used. The mechanically salty nature of synthetic fibers is made into a soft, non-toxic, antibacterial and anti-inflammatory dressing that provides better biocompatibility and comfort. In addition, since the green scorpion cocoa reduces the affinity of the soybean fiber to the chitosan film, it does not excessively adhere, and can effectively overcome the secondary damage caused by the replacement of the dressing. In addition, the embodiment of the present invention further discloses that the soybean protein fiber is used, the cloth Y is matched with the green scorpion protein of the present invention, and the chitosan film is cross-linked and the medium is added to the solution of the Chinese lycopene solution, and the white scorpion has the hemostasis and antibacterial effect. The pharmacological action of astringent and myogenic swelling can accelerate wound healing more effectively. Therefore, the degradable wound dressing of the invention can fully meet the clinical application of wound healing, and is not only non-toxic and has high biocompatibility, but also enables the wound to heal quickly in a clean and comfortable environment, and has a long service life. It has the advantages of bio-safety and good healing effect. The specific time, concentration, size, and the like in the above-described embodiments are merely intended to aid the reader in understanding the principles of the present invention and the technical concept, and are not intended to limit the present invention. Although the present invention has been disclosed in the above embodiments, it is not intended to limit the present invention, and the present invention can be modified and retouched without departing from the spirit and scope of the present invention. The scope is subject to the definition of the scope of the patent application attached. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects, features, advantages and embodiments of the present invention will become more <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; A schematic diagram of a biodegradable wound dressing structure of the embodiment. Figure 2 shows the results of the adhesion test of the green scorpionin cross-linked chitosan film and the L-929 cell. Fig. 3 is a photograph showing the surface type of the green scorpion-crosslinked chitosan thin film-bound soybean fiber non-woven fabric according to an embodiment of the present invention. Fig. 4 is a histogram of a tissue of the wound dressing of the present invention implanted into the skin of a mouse for one week. Fig. 5 is a histogram of the tissue of the wound dressing of the present invention implanted in the skin of the mouse two weeks later. Figure 6 is a section of the control tissue after two weeks of implantation into the skin of the mouse. [Main component symbol description] 100: Wound dressing 110: Base cloth 120: Green hazelnut cross-linked chitosan film 15