TW201940145A - Method of testing dressing composition with color change indicating function capable of determining the current state of a wound by a color change effect to reduce unnecessary replacement of wound dressings - Google Patents

Method of testing dressing composition with color change indicating function capable of determining the current state of a wound by a color change effect to reduce unnecessary replacement of wound dressings Download PDF

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TW201940145A
TW201940145A TW108127576A TW108127576A TW201940145A TW 201940145 A TW201940145 A TW 201940145A TW 108127576 A TW108127576 A TW 108127576A TW 108127576 A TW108127576 A TW 108127576A TW 201940145 A TW201940145 A TW 201940145A
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color change
dressing composition
wound
film
acid solution
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TW108127576A
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TWI691314B (en
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白孟宜
王鼎騰
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白孟宜
王鼎騰
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Abstract

The present invention relates to a method of testing a dressing composition with a color change indicating function, in which a color change indicating film of the dressing composition is formed by using an electrospinning process and coating with an ellagic acid solution. Furthermore, the color change indicating film is irradiated with ultraviolet light, and a color change effect produced by the reaction of the ellagic acid solution and metal ions is used to determine the current state of a wound, thereby reducing unnecessary replacement of wound dressings. The method includes the steps of: taking a dressing composition; irradiating a color change indicating film of the dressing compositions with ultraviolet light to enable the color change indicating film to emit a blue-green light, wherein the color change indicating film is provided with an ellagic acid solution; and reacting the ellagic acid solution of the color change indicating film and metal ions to enable the color change indicating film to emit blue-purple light under the ultraviolet light.

Description

具變色指示功能之敷料組合物之檢驗方法Test method for dressing composition with discoloration indicating function

本發明係申請案106145819之分割案。本發明係有關一種敷料組合物,特別是一種具變色指示功能之敷料組合物之檢驗方法。The invention is a division of application 106145819. The invention relates to a test method for a dressing composition, in particular to a dressing composition having a discoloration indicating function.

皮膚是人體最大的組織器官,亦是抵抗外來病源的第一道防線,若發生創傷時,能迅速癒合傷口,並恢復防禦力為刻不容緩之要務。The skin is the largest tissue and organ of the human body, and it is also the first line of defense against foreign diseases. In case of trauma, it is necessary to heal the wound quickly and restore defense.

而根據近年來的科學和統計報導,全球創傷市場的需求越來越大,特別是在外科手術類的創傷。全球創傷市場每年之總人數已經突破1億人次,並呈逐年增長的趨勢。每年約有2千萬人次因意外事故造成創傷與撕裂傷,而燒燙傷數量則約每年1千萬人次;此外每年因慢性疾病、糖尿病、衰老退化所造成的潰瘍性傷口則已經超過了3千萬人次。According to recent scientific and statistical reports, the demand for the global trauma market is growing, especially in surgical trauma. The total number of people in the global trauma market has exceeded 100 million person-times each year, and it is increasing year by year. Every year, about 20 million people suffer trauma and lacerations due to accidents, and the number of burns and scalds is about 10 million people per year. In addition, ulcerative wounds caused by chronic diseases, diabetes, and aging have exceeded 3 each year. Ten million people.

現今,外科手術已大幅降低手術所造成的風險,但隨之而來的卻是對於較佳的傷口照護及預防術後疤痕的需求。目前已經出現借助各種先進敷料進行傷口照護的方法,藉以縮短傷口癒合時間且同時消除疤痕。Nowadays, surgery has greatly reduced the risks caused by surgery, but with it comes the need for better wound care and the prevention of postoperative scars. Wound care methods have been developed with the help of various advanced dressings to shorten wound healing time and eliminate scars at the same time.

一般而言,傳統的傷口敷料應具備的要件包括:(1)無毒性且具有生物可相容性(biocompatible)、(2)可以有效隔絕病原以及(3)能提供抗菌與止血功能。Generally speaking, the requirements for traditional wound dressings include: (1) non-toxic and biocompatible, (2) effective isolation of pathogens, and (3) providing antibacterial and hemostatic functions.

傷口敷料是一類重要的醫療與化妝用品,其中醫用敷料是覆蓋傷口之材料,主要功能是控制傷口滲液、保護傷口免受細菌及塵粒的污染。傳統紗布敷料雖能保護傷口,但對傷口癒合無促進作用,滲液管理能力差,更換敷料時,容易因沾黏傷口新生組織導致反覆損傷與疼痛、瘢痕形成等不適反應,故難以滿足現代人對外觀及時效的訴求。Wound dressings are an important class of medical and cosmetic products. Among them, medical dressings are materials that cover wounds. Their main function is to control wound exudate and protect the wound from bacteria and dust particles. Although traditional gauze dressings can protect wounds, they do not promote wound healing and poor exudate management. When changing dressings, it is easy to cause discomforts such as repeated injuries and pain, scar formation, etc. due to adhesion of wounded new tissue, so it is difficult to satisfy modern people Demand for appearance and timeliness.

因此,傷口的處理模式逐漸從“乾燥傷口癒合”轉變為“潤濕傷口癒合”。而就傷口敷料而言,也從傳統敷料,像是紗布、膠帶等轉變為溼式敷料,像是親水性敷料等。近期也有了生物材料敷料抑或是功能性敷料等。而就現今敷料的選擇上,相較於以往,對於成分的訴求為純天然、高吸收及低回滲等。Therefore, the treatment mode of the wound has gradually changed from "dry wound healing" to "wetting wound healing". As for wound dressings, they have also changed from traditional dressings such as gauze and tape to wet dressings such as hydrophilic dressings. Recently there are also biological material dressings or functional dressings. As for the choice of dressings today, compared with the past, the demands for ingredients are pure natural, high absorption and low back permeability.

目前就蠶絲蛋白而言,蠶絲蛋白為一種天然生物高分子蛋白,它的主要成分是絲膠蛋白〈sericin〉和絲素蛋白〈fibroin〉,絲膠蛋白約占蠶絲蛋白總量的20%~30%,絲素蛋白的含量則佔蠶絲蛋白總量的70%~80%。As far as silk protein is concerned, silk protein is a natural biopolymer protein. Its main components are sericin <fibrin> and silk fibroin <fibroin>. Sericin accounts for about 20% to 30% of the total silk protein. %, Silk fibroin content accounts for 70% to 80% of the total silk protein.

絲素蛋白含有18種氨基酸,其中甘氨酸(gly)、丙氨酸(ala)和絲氨酸(ser)約佔總組成的80%以上。絲素本身具有良好的機械性能和理化性質,如良好的柔韌性和抗拉伸強度、透氣透濕性、緩釋性等,而且經過不同處理可以得到不同的形態,如纖維、溶液、粉、膜以及凝膠等。Silk fibroin contains 18 kinds of amino acids, of which glycine (gly), alanine (ala) and serine (ser) account for about 80% of the total composition. Silk fibroin itself has good mechanical properties and physical and chemical properties, such as good flexibility and tensile strength, breathable moisture permeability, slow release, etc., and different forms can be obtained through different treatments, such as fiber, solution, powder, Film and gel.

而,絲膠蛋白結構上由18種不同的胺基酸所組成,其中的32%為絲氨酸。且絲膠蛋白本身具有抑制自由基、抗氧化功能,能抵禦日光中的紫外線對皮膚的侵蝕、並具有抑制酪氨酸酶活性的作用進而達到抑制皮膚黑色素的生成。However, sericin is structurally composed of 18 different amino acids, of which 32% are serine. Moreover, sericin itself has the functions of inhibiting free radicals and anti-oxidation, can resist the skin's erosion by ultraviolet rays in sunlight, and can inhibit the activity of tyrosinase to thereby inhibit the production of melanin in the skin.

但,傷口敷料仍會面臨狀態上的問題,像是敷料濕度、傷口癒合程度的問題以及更換時間等問題,像傷口敷料何時需要更換或是傷口敷料濕潤狀態。無法藉由傷口敷料的外觀輕易看出傷口狀態,往往會在更換傷口敷料後才能知道傷口狀態。為此,往往浪費過多的傷口敷料。However, the wound dressing still faces problems in the condition, such as the humidity of the dressing, the degree of wound healing, and the time of replacement, such as when the wound dressing needs to be replaced or the wound dressing is wet. The wound state cannot be easily seen by the appearance of the wound dressing, and the wound state is often not known until the wound dressing is changed. For this reason, excessive wound dressings are often wasted.

因此,如何在不更換傷口敷料的情況下,僅憑傷口敷料的外觀來判斷傷口的狀態。為本領域技術人員所要解決的問題。Therefore, how to judge the state of the wound based on the appearance of the wound dressing without changing the wound dressing. Problems to be solved by those skilled in the art.

本發明之主要目的,係提供一種具變色指示功能之敷料組合物之檢驗方法。藉由敷料上之變色指示薄膜的變色來判斷目前傷口的狀態。以減少不必要的傷口敷料更換。The main object of the present invention is to provide a test method for a dressing composition having a discoloration indicating function. The current state of the wound is judged by the discoloration of the discoloration indicator film on the dressing. To reduce unnecessary wound dressing changes.

為了達到上述目的及功效,本發明揭示了一種具變色指示功能之敷料組合物之製備方法。藉由電紡織製程,電紡絲素蛋白/ 聚乙烯醇混合液形成不織布膜後,在塗佈鞣花酸溶液以形成變色指示膜。並放置變色指示膜於由絲膠蛋白/聚乙烯醇混合液形成之親水性基質上,進行處理製備形成敷料組合物。並藉由敷料組合物上鞣花酸溶液之變色效果,來判斷傷口的狀態。In order to achieve the above-mentioned objects and effects, the present invention discloses a method for preparing a dressing composition with a color-changing indicator function. After the electrospinning process, the electrospin protein / polyvinyl alcohol mixed solution is used to form a non-woven fabric film, and then the ellagic acid solution is applied to form a discoloration indicating film. The discoloration indicating film is placed on a hydrophilic substrate formed by a sericin / polyvinyl alcohol mixed solution, and processed to form a dressing composition. The state of the wound was judged by the discoloration effect of the ellagic acid solution on the dressing composition.

本發明提供一實施例,其內容在於具變色指示功能之敷料組合物之製備方法,其中該第一混合液為一絲素蛋白/ 聚乙烯醇混合液。The present invention provides an embodiment, the content of which is a method for preparing a dressing composition with a color-change indicating function, wherein the first mixed solution is a silk fibroin / polyvinyl alcohol mixed solution.

本發明提供一實施例,其內容在於具變色指示功能之敷料組合物之製備方法,其中該第二混合液為一絲膠蛋白/聚乙烯醇混合液。The present invention provides an embodiment, the content of which is a method for preparing a dressing composition with a color-change indicating function, wherein the second mixed solution is a sericin / polyvinyl alcohol mixed solution.

本發明提供一實施例,其內容在於具變色指示功能之敷料組合物之製備方法,其中於進行一電紡織製程,電紡該第一混合液至一圓形片上形成一不織布膜之步驟前,進一步包含步驟:調整一電紡參數。The present invention provides an embodiment, the content of which is a method for preparing a dressing composition with a discoloration indicating function. Before performing an electrospinning process, electrospinning the first mixed liquid to a circular sheet to form a non-woven film, The method further includes the step of adjusting an electrospinning parameter.

本發明提供一實施例,其內容在於具變色指示功能之敷料組合物之製備方法,其中該電紡參數進一步包含一電壓數值、一工作距離以及一流動速度。The present invention provides an embodiment, the content of which is a method for preparing a dressing composition with a color-change indication function, wherein the electrospinning parameter further includes a voltage value, a working distance, and a flow speed.

本發明提供一實施例,其內容在於具變色指示功能之敷料組合物之製備方法,其中該鞣花酸溶液須預先進行一酒精處理。The present invention provides an embodiment, the content of which is a method for preparing a dressing composition with a discoloration indicating function, wherein the ellagic acid solution must be subjected to an alcohol treatment in advance.

另,本發明揭示了一種具變色指示功能之敷料組合物,其包含:一親水性基質;以及一變色指示膜,設置於該親水性基質之上,且該變色指示膜包含一絲素蛋白/聚乙烯醇混合液及一鞣花酸溶液,且該鞣花酸溶液於該變色指示膜上形成一變色指示圖式。In addition, the present invention discloses a dressing composition having a discoloration indicating function, comprising: a hydrophilic substrate; and a discoloration indicating film disposed on the hydrophilic substrate, and the discoloration indicating film comprises a silk fibroin / poly A mixed solution of vinyl alcohol and an ellagic acid solution, and the ellagic acid solution forms a color-change indicator pattern on the color-change indicator film.

本發明提供一實施例,其內容在於具變色指示功能之敷料組合物,其中該親水性基質,其係包含一絲膠蛋白/聚乙烯醇混合液。The present invention provides an embodiment, the content of which is a dressing composition with a color-change indicating function, wherein the hydrophilic matrix comprises a sericin / polyvinyl alcohol mixed solution.

又,本發明揭示了一種具變色指示功能之敷料組合物之檢驗方法,其步驟包含:取一敷料組合物;以一紫外光照射該敷料組合物之一變色指示膜時,該變色指示膜發出一藍綠色光,該變色指示膜包含一鞣花酸溶液;以及當該變色指示膜之該鞣花酸溶液與一金屬離子反應後,該變色指示膜於該紫外光下發出一藍紫色光。In addition, the present invention discloses a method for inspecting a dressing composition having a discoloration indicating function, the steps include: taking a dressing composition; and irradiating a discoloration indicating film of the dressing composition with an ultraviolet light, the discoloration indicating film emits A blue-green light, the discoloration indicating film comprises a ellagic acid solution; and when the ellagic acid solution of the discoloration indicating film reacts with a metal ion, the discoloration indicating film emits a blue-violet light under the ultraviolet light.

本發明提供一實施例,其內容在於具變色指示功能之敷料組合物之檢驗方法,其中該金屬離子係來自於一組織液。The present invention provides an embodiment, the content of which is a method for inspecting a dressing composition having a discoloration indicating function, wherein the metal ion is derived from an interstitial fluid.

本發明提供一實施例,其內容在於具變色指示功能之敷料組合物之檢驗方法,其中該紫外光之波長為365nm。The present invention provides an embodiment, the content of which is a method for inspecting a dressing composition having a discoloration indicating function, wherein the wavelength of the ultraviolet light is 365 nm.

為使 貴審查委員對本發明之特徵及所達成之功效有更進一步之瞭解與認識,謹佐以實施例及配合說明,說明如後:In order to make the reviewing committee members have a better understanding and understanding of the features of the present invention and the effects achieved, I would like to provide examples and cooperative descriptions, as described below:

有鑑於無法藉由傷口敷料的外觀輕易看出傷口狀態,往往在更換傷口敷料後才能知道傷口狀態,因而浪費過多傷口敷料的影響,據此,本發明遂提出一種具變色指示功能之敷料組合物之檢驗方法,以解決習知技術所造成之問題。In view of the fact that the wound state cannot be easily seen by the appearance of the wound dressing, the wound state is often known only after the wound dressing is changed, and the effect of excessive wound dressing is wasted. Based on this, the present invention proposes a dressing composition with a discoloration indicator Test methods to solve the problems caused by conventional technology.

以下,將進一步說明本發明之具變色指示功能之敷料組合物之檢驗方法所包含之特性、所搭配之結構及其方法:In the following, the characteristics included in the inspection method of the dressing composition with a discoloration indicating function of the present invention, the matched structure and the method thereof will be further explained:

請參閱第1圖,其係為本發明之製備方法之流程圖。如圖所示,本發明之一種具變色指示功能之敷料之製備方法,其步驟包含:Please refer to FIG. 1, which is a flowchart of the preparation method of the present invention. As shown in the figure, a method for preparing a dressing with a discoloration indicating function according to the present invention includes the following steps:

S1:製備第一混合液及第二混合液,第一混合液包含絲素蛋白(silk fibroin protein, SFP)及聚乙烯醇,而第二混合液包含絲膠蛋白(silk sericin protein, SSP)及聚乙烯醇;S1: preparing a first mixed solution and a second mixed solution. The first mixed solution includes silk fibroin protein (SFP) and polyvinyl alcohol, and the second mixed solution includes silk sericin protein (SSP) and Polyvinyl alcohol

S3:進行電紡織製程,電紡第一混合液至圓形片上形成不織布膜;S3: Perform an electrospinning process, and electrospin the first mixed solution to form a non-woven film on the circular sheet;

S5:塗佈鞣花酸溶液於不織布膜上形成變色指示圖式,並形成變色指示膜;S5: apply the ellagic acid solution on the non-woven film to form a discoloration indicating pattern, and form a discoloration indicating film;

S7:放置變色指示膜於圓形平皿之內且蓋上圓形模蓋,加入第二混合液於圓形模蓋中後冷凍乾燥,形成親水性基質;以及S7: placing the color-changing indicator film inside the round dish and covering the round mold cover, adding the second mixed liquid to the round mold cover, and freeze-drying to form a hydrophilic matrix; and

S9:移除圓形平皿及圓形模蓋後,即得敷料組合物。S9: After removing the round plate and the round mold cover, a dressing composition is obtained.

如步驟S1所示,秤取50mg之一絲膠蛋白(silk sericin protein, SSP)放入一個乾淨的樣品瓶中,並吸取2ml之一聚乙烯醇(Polyvinyl alcohol, PVA)(25 mg / ml)加入樣品瓶中與該絲膠蛋白混合,並以磁石攪拌器快速攪拌,形成一第二混合液,而該第二混合液為一絲膠蛋白/聚乙烯醇混合液。As shown in step S1, weigh 50mg of silk sericin protein (SSP) into a clean sample bottle, and draw 2ml of polyvinyl alcohol (PVA) (25 mg / ml) and add The sample bottle is mixed with the sericin and rapidly stirred with a magnetic stirrer to form a second mixed solution, and the second mixed solution is a sericin / polyvinyl alcohol mixed solution.

再者,秤取60mg之一絲素蛋白1(silk fibroin protein, SFP)與40mg之該聚乙烯醇(Polyvinyl alcohol, PVA)放入一個乾淨的樣品瓶中,並吸取1ml甲酸加入樣品瓶中與該絲素蛋白1及該聚乙烯醇混合,並以磁石攪拌器快速攪拌,形成一第一混合液,而該第一混合液為一絲素蛋白/聚乙烯醇混合液。Furthermore, 60 mg of silk fibroin protein 1 (SFP) and 40 mg of the polyvinyl alcohol (PVA) were weighed into a clean sample bottle, and 1 ml of formic acid was added to the sample bottle and the The silk fibroin 1 and the polyvinyl alcohol are mixed and quickly stirred with a magnetic stirrer to form a first mixed liquid, and the first mixed liquid is a silk fibroin / polyvinyl alcohol mixed liquid.

接續如步驟S3所示,於進行一電紡織製程,電紡該第一混合液至一圓形片上形成一不織布膜之步驟前,先進行調整一電紡參數之步驟,其中該電紡參數進一步包含一電壓數值、一工作距離以及一流動速度。As shown in step S3, before performing an electrospinning process, electrospinning the first mixed solution to form a non-woven film on a circular sheet, first perform a step of adjusting an electrospinning parameter, wherein the electrospinning parameter is further It includes a voltage value, a working distance, and a flow speed.

接續上述,先開啟除濕機將實驗環境濕度控制在40~45%之間,將該第一混合液用針筒吸取,並置入電紡織(electrospinning)裝置中。調整該電紡參數(該電壓數值 : 17kV、該工作距離 : 7.5cm、該流動速度 : 5µl/min),後將第一混合液電紡織於該圓形片上成膜,取下後即得該不織布膜。Following the above, the dehumidifier was turned on to control the humidity of the experimental environment between 40 and 45%, and the first mixed solution was sucked with a syringe and placed in an electrospinning device. Adjust the electrospinning parameters (the voltage value: 17kV, the working distance: 7.5cm, the flow speed: 5µl / min), and then form the first mixed liquid electrospun on the circular sheet to form a film. Non-woven film.

接續如步驟S5所示,於塗佈一鞣花酸溶液於該不織布膜上形成一變色指示圖式322,並形成一變色指示膜32之步驟前,該鞣花酸溶液須預先進行一酒精處理。Continuing as shown in step S5, before the steps of applying a ellagic acid solution on the non-woven fabric film to form a discoloration indicator pattern 322 and forming a discoloration indicator film 32, the ellagic acid solution must be subjected to an alcohol treatment in advance. .

接續上述,將一鞣花酸2(ellagic acid, EA)加熱溶解於一酒精中(300 µg/ml)製備成該鞣花酸溶液。Following the above, an ellagic acid (EA) was heated and dissolved in an alcohol (300 µg / ml) to prepare the ellagic acid solution.

並將該不織布膜固定後,於該不織布膜之一表面塗佈該鞣花酸溶液形成該變色指示圖式322,該變色指示圖式322為一十字狀。再放入真空抽氣機中抽乾該變色指示圖式322之該鞣花酸溶液,重複執行4次,即得該變色指示膜32,其中該變色指示膜32之吸收波長為365nm。After the non-woven fabric film is fixed, the ellagic acid solution is coated on one surface of the non-woven fabric film to form the discoloration indicator pattern 322, and the discoloration indicator pattern 322 is a cross shape. Then put it into a vacuum pump to dry the ellagic acid solution of the discoloration indicator pattern 322 and repeat the process 4 times to obtain the discoloration indicator film 32, wherein the absorption wavelength of the discoloration indicator film 32 is 365 nm.

再者,如步驟S7所示,放置該變色指示膜32(該變色指示圖示322朝下)於該圓形平皿之內且蓋上一圓形模蓋。Furthermore, as shown in step S7, the color-changing indicating film 32 (the color-changing indicating icon 322 faces downward) is placed inside the circular dish and covered with a circular mold cover.

並於該變色指示膜32上塗佈一層該第二混合液後放入-80°C冰凍1分鐘,取出後重複此步驟1次,在該變色指示膜32上形成冰層後,倒入該第二混合液於該圓形模蓋中後放入-80°C冰凍24小時,再進行冷凍乾燥處理24小時,即得一親水性基質30。And apply a layer of the second mixed liquid on the color-changing indicating film 32, and then freeze it at -80 ° C for 1 minute. After taking out, repeat this step once. After forming an ice layer on the color-changing indicating film 32, pour the The second mixed liquid was placed in the circular mold cover and frozen at -80 ° C for 24 hours, and then subjected to freeze-drying treatment for 24 hours to obtain a hydrophilic matrix 30.

最後如步驟S9所示,移除該圓形平皿及該圓形模蓋後,即得一敷料組合物3。Finally, as shown in step S9, after removing the round plate and the round mold cover, a dressing composition 3 is obtained.

並請搭配第2圖,其係為本發明之變色指示膜之吸收光光譜圖。由圖可知,加入該鞣花酸溶液之該變色指示圖式(鞣花酸溶液+絲素蛋白)的吸光波峰值為365nm。Please also match FIG. 2, which is an absorption light spectrum chart of the color-changing indicating film of the present invention. It can be seen from the figure that the peak of the absorption wave of the discoloration indicator pattern (elfin acid solution + silk fibroin) added with the ellagic acid solution is 365 nm.

再請搭配第3A-3B圖,其係為本發明之變色指示膜之結構示意圖。而該變色指示膜之指示原理為,通常螢光較常發生於低能量躍遷類型π→π*的化合物,因為π→π*躍遷的莫耳吸收係數通常較n→π*的過程大100到1000倍。而該變色指示膜中之該絲素蛋白1具有一絲素β片狀結構(Fibroin β sheet structure),使未塗佈該鞣花酸溶液之部分其電子吸收能量後從π躍遷至π*,釋放能量後呈現藍紫偏強的放光(如第3A圖)。Please also match Figs. 3A-3B, which are schematic structural diagrams of the color-changing indicating film of the present invention. The indication principle of the color-changing indicator film is that fluorescence usually occurs in compounds of low energy transition type π → π *, because the Mohr absorption coefficient of π → π * transition is usually 100 to 100 times larger than the process of n → π *. 1000 times. The silk fibroin 1 in the discoloration indicating film has a fibroin β sheet structure, so that the part that is not coated with the ellagic acid solution absorbs electrons and then transitions from π to π * and releases After the energy, blue-violet light is emitted (as shown in Figure 3A).

而在塗佈該鞣花酸溶液之該十字狀,有該鞣花酸2結合在該絲素蛋白1之該絲素β片狀結構之間,該鞣花酸2所具有的–OH為助色團的一種,助色團本身不會吸收紫外線範圍的輻射,但會讓有帶色基團的峰線飄移至較長波長處且會增加峰線強度。因此,結構的改變與助色團的影響讓吸收峰波長向長波方向移動(紅移)並讓放光波長往長波長變化,當該絲素蛋白1的π→π*吸收的能量在放出時,電子降至能接較小之該鞣花酸2的π軌域,放出較小的能量放光,呈現出波長較長的藍綠螢光(如第3B圖)。In the cross-shaped coating of the ellagic acid solution, the ellagic acid 2 is bound between the silk fibroin β sheet structure of the silk fibroin 1, and the -OH of the ellagic acid 2 is helpful A type of chromophore, the chromophore itself will not absorb radiation in the ultraviolet range, but will shift the peak lines with chromophores to longer wavelengths and increase the intensity of the peak lines. Therefore, the change in structure and the influence of the chromophore shift the absorption peak wavelength to the long wave direction (red shift) and change the light emission wavelength to the long wavelength. When the energy absorbed by π → π * of the silk fibroin 1 is released, The electron drops to a smaller π orbital range of the ellagic acid 2 and emits smaller energy to emit light, showing a longer blue-green fluorescent light (as shown in FIG. 3B).

接續搭配第4圖,其係為本發明之具變色指示功能之敷料組合物之示意圖。如圖所示,一種具變色指示功能之敷料組合物3,其包含:該親水性基質30;以及該變色指示膜32,設置於該親水性基質30之上,且該變色指示膜32包含該絲素蛋白/聚乙烯醇混合液及該鞣花酸溶液,且該鞣花酸溶液於該變色指示膜32上形成該變色指示圖式322。其中該親水性基質30,其係包含該絲膠蛋白/聚乙烯醇混合液。Continuing with Figure 4, it is a schematic diagram of a dressing composition with a color-changing indicator function according to the present invention. As shown in the figure, a dressing composition 3 having a discoloration indicating function includes: the hydrophilic substrate 30; and the discoloration indicating film 32 disposed on the hydrophilic substrate 30, and the discoloration indicating film 32 includes the The silk fibroin / polyvinyl alcohol mixed solution and the ellagic acid solution, and the ellagic acid solution formed the discoloration indicating pattern 322 on the discoloration indicating film 32. The hydrophilic matrix 30 comprises the sericin / polyvinyl alcohol mixed solution.

請搭配第5圖,其係為本發明之檢驗方法之流程圖。如圖所示,本發明之一種具變色指示功能之敷料組合物之檢驗方法,其步驟包含:Please refer to Figure 5, which is a flowchart of the inspection method of the present invention. As shown in the figure, a method for inspecting a dressing composition with a discoloration indicating function according to the present invention includes the following steps:

S2:取敷料組合物;S2: take the dressing composition;

S4:以紫外光照射敷料組合物之變色指示膜時,變色指示膜發出藍綠色光,變色指示膜包含鞣花酸溶液;以及S4: When the discoloration indicating film of the dressing composition is irradiated with ultraviolet light, the discoloration indicating film emits blue-green light, and the discoloration indicating film includes a ellagic acid solution; and

S6:當變色指示膜之鞣花酸溶液與金屬離子反應後,變色指示膜於紫外光下發出藍紫色光。S6: After the ellagic acid solution of the discoloration indicating film reacts with metal ions, the discoloration indicating film emits blue-violet light under ultraviolet light.

如步驟S2所示,取該敷料組合物,其係將放置於一傷口上。As shown in step S2, the dressing composition is taken and placed on a wound.

接續如步驟S4,以一紫外光照射該敷料組合物3之一變色指示膜32時,該變色指示膜32發出一藍綠色光,該變色指示膜32包含該鞣花酸溶液,並請搭配第6A圖,其係為本發明之變色指示膜之放光光譜圖。由圖可知,其加入該鞣花酸溶液之該十字狀部分(鞣花酸溶液+絲素蛋白)為該藍綠色光,而未塗佈該鞣花酸溶液之部分(絲素蛋白)為一藍紫色光。Continuing step S4, when one of the dressing composition 3's color-changing indicating film 32 is irradiated with an ultraviolet light, the color-changing indicating film 32 emits a blue-green light, and the color-changing indicating film 32 includes the ellagic acid solution. FIG. 6A is a light emission spectrum chart of the color-changing indicating film of the present invention. It can be seen from the figure that the cross-shaped portion (elfinic acid solution + silk fibroin) added to the ellagic acid solution is the blue-green light, and the portion (filin protein) that is not coated with the ellagic acid solution is Blue-purple light.

接續如步驟S6所示,當該變色指示膜32之該鞣花酸溶液與一金屬離子反應後,該變色指示膜32於該紫外光下發出該藍紫色光,其中該金屬離子係來自於一組織液且該紫外光之波長為365nm。Then, as shown in step S6, after the ellagic acid solution of the discoloration indicating film 32 reacts with a metal ion, the discoloration indicating film 32 emits the blue-violet light under the ultraviolet light, wherein the metal ion comes from a Tissue fluid and the wavelength of the ultraviolet light is 365 nm.

並請搭配第6B-6C圖,其係為本發明之變色指示膜之放光光譜圖。由圖可知,該組織液可為一去離子水(DI)或一人體模擬體液(simulated body fluid , SBF),該十字狀部分之該鞣花酸溶液與該去離子水或與該人體模擬體液之該金屬離子反應後,會使光波長進行位移,進而發出與未塗佈該鞣花酸溶液之部分相同之該藍紫色光。Please also match Figures 6B-6C, which are the light spectrum spectra of the color-changing indicator film of the present invention. It can be seen from the figure that the interstitial fluid can be a deionized water (DI) or a simulated body fluid (SBF), the ellagic acid solution in the cross-shaped part and the deionized water or the simulated body fluid After the metal ions react, the wavelength of light is shifted, and then the blue-violet light that is the same as the portion where the ellagic acid solution is not applied is emitted.

請接續搭配第6D圖,其係為本發明之變色指示膜之放光光譜圖。由圖可知,當該十字狀部分之該鞣花酸溶液與該傷口分泌之一基質金屬蛋白酵素2(matrix metalloproteinase 2, MMP2)上該金屬離子反應時,也會使光波長進行位移,進而發出與未塗佈該鞣花酸溶液之部分相同之該藍紫色光。Please continue to match Fig. 6D, which is a light emission spectrum diagram of the color-changing indicating film of the present invention. It can be seen from the figure that when the ellagic acid solution in the cross-shaped portion reacts with the metal ion on a matrix metalloproteinase 2 (MMP2) secreted by the wound, it will also shift the wavelength of light, and then emit The blue-violet light is the same as the portion where the ellagic acid solution is not applied.

接續請參閱第7圖,其係為本發明之具變色指示功能之敷料組合物之使用狀態圖。由圖可知,當該敷料組合物3經由一段時間(24小時)後,該十字狀部分之該鞣花酸溶液與該去離子水或與該人體模擬體液之該金屬離子反應後,逐漸改變其色光。Please refer to FIG. 7 for the continuation, which is a use state diagram of the dressing composition with a discoloration indicating function of the present invention. As can be seen from the figure, after the dressing composition 3 has passed for a period of time (24 hours), the ellagic acid solution in the cross-shaped portion reacts with the deionized water or the metal ion of the human body simulated body fluid, and gradually changes its Shade.

故本發明實為一具有新穎性、進步性及可供產業上利用者,應符合我國專利法專利申請要件無疑,爰依法提出發明專利申請,祈 鈞局早日賜准專利,至感為禱。Therefore, the present invention is truly novel, progressive, and available for industrial use. It should comply with the patent application requirements of China's patent law. No doubt, the invention patent application was filed in accordance with the law.

惟以上所述者,僅為本發明之較佳實施例而已,並非用來限定本發明實施之範圍,舉凡依本發明申請專利範圍所述之形狀、構造、特徵及精神所為之均等變化與修飾,均應包括於本發明之申請專利範圍內。However, the above are only preferred embodiments of the present invention, and are not intended to limit the scope of implementation of the present invention. For example, all changes and modifications of the shapes, structures, features, and spirits in accordance with the scope of the patent application for the present invention are made. Shall be included in the scope of patent application of the present invention.

1‧‧‧絲素蛋白1‧‧‧ silk fibroin

2‧‧‧鞣花酸 2‧‧‧ Ellagic acid

3‧‧‧敷料組合物 3‧‧‧ dressing composition

30‧‧‧親水性基質 30‧‧‧ hydrophilic matrix

32‧‧‧變色指示膜 32‧‧‧Discoloration indicating film

322‧‧‧變色指示圖式 322‧‧‧Color Change Indicator

S1-S9‧‧‧步驟流程 S1-S9‧‧‧step flow

第1圖:其係為本發明之製備方法之流程圖;Figure 1: It is a flowchart of the preparation method of the present invention;

第2圖:其係為本發明之變色指示膜之吸收光光譜圖; Figure 2: It is the absorption light spectrum chart of the color-changing indicating film of the present invention;

第3A-3B圖:其係為本發明之變色指示膜之結構示意圖; 3A-3B: a schematic diagram of the structure of the color-changing indicator film of the present invention;

第4圖:其係為本發明之具變色指示功能之敷料組合物之示意圖; FIG. 4 is a schematic diagram of a dressing composition having a discoloration indicating function according to the present invention;

第5圖:其係為本發明之檢驗方法之流程圖; FIG. 5 is a flowchart of the inspection method of the present invention;

第6A-6D圖:其係為本發明之變色指示膜之放光光譜圖;以及 Figures 6A-6D: a light emission spectrum of the color-changing indicator film of the present invention; and

第7圖:其係為本發明之具變色指示功能之敷料組合物之使用狀態圖。 FIG. 7 is a diagram showing a state of use of a dressing composition having a discoloration indicating function according to the present invention.

Claims (3)

一種具變色指示功能之敷料組合物之檢驗方法,其步驟包含: 取一敷料組合物; 以一紫外光照射該敷料組合物之一變色指示膜時,該變色指示膜發出一藍綠色光,該變色指示膜包含一鞣花酸溶液;以及 當該變色指示膜之該鞣花酸溶液與一金屬離子反應後,該變色指示膜於該紫外光下發出一藍紫色光。A test method for a dressing composition with a discoloration indicating function, the steps include: Take a dressing composition; When one of the discoloration indicating films of the dressing composition is irradiated with an ultraviolet light, the discoloration indicating films emit a blue-green light, and the discoloration indicating films include a ellagic acid solution; and When the ellagic acid solution of the discoloration indicating film reacts with a metal ion, the discoloration indicating film emits a blue-violet light under the ultraviolet light. 如申請專利範圍第1項所述之具變色指示功能之敷料組合物之檢驗方法,其中該金屬離子係來自於一組織液。The test method for a dressing composition with a discoloration indicating function as described in item 1 of the scope of the patent application, wherein the metal ion is derived from an interstitial fluid. 如申請專利範圍第1項所述之具變色指示功能之敷料組合物之檢驗方法,其中該紫外光之波長為365nm。The inspection method of the dressing composition with a discoloration indicating function as described in item 1 of the scope of the patent application, wherein the wavelength of the ultraviolet light is 365 nm.
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