TWI691314B - Inspection method of dressing composition with color change indication function - Google Patents

Abstract

The invention relates to a method for testing a dressing composition with a color-changing indicator function. The color change indicator film of the dressing composition is formed by the electro-textile process and applying the ellagic acid solution. It is irradiated with ultraviolet light, and the current condition of the wound is judged by the discoloration effect produced by the reaction of the ellagic acid solution with the metal ions, so as to reduce unnecessary wound dressing replacement.

Description

Inspection method of dressing composition with color change indication function

The present invention is a divisional case of application 106145819. The invention relates to a dressing composition, in particular to a method for testing a dressing composition with a color-changing indicator function.

The skin is the body's largest tissue and organ, and it is also the first line of defense against foreign pathogens. If a wound occurs, it can heal the wound quickly and restore its defense. It is an urgent task.

According to scientific and statistical reports in recent years, the global trauma market is increasingly in demand, especially in surgical trauma. The total number of people in the global trauma market has exceeded 100 million person-times each year, and the trend is increasing year by year. Every year, about 20 million people suffer trauma and lacerations due to accidents, while the number of burns and scalds is about 10 million people per year. In addition, the number of ulcerative wounds caused by chronic diseases, diabetes, and aging has exceeded 3 Ten million people.

Nowadays, surgery has greatly reduced the risks caused by surgery, but with it comes the need for better wound care and prevention of postoperative scars. At present, methods of wound care by means of various advanced dressings have appeared to shorten the healing time of wounds and eliminate scars at the same time.

In general, the requirements of traditional wound dressings include: (1) non-toxic and biocompatible (2) can effectively isolate pathogens and (3) can provide antibacterial and hemostatic functions.

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 fluid leakage and protect wounds from contamination by bacteria and dust particles. Although the traditional gauze dressing can protect the wound, it does not promote wound healing, and has poor ability to manage exudate. When changing the dressing, it is easy to cause uncomfortable reactions such as repeated injury and pain, scar formation due to sticking to the wound new tissue, so it is difficult to satisfy modern people. Appeal for appearance and timeliness.

Therefore, the treatment mode of wounds gradually changed from "dry wound healing" to "wet wound healing". As far as wound dressings are concerned, they have also changed from traditional dressings such as gauze and tape to wet dressings such as hydrophilic dressings. Recently, there are biomaterial dressings or functional dressings. As for the choice of dressings today, compared with the past, the demands for ingredients are natural, high absorption and low reperfusion.

As far as silk proteins are concerned, silk proteins are a kind of natural biopolymer protein. Its main components are sericin <sericin> and fibroin <fibroin>. Sericin accounts for about 20% to 30% of the total silk protein %, the content of silk fibroin accounts for 70% to 80% of the total silk protein.

Silk fibroin contains 18 kinds of amino acids, of which glycine (gly), alanine (ala) and serine (ser) account for more than 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 can be obtained in different forms after different treatments, such as fiber, solution, powder, Membrane and gel etc.

However, the structure of sericin is composed of 18 different amino acids, 32% of which are serine. And sericin itself has the functions of inhibiting free radicals and anti-oxidation, can resist the erosion of the skin by ultraviolet rays in sunlight, and has the effect of inhibiting the activity of tyrosinase to inhibit the production of skin melanin.

However, wound dressings still face problems in terms of condition, such as dressing moisture, wound healing, and time to change, such as when the wound dressing needs to be replaced or the wound dressing is moist. The wound status cannot be easily seen from the appearance of the wound dressing, and the wound status is often known after the wound dressing is changed. For this reason, too much wound dressing is often wasted.

Therefore, how to judge the state of the wound based on the appearance of the wound dressing without changing the wound dressing. It is a problem to be solved by those skilled in the art.

The main object of the present invention is to provide a method for testing a dressing composition with a color-changing indicator function. Use the discoloration on the dressing to indicate the discoloration of the film to determine the current wound status. To reduce unnecessary wound dressing replacement.

In order to achieve the above objects and effects, the present invention discloses a method for preparing a dressing composition with a color-changing indicator function. Through the electrospinning process, after the electrospun fibroin/polyvinyl alcohol mixed solution forms a nonwoven film, a ellagic acid solution is applied to form a color change indicator film. The color-changing indicator film is placed on the hydrophilic matrix formed by the sericin/polyvinyl alcohol mixed liquid, and processed to prepare a dressing composition. And by the discoloration effect of the ellagic acid solution on the dressing composition, the state of the wound is judged.

The present invention provides an embodiment, which includes a method for preparing a dressing composition having a color-changing indicator function, wherein the first mixed liquid is a silk fibroin/polyvinyl alcohol mixed liquid.

The present invention provides an embodiment, which includes a method for preparing a dressing composition having a color-changing indicator function, wherein the second mixed liquid is a sericin/polyvinyl alcohol mixed liquid.

The present invention provides an embodiment, which includes a method for preparing a dressing composition having a color-changing indicator function, wherein before performing an electrospinning process, electrospinning the first mixed liquid onto a circular sheet to form a nonwoven film, It further includes the steps of adjusting an electrospinning parameter.

The present invention provides an embodiment, which includes a method for preparing a dressing composition having a color-changing indicator function, wherein the electrospinning parameters further include a voltage value, a working distance, and a flow speed.

The present invention provides an embodiment, which includes a method for preparing a dressing composition having a color-changing indicator function, wherein the ellagic acid solution must be pre-treated with an alcohol.

In addition, the present invention discloses a dressing composition with a color-changing indicator function, which comprises: a hydrophilic matrix; and a color-changing indicator film, which is arranged on the hydrophilic matrix, and the color-changing indicator film comprises a silk fibroin/polymer The vinyl alcohol mixed solution and an ellagic acid solution, and the ellagic acid solution forms a color-changing indicator pattern on the color-changing indicator film.

The present invention provides an embodiment, which includes a dressing composition having a color-changing indicator function, wherein the hydrophilic matrix includes a sericin/polyvinyl alcohol mixture.

In addition, the present invention discloses a method for inspecting a dressing composition with a color-changing indicator function. The steps include: taking a dressing composition; when a color-changing indicator film of the dressing composition is irradiated with an ultraviolet light, the color-changing indicator film emits A blue-green light, the color-changing indicator film contains a ellagic acid solution; and when the ellagic acid solution of the color-changing indicator film reacts with a metal ion, the color-changing indicator film emits a blue-violet light under the ultraviolet light.

The present invention provides an embodiment, which includes a method for testing a dressing composition having a color-changing indicator function, wherein the metal ion comes from a tissue fluid.

The present invention provides an embodiment, which includes a method for testing a dressing composition having a color-changing indicator function, wherein the wavelength of the ultraviolet light is 365 nm.

In order to make your review committee have a better understanding and understanding of the features and effects of the present invention, we will use the examples and supporting descriptions as follows:

In view of the fact that the wound state cannot be easily seen from the appearance of the wound dressing, the wound state can often be known only after the wound dressing is replaced, thus wasting the impact of excessive wound dressing. Based on this, the present invention proposes a dressing composition with a color-changing indicator function Test method to solve the problems caused by the conventional technology.

In the following, the characteristics, the structure and the method included in the inspection method of the dressing composition with the color change indicating function of the present invention will be further described:

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 color-changing indicator function of the present invention includes the following steps:

S1: Prepare 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: The electro-textile process is carried out, and the first mixed liquid is electro-spun to form a non-woven film on the circular sheet;

S5: apply ellagic acid solution on the non-woven fabric film to form a color-changing indicator pattern and form a color-changing indicator film;

S7: Place the color-changing indicator film in a round dish and cover with a round mold cover, add the second mixed liquid to the round mold cover and freeze-dry to form a hydrophilic matrix; and

S9: After removing the round dish and the round mold cover, the dressing composition is obtained.

As shown in step S1, weigh 50mg of silk sericin protein (SSP) into a clean sample bottle, and draw 2ml of polyvinyl alcohol (Polyvinyl alcohol, PVA) (25 mg/ml) and add The sample bottle is mixed with the sericin and rapidly stirred with a magnet stirrer to form a second mixed solution, and the second mixed solution is a mixed solution of sericin/polyvinyl alcohol.

Furthermore, weigh 60mg of silk fibroin protein 1 (SFP) and 40mg of the polyvinyl alcohol (Polyvinyl alcohol, PVA) into a clean sample bottle, and draw 1ml of formic acid into the sample bottle and the The silk fibroin 1 and the polyvinyl alcohol are mixed and quickly stirred with a magnet stirrer to form a first mixed liquid, and the first mixed liquid is a mixed silk fibroin/polyvinyl alcohol liquid.

Next, as shown in step S3, before the step of electrospinning the process of electrospinning the first mixed liquid onto a circular sheet to form a nonwoven film, a step of adjusting an electrospinning parameter is carried out, wherein the electrospinning parameter is further Including a voltage value, a working distance and a flow speed.

Following the above, the dehumidifier is first turned on to control the humidity of the experimental environment between 40 and 45%, the first mixed liquid is 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 electrospinning the first mixed liquid on the circular sheet to form a film, which is obtained after removal Non-woven film.

Next, as shown in step S5, before applying a ellagic acid solution on the non-woven fabric film to form a color-changing indicator pattern 322 and forming a color-changing indicator film 32, the ellagic acid solution must be subjected to an alcohol treatment in advance .

Following the above, a ellagic acid 2 (ellagic acid, EA) was heated and dissolved in an alcohol (300 µg/ml) to prepare the ellagic acid solution.

After fixing the nonwoven fabric film, the ellagic acid solution is coated on one surface of the nonwoven fabric film to form the color change indicator pattern 322, and the color change indicator pattern 322 is a cross shape. Then put it in a vacuum evacuator to dry the ellagic acid solution of the discoloration indicator pattern 322, and repeat it 4 times to obtain the discoloration indicator film 32, wherein the absorption wavelength of the discoloration indicator film 32 is 365nm.

Furthermore, as shown in step S7, the color-changing indicator film 32 (with the color-changing indicator icon 322 facing down) is placed in the circular dish and covered with a circular mold cover.

And coat a layer of the second mixed liquid on the color-changing indicator film 32, put it into -80°C and freeze for 1 minute, and after taking it out, repeat this step once, after forming an ice layer on the color-changing indicator film 32, pour into the The second mixed liquid is placed in the circular mold cover and placed in -80°C to freeze for 24 hours, and then freeze-dried for 24 hours to obtain a hydrophilic substrate 30.

Finally, as shown in step S9, after removing the round dish and the round mold cover, a dressing composition 3 is obtained.

Please also refer to Figure 2, which is the absorption spectrum of the color-changing indicator film of the present invention. It can be seen from the figure that the absorption peak of the color change indicator pattern (ellagic acid solution + silk fibroin) added with the ellagic acid solution is 365 nm.

Please also refer to Figures 3A-3B, which are schematic structural diagrams of the color-changing indicator 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 molar absorption coefficient of π→π* transition is usually 100 to 100 larger than that of n→π*. 1000 times. The silk fibroin 1 in the color-changing indicator film has a fibroin β sheet structure, so that the portion of the ellagic acid solution that is not coated with the electron absorbs energy and then transitions from π to π* to release After the energy, it shows a strong blue-violet emission (as shown in Figure 3A).

In the cruciform shape coated with the ellagic acid solution, the ellagic acid 2 is bound between the silk fibroin β sheet-like structures of the silk fibroin 1, and the -OH of the ellagic acid 2 is used as an aid A type of chromophore, the auxiliary chromophore itself will not absorb radiation in the ultraviolet range, but will shift the peak of the chromophore to a longer wavelength and increase the intensity of the peak. Therefore, the structural change and the influence of the auxiliary chromophore shift the absorption peak wavelength to the long-wave direction (red shift) and the emission wavelength to the long wavelength. When the energy absorbed by the π→π* of the silk fibroin 1 is released , The electron is reduced to the π orbital region of the ellagic acid 2 which can be smaller, and emits a smaller energy to emit light, showing a blue-green fluorescent light with a longer wavelength (as shown in Figure 3B).

Continued with FIG. 4, which is a schematic diagram of the dressing composition with the color change indicating function of the present invention. As shown in the figure, a dressing composition 3 with a color-changing indicator function includes: the hydrophilic matrix 30; and the color-changing indicator film 32 is disposed on the hydrophilic substrate 30, and the color-changing indicator film 32 includes the The silk fibroin/polyvinyl alcohol mixed solution and the ellagic acid solution, and the ellagic acid solution forms the color change indicator pattern 322 on the color change indicator film 32. The hydrophilic matrix 30 contains the sericin/polyvinyl alcohol mixture.

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 testing a dressing composition with a color-changing indicator function of the present invention includes the following steps:

S2: Take the dressing composition;

S4: When the color change indicator film of the dressing composition is irradiated with ultraviolet light, the color change indicator film emits blue-green light, and the color change indicator film contains a ellagic acid solution; and

S6: When the ellagic acid solution of the color-changing indicator film reacts with metal ions, the color-changing indicator film emits blue-violet light under ultraviolet light.

As shown in step S2, the dressing composition is taken and placed on a wound.

Following step S4, when one of the color change indicator films 32 of the dressing composition 3 is irradiated with an ultraviolet light, the color change indicator film 32 emits a blue-green light, and the color change indicator film 32 includes the ellagic acid solution. Figure 6A is a light emission spectrum diagram of the color-changing indicator film of the present invention. It can be seen from the figure that the cross-shaped portion (ellagic acid solution + silk fibroin) added to the ellagic acid solution is the blue-green light, and the portion (silk protein) not coated with the ellagic acid solution is a Blue purple light.

Next, as shown in step S6, when the ellagic acid solution of the color change indicator film 32 reacts with a metal ion, the color change indicator 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 365nm.

Please also match with Figure 6B-6C, which is the light emission spectrum of the color-changing indicator film of the present invention. It can be seen from the figure that the tissue fluid can be a DI water or a simulated body fluid (SBF), the cross-shaped portion of the ellagic acid solution and the DI water or the human body fluid After the metal ion reacts, the wavelength of light is shifted, and the blue-violet light that is the same as the portion not coated with the ellagic acid solution is emitted.

Please continue to match the 6D figure, which is the light emission spectrum of the color-changing indicator film of the present invention. It can be seen from the figure that when the ellagic acid solution of the cross-shaped portion reacts with the metal ion on matrix metalloproteinase 2, MMP2 secreted by the wound, the wavelength of light is also shifted, and then emitted The blue-violet light that is the same as the part not coated with the ellagic acid solution.

Please refer to FIG. 7 for the continuation, which is a state diagram of the use of the dressing composition with the color change indicating function of the present invention. It can be seen from the figure that after the dressing composition 3 passes for a period of time (24 hours), the ellagic acid solution of the cross-shaped portion reacts with the deionized water or the metal ion of the simulated body fluid of the human body, and then gradually changes its Shades.

Therefore, the present invention is truly novel, progressive and available for industrial use. It should meet the patent application requirements of my country's Patent Law. It is undoubtedly necessary to file an invention patent application in accordance with the law and pray for the early grant of patents.

However, the above are only the preferred embodiments of the present invention and are not intended to limit the scope of the implementation of the present invention. Any changes and modifications based on the shape, structure, features and spirit described in the patent application scope of the present invention , Should be included in the scope of the patent application of the present invention.

1‧‧‧ silk fibroin 2‧‧‧ellagic acid 3‧‧‧dressing composition 30‧‧‧Hydrophilic matrix 32‧‧‧Discoloration indicator film 322‧‧‧Color change indicator pattern S1-S9‧‧‧Step flow

Figure 1: It is a flow chart of the preparation method of the present invention; Figure 2: This is the absorption light spectrum of the color-changing indicator film of the present invention; Figures 3A-3B: It is a schematic diagram of the structure of the color-changing indicator film of the present invention; Figure 4: It is a schematic diagram of the dressing composition with the color change indicating function of the present invention; Figure 5: It is a flow chart of the inspection method of the present invention; Figures 6A-6D: This is the light emission spectrum of the color-changing indicator film of the present invention; and Figure 7: This is the use state diagram of the dressing composition with the color change indicating function of the present invention.

S2‧‧‧Step flow

S4‧‧‧Step flow

S6‧‧‧Step flow

Claims (3)

An inspection method of a dressing composition with a color-changing indicator function, the steps of which include: Take a dressing composition; When a color change indicator film of the dressing composition is irradiated with an ultraviolet light, the color change indicator film emits a blue-green light, and the color change indicator film includes a ellagic acid solution; and When the ellagic acid solution of the discoloration indicator film reacts with a metal ion, the discoloration indicator film emits a blue-violet light under the ultraviolet light. The method for testing a dressing composition with a color-changing indicator function as described in item 1 of the patent application scope, wherein the metal ion comes from a tissue fluid. The method for testing a dressing composition with a color-changing indicator function as described in item 1 of the patent application, wherein the wavelength of the ultraviolet light is 365 nm.

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