Method for manufacturing artificial bandages

Abstract

To provide an artificial dressing suitable for promoting wound healing and a method for manufacturing the artificial dressing.SOLUTION: The artificial dressing comprises a gelatin, a polysorbate-20 and a glutaraldehyde. The manufacturing method of the artificial dressing comprises subjecting the composition of the gelatin, the glutaraldehyde and the polysorbate-20 to a mixing and foaming step, a molding step, and a freeze-drying step in sequence. The artificial dressing has obvious pores and is capable of absorbing liquid about 25 to 35 times its own weight.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a dressing and its use, and particularly to an artificial dressing for promoting wound healing and its use.

Background Art

[0002] Diabetic foot ulcers (DFU) are one of the severe complications of diabetes, and patients with DFU account for 25% of the total diabetic population. Among them, 50% of the patients require amputation, and the mortality rate within 5 years after amputation is as high as 50%. For diabetic foot ulcers, wet dressings are performed to adjust the balance of the extracellular matrix and promote wound healing.

[0003] Wet dressings can provide a moist environment for the wound, perform autolytic debridement of the wound, relieve pain, activate collagen synthesis to promote keratinocytes, and enable cells to move within the wound bed to promote wound healing. Wet dressings heal 3 to 5 times faster than conventional dressings (such as gauze, bandages, etc.). Dressings commonly used in wet dressings include foams, hydrocolloids, and hydrogels. The commercially available foam dressings for wet dressings are mainly collagen dressings, but their cost is high.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The main component used in the artificial dressing of the present invention is gelatin, which has the advantages of biocompatibility, low cost, and the ability to absorb water and form a gel. Furthermore, the artificial dressing of the present invention is a sheet-shaped gelatin dressing (SIPSIP

[0004] ), which has obvious pores and can absorb about 25 to 35 times its own weight of liquid. As a result of heat disintegration experiments and sticking tests, no disintegration was observed. Furthermore, as a result of animal experiments, compared with commercially available dressings, the artificial dressing of the present invention can promote wound healing when applied dry and can proliferate the functional tissues of the wound when applied wet. [Means for solving the problem]

[0005] The present invention provides an artificial bandage for promoting wound healing, comprising gelatin, polysorbate-20, and glutaraldehyde.

[0006] In certain examples, the concentration of gelatin is 5% (g / mL, w / v) to 10% (g / mL, w / v), the concentration of polysorbate-20 (tween 20) is 0.005% (mL / mL, v / v) to 0.1% (mL / mL, v / v), and the concentration of glutaraldehyde is 0.01% (mL / mL, v / v) to 0.3% (mL / mL, v / v).

[0007] The present invention also provides an artificial bandage having a thickness of 1 mm to 10 mm.

[0008] In certain embodiments, the pore size of the artificial bandage is 60 μm to 70 μm.

[0009] In another specific embodiment, the void ratio of the artificial bandage is 60% to 67%.

[0010] The wounds in this invention include, but are not limited to, bruises, knife wounds, common acute wounds, first- and second-degree burns, surgical wounds, pressure ulcers, and ulcers.

[0011] The artificial bandage of this invention is in the form of a sheet.

[0012] The artificial bandage of the present invention becomes gel-like upon humidification or absorption of tissue fluid.

[0013] The artificial bandage of the present invention is resistant to high-energy gamma-ray radiation exposure doses of 15 kGy to 25 kGy, and its texture and function are not affected.

[0014] The present invention also includes a step (1) of mixing gelatin, glutaraldehyde, and polysorbate-20 to form a mixture, and stirring to cause foaming, After the mixing and foaming step is completed, step (2) is performed in which the mixture is poured into a mold and spread evenly, The present invention provides a method for manufacturing an artificial bandage, which includes a freeze-drying step (3) in which the mold is placed in a freeze-dryer and frozen, and freeze-dried to form an artificial bandage.

[0015] In a specific implementation method, the gelatin concentration is 5% (w / v) to 10% (w / v).

[0016] In another specific implementation, the concentration of polysorbate-20 is 0.005% (v / v) to 0.1% (v / v).

[0017] In another specific implementation, the concentration of glutaraldehyde is 0.01% (v / v) to 0.3% (v / v).

[0018] The present invention also provides a method of using a composition to promote wound healing, which includes applying the above-mentioned artificial bandage to a patient's wound.

[0019] In certain implementation methods, the composition is used in moist wound healing.

[0020] The present invention also provides the use of a composition for producing an artificial bandage that promotes wound healing, wherein the composition comprises gelatin, polysorbate-20, and glutaraldehyde.

[0021] In certain embodiments, the composition promotes wound healing by (1) absorbing tissue fluid of the wound, (2) inhibiting the proliferation of granuloma tissue of the wound, (4) reducing inflammation of the wound, (5) promoting angiogenesis within the wound tissue, and (6) reducing adhesion to the wound.

[0022] In another specific embodiment, the wound includes, but is not limited to, contusions, knife wounds, general acute wounds, first-degree / second-degree burns, surgical wounds, pressure ulcers and ulcers.

Advantages of the Invention

[0023] Based on the above, the artificial dressing of the present invention, its use and manufacturing method for promoting wound healing have the following advantages.

[0024] (1) The artificial dressing of the present invention has obvious pores and can absorb liquids about 25 to 35 times its own weight. As a result of the thermal collapse experiment and the adhesion test, no collapse was observed.

[0025] (2) The artificial dressing of the present invention can promote wound healing when applied dry, and can proliferate the functional tissues in the wound when applied wet.

[0026] (3) The artificial dressing of the present invention is significantly cheaper than conventional wet therapy and conventional dressings, and the uses of the artificial dressing of the present invention are wider.

[0027] (4) The artificial dressing of the present invention can absorb the tissue fluid of the wound, inhibit the growth of granulation tissue of the wound, promote angiogenesis in the wound tissue, and promote wound healing.

[0028] In order to further understand the technical features of the present invention and the achievable technical effects, preferred embodiments and detailed descriptions are provided below.

Brief Description of the Drawings

[0029] [Figure 1] It is a flowchart of the manufacture of the artificial dressing of the present invention. [Figure 2]Figure 2A shows cross-sectional views of gelatin bandages crosslinked with different glutaraldehyde concentrations according to the present invention. Figure 2B shows a glutaraldehyde concentration of 0.30%, Figure 2C shows a glutaraldehyde concentration of 0.10%, Figure 2D shows a glutaraldehyde concentration of 0.05%, and Figure 2E shows a glutaraldehyde concentration of 0.01%. [Figure 3] This is a test chart for artificial bandages. Figure 3(A) shows the results of the thermal disintegration test of the artificial bandage. Figure 3(B) shows the results of the adhesiveness test of the artificial bandage. [Figure 4] This is a schematic diagram of animal experiments with artificial bandages. [Figure 5] This is a schematic diagram showing the analysis of mouse wound area using ImageJ software. [Figure 6] This is a statistical chart of the wound area in mice from day 0 to day 31 in different bandaging groups. [Figure 7] This image shows H&E staining analysis of animal skin sections (Group A: No bandage NC group). The orange arrows indicate the wound bed, the green arrows indicate polymorphonuclear leukocytes (neutrophils), the red circles indicate granuloma tissue, and the light pink spindle-shaped areas in the right image are fibroblasts. The scale bar in the left image is 1 mm, and the scale bar in the right image is 100 μm. [Figure 8] This image shows H&E staining analysis of animal skin sections (Group B: commercially available collagen bandage PC group). The orange arrows indicate wound bed, the green arrows indicate polymorphonuclear leukocytes, the red circles indicate granulation tissue, and the light pink spindle-shaped areas in the right image are fibroblasts. The scale bar in the left image is 1 mm, and the scale bar in the right image is 100 μm. [Figure 9] This image shows the H&E staining analysis of animal skin sections (Group C: artificial bandage applied dry). The orange arrows indicate the wound bed, the blue arrows indicate newly formed functional tissue, the red arrows indicate new blood vessels, the light pink area in the right image is collagen, and the spindle-shaped parts are fibroblasts. The scale bar in the left image is 1 mm, and the scale bar in the right image is 100 μm. [Figure 10]This image shows the H&E staining analysis of animal skin sections (Group D: group treated with moist artificial bandages). The orange arrows indicate the wound bed, the blue arrows indicate mononuclear cells (monocytes), and the red arrows indicate newly formed functional tissue. The scale bar in the left image is 1 mm, and the scale bar in the right image is 100 μm. [Modes for carrying out the invention]

[0030] To facilitate understanding of the technical features, content, advantages, and effects that can be achieved by the present invention, the present invention will be described in detail below in the form of embodiments with reference to drawings. The drawings used herein are for illustrative and supplementary purposes only and may not represent the true proportions or exact configuration of the present invention after implementation. Therefore, the proportions and configurations in the accompanying drawings should not be construed as limiting the actual scope of the present invention. For ease of understanding, identical elements will be denoted by the same reference numerals in the following embodiments.

[0031] Furthermore, unless otherwise specified, terms used throughout this specification and the scope of the patent application have the common meanings of each term used in the art, the content disclosed herein, and in specific contexts. Specific terms used to describe the present invention are described below or elsewhere in this specification to provide additional guidance to those skilled in the art in describing the invention.

[0032] The use of terms such as "first," "second," and "third" in this specification does not imply any particular order or priority, nor is it intended to limit the invention. This terminology is used only to distinguish components or operations described by the same technical terms.

[0033] Next, wherever words such as “inclusion,” “include,” “have,” and “contain” are used herein, they are all open terms, meaning that “include” is not limited.

[0034] The following examples are non-limiting and merely represent various aspects and features of the present invention.

[0035] The present invention provides an artificial bandage for promoting wound healing, comprising a composition of gelatin, polysorbate 20 (tween 20), and glutaraldehyde. This composition is used to manufacture an artificial bandage that promotes wound healing. This composition can be used as a moist wound healing agent or as a dry patch. The thickness of the artificial bandage is 1 mm to 10 mm, the pore size is 60 μm to 70 μm, and the porosity is 60% to 67%. The artificial bandage is in sheet form. The artificial bandage becomes gel-like upon humidification or absorption of tissue fluid. The artificial bandage of the present invention is resistant to high-energy gamma-ray radiation exposure doses (15 kGy to 25 kGy) and is unaffected in terms of texture and function. The wounds described above include, but are not limited to, bruises, knife wounds, common acute wounds, first / second degree burns, surgical wounds, pressure ulcers, and ulcers (e.g., diabetic foot ulcers).

[0036] Example 1: The manufacturing procedure for an artificial bandage is shown in Figure 1.

[0037] The method for manufacturing an artificial bandage includes the following steps:

[0038] (1) Mixing and foaming step S10: Mix 5% (g / mL, w / v) to 10% (g / mL, w / v) of gelatin, 0.005% (mL / mL, v / v) to 0.1% (mL / mL, v / v) of polysorbate-20, and 0.01% (mL / mL, v / v) to 0.3% (mL / mL, v / v) of glutaraldehyde to form a mixture, which is then stirred to cause foaming. The concentrations of gelatin, polysorbate-20, and glutaraldehyde can be any value and range within the corresponding numerical ranges described above, with the remainder being water. In the manufacture of artificial bandages in this invention, gelatin refers to an aqueous gelatin solution with a gelatin concentration of 5% (g / mL, w / v) to 10% (g / mL, w / v). This concentration may be any value and range within this range. In this invention, the above stirring and foaming step is performed using, for example, a commercially available stirrer (fine particle emulsifying homogenizer, HMB-312SS, manufactured by Quanhua Confidential Co., Ltd.), but is not limited thereto. The stirring time for the above stirring and foaming step is, for example, 10 to 15 minutes, but is not limited thereto, and the stirring speed is, for example, 1500 rpm to 3000 rpm, but is not limited thereto. The stirring time and stirring speed in this invention may be any value and range within the corresponding numerical ranges above, or other values ​​or ranges outside the corresponding numerical ranges above, as long as the above composition (gelatin, glutaraldehyde, and polysorbate-20) can be uniformly mixed and foamed, all of these are within the scope of protection claimed by this invention. The sources of the above compositions are, for example, commercially available products. For example, gelatin is purchased from Sigma-Aldrich (product name G2500), glutaraldehyde is purchased from Tokyo Chemical Industry (TCI) (product name G0068), and polysorbate-20 is purchased from Sigma-Aldrich (product name P1379), but these are not limited to these.

[0039] (2) Molding step S20: After the above mixing and foaming step is completed, the mixture is poured into the mold and spread evenly. The mold is a container having a housing space, but the mold of the present invention is not limited to a particular form or style and may be any form or style.

[0040] (3) Freeze-drying step S30: The mold is placed in a freeze-dryer that has been pre-cooled (pre-cooling temperature -20℃ to -60℃) and frozen, and freeze-dried to form an artificial bandage. The freeze-dryer is, for example, a 15-liter shelf-type freeze-dryer of model TYFD80015 purchased from Taiyi Industrial Co., Ltd. The composition of the artificial bandage after freeze-drying contains 92.6% (g / mL, w / v) to 99.8% (g / mL, w / v) of gelatin, 0.05% (mL / mL, v / v) to 1.85% (mL / mL, v / v) of polysorbate-20 (tween 20), and 0.15% (mL / mL, v / v) to 5.55% (mL / mL, v / v) of glutaraldehyde. Similarly, the concentrations of gelatin, polysorbate-20, and glutaraldehyde in the freeze-dried artificial bandage may be any value and any range within the corresponding numerical ranges described above.

[0041] The above freezing procedure is completed by freeze-drying according to the operating steps and freeze-drying parameters of a shelf-type freeze-dryer. The freeze-drying parameters for the freeze-dryer are shown in Table 1.

[0042] Table 1. Freeze drying parameters of a shelf-type freeze dryer.

[0043] [Table 1]

[0044] The freeze-drying time for the freeze-drying step S30 described above is shown in Table 1, but the present invention is not limited thereto, and any freeze-drying time is included in the scope of the present invention as long as a freeze-dried artificial bandage is obtained. For example, the freeze-drying time described above is greater than 1 hour.

[0045] Example 2: Scanning electron microscopy (SEM) image of an artificial bandage.

[0046] The artificial bandage manufactured as described above was used as the test sample. The sample was cut in section view, secured to a dedicated stage with copper tape, and moved to a gold plating apparatus. The sample was then vacuum-suctioned to 40 Pa and plated with platinum for 60 seconds to enhance its conductivity. The stage containing the test sample was placed in the sample chamber of a scanning electron microscope, the working distance of the stage was adjusted, the sample chamber was vacuum-suctioned, and an image of the test sample was observed through the screen. The three-dimensional coordinate XYZ axis knobs were adjusted to align the stage position with the field of view, and the sample was scanned with an electron beam intensity of Spotsize 50 and a voltage of 15kV. The surface morphology and structure of the artificial bandage were observed and captured from the recorded images, which are shown in Figure 2.

[0047] Example 3: Porosity of artificial bandage

[0048] The SEM images from Example 2 were imported into conventional ImageJ software, and the pore diameter and porosity of the artificial bandage at various glutaraldehyde concentrations were estimated. By correcting and transforming the pixel ratio of each image file using an image scale, adjusting the threshold interval for the image's brightness and darkness contrast, excluding excessively small noise shadows, and selecting the pore area to calculate, the average pore diameter and porosity area of ​​the artificial bandage could be estimated and counted. The porosity of the artificial bandage calculated using the ImageJ software from the SEM images is shown in Table 2.

[0049] Table 2. Results of pore size analysis of artificial bandages in SEM images.

[0050] [Table 2]

[0051] SEM images of each group showed that the artificial bandages in each group had complete and dense porosity. Software calculations revealed that the pore size was distributed on average between 60 and 70 μm, and the porosity was approximately 60% to 67%. This indicates that glutaraldehyde within this concentration range does not affect the pore size and porosity of the artificial bandages. The porosity of the artificial bandages may be any value or range within the above numerical range (60% to 67%).

[0052] Example 4: Absorbency of artificial bandages

[0053] The water absorption of the artificial bandage was tested according to the standard method EN-13726-1.

[0054] From Table 3, 4cm 2 It was found that the artificial bandage can absorb 25 to 35 times its own weight in liquid.

[0055] Table 3. Results of water absorption tests of artificial bandages (I) and (II)

[0056] [Table 3]

[0057] TIFF0007862497000004.tif128155

[0058] Example 5: Thermal disintegration test of artificial bandages

[0059] The purpose of this thermal disintegration test was to determine whether the artificial bandage would disintegrate. In the thermal disintegration test, the artificial bandage was immersed in an excess of liquid under harsh conditions and left in an environment at a temperature of 37°C for 24 hours.

[0060] Artificial bandages were placed in 4 mL of deionized water and left in an incubator at 37°C for 24 hours. After 24 hours, the artificial bandages were removed and photographed, as shown in Figure 3(A). Figure 3(A) shows the results of a test to see if the artificial bandages would thermally disintegrate after being irradiated with gamma rays (γ-rays) of different intensities.

[0061] Figure 3(A) shows that the artificial bandage of the present invention can retain its hydrophilic colloidal texture and does not disintegrate after exposure to various radiation intensities and harsh test conditions.

[0062] Example 6: Adhesion test of artificial bandages

[0063] As shown in Figure 3(A), the artificial bandage does not disintegrate, so based on this result, the present invention tests the actual situation when the artificial bandage is applied to the hand.

[0064] A 2cm x 2cm artificial bandage was applied to the arm, 0.75mL of physiological saline solution was dropped onto it, and the area was covered with a waterproof, breathable bandage sheet (e.g., 3M Tegaderm), and left for 7 hours. After 7 hours, another photograph was taken, and the ease with which the artificial bandage could be peeled off the hand and whether it adhered to the waterproof, breathable bandage sheet (e.g., Tegaderm) was observed, as shown in Figure 3(B). Figure 3(B) shows the results of testing the adhesion of the artificial bandage by irradiating it with gamma rays of various intensities. From Figure 3(B), it was found that the artificial bandage could be peeled off the skin and the waterproof, breathable bandage sheet (e.g., Tegaderm), maintained a certain degree of integrity in appearance, and was not sticky.

[0065] Example 7: Animal experiments with artificial bandages

[0066] As shown in Figure 4, wound healing using artificial bandages was observed through a mouse wound animal model. The day before the trauma surgery, the hair on the back of the mice needed to be shaved. The mice used were purchased from the National Center for Experimental Animals in Taiwan (BALB / cByJNar1 strain). On the day of surgery, the mice were given an intraperitoneal injection (anesthetic dose: 80 mg / kg~160 mg / kg), and after confirming deep anesthesia by observing the pain response when pressing on the hind limbs, a marker pen was used to mark an area of ​​1 × 1 cm on the back. 2The trauma surgery is completed by drawing a square, lifting the skin on the back with forceps, and cutting out the skin along the drawn rectangle. One week after the surgery, the experimental mice were given daily subcutaneous injections (analgesic dosage: 5 mg / kg), and the health status of the mice after surgery was observed and recorded. After surgery, the experimental mice were given artificial bandages (1.25 × 1.25 cm). 2 The bandage was changed and reapplied every two days, and the wound healing status was recorded at the same time. The bandage change continued for four weeks until the wound was completely closed.

[0067] Example 8: Animal Experiments - Wound Area Statistics

[0068] Wound images were imported into ImageJ software to estimate their area, the pixel ratio of each image file was corrected and converted using the scale bar in the image, and the area of ​​the unhealed wound in the image was circled, with the original skin morphology around the wound used as a boundary standard, and the wound area was calculated as shown in Figure 5.

[0069] Example 9: Animal experiment - Tissue section

[0070] It takes approximately 30 days from the completion of surgical incision in experimental mice to healing and closure. After sacrificing the mice, skin tissue was collected from the newly formed area of ​​the wound, embedded and stained, and then hematoxylin-eosin (H&E) stained. H&E pathological sections were prepared, and the differences between the newly formed epidermal tissue and the original epidermal tissue were observed. In the H&E sections, newly formed epidermis and proliferated fibroblasts were observed, and the following three points were used as criteria to judge the degree of wound healing: (1) Since fibroblasts can synthesize and secrete collagen, the degree of wound healing can also be judged by the difference in collagen density. The higher the density, the more complete the wound healing. (2) The representative cell of acute inflammation is the polymorphonuclear leukocyte (neutrophil). During acute inflammation, cells die quickly, and at this time, polymorphonuclear leukocytes enter the inflamed tissue and phagocytose necrotic cells and bacteria. Therefore, the presence of polymorphonuclear leukocytes in the tissue section indicates that the wound is in the acute inflammatory stage. (3) The typical cells of chronic inflammation are monocytes and lymphocytes. Chronic inflammation has a barrier effect against lesions, but prolonged chronic inflammation can cause connective tissue hyperplasia. The presence of mononuclear cells and lymphocytes in this section indicates that the wound is in the chronic inflammatory stage. If fibrous connective tissue granuloma appears, it is the result of prolonged chronic inflammation.

[0071] The experiment was conducted with several groups, and the control group used commercially available collagen foam bandages. These groups are shown in Table 4. In addition to comparison with the control group, in order to understand the difference between dry and wet bandage application and the optimal use of artificial bandages, Group D had their bandages moistened beforehand and observed the results of wound healing.

[0072] Table 4. Grouping of experimental groups

[0073] [Table 4]

[0074] Table 5. Wound healing rate, standard deviation, and coefficient of variation (%) from day 0 to day 23.

[0075] [Table 5]

[0076] Figure 6 shows that the wound areas in groups A-D were all approaching healing by day 23. Table 5 shows the wound healing rate, standard deviation, and coefficient of variation calculated based on Figure 6. The wound healing rate is the percentage of wound area that closes within each period, while the standard deviation and coefficient of variation indicate the degree of change in the wound healing rate. Smaller standard deviations and coefficients of variation indicate smaller changes in the wound healing rate, suggesting that the wound healing rate in this group is relatively stable, and a stable wound healing rate promotes wound healing. The coefficients of variation for the no-bandage group and the moist artificial bandage group (groups A and D) were similar, indicating that the stability of the wound healing rate in the moist artificial bandage group was similar to that of the no-bandage group. The commercially available collagen bandage group (group B) showed a fast initial wound healing rate, but its overall coefficient of variation was the highest among the four groups, indicating an unstable wound healing process. The group treated with dried artificial bandages (Group C) had the smallest coefficient of variation among the four groups, suggesting that the wound was the most stable during the healing phase and had the best prognosis.

[0077] Example 10: Animal experiment - Analysis of tissue section results

[0078] Figure 7 shows the results of tissue sections from the group without bandages (Group A). ​​The wound bed shows fibrosis, the surface has proliferated granulation tissue, and the deeper tissue contains polymorphonuclear leukocytes, indicating that the acute inflammatory stage is still ongoing.

[0079] Figure 8 shows the results of tissue sections from the commercially available bandage group (Group B). There is fibrosis in the wound bed, but the structure is relatively loose, granulation tissue is still present on the surface, and polymorphonuclear leukocytes are found in the deeper tissue, indicating that it is still in the acute inflammatory stage.

[0080] Figure 9 shows the results of tissue sections from the group treated with dried artificial bandages (Group C). The wound bed had prominent pale pink fibroblasts and collagenous tissue, and the wound was fibrotic and had a dense structure, but no inflammatory response such as leukocytes was observed, the skin surface was intact, and some newly formed functional tissue and blood vessels were observed, suggesting that the wound had reached the late proliferative and reconstructive stages.

[0081] Figure 10 shows the results of tissue sections from the group treated with moist artificial bandages (Group D). Mild fibrosis and granulation tissue were observed in the wound bed, functional tissue proliferation of the skin was also observed, and the distribution of mononuclear cells beneath the wound bed suggested that the wound was in the late inflammatory stage.

[0082] Combining wound healing and tissue section results, the internal tissues of the unbandaged group (Group A) and the commercially bandaged group (Group B) were still in the acute inflammatory stage, with relatively loose fibrous tissue structures, granulation tissue on the surface, and a relatively high likelihood of scarring. In the group with dry artificial bandages (Group C), there was no inflammatory response in the internal tissues, and some neofunctional tissue and blood vessels were observed. The fibrous tissue structure of the wounds was dense, the skin surface was intact, and no scarring occurred.

[0083] When comparing the wound healing status of groups (Groups C and D) with moist and dry artificial bandages, the group with dry artificial bandages (Group C) showed a faster wound healing rate because the bandage itself absorbed the tissue, while the group with moist artificial bandages (Group D) showed more newly formed structural tissue and blood vessels. This was presumed to be because the chronic inflammatory response promotes the formation of new functional tissue and neovascularization in the skin.

[0084] The tissue section results are consistent with those in Table 5. In Table 5, the group treated with dried artificial bandages (Group C) had the smallest coefficient of variation and the most stable wound healing rate. Compared with the section results in Figure 9, the group treated with dried artificial bandages (Group C) had the best post-healing condition. In the group treated with commercially available bandages (Group B), the initial wound healing rate was fast, but the overall coefficient of variation was the highest. Comparing this with the cross-sectional results in Figure 8, granulation tissue was formed on the wound surface, but the deeper tissue was still in the acute inflammatory stage, indicating that the wound had not completely healed. To promote wound healing, in addition to a stable healing rate, dense fibrous tissue is also necessary. Therefore, the artificial bandage of the present invention meets the above requirements and can promote wound healing.

[0085] Example 11: Method of using an artificial bandage

[0086] According to experimental results, the best way to use the artificial bandage of the present invention is as follows: In the initial stages of wound healing, the artificial bandage was applied directly and dry to promote the growth of fibroblasts and collagen. In the later stages of wound healing, as tissue fluid had decreased relatively, the artificial bandage was moistened with a small amount of water and used to promote the functional tissue of the epidermis and angiogenesis, providing the most complete wound care. The artificial bandage of the present invention is a composition used in moist wound healing, comprising gelatin, polysorbate-20, and glutaraldehyde, which promotes wound healing by (1) absorbing tissue fluid from the wound, (2) inhibiting the proliferation of granulation tissue in the wound, (3) reducing inflammation of the wound, (4) promoting angiogenesis in the wound tissue, and (5) reducing adhesion to the wound. The wounds mentioned above include, but are not limited to, bruises, knife wounds, common acute wounds, first / second degree burns, surgical wounds, pressure ulcers, and ulcers.

[0087] In summary, the artificial bandage of the present invention, its use for promoting wound healing, and its method of manufacture have the following advantages.

[0088] (1) The artificial bandage of the present invention has clear pores and can absorb liquid approximately 25 to 35 times its own weight, and no disintegration was observed in thermal disintegration experiments and patch tests.

[0089] (2) The artificial bandage of the present invention promotes wound healing when applied dry, and promotes the growth of functional tissue within the wound when applied moist.

[0090] (3) The artificial bandage of the present invention is significantly cheaper than conventional moist wound healing and conventional bandages, and has a wider range of applications.

[0091] (4) The artificial bandage of the present invention can absorb tissue fluid from a wound, suppress the proliferation of granulation tissue in the wound, promote angiogenesis in the wound tissue, and promote wound healing.

[0092] The foregoing is merely illustrative and not limiting. Any equivalent modifications or changes that do not depart from the spirit and scope of the present invention shall be included in the appended scope of the patent. [Explanation of symbols]

[0093] S10, S20, S30: Step

Claims

[Claim 1] A method for manufacturing an artificial bandage having a composition of a wound healing promoting agent, A mixing and foaming step involves mixing gelatin at a concentration of 5-10% (g / mL, w / v), polysorbate-20 at a concentration of 0.005-0.1% (mL / mL, v / v), and glutaraldehyde at a concentration of 0.01-0.3% (mL / mL, v / v) to form a mixture, and then stirring the mixture to cause foaming. Following the mixing and foaming step, a molding step is performed in which the mixture is molded in a mold, Following the molding step, a freeze-drying step is performed to freeze-dry the mold, Includes, The composition is formed when the foam generated in the mixture during the mixing and foaming step is dispersed in the mixture molded in the mold during the molding and freeze-drying step, resulting in a porous body with a pore size of 60 to 70 μm, which forms an artificial bandage. A method for manufacturing an artificial bandage, characterized by the following:

Images