WO2023198086A1 - 一种抗菌促愈合功能化敷料及其制备方法 - Google Patents
一种抗菌促愈合功能化敷料及其制备方法 Download PDFInfo
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- WO2023198086A1 WO2023198086A1 PCT/CN2023/087706 CN2023087706W WO2023198086A1 WO 2023198086 A1 WO2023198086 A1 WO 2023198086A1 CN 2023087706 W CN2023087706 W CN 2023087706W WO 2023198086 A1 WO2023198086 A1 WO 2023198086A1
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- antibacterial
- healing
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
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- A61L15/42—Use of materials characterised by their function or physical properties
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- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/44—Medicaments
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/23—Carbohydrates
- A61L2300/236—Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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- A—HUMAN NECESSITIES
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
Definitions
- the present invention relates to the technical field of medical dressings, and in particular to an antibacterial and healing-promoting functional dressing and a preparation method thereof.
- the skin is the natural protective barrier of the human body. After trauma, burns or ulcers, it is easy to produce a large amount of wound exudate containing pus, toxins and toxic products. If these harmful substances stay in the wound for a long time, it will hinder the healing of the wound.
- the use of wound dressings to absorb exudate, cover and protect the wound is one of the more effective methods among the existing technical means of wound treatment.
- the global outbreak of bacterial drug resistance, the aging of the population, and the continued increase in the incidence of diabetes and obesity. Infectious wounds caused by multi-drug-resistant bacteria, as well as chronic wound care such as diabetic foot ulcers, bedsores, and venous lower limb ulcers have put forward new challenges for medical dressings. higher requirements.
- the filled foam dressing which is composed of polyurethane foam in the central part, is soft, fine, and has uniform pores. It can not only absorb wound exudate more than 10 times its own weight, but also reduce the shear force and friction of the incision, avoiding contact with the wound. Adhesion occurs in the wound, effectively protecting the granulation particles and new skin from being damaged by changing dressings. It can be seen that polyurethane foam dressing can provide an ideal environment for general wounds to heal and contribute to the repair and regeneration of skin tissue.
- ZL201811325396.1 discloses an antibacterial and healing foam dressing and its preparation method and application. By adding antibacterial Chinese medicine extracts and alginate during the foaming process, a antibacterial effect while maintaining moisturizing is prepared.
- Environmental pro-wound healing dressings However, the process conditions of this method are unstable, and the active ingredients are unevenly distributed in the foam during the production process, or the biological activity is destroyed due to being directly wrapped in the foam. Therefore, the yield of functional dressings is limited and the production cost is high.
- the process of impregnating functional component solution and drying is relatively simple and convenient, and avoids the loss of biological activity of functional components.
- ZL201811325383.4 discloses a hemostatic and healing foam dressing and its preparation method and application.
- Dendrobium nobile extract By adsorbing Dendrobium nobile extract, the medicinal efficacy of the foam dressing is increased. However, as these functional substances attached to the surface of the foam dressing are dissolved by the wound exudate, the formed solution stays at the wound site for a short time, and the volatilization of the solution causes the wound to dry out, which is not conducive to wound healing.
- the purpose of the present invention is to overcome the problems of the prior art and provide an antibacterial and healing functional dressing.
- An antibacterial and pro-healing functional dressing including a backing layer, a polyurethane foam layer and an antibacterial and pro-healing functional layer that are bonded in sequence.
- the antibacterial and pro-healing functional layer includes an antibacterial and pro-healing functional component, a moisturizer and a thickener.
- the mass fraction of the healing functional component is 0.03%-20%.
- the antibacterial and healing functional component is composed of one or more water-soluble chitosan with good solubility, antibacterial properties and the function of promoting skin cell proliferation.
- water-soluble chitosan includes monoguanidine-modified chitosan, biguanide-modified chitosan, PEGylated chitosan and chitosan-antimicrobial peptide conjugates.
- the base layer is made of adhesive breathable non-woven fabric or waterproof polyurethane film.
- the humectant is an alcohol small molecule or oligomer
- the oligomer includes glycerin, D-panthenol, polyethylene glycol 600 or polyethylene glycol 400.
- the thickener is cellulose.
- the cellulose is hydroxyethyl cellulose with a viscosity of 4500-6500 mPa.s.
- the peeling layer is glassine silicone oil paper, and the weight of the glassine silicone oil paper is 40-90g/m 2 .
- a method for preparing an antibacterial and healing functional dressing including the following steps:
- S10 stacks polyurethane foam layers on top of the base liner to form the main body of the foam dressing structure
- S20 fully dissolves and mixes the antibacterial and pro-healing functional components, moisturizer and thickener with a solvent to form an antibacterial and pro-healing functional polymer solution.
- the mass components of the antibacterial and pro-healing functional polymer solution include: antibacterial and pro-healing 0.01-5 parts of functional components, 0.1-10 parts of moisturizer, 1-10 parts of thickener and 100 parts of solvent; the antibacterial and healing promoting functional component consists of one with good solubility, antibacterial properties and the function of promoting skin cell proliferation. Or composed of multiple water-soluble chitosan;
- S30 evenly coats the antibacterial and pro-healing functional polymer solution on the surface of the main structure of the foam dressing, and then completely dries the antibacterial and pro-healing functional polymer solution to form an antibacterial and pro-healing functional layer;
- S40 uses a peeling layer to cover the antibacterial and pro-healing functional layer to obtain a complete antibacterial and pro-healing functional dressing.
- the humectant is alcohol small molecules or oligomers, and the oligomers include glycerol, D-panthenol, polyethylene glycol 600 or polyethylene glycol 400; the thickener is cellulose; The solvent is deionized water or physiological saline or phosphate buffer.
- drying temperature of the antibacterial and healing-promoting functional polymer solution in step S30 is 4°C-37°C.
- the present invention has the following advantages: 1. Mixing polymer materials with antibacterial and healing-promoting functions and polymers with moisturizing and swelling properties to form a functionalized polymer solution with a certain viscosity, retaining The antibacterial properties and biocompatibility of the material solve the problem of short residence time of antibacterial and healing-promoting functional materials at the wound site. 2. The viscous functionalized polymer solution is coated on the surface of traditional polyurethane foam dressing and dried naturally.
- the foam dressing functionality While giving the foam dressing functionality, it retains the ability of the foam dressing to absorb wound exudate; in addition, the wound exudate absorbed by the dressing can also be used as a solvent to quickly swell and dissolve the dry antibacterial and healing-promoting polymer, restoring the semi-gel state, stably and continuously maintain a moist environment of the wound, prolong the residence time of the antibacterial and healing-promoting functional components at the wound site, thereby providing a moist environment suitable for cell growth for wound healing.
- the present invention does not require blending.
- the base liner, foam dressing layer, antibacterial and healing-promoting functional layer and peeling layer are stacked layer by layer.
- Figure 1 is a schematic front structural view of an antibacterial and healing-promoting functional dressing of the present invention.
- Figure 2 is a schematic side structural view of an antibacterial and healing-promoting functional dressing of the present invention.
- Figure 3 is the biological safety evaluation results of the antibacterial and healing-promoting functional dressing of the present invention.
- Figure 4 is the antibacterial evaluation results of the antibacterial and healing-promoting functional dressing of the present invention.
- Figure 5 shows the wound healing status of rats at different times after injury according to the present invention.
- an antibacterial and pro-healing functional dressing includes a backing layer 1, a polyurethane foam layer 2 and an antibacterial and pro-healing functional layer 3 that are bonded in sequence.
- the antibacterial and pro-healing functional layer 3 includes an antibacterial and pro-healing function. Components, moisturizers and thickeners.
- the mass fraction of the antibacterial and pro-healing functional component is 0.03%-20%.
- the antibacterial and pro-healing functional component is composed of one or more substances with good solubility, antibacterial properties and the function of promoting skin cell proliferation. Composed of a variety of water-soluble chitosan.
- the backing layer 1 is a sticky breathable non-woven fabric or a waterproof polyurethane film; the shape includes but is not limited to conventional shapes such as circles and squares or special shapes such as heel type and sacrum type; the area is not smaller than the polyurethane foam dressing covered above area.
- the base liner 1 can be based on the thickness of the foam dressing layer and the method of fixing the fully formed dressing (such as direct adhesion or assisted fixation with medical bandage tape).
- a base liner 1 with an area slightly larger than the foam dressing layer or with The foam dressing area is exactly the same as the backing layer 1.
- water-soluble chitosan includes monoguanidine-modified chitosan, biguanide-modified chitosan, PEGylated chitosan and chitosan-antimicrobial peptide conjugates.
- the base layer 1 is a sticky breathable non-woven fabric or a waterproof polyurethane film.
- the humectant is an alcohol small molecule or oligomer
- the oligomer includes glycerol, D-panthenol, polyethylene glycol 600 or polyethylene glycol 400.
- the thickener is cellulose.
- the cellulose is hydroxyethyl cellulose with a viscosity of 4500-6500 mPa.s.
- a peeling layer is also provided above the antibacterial and healing-promoting functional layer 3.
- the peeling layer is glassine silicone oil paper, and the weight of the glassine silicone oil paper is 40-90g/m 2 .
- the antibacterial and healing-promoting functional dressing can be used for acute and chronic refractory wounds such as infectious wounds, frostbite, burns, diabetic foot, pressure ulcers, and venous ulcers of the lower limbs.
- the application steps are: 1. Remove the peeling layer of the antibacterial and pro-healing functional dressing, and place the antibacterial and pro-healing functional layer 3 toward the wound to directly cover the wound surface. 2. Depending on whether the backing layer 1 is sticky, directly apply light Press lightly or use elastic bandage, 3M breathable tape, etc. to fix the dressing on the affected area. 3. Remove the dressing and replace it with a new one every 6-72 hours; preferably, replace the dressing every 12-24 hours.
- a method for preparing an antibacterial and healing functional dressing including the following steps:
- S20 fully dissolves and mixes the antibacterial and pro-healing functional components, moisturizer and thickener with a solvent to form an antibacterial and pro-healing functional polymer solution.
- the mass components of the antibacterial and pro-healing functional polymer solution include: antibacterial and pro-healing 0.01-5 parts of functional components, 0.1-10 parts of moisturizer, 1-10 parts of thickener and 100 parts of solvent; the antibacterial and healing promoting functional component consists of one with good solubility, antibacterial properties and the function of promoting skin cell proliferation. Or composed of multiple water-soluble chitosan;
- S40 covers the antibacterial and pro-healing functional layer 3 with a peeling layer to obtain a complete antibacterial and pro-healing functional dressing.
- the humectant in step S20 is alcohol small molecules or oligomers, and the oligomers include glycerol, D-panthenol, polyethylene glycol 600 or polyethylene glycol 400; the thickener is cellulose; The solvent is deionized water or physiological saline or phosphate buffer.
- the drying temperature of the antibacterial and healing-promoting functional polymer solution in step S30 is 4°C-37°C.
- the preferred drying temperature is 20°C-30°C.
- the present invention has the following advantages: 1. Mixing polymer materials with antibacterial and healing-promoting functions and polymers with moisturizing and swelling properties to form a functionalized polymer solution with a certain viscosity, retaining Antibacterial properties and biocompatibility of materials, This solves the problem of short residence time of antibacterial and healing-promoting functional materials at the wound site. 2.
- the viscous functionalized polymer solution is coated on the surface of traditional polyurethane foam dressing and dried naturally.
- the liquid can also be used as a solvent to quickly swell and dissolve the dry antibacterial and healing-promoting polymers, restore the semi-gel state, stably and continuously maintain a moist environment for the wound, and prolong the residence time of the antibacterial and pro-healing functional components at the wound site, thus providing suitable conditions for wound healing.
- the present invention does not require blending.
- the backing layer 1 By stacking the backing layer 1, the foam dressing layer, the antibacterial and healing-promoting functional layer 3 and the peeling layer layer by layer, it can not only directly perform functions on the existing foam dressing quickly and in batches It can also prepare functional dressings that can be used on different types of wounds by adjusting the composition and characteristics of different structures. The operation is simple and the output is high. It provides antibacterial and healing functional dressings for wound repair.
- an antibacterial and pro-healing functional dressing of this embodiment is composed of a base layer 1, a polyurethane foam layer 2, an antibacterial and pro-healing functional layer 3 and a peeling layer from bottom to top;
- the backing layer 1 is a 10cm ⁇ 10cm sticky breathable non-woven fabric;
- the polyurethane foam layer 2 is composed of a 7cm ⁇ 7cm polyurethane foam material with a thickness of 4mm;
- the antibacterial and pro-healing functional layer 3 is an antibacterial and pro-healing viscous polymer aqueous solution evenly coated on The foam layer is formed after drying at 25°C.
- the viscous polymer aqueous solution is composed of 0.35 parts of biguanide modified chitosan, 5 parts of polyethylene glycol 400, 2.2 parts of hydroxyethyl cellulose in 100 parts of deionized It is fully mixed and dissolved in water; the peeling layer is composed of 10cm ⁇ 10cm glassine silicone paper with a weight of 40-90g/ m2 .
- peel off the peeling layer align the antibacterial and healing-promoting functional layer 3 to the affected area, and then lightly press the surrounding adhesive backing layer 1 to fix the dressing on the skin wound.
- High-density polyethylene was used as a negative control and ZDEC film was used as a positive control.
- GB/T16886.5-2017 "Biological Evaluation of Medical Devices Part 5: In vitro cytotoxicity test”
- the biosafety evaluation of the antibacterial and pro-healing functional dressing and its antibacterial and pro-healing functional layer 3 in Example 1 was carried out using the method in "Experiment”.
- the cells were mouse fibroblast L929, and the results are shown in Figure 3. There is no significant difference in biological safety between the antibacterial and pro-healing functionalized dressing and its functional layer, indicating that the technical solution of coating the antibacterial and pro-healing functional polymer viscous solution in the present invention can realize the functionalization of traditional foam dressings.
- Example 1 There is a significant difference (p ⁇ 0.01) and a very significant difference (p ⁇ 0.001) between Example 1 and the negative control group and the positive control group, which confirms that the functionalized dressing has good biocompatibility and has the ability to promote cell growth. Proliferation potential (cell survival rate >100%).
- the antibacterial and pro-healing functional dressing and its anti-bacterial and pro-healing functional layer 3 in Example 1 were evaluated for antibacterial properties according to the method in GB15979-2002 "Standard for Disposable Sanitary Products". Staphylococcus aureus, Escherichia coli, white Candida was used as representative strains of Gram-positive bacteria, Gram-negative bacteria, and fungi respectively. The results are shown in Figure 4. The results show that the antibacterial and healing-promoting functional dressing has good antibacterial effects on a variety of pathogenic microorganisms.
- Comparative Example 1 did not perform any treatment on the infected wound except for simple irrigation and debridement with normal saline. Comparative Example 2 uses a general foam dressing without antibacterial and pro-healing functional layer 3 to treat infected wounds in rats.
- An antibacterial and pro-healing functional dressing in this embodiment is composed of a backing layer 1, a polyurethane foam layer 2, an antibacterial and pro-healing functional layer 3 and a peeling layer from bottom to top;
- the backing layer 1 is butterfly-shaped Waterproof polyurethane film;
- polyurethane foam layer 2 is composed of 10cm ⁇ 10cm polyurethane foam material with a thickness of 4mm;
- the peeling layer is composed of butterfly-shaped glassine silicone paper with a weight of 40-90g
- An antibacterial and pro-healing functional dressing in this embodiment is composed of a backing layer 1, a polyurethane foam layer 2, an antibacterial and pro-healing functional layer 3 and a peeling layer from bottom to top;
- the backing layer 1 is 8 cm in diameter circular sticky breathable non-woven fabric;
- the polyurethane foam layer 2 is composed of a circular polyurethane foam material with a thickness of 4mm and a diameter of 4cm;
- the antibacterial and pro-healing functional layer 3 is an antibacterial and pro-healing viscous polymer aqueous solution evenly coated on the foam layer.
- the viscous polymer aqueous solution is composed of 0.5 parts of polyethylene glycol monomethyl ether modified chitosan, 6 parts of D-panthenol, and 2 parts of methylcellulose in 100 parts of physiological saline It is formed by thoroughly mixing and dissolving in medium; the peeling layer is composed of a round glassine silicone paper with a diameter of 8cm and a weight of 40-90g/ m2 .
- peel off the peeling layer align the antibacterial and healing-promoting functional layer 3 to the heel affected area, and then lightly press the surrounding adhesive backing layer 1 to fix the dressing on the heel skin wound.
- An antibacterial and healing-promoting functional dressing in this embodiment is composed of base layer 1, It consists of a polyurethane foam layer 2, an antibacterial and healing-promoting functional layer 3 and a peeling layer; the bottom lining layer 1 is a 10cm ⁇ 10cm sticky waterproof polyurethane film; the polyurethane foam layer 2 is composed of a 10cm ⁇ 10cm polyurethane foam material with a thickness of 4mm; antibacterial The pro-healing functional layer 3 is formed by uniformly coating the antibacterial and pro-healing viscous polymer aqueous solution on the foam layer and drying it at 28°C.
- the viscous polymer aqueous solution is composed of 0.35 parts of monoguanidine-modified chitosan, 4 parts of Glycerol and 2.5 parts of hydroxyethyl cellulose are thoroughly mixed and dissolved in 100 parts of deionized water; the peeling layer is composed of 10cm ⁇ 10cm glassine silicone paper with a weight of 40-90g/ m2 .
- peel off the peeling layer align the antibacterial and healing-promoting functional layer 3 to the affected area, then gently press the center of the backing layer 1, and use cotton gauze, elastic bandage or breathable tape to fix the dressing on the skin wound.
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Abstract
本发明公开了一种抗菌促愈合功能化敷料，包括依次粘合的底衬层、聚氨酯泡沫层和抗菌促愈合功能层，抗菌促愈合功能层包括抗菌促愈合功能组分、保湿剂和增稠剂，抗菌促愈合功能组分的质量分数为0.03％-20％，抗菌促愈合功能组分由溶解性好、具有抗菌性和促进皮肤细胞增殖功能的一种或多种水溶性壳聚糖组成。将具有抗菌促愈合功能的高分子材料与具有保湿、溶胀特性的聚合物混合，保留了材料的抗菌性及生物相容性。粘性功能化高分子溶液在赋予泡沫敷料功能性的同时保留了吸收伤口渗出液的作用；敷料吸附的伤口渗出液还能够作为溶剂，使干燥的抗菌促愈合高分子迅速溶胀溶解恢复半凝胶状态，稳定持续保持伤口湿润环境。
Description
本发明涉及医用敷料技术领域，特别是涉及一种抗菌促愈合功能化敷料及其制备方法。
皮肤是人体的天然保护屏障，在创伤、烧伤或溃疡后，易产生大量含有脓液、毒素及毒性产物的伤口渗出液，这些有害物质若长期停留在伤口中会阻碍伤口的愈合。使用伤口敷料吸收渗液、覆盖并保护创面是创面治疗现有技术手段中较为有效的方法之一。而全球细菌耐药性爆发，人口老龄化问题日趋严重，糖尿病、肥胖症等发病率持续增长，多重耐药菌感染性创面以及糖尿病足溃疡、褥疮、下肢静脉溃疡等慢性伤口护理对医用敷料提出了更高的要求。
传统的脱脂棉纱布等能够覆盖创面、吸收渗出物，但仅能为创面提供有限的保护作用，且由于容易与组织发生粘连而在更换的过程中极易造成二次损伤，引发炎症，不利于伤口愈合。相比之下，中央部位由聚氨酯泡沫组成的填充型泡沫敷料，柔软细腻、孔隙均匀，不仅能够吸收自重10倍以上的伤口渗出液，还能减少切口的剪切力和摩擦力，避免与伤口发生粘连，有效保护肉芽颗粒及新生皮肤不会因为更换敷料而受到破坏。可见，聚氨酯泡沫敷料能够为一般的创面提供适宜愈合的理想环境，有助于皮肤组织的修复与再生。
但对于病原微生物定植严重的感染创面或是过度炎症刺激而迁延不愈的慢性创面，普通的泡沫敷料仅靠隔绝污染、吸收渗液或减轻压力并不具备进一步杀灭创面病原微生物或主动促进皮肤组织再生的功能。通过向泡沫敷料中添加活性组分，制备功能化的泡沫敷料，能够赋予泡沫敷料一定的生物功能性。其中，在发泡过程中添加功能组分是较为常用的方法。如ZL201510130794.8在发泡过程中将银锌抗菌材料均匀分散在发泡混合液中，得到了一种含复合银锌抗菌材料的泡沫敷料。ZL201811325396.1中公开了一种抑菌促愈合泡沫敷料及其制备方法和应用，通过在发泡过程中添加具有抑菌性的中药提取物和海藻酸盐，制备了具有抑菌效果同时维持保湿环境的促伤口愈合敷料。但这类方法工艺条件不稳定，生产过程中活性成分在泡沫中分布不均匀，或是由于直接被泡沫包裹而导致生物活性被破坏，因此功能化敷料产率有限、生产成本较高。而浸渍功能成分溶液并干燥这一工艺流程相对简单便捷，且避免了功能组分生物活性的损失。ZL201811325383.4中公开了一种止血促愈泡沫敷料及其制备方法和应用，通过吸附金钗石斛提取液，增加了泡沫敷料的药用功效。但随着这些附着于泡沫敷料表面的功能物质被伤口渗出液溶解，形成的溶液在伤口部位停留时间较短，且溶液挥发导致伤口干燥，不利于创面愈合。
因此，如何在保留传统泡沫敷料吸液、保湿作用的基础上，增加敷料的抗菌促愈合功能，且延长功能成分在伤口部位的停留时间，并用于感染创面、慢性创面等复杂创面的治疗，在医药技术领域具有重要意义。
发明内容
本发明的目的是克服了现有技术的问题，提供了一种抗菌促愈合功能化敷料。
为了达到上述目的，本发明采用以下方案：
一种抗菌促愈合功能化敷料，包括依次粘合的底衬层、聚氨酯泡沫层和抗菌促愈合功能层，抗菌促愈合功能层包括抗菌促愈合功能组分、保湿剂和增稠剂，抗菌促愈合功能组分的质量分数为0.03％-20％，抗菌促愈合功能组分由溶解性好、具有抗菌性和促进皮肤细胞增殖功能的一种或多种水溶性壳聚糖组成。
进一步的，水溶性壳聚糖包括单胍改性壳聚糖、双胍改性壳聚糖、聚乙二醇化壳聚糖和壳聚糖－抗菌肽偶联物。
进一步的，底衬层为粘性透气无纺布或防水性聚氨酯薄膜。
进一步的，保湿剂为醇类小分子或低聚物，低聚物包括丙三醇、D－泛醇、聚乙二醇600或聚乙二醇400。
进一步的，增稠剂为纤维素。
进一步的，纤维素为粘度4500-6500mPa.s的羟乙基纤维素。
进一步的，抗菌促愈合功能层上方还设有剥离层，剥离层为格拉辛硅油纸，的格拉辛硅油纸的克重为40-90g/m2。
一种抗菌促愈合功能化敷料的制备方法，包括以下步骤：
S10将聚氨酯泡沫层叠置于底衬层上方形成泡沫敷料结构主体；
S20将抗菌促愈合功能组分、保湿剂、增稠剂用溶剂充分溶解并混匀形成抗菌促愈合功能性高分子溶液，抗菌促愈合功能性高分子溶液的质量组成份数包括：抗菌促愈合功能组分0.01-5份、保湿剂0.1-10份、增稠剂1-10份和溶剂100份；抗菌促愈合功能组分由溶解性好、具有抗菌性和促进皮肤细胞增殖功能的一种或多种水溶性壳聚糖组成；
S30将抗菌促愈合功能性高分子溶液均匀涂覆在泡沫敷料主体结构表层，将抗菌促愈合功能性高分子溶液完全干燥后形成抗菌促愈合功能层；
S40用剥离层覆盖抗菌促愈合功能层，得到完整的抗菌促愈合功能化敷料。
进一步的，S20步骤中保湿剂为醇类小分子或低聚物，低聚物包括丙三醇、D－泛醇、聚乙二醇600或聚乙二醇400；增稠剂为纤维素；溶剂为去离子水或生理盐水或磷酸盐缓冲液。
进一步的，S30步骤中抗菌促愈合功能性高分子溶液的干燥温度为4℃-37℃。
与现有的技术相比，本发明具有如下优点：一、将具有抗菌促愈合功能的高分子材料与具有保湿、溶胀特性的聚合物混合，形成具有一定粘性的功能化高分子溶液，保留了材料的抗菌性及生物相容性，解决了抗菌促愈合功能材料在伤口部位停留时间短的问题。二、粘性功能化高分子溶液涂覆于传统的聚氨酯泡沫敷料表面并自然干燥，在
赋予泡沫敷料功能性的同时，保留了泡沫敷料吸收伤口渗出液的作用；此外，敷料吸附的伤口渗出液还能够作为溶剂，使干燥的抗菌促愈合高分子迅速溶胀溶解，恢复半凝胶状态，稳定持续保持伤口湿润环境，延长抗菌促愈合功能组分在伤口部位的停留时间从而为伤口愈合提供适宜细胞生长的湿润环境。三、本发明无需共混，将底衬层、泡沫敷料层、抗菌促愈合功能层及剥离层逐层叠加，不仅能够快速、批量化地在现有泡沫敷料基础上直接对其进行功能化，还能通过调整不同结构的组成和特性，制备可用于不同类型创面的功能性敷料，操作简单、产量较高，为创面修复提供了抗菌促愈合功能化的敷料。
下面结合附图和具体实施方式对本申请作进一步详细的说明。
图1是本发明的一种抗菌促愈合功能化敷料的正面结构示意图。
图2是本发明的一种抗菌促愈合功能化敷料的侧面结构示意图。
图3是本发明的抗菌促愈合功能化敷料的生物安全性评价结果。
图4是本发明的抗菌促愈合功能化敷料的抗菌性评价结果。
图5是本发明的出伤后不同时间大鼠创面的愈合情况。
下面结合附图和实施例，对本发明的具体实施方式作进一步详细描述。以下实施例用于说明本发明，但不用来限制本发明的范围。
实施例一
如图1和2所示，一种抗菌促愈合功能化敷料，包括依次粘合的底衬层1、聚氨酯泡沫层2和抗菌促愈合功能层3，抗菌促愈合功能层3包括抗菌促愈合功能组分、保湿剂和增稠剂，抗菌促愈合功能组分的质量分数为0.03％-20％，抗菌促愈合功能组分由溶解性好、具有抗菌性和促进皮肤细胞增殖功能的一种或多种水溶性壳聚糖组成。底衬层1为粘性透气无纺布或防水性聚氨酯薄膜；形状包括但不限于如圆形、正方形等常规形状或足跟型、骶骨型等异型形状；面积不小于上方所覆盖的聚氨酯泡沫敷料面积。在另一实施例中底衬层1可根据泡沫敷料层厚度及完全成型后的敷料固定方式(如直接粘贴或医用绷带胶带辅助固定)，选用面积略大于泡沫敷料层的底衬层1或与泡沫敷料面积完全相同的底衬层1。
优选的，水溶性壳聚糖包括单胍改性壳聚糖、双胍改性壳聚糖、聚乙二醇化壳聚糖和壳聚糖－抗菌肽偶联物。
优选的，底衬层1为粘性透气无纺布或防水性聚氨酯薄膜。
优选的，保湿剂为醇类小分子或低聚物，低聚物包括丙三醇、D－泛醇、聚乙二醇600或聚乙二醇400。
优选的，增稠剂为纤维素。
优选的，纤维素为粘度4500-6500mPa.s的羟乙基纤维素。
优选的，抗菌促愈合功能层3上方还设有剥离层，剥离层为格拉辛硅油纸，的格拉辛硅油纸的克重为40-90g/m2。
该抗菌促愈合功能化敷料可用于感染性创伤、冻伤、烧烫伤、糖尿病足、压疮、下肢静脉溃疡等急性和慢性难愈性伤口。运用步骤为一、去除抗菌促愈合功能化敷料的剥离层，并将抗菌促愈合功能层3朝向伤口，直接覆盖创面。二、根据底衬层1是否具有粘性，直接轻
轻按压或用弹力绷带、3M透气性胶带等将敷料固定在患处。三、每6-72小时频率取下敷料并更换新一片敷料；优选的，每12-24小时更换一次敷料。
一种抗菌促愈合功能化敷料的制备方法，包括以下步骤：
S10将聚氨酯泡沫层2叠置于底衬层1上方形成泡沫敷料结构主体；
S20将抗菌促愈合功能组分、保湿剂、增稠剂用溶剂充分溶解并混匀形成抗菌促愈合功能性高分子溶液，抗菌促愈合功能性高分子溶液的质量组成份数包括：抗菌促愈合功能组分0.01-5份、保湿剂0.1-10份、增稠剂1-10份和溶剂100份；抗菌促愈合功能组分由溶解性好、具有抗菌性和促进皮肤细胞增殖功能的一种或多种水溶性壳聚糖组成；
S30将抗菌促愈合功能性高分子溶液均匀涂覆在泡沫敷料主体结构表层，将抗菌促愈合功能性高分子溶液完全干燥后形成抗菌促愈合功能层3；
S40用剥离层覆盖抗菌促愈合功能层3，得到完整的抗菌促愈合功能化敷料。
优选的，S20步骤中保湿剂为醇类小分子或低聚物，低聚物包括丙三醇、D－泛醇、聚乙二醇600或聚乙二醇400；增稠剂为纤维素；溶剂为去离子水或生理盐水或磷酸盐缓冲液。
优选的，S30步骤中抗菌促愈合功能性高分子溶液的干燥温度为4℃-37℃。在本实施例中优选的干燥温度为20℃-30℃。
与现有的技术相比，本发明具有如下优点：一、将具有抗菌促愈合功能的高分子材料与具有保湿、溶胀特性的聚合物混合，形成具有一定粘性的功能化高分子溶液，保留了材料的抗菌性及生物相容性，
解决了抗菌促愈合功能材料在伤口部位停留时间短的问题。二、粘性功能化高分子溶液涂覆于传统的聚氨酯泡沫敷料表面并自然干燥，在赋予泡沫敷料功能性的同时，保留了泡沫敷料吸收伤口渗出液的作用；此外，敷料吸附的伤口渗出液还能够作为溶剂，使干燥的抗菌促愈合高分子迅速溶胀溶解，恢复半凝胶状态，稳定持续保持伤口湿润环境，延长抗菌促愈合功能组分在伤口部位的停留时间从而为伤口愈合提供适宜细胞生长的湿润环境。三、本发明无需共混，将底衬层1、泡沫敷料层、抗菌促愈合功能层3及剥离层逐层叠加，不仅能够快速、批量化地在现有泡沫敷料基础上直接对其进行功能化，还能通过调整不同结构的组成和特性，制备可用于不同类型创面的功能性敷料，操作简单、产量较高，为创面修复提供了抗菌促愈合功能化的敷料。
实施例二
如图1和2所示，本实施例的一种抗菌促愈合功能化敷料，从下到上依次由底衬层1、聚氨酯泡沫层2、抗菌促愈合功能层3和剥离层组成；所述的底衬层1为10cm×10cm粘性透气无纺布；聚氨酯泡沫层2由厚度为4mm的7cm×7cm聚氨酯泡沫材料组成；抗菌促愈合功能层3为抗菌促愈合粘性高分子水溶液均匀涂覆在泡沫层后，在25℃下干燥后形成，所述的粘性高分子水溶液是由0.35份双胍改性壳聚糖、5份聚乙二醇400、2.2份羟乙基纤维素在100份去离子水中充分混合溶解而成；剥离层由克重为40-90g/m2的10cm×10cm格拉辛硅油纸组成。
使用时，揭开剥离层，将抗菌促愈合功能层3对准患处，然后轻按四周的粘性底衬层1以便使敷料固定于皮肤伤口处即可。
以高密度聚乙烯作为阴性对照，ZDEC薄膜作为阳性对照，按照GB/T16886.5-2017《医疗器械生物学评价第5部分：体外细胞毒性试
验》中的方法对实施例1中的抗菌促愈合功能化敷料及其抗菌促愈合功能层3进行生物安全性评价，细胞选用小鼠成纤维细胞L929，结果如图3所示。抗菌促愈合功能化敷料与其功能层在生物安全性方面并无显著性差异，表明采用本发明中涂覆抗菌促愈合功能性高分子粘溶液的技术方案能够实现对传统泡沫敷料的功能化。而实施例1与阴性对照组与阳性对照组有显著性差异(p<0.01)与极显著性差异(p<0.001)，证实了该功能化敷料的生物相容性较好，且具有促进细胞增殖的潜力(细胞存活率＞100％)。
按照GB15979-2002《一次性使用卫生用品标准》中的方法对实施例1中的抗菌促愈合功能化敷料及其抗菌促愈合功能层3进行抗菌性评价，以金黄色葡萄球菌、大肠杆菌、白色念珠菌分别作为革兰氏阳性菌、革兰氏阴性菌、真菌的代表菌株，结果如图4所示。结果表明，抗菌促愈合功能化敷料对多种病原微生物均有良好的抗菌作用。
对SD鼠进行称重，使用4％体积分数水合氯醛以0.1mL/10g对大鼠进行麻醉，使用电动剃毛刀对大鼠背部进行剃毛，使用镊子和剪刀在大鼠背部皮肤制造一个直径约为20mm的圆形伤口，避免伤及肌肉组织。对伤口滴加100μL培养12小时的MRSA菌液。放回笼中饲养72小时。对大鼠进行随机分组，每组为3只，观察大鼠伤口并拍照记录。于第2、3、5、8、11、13天进行上样并对大鼠伤口进行拍照记录，结果如图4所示。使用实施例1中抗菌促愈合功能化敷料的大鼠创面闭合较快，说明该功能化敷料促进了大鼠感染创面愈合。
图5中的比例尺表示1cm，对比例1为除用生理盐水简单冲洗清创，对感染创面不做任何处理。对比例2为用不含抗菌促愈合功能层3的一般泡沫敷料处理大鼠感染创面。
实施例三
本实施例的一种抗菌促愈合功能化敷料，从下到上依次由底衬层1、聚氨酯泡沫层2、抗菌促愈合功能层3和剥离层组成；所述的底衬层1为蝴蝶形防水聚氨酯薄膜；聚氨酯泡沫层2由厚度为4mm的10cm×10cm聚氨酯泡沫材料组成；抗菌促愈合功能层3为抗菌促愈合粘性高分子水溶液均匀涂覆在泡沫层后，在20℃下干燥后形成，所述的粘性高分子水溶液是由0.2份双壳聚糖－抗菌肽偶联物、4份聚乙二醇600、3份羟丙基纤维素在100份PBS缓冲液(pH＝7.2-7.4，0.01M)中充分混合溶解而成；剥离层由克重为40-90g/m2的蝴蝶形格拉辛硅油纸组成。使用时，揭开剥离层，将抗菌促愈合功能层3对准骶骨皮肤患处，然后轻按四周的粘性底衬层1以便使敷料固定于骶骨皮肤伤口处即可。
实施例四
本实施例的一种抗菌促愈合功能化敷料，从下到上依次由底衬层1、聚氨酯泡沫层2、抗菌促愈合功能层3和剥离层组成；所述的底衬层1为直径8cm的圆形粘性透气无纺布；聚氨酯泡沫层2由厚度为4mm的直径4cm的圆形聚氨酯泡沫材料组成；抗菌促愈合功能层3为抗菌促愈合粘性高分子水溶液均匀涂覆在泡沫层后，在37℃下干燥后形成，所述的粘性高分子水溶液是由0.5份聚乙二醇单甲醚改性壳聚糖、6份D－泛醇、2份甲基纤维素在100份生理盐水中充分混合溶解而成；剥离层由克重为40-90g/m2的直径8cm圆形格拉辛硅油纸组成。
使用时，揭开剥离层，将抗菌促愈合功能层3对准足跟患处，然后轻按四周的粘性底衬层1以便使敷料固定于足跟皮肤伤口处即可。
实施例五
本实施例的一种抗菌促愈合功能化敷料，从下到上依次由底衬层1、
聚氨酯泡沫层2、抗菌促愈合功能层3和剥离层组成；所述的底衬层1为10cm×10cm粘性防水聚氨酯薄膜；聚氨酯泡沫层2由厚度为4mm的10cm×10cm聚氨酯泡沫材料组成；抗菌促愈合功能层3为抗菌促愈合粘性高分子水溶液均匀涂覆在泡沫层后，在28℃下干燥后形成，所述的粘性高分子水溶液是由0.35份单胍改性壳聚糖、4份丙三醇、2.5份羟乙基纤维素在100份去离子水中充分混合溶解而成；剥离层由克重为40-90g/m2的10cm×10cm格拉辛硅油纸组成。
使用时，揭开剥离层，将抗菌促愈合功能层3对准患处，然后轻按底衬层1中央，并用棉纱布、弹性绷带或透气胶带等将敷料固定于皮肤伤口处。
以上所述仅是本申请的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请技术原理的前提下，还可以做出若干改进和替换，这些改进和替换也应视为本申请的保护范围。
Claims (10)
- 一种抗菌促愈合功能化敷料，包括依次粘合的底衬层、聚氨酯泡沫层和抗菌促愈合功能层，其特征在于，所述抗菌促愈合功能层包括抗菌促愈合功能组分、保湿剂和增稠剂，所述抗菌促愈合功能组分的质量分数为0.03％-20％，所述抗菌促愈合功能组分由溶解性好、具有抗菌性和促进皮肤细胞增殖功能的一种或多种水溶性壳聚糖组成。
- 根据权利要求1所述的一种抗菌促愈合功能化敷料，其特征在于，所述水溶性壳聚糖包括单胍改性壳聚糖、双胍改性壳聚糖、聚乙二醇化壳聚糖和壳聚糖－抗菌肽偶联物。
- 根据权利要求1所述的一种抗菌促愈合功能化敷料，其特征在于，所述底衬层为粘性透气无纺布或防水性聚氨酯薄膜。
- 根据权利要求1所述的一种抗菌促愈合功能化敷料，其特征在于，所述保湿剂为醇类小分子或低聚物，所述低聚物包括丙三醇、D－泛醇、聚乙二醇600或聚乙二醇400。
- 根据权利要求1所述的一种抗菌促愈合功能化敷料，其特征在于，所述增稠剂为纤维素。
- 根据权利要求5所述的一种抗菌促愈合功能化敷料，其特征在于，所述纤维素为粘度4500-6500mPa.s的羟乙基纤维素。
- 根据权利要求1所述的一种抗菌促愈合功能化敷料，其特征在于，所述抗菌促愈合功能层上方还设有剥离层，所述剥离层为格拉辛硅油纸，所述的格拉辛硅油纸的克重为40-90g/m2。
- 一种抗菌促愈合功能化敷料的制备方法，其特征在于，包括以下步骤：S10将聚氨酯泡沫层叠置于底衬层上方形成泡沫敷料结构主体；S20将抗菌促愈合功能组分、保湿剂、增稠剂用溶剂充分溶解并混匀形成抗菌促愈合功能性高分子溶液，所述抗菌促愈合功能性高分子溶液的质量组成份数包括：抗菌促愈合功能组分0.01-5份、保湿剂0.1-10份、增稠剂1-10份和溶剂100份；所述抗菌促愈合功能组分由溶解性好、具有抗菌性和促进皮肤细胞增殖功能的一种或多种水溶性壳聚糖组成；S30将所述抗菌促愈合功能性高分子溶液均匀涂覆在所述泡沫敷料主体结构表层，将所述抗菌促愈合功能性高分子溶液完全干燥后形成抗菌促愈合功能层；S40用剥离层覆盖所述抗菌促愈合功能层，得到完整的抗菌促愈合功能化敷料。
- 根据权利要求8所述的一种抗菌促愈合功能化敷料的制备方法，其特征在于，所述S20步骤中所述保湿剂为醇类小分子或低聚物，所述低聚物包括丙三醇、D－泛醇、聚乙二醇600或聚乙二醇400；所述增稠剂为纤维素；所述溶剂为去离子水或生理盐水或磷酸盐缓冲液。
- 根据权利要求8所述的一种抗菌促愈合功能化敷料的制备方法，其特征在于，所述S30步骤中所述抗菌促愈合功能性高分子溶液的干燥温度为4℃-37℃。
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