WO2016163225A1 - Wound covering material and wound covering material manufacturing method - Google Patents

Wound covering material and wound covering material manufacturing method Download PDF

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Publication number
WO2016163225A1
WO2016163225A1 PCT/JP2016/058997 JP2016058997W WO2016163225A1 WO 2016163225 A1 WO2016163225 A1 WO 2016163225A1 JP 2016058997 W JP2016058997 W JP 2016058997W WO 2016163225 A1 WO2016163225 A1 WO 2016163225A1
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WO
WIPO (PCT)
Prior art keywords
wound
substance
support
wound dressing
sticking
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PCT/JP2016/058997
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French (fr)
Japanese (ja)
Inventor
拓郎 金蔵
正孝 岩元
Original Assignee
国立大学法人 鹿児島大学
カクイ株式会社
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Application filed by 国立大学法人 鹿児島大学, カクイ株式会社 filed Critical 国立大学法人 鹿児島大学
Publication of WO2016163225A1 publication Critical patent/WO2016163225A1/en

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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
    • 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
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • 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
    • A61L15/44—Medicaments

Definitions

  • the present invention relates to a wound dressing and a method for producing the wound dressing.
  • Wound surface dressing is used to protect wound surfaces such as trauma and burns.
  • wound dressing materials that supply wound healing promoters such as eggshell membrane protein (hereinafter also referred to as “EMP”) to the wound surface in order to promote the recovery of the wound surface are known. Yes.
  • EMP eggshell membrane protein
  • Patent Document 1 discloses a wound dressing material in which a layer of a hydrogel paste containing a hydrolyzed eggshell membrane is provided on a support. Yes.
  • Patent Document 2 discloses a wound dressing made of a fiber assembly produced by spinning using a solution containing an eggshell membrane component by an electrospinning method.
  • the above hydrolyzed eggshell membrane and eggshell membrane components heal wound surfaces by activating fibroblasts.
  • the wound dressing that holds the hydrolyzed eggshell membrane and the like easily adheres to the wound surface due to intermolecular interactions. Therefore, in the wound dressing disclosed in Patent Document 1 and Patent Document 2, when the wound dressing is peeled off, the fragile new tissue formed on the wound surface and the surrounding tissue are peeled off and accompanying the damage. Pain may occur.
  • the present invention has been made in view of the above circumstances, and an object thereof is to provide a wound dressing and a method for producing the wound dressing that can suppress damage and pain on the wound surface as much as possible.
  • the wound dressing according to the first aspect of the present invention A support having water absorption; A non-adherent substance to the wound surface, spaced apart on the surface of the support opposite the wound surface; A wound healing promoter carried on the non-sticking substance; Is provided.
  • the non-sticking substance is Arranged in a mesh pattern on the surface, It is good as well.
  • the non-sticking substance is Arranged in 70 to 90% of the surface area, It is good as well.
  • the support is Supporting a wound healing promoter on the surface where the non-sticking substance is not disposed; It is good as well.
  • the non-sticking substance is Is silicone, It is good as well.
  • the wound healing promoter is Eggshell membrane protein, It is good as well.
  • the support is Cotton wool, It is good as well.
  • the method for producing a wound dressing according to the second aspect of the present invention A coating process in which the surface of the support is coated with a mask material at intervals; A first exposure step of exposing the surface of the support to a substance that is non-adherent to the wound surface; A removing step of removing the mask material from the surface of the support; A second exposure step of exposing the surface of the non-sticking substance to a wound healing promoter; including.
  • FIG. 6 is a diagram showing a wound surface of case 2 in Example 2.
  • FIG. (A) shows the state before affixing.
  • (B) shows the state on the 10th day from the pasting.
  • (C) shows the state after 4 months from pasting.
  • 6 is a diagram showing a wound surface of case 7 in Example 2.
  • FIG. (A) shows the state before affixing.
  • (B) shows the state on the 11th day from the pasting.
  • C) shows the state after 4 months from pasting.
  • FIG. 1 shows a perspective view of a wound dressing 100 according to the present embodiment.
  • the upper surface of the wound dressing 100 shown in FIG. 1 is the surface that faces the wound surface during use, that is, the surface that contacts the wound surface.
  • FIG. 2 shows a conceptual diagram of a cross section taken along the broken line AA ′ shown in FIG.
  • the wound dressing 100 includes a support 1, a substance 2 that is non-adherent to the wound surface, and a wound healing promoter 3.
  • the support 1 is optional as long as it has water absorption.
  • water absorption refers to the property of absorbing liquids such as water, body fluids, suspensions and solutions.
  • the support body 1 may have water retention.
  • Water retention refers to the property of retaining absorbed liquid.
  • the support 1 can be formed of any material as long as it is a material having water absorption properties such as fibers, polymers, and gels.
  • the support body 1 is absorbent cotton.
  • the absorbent cotton is not particularly limited, but absorbent cotton having a fluff pressing process on the surface is particularly preferable in terms of enhancing the adhesion of the wound dressing 100 to the wound surface.
  • Fluff pressing can be performed on the surface of absorbent cotton by a known method, for example, embossing press.
  • the non-sticking substance 2 is arranged on the surface S of the support 1 facing the wound surface with a gap.
  • any substance can be adopted as long as it is non-sticking to the wound surface.
  • non-adhesiveness refers to the property of not adhering to the wound surface due to adhesion and adhesion to cells or living tissues, or coagulation of body fluids.
  • the non-sticking substance 2 preferably contains a silicon compound.
  • the non-sticking substance 2 is preferably silicone. More specifically, examples of the non-sticking substance 2 include MG 7-9850 Soft Skin Adhesive Parts A & B and 7-9800 Soft Skin Adhesive Parts A & B manufactured by Toray Dow Corning.
  • the non-sticking substance 2 on the surface S of the support 1 may be arranged at a constant length interval, or may be arranged at a plurality of length intervals.
  • the arrangement pattern of the non-sticking substance 2 on the surface S is arbitrary as long as the non-sticking substance 2 is arranged at intervals.
  • the non-sticking substances 2 may be arranged in a lattice shape, or may be arranged in a plurality of rows in the vertical or horizontal direction.
  • the non-sticking substance 2 is arranged on the surface S of the support 1 in a mesh shape.
  • the mesh opening can be set as appropriate, but it is 0.5 to 5 mm, 1 to 3 mm, and preferably 1.8 to 2.2 mm.
  • the ratio of the non-sticking substance 2 to the area of the surface S of the support 1 is arbitrary as long as it is less than 100%.
  • the non-sticking substance 2 is arranged in 70 to 90%, 75 to 85%, preferably 80% of the area of the surface S.
  • the height of the non-sticking substance 2 is, for example, 1 to 20 ⁇ m, preferably 5 to 15 ⁇ m, more preferably 8 to 12 ⁇ m, and particularly preferably 10 ⁇ m.
  • the wound healing promoter 3 carried on the non-adherent substance 2 is optional as long as it has a fibroblast proliferation action, angiogenesis action, granulation formation promotion action, and the like.
  • the wound healing promoter 3 is, for example, a functional protein involved in the wound healing process.
  • the wound healing promoter 3 is EMP.
  • EMP is a thin film having a thickness of about 70 ⁇ m that exists inside an eggshell such as a chicken egg.
  • EMP is rich in bridging amino acids such as proline and cysteine.
  • EMP has high adhesion to animal cells. EMP promotes collagen production by fibroblasts.
  • the wound healing promoter 3 may be carried directly on the surface of the non-sticking substance 2. Further, the wound healing promoter 3 may be supported on the non-sticking substance 2 by laminating a solution and a suspension containing the wound healing promoter 3 on the surface of the non-sticking substance 2. .
  • the wound healing promoter 3 is supported on the surface S of the support 1 on which the non-sticking substance 2 is not arranged, in addition to being supported by the non-sticking substance 2. Also good.
  • FIG. 3 is a diagram showing a flow of a method for manufacturing the wound dressing 100.
  • the manufacturing method includes a coating step, a first exposure step, a removal step, and a second exposure step.
  • the surface S of the support 1 is covered with the mask material 4 at intervals (step S1).
  • the shape of the mask material 4 is determined according to the arrangement pattern of the non-sticking substance 2 on the surface S of the support 1. For example, when the non-sticking substance 2 is arranged on the surface S in a mesh shape, a stainless steel net (mesh) may be arranged on the surface S as shown in FIG.
  • the surface S of the support 1 is exposed to the non-sticking substance 2 (step S2).
  • a solution of the non-sticking substance 2 may be sprayed on the surface S, or the surface S may be immersed in the solution of the non-sticking substance 2.
  • silicone when silicone is used as the non-sticking substance 2, a silicone solution in an amount of 2 to 20 mg / cm 2 , 6 to 14 mg / cm 2 , preferably 8 to 12 mg / cm 2 is used in the first exposure step.
  • the surface S may be sprayed.
  • the mask material 4 is removed from the surface S of the support 1 (step S3).
  • the mask material 4 may be removed after a lapse of a certain time after the first exposure step.
  • the support 1 may be subjected to heat treatment according to the physical properties of the non-sticking substance 2.
  • the non-sticking substance 2 is silicone
  • the heat treatment is performed at 100 ° C. for 30 minutes, for example.
  • a layer of the non-sticking substance 2 is formed on the portion of the surface S that has not been coated in step S1.
  • FIG. 5 is a conceptual view of a cross section of the support 1 similar to FIG. 2 after the first exposure step and after the removal step.
  • the non-sticking substance 2 is laminated on the mask material 4 and on the surface S that is not covered with the mask material 4.
  • the removing step when the mask material 4 is removed, the non-adhesive substance 2 laminated on the mask material 4 together with the mask material 4 is removed, so that the non-adhesive property remaining on the surface S is removed.
  • the substance 2 is arranged on the surface S at intervals according to the pattern of the mask material 4.
  • the surface of the non-sticking substance 2 is exposed to the wound healing promoter 3 (step S4).
  • the wound healing promoter 3 is, for example, dissolved, dispersed or suspended in a suitable solvent and sprayed on the surface S of the support 1 on which the non-sticking substance 2 is arranged. By doing so, the surface of the non-sticking substance 2 and the surface S of the support 1 on which the non-sticking substance 2 is not disposed are exposed to the wound healing promoter 3.
  • the EMP ethanol aqueous dispersion may be sprayed so as to be 1 to 10 mg / cm 2 , 2 to 8 mg / cm 2 , preferably 4 to 6 mg / cm 2 .
  • the manufacturing method of the wound dressing material 100 may further include a sterilization process for sterilizing the wound dressing material 100 in addition to the above steps.
  • the wound dressing 100 since the wound healing promoter 3 is supplied to the wound surface, rapid epithelialization of the wound surface can be promoted.
  • the wound healing promoter 3 since the wound healing promoter 3 is carried on the non-sticking substance 2, even if the wound healing promoter 3 is supplied to the wound surface, the wound healing promoter 3 is interposed between the support 1 and the wound surface. The non-sticking substance 2 is interposed. For this reason, sticking to the wound surface of the wound dressing 100 is suppressed, and the wound dressing 100 can be easily peeled off. Thereby, when removing the wound dressing 100, such as when the wound dressing 100 is replaced, damage to the wound surface due to peeling of the epidermis can be suppressed as much as possible. Furthermore, pain when peeling the wound dressing 100 can be reduced.
  • the surface S is non-adhesive substance 2. It is not completely covered with. As a result, exudate from the wound surface is absorbed and retained by the support 1 having water absorption from the portion where the non-sticking substance 2 is not disposed. As a result, the wet state of the wound surface is appropriately maintained.
  • the non-sticking substance 2 may be arranged on the surface S of the support 1 in a mesh shape.
  • the non-adhesive substance 2 By disposing the non-adhesive substance 2 in a mesh shape, the non-adhesive substance 2 can be arranged uniformly on the entire surface S with appropriate intervals. Thereby, the wound healing promoter 3 can be reliably supplied to the wound surface.
  • the area of the portion of the surface S where the non-adhesive substance 2 is not arranged becomes constant, so that exudation from the entire wound surface The liquid can be efficiently absorbed by the support 1.
  • the non-sticking substance 2 may be arranged in 70 to 90% of the area of the surface S.
  • the support 1 may support the wound healing promoter 3 on the surface S where the non-sticking substance 2 is not disposed. Thereby, since the wound healing promoter 3 supported by the surface S of the support 1 is also supplied to the wound surface, epithelization of the wound surface can be further promoted.
  • non-sticking substance 2 may be silicone. Silicone does not stick to the wound surface and is also biocompatible so it is safe to contact the wound surface.
  • the non-adhesive substance 2 may be a substance that is known not to have adhesiveness on the wound surface, such as an alginate gel and a carboxymethyl cellulose (CMC) gel.
  • the wound healing promoter 3 may be EMP. Since EMP has been confirmed to be safe in safety tests in various animal tests and human skin allergy tests, it is suitable for the wound dressing 100 used on the wound surface. In addition, EMP is effective in wound healing because it has an effect of promoting wound healing.
  • the wound healing promoter 3 may be a fibroblast growth factor (FGF).
  • FGF fibroblast growth factor
  • FGF promotes the proliferation of fibroblasts to promote secretion of dermal components such as collagen, elastin and hyaluronic acid synthesized by fibroblasts.
  • FGF promotes vascular elongation, formation of granulation tissue in the early stages of wound healing, and repair of skin and mucosal tissue on the wound surface.
  • Examples of FGF as the wound healing promoter 3 include acidic fibroblast growth factor (FGF1), basic fibroblast growth factor (FGF2), keratinocyte growth factor (FGF10), and keratinocyte growth factor (FGF7). is there.
  • the wound healing promoter 3 may be a platelet lysate, human fibronectin, camellia leaf extract, aloe extract, anti-inflammatory agent, kallikrein, collagen, and the like.
  • the wound healing promoter 3 may be a peptide such as Comb-1 and UN-3 involved in promoting angiogenesis.
  • the support 1 may be absorbent cotton.
  • Absorbent cotton is easy to process and excellent in water absorption and water retention, so that the wet state of the wound surface can be suitably maintained.
  • adhesiveness with a wound surface can be improved by performing a fluff pressing process on the surface of absorbent cotton.
  • the support 1 is not limited to absorbent cotton but may be a nonwoven fabric or the like.
  • the non-sticking substance 2 was arranged on the surface S at intervals. By doing so, the non-sticking substance 2 in a desired pattern can be easily arranged on the surface S.
  • the wound dressing 100 can be fixed to the wound surface by any method.
  • the wound dressing 100 may be fixed to the wound surface by applying an adhesive that adheres to the skin to the periphery of the surface S of the support 1 facing the wound surface.
  • the area of the surface S is preferably larger than the area of the wound surface so that the adhesive does not contact the wound surface.
  • the wound dressing 100 may be fixed to the wound surface using a surgical tape or the like.
  • Example 1 Production of wound dressing
  • fluff pressing processing was performed on the surface of the sheet-like absorbent cotton with an emboss press.
  • a mask material was placed on the absorbent cotton.
  • Stainless steel mesh was used as the mask material.
  • the mesh opening was 2 mm.
  • a silicone solution prepared by dissolving silicone in normal hexane so as to have a silicone concentration of 30% was sprayed on absorbent cotton provided with a mask material so that the concentration was 10 mg / cm 2 .
  • Silicone is MG 7-9850 Soft Skin Adhesive Part A & B manufactured by Toray Dow Corning.
  • the mask material was removed, and the absorbent cotton was heated at 100 ° C. for 30 minutes. Thereby, the silicone layer was formed in the part which was not masked on absorbent cotton.
  • the area of silicone was about 80% with respect to the area of the surface of absorbent cotton.
  • positioned on absorbent cotton at mesh shape is estimated to be 10 micrometers.
  • Example 1 An EMP ethanol aqueous dispersion containing EMP (manufactured by Kewpie) was sprayed on the absorbent cotton on which the silicone was disposed so as to be 10 mg / cm 2 .
  • the absorbent cotton was dried at 50 ° C. for 30 minutes, and the wound dressing was produced by immobilizing EMP on the absorbent cotton and silicone surfaces. Subsequently, the wound dressing was sterilized at 124 ° C. for 15 minutes using an autoclave.
  • FIG. 6 shows the surface of the obtained EMP-carrying wound dressing (hereinafter referred to as “Example 1”) on the side in contact with the wound surface.
  • Example 2 a wound dressing (hereinafter referred to as “Comparative Example”) in which a silicone layer was formed on absorbent cotton and EMP was not immobilized was produced in the same manner as in Example 1 above.
  • Example 2 Evaluation of effectiveness of wound dressing
  • Example 1 As the wound surface, with respect to the cases shown in Table 1, the skin area in split layer skin grafting or the wound surface of refractory skin ulcer is divided into two regions on the left and right, Example 1 in one region and Comparative example in the other region was pasted.
  • Day 0 the day after application
  • Day 3 Day 7 and Day 14
  • degree of epithelialization, erosion / ulcer remaining, wound surface pain Visual Analogue Scale: VAS)
  • the wet state were evaluated by a physician global assessment (Physician Global Assessment).
  • Example 1 and the comparative example were exchanged on the first day, the third day, and the seventh day, and the wound surface was observed during the exchange.
  • FIG. 7 shows the wound surface of Case 2.
  • the epithelium that was not seen on the wound surface before the application shown in (a) was formed in Example 1 on the 10th day after the application shown in (b).
  • Four months after application wound healing was clearly promoted in the region where Example 1 was applied compared to the comparative example.
  • FIG. 8 shows the wound surface of case 7.
  • epithelialization was observed in the region where Example 1 was applied rather than the comparative example, as shown in (b).
  • the wound surface in the region where Example 1 was pasted was more recovered than the comparative example.
  • Table 2 shows the results of comprehensive doctor evaluation.
  • the number of days on which the epithelialization of the region where Example 1 was pasted was confirmed on the wound surface of each case.
  • the effectiveness of Example 1 was observed in 7 cases including 2 cases.
  • the time when a clear difference in epithelialization in the pasted area was recognized between the comparative example and Example 1 was 10.1 days on average.
  • Example 1 was shown to reduce pain on the wound surface more than the comparative example.
  • the wound dressing material in which EMP is immobilized on the surface of absorbent cotton and silicone promotes the regeneration of the skin, cleans the wound surface, and is easy to peel off from the wound surface, thereby reducing pain. Indicated. Moreover, it was shown that the said wound dressing can maintain the wet state of a wound surface favorably.
  • Example 3 Evaluation of safety of wound dressing
  • egg yolk and egg white prick tests were performed on all the above cases.
  • blood samples were collected from the patients of all the cases before and 1 week after application of Example 1 and Comparative Example, and peripheral blood test and biochemical test were performed to evaluate egg yolk IgE and egg white IgE.
  • the present invention is useful for covering the wound surface and protecting the wound surface.
  • the wound dressing according to the present invention promotes skin regeneration, is easy to peel off from the wound surface, and is safe, thus contributing to skin treatment.

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Abstract

Provided is a wound covering material (100), comprising a support body (1), a substance (2) which is non-adhesive with respect to a wound surface, and a wound healing promotion agent (3). The support body (1) is water-absorbent. The non-adhesive substance (2) is positioned upon the surface of the support body (1) which faces the wound surface, with gaps interposed thereamong. The wound healing promotion agent (3) is supported by the non-adhesive substance (2). The non-adhesive substance (2) may be positioned upon the surface of the support body (1) in a reticulated manner.

Description

創傷被覆材および創傷被覆材の製造方法Wound dressing and method for producing wound dressing
　本発明は、創傷被覆材および創傷被覆材の製造方法に関する。 The present invention relates to a wound dressing and a method for producing the wound dressing.
　外傷および熱傷などの創傷面を保護するために、創傷面被覆材が使用される。創傷面の保護に加え、創傷面の回復を促すために、卵殻膜タンパク（Ｅｇｇｓｈｅｌｌ　Ｍｅｍｂｒａｎｅ　Ｐｒｏｔｅｉｎ、以下「ＥＭＰ」ともいう）などの創傷治癒促進剤を創傷面に供給する創傷被覆材が知られている。 Wound surface dressing is used to protect wound surfaces such as trauma and burns. In addition to protecting the wound surface, wound dressing materials that supply wound healing promoters such as eggshell membrane protein (hereinafter also referred to as “EMP”) to the wound surface in order to promote the recovery of the wound surface are known. Yes.
　創傷治癒促進剤を創傷面に供給する創傷被覆材として、例えば、特許文献１には、支持体上に加水分解卵殻膜を含有する含水ゲル膏体の層を設けた創傷被覆材が開示されている。 As a wound dressing material for supplying a wound healing promoter to a wound surface, for example, Patent Document 1 discloses a wound dressing material in which a layer of a hydrogel paste containing a hydrolyzed eggshell membrane is provided on a support. Yes.
　また、特許文献２には、エレクトロスピニング法によって卵殻膜成分を含有する溶液を用いて紡糸することで製造された繊維集合体からなる創傷被覆材が開示されている。 Further, Patent Document 2 discloses a wound dressing made of a fiber assembly produced by spinning using a solution containing an eggshell membrane component by an electrospinning method.
特開２００３－２２５２９８号公報JP 2003-225298 A 特開２００９－８９８５９号公報JP 2009-89859 A
　上述の加水分解卵殻膜および卵殻膜成分は、線維芽細胞を活性化することで創傷面を治癒する。しかし、加水分解卵殻膜および卵殻膜成分はタンパク質を含むため、分子間相互作用などにより、加水分解卵殻膜などを保持する創傷被覆材と創傷面とが固着しやすい。したがって、上記特許文献１および上記特許文献２に開示された創傷被覆材では、創傷被覆材を剥がす際に創傷面に形成された脆弱な新生組織および周辺組織が剥離するという損傷および該損傷に伴う疼痛が発生することがある。 The above hydrolyzed eggshell membrane and eggshell membrane components heal wound surfaces by activating fibroblasts. However, since the hydrolyzed eggshell membrane and eggshell membrane components contain proteins, the wound dressing that holds the hydrolyzed eggshell membrane and the like easily adheres to the wound surface due to intermolecular interactions. Therefore, in the wound dressing disclosed in Patent Document 1 and Patent Document 2, when the wound dressing is peeled off, the fragile new tissue formed on the wound surface and the surrounding tissue are peeled off and accompanying the damage. Pain may occur.
　本発明は、上記実情に鑑みてなされたものであり、創傷面の損傷および疼痛を極力抑えることができる創傷被覆材および創傷被覆材の製造方法を提供することを目的とする。 The present invention has been made in view of the above circumstances, and an object thereof is to provide a wound dressing and a method for producing the wound dressing that can suppress damage and pain on the wound surface as much as possible.
　本発明の第１の観点に係る創傷被覆材は、
　吸水性を有する支持体と、
　創傷面に対向する前記支持体の表面上に間隔を置いて配置された、該創傷面に対して非固着性の物質と、
　前記非固着性の物質に担持された創傷治癒促進剤と、
　を備える。 The wound dressing according to the first aspect of the present invention,
A support having water absorption;
A non-adherent substance to the wound surface, spaced apart on the surface of the support opposite the wound surface;
A wound healing promoter carried on the non-sticking substance;
Is provided.
　この場合、前記非固着性の物質は、
　前記表面上に網目状に配置されている、
　こととしてもよい。 In this case, the non-sticking substance is
Arranged in a mesh pattern on the surface,
It is good as well.
　また、前記非固着性の物質は、
　前記表面の面積の７０～９０％に配置されている、
　こととしてもよい。 The non-sticking substance is
Arranged in 70 to 90% of the surface area,
It is good as well.
　また、前記支持体は、
　前記非固着性の物質が配置されていない前記表面において創傷治癒促進剤を支持する、
　こととしてもよい。 Further, the support is
Supporting a wound healing promoter on the surface where the non-sticking substance is not disposed;
It is good as well.
　また、前記非固着性の物質は、
　シリコーンである、
　こととしてもよい。 The non-sticking substance is
Is silicone,
It is good as well.
　また、前記創傷治癒促進剤は、
　卵殻膜タンパクである、
　こととしてもよい。 The wound healing promoter is
Eggshell membrane protein,
It is good as well.
　また、前記支持体は、
　脱脂綿である、
　こととしてもよい。 Further, the support is
Cotton wool,
It is good as well.
　また、前記脱脂綿の表面には、
　毛羽押さえ加工が施されている、
　こととしてもよい。 In addition, on the surface of the absorbent cotton,
Fluff holding processing is given,
It is good as well.
　本発明の第２の観点に係る創傷被覆材の製造方法は、
　支持体の表面を、間隔を置いてマスク材で被覆する被覆工程と、
　前記支持体の表面を、創傷面に対して非固着性の物質に暴露する第１の暴露工程と、
　前記マスク材を前記支持体の表面から除去する除去工程と、
　前記非固着性の物質の表面を、創傷治癒促進剤に暴露する第２の暴露工程と、
　を含む。 The method for producing a wound dressing according to the second aspect of the present invention,
A coating process in which the surface of the support is coated with a mask material at intervals;
A first exposure step of exposing the surface of the support to a substance that is non-adherent to the wound surface;
A removing step of removing the mask material from the surface of the support;
A second exposure step of exposing the surface of the non-sticking substance to a wound healing promoter;
including.
　本発明によれば、創傷面の損傷および疼痛を極力抑えることができる。 According to the present invention, damage and pain on the wound surface can be suppressed as much as possible.
実施の形態に係る創傷被覆材の外観を示す図である。It is a figure which shows the external appearance of the wound dressing which concerns on embodiment. 図１に示す創傷被覆材の断面を示す概念図である。It is a conceptual diagram which shows the cross section of the wound dressing shown in FIG. 創傷被覆材の製造方法のフローチャートを示す図である。It is a figure which shows the flowchart of the manufacturing method of a wound dressing material. マスク材を配置した支持体の外観を示す図である。It is a figure which shows the external appearance of the support body which has arrange | positioned the mask material. 第１の暴露工程後および除去工程後の支持体を示す概念図である。It is a conceptual diagram which shows the support body after a 1st exposure process and a removal process. 実施例１に係る創傷被覆材の表面を示す図である。It is a figure which shows the surface of the wound dressing which concerns on Example 1. FIG. 実施例２における症例２の創傷面を示す図である。（ａ）は貼り付け前の状態を示す。（ｂ）は貼り付けから１０日目の状態を示す。（ｃ）は貼り付けから４ヶ月後の状態を示す。6 is a diagram showing a wound surface of case 2 in Example 2. FIG. (A) shows the state before affixing. (B) shows the state on the 10th day from the pasting. (C) shows the state after 4 months from pasting. 実施例２における症例７の創傷面を示す図である。（ａ）は貼り付け前の状態を示す。（ｂ）は貼り付けから１１日目の状態を示す。（ｃ）は貼り付けから４ヶ月後の状態を示す。6 is a diagram showing a wound surface of case 7 in Example 2. FIG. (A) shows the state before affixing. (B) shows the state on the 11th day from the pasting. (C) shows the state after 4 months from pasting.
　本発明に係る実施の形態について図面を参照して説明する。なお、本発明は下記の実施の形態および図面によって限定されるものではない。 Embodiments according to the present invention will be described with reference to the drawings. In addition, this invention is not limited by the following embodiment and drawing.
　（実施の形態）
　まず、実施の形態について詳細に説明する。図１は、本実施の形態に係る創傷被覆材１００の斜視図を示す。図１に示す創傷被覆材１００の上面が、使用時に創傷面に対向する、すなわち創傷面に接触する面である。図１に示す破線Ａ－Ａ’で切断した断面の概念図を図２に示す。創傷被覆材１００は、支持体１と、創傷面に対して非固着性の物質２と、創傷治癒促進剤３とを、備える。 (Embodiment)
First, embodiments will be described in detail. FIG. 1 shows a perspective view of a wound dressing 100 according to the present embodiment. The upper surface of the wound dressing 100 shown in FIG. 1 is the surface that faces the wound surface during use, that is, the surface that contacts the wound surface. FIG. 2 shows a conceptual diagram of a cross section taken along the broken line AA ′ shown in FIG. The wound dressing 100 includes a support 1, a substance 2 that is non-adherent to the wound surface, and a wound healing promoter 3.
　支持体１は、吸水性を有するものであれば任意である。ここで、吸水性とは、水、体液、懸濁液および溶液などの液体を吸収する性質をいう。好適には、支持体１は、保水性を有してもよい。保水性とは、吸収した液体を保持する性質をいう。 The support 1 is optional as long as it has water absorption. Here, water absorption refers to the property of absorbing liquids such as water, body fluids, suspensions and solutions. Suitably, the support body 1 may have water retention. Water retention refers to the property of retaining absorbed liquid.
　より具体的には、支持体１は、繊維、ポリマーおよびゲルなど吸水性を有する材質であれば任意の物質で成形することができる。好適には、支持体１は、脱脂綿である。脱脂綿は、特に限定されないが、表面に毛羽押さえ加工が施されている脱脂綿が創傷被覆材１００の創傷面への密着性を高める点で特に好ましい。毛羽押さえ加工は、公知の方法、例えば、エンボスプレスで脱脂綿の表面に施すことができる。 More specifically, the support 1 can be formed of any material as long as it is a material having water absorption properties such as fibers, polymers, and gels. Suitably, the support body 1 is absorbent cotton. The absorbent cotton is not particularly limited, but absorbent cotton having a fluff pressing process on the surface is particularly preferable in terms of enhancing the adhesion of the wound dressing 100 to the wound surface. Fluff pressing can be performed on the surface of absorbent cotton by a known method, for example, embossing press.
　非固着性の物質２は、創傷面に対向する支持体１の表面Ｓ上に間隔を置いて配置される。非固着性の物質２として、創傷面に対して非固着性であれば任意の物質を採用できる。ここで、非固着性とは、細胞または生体組織への接着および粘着、または体液の凝固などによって創傷面に固着しない性質をいう。非固着性の物質２は、好適にはケイ素化合物を含む。例えば、非固着性の物質２として、シリコーンが好ましい。より具体的には、非固着性の物質２として、東レ・ダウコーニング社製のＭＧ　７－９８５０　Ｓｏｆｔ　Ｓｋｉｎ　Ａｄｈｅｓｉｖｅ　Ｐａｒｔｓ　Ａ＆Ｂおよび７－９８００　Ｓｏｆｔ　Ｓｋｉｎ　Ａｄｈｅｓｉｖｅ　Ｐａｒｔｓ　Ａ＆Ｂなどが挙げられる。 The non-sticking substance 2 is arranged on the surface S of the support 1 facing the wound surface with a gap. As the non-sticking substance 2, any substance can be adopted as long as it is non-sticking to the wound surface. Here, non-adhesiveness refers to the property of not adhering to the wound surface due to adhesion and adhesion to cells or living tissues, or coagulation of body fluids. The non-sticking substance 2 preferably contains a silicon compound. For example, the non-sticking substance 2 is preferably silicone. More specifically, examples of the non-sticking substance 2 include MG 7-9850 Soft Skin Adhesive Parts A & B and 7-9800 Soft Skin Adhesive Parts A & B manufactured by Toray Dow Corning.
　支持体１の表面Ｓ上における非固着性の物質２は、一定の長さの間隔で配置されてもよいし、複数の長さの間隔で配置されてもよい。表面Ｓ上での非固着性の物質２の配置のパターンは、非固着性の物質２が間隔を置いて配置される限り任意である。例えば、非固着性の物質２は、格子状に配置されてもよいし、縦または横の複数列に配置されてもよい。好ましくは、非固着性の物質２は、支持体１の表面Ｓ上に網目状に配置される。この場合、網目の開きは、適宜設定できるが、０．５～５ｍｍ、１～３ｍｍ、好ましくは、１．８～２．２ｍｍである。 The non-sticking substance 2 on the surface S of the support 1 may be arranged at a constant length interval, or may be arranged at a plurality of length intervals. The arrangement pattern of the non-sticking substance 2 on the surface S is arbitrary as long as the non-sticking substance 2 is arranged at intervals. For example, the non-sticking substances 2 may be arranged in a lattice shape, or may be arranged in a plurality of rows in the vertical or horizontal direction. Preferably, the non-sticking substance 2 is arranged on the surface S of the support 1 in a mesh shape. In this case, the mesh opening can be set as appropriate, but it is 0.5 to 5 mm, 1 to 3 mm, and preferably 1.8 to 2.2 mm.
　非固着性の物質２が支持体１の表面Ｓの面積に占める割合は、１００％未満であれば任意である。例えば、非固着性の物質２は、表面Ｓの面積の７０～９０％、７５～８５％、好ましくは８０％に配置される。 The ratio of the non-sticking substance 2 to the area of the surface S of the support 1 is arbitrary as long as it is less than 100%. For example, the non-sticking substance 2 is arranged in 70 to 90%, 75 to 85%, preferably 80% of the area of the surface S.
　非固着性の物質２の高さは、例えば、１～２０μｍ、好ましくは５～１５μｍ、より好ましくは８～１２μｍ、特に好ましくは１０μｍである。 The height of the non-sticking substance 2 is, for example, 1 to 20 μm, preferably 5 to 15 μm, more preferably 8 to 12 μm, and particularly preferably 10 μm.
　非固着性の物質２に担持される創傷治癒促進剤３は、線維芽細胞増殖作用、血管新生作用および肉芽形成促進作用などを有するものであれば任意である。創傷治癒促進剤３は、例えば、創傷治癒の過程に関与する機能性タンパク質である。好適には、創傷治癒促進剤３は、ＥＭＰである。ＥＭＰは、鶏卵などの卵殻の内側に存在する厚さ約７０μｍの薄膜である。ＥＭＰは、プロリン、システィンなどの架橋アミノ酸を豊富に含有する。ＥＭＰは、動物の細胞に高い接着性を有する。ＥＭＰは、線維芽細胞によるコラーゲンの産生を促進する。 The wound healing promoter 3 carried on the non-adherent substance 2 is optional as long as it has a fibroblast proliferation action, angiogenesis action, granulation formation promotion action, and the like. The wound healing promoter 3 is, for example, a functional protein involved in the wound healing process. Suitably, the wound healing promoter 3 is EMP. EMP is a thin film having a thickness of about 70 μm that exists inside an eggshell such as a chicken egg. EMP is rich in bridging amino acids such as proline and cysteine. EMP has high adhesion to animal cells. EMP promotes collagen production by fibroblasts.
　創傷治癒促進剤３は、非固着性の物質２の表面に直接担持されてもよい。また、創傷治癒促進剤３は、創傷治癒促進剤３を含む溶液および懸濁液などが非固着性の物質２の表面に積層されることで、非固着性の物質２に担持されてもよい。 The wound healing promoter 3 may be carried directly on the surface of the non-sticking substance 2. Further, the wound healing promoter 3 may be supported on the non-sticking substance 2 by laminating a solution and a suspension containing the wound healing promoter 3 on the surface of the non-sticking substance 2. .
　図２に示すように、創傷治癒促進剤３は、非固着性の物質２に担持されるのに加えて、非固着性の物質２が配置されていない支持体１の表面Ｓにおいて支持されてもよい。 As shown in FIG. 2, the wound healing promoter 3 is supported on the surface S of the support 1 on which the non-sticking substance 2 is not arranged, in addition to being supported by the non-sticking substance 2. Also good.
　次に、本実施の形態に係る創傷被覆材１００に好適な製造方法を例示する。図３は、創傷被覆材１００の製造方法のフローを示す図である。該製造方法は、被覆工程と、第１の暴露工程と、除去工程と、第２の暴露工程とを含む。 Next, a suitable manufacturing method for the wound dressing 100 according to the present embodiment will be exemplified. FIG. 3 is a diagram showing a flow of a method for manufacturing the wound dressing 100. The manufacturing method includes a coating step, a first exposure step, a removal step, and a second exposure step.
　被覆工程では、支持体１の表面Ｓを、間隔を置いてマスク材４で被覆する（ステップＳ１）。マスク材４の形状は、支持体１の表面Ｓ上における非固着性の物質２の配置のパターンに応じて決定される。例えば、非固着性の物質２を表面Ｓ上に網目状に配置する場合は、図４に示すように、ステンレス製の網（メッシュ）を、表面Ｓ上に配置すればよい。 In the covering step, the surface S of the support 1 is covered with the mask material 4 at intervals (step S1). The shape of the mask material 4 is determined according to the arrangement pattern of the non-sticking substance 2 on the surface S of the support 1. For example, when the non-sticking substance 2 is arranged on the surface S in a mesh shape, a stainless steel net (mesh) may be arranged on the surface S as shown in FIG.
　図３に戻って、第１の暴露工程では、支持体１の表面Ｓを、非固着性の物質２に暴露する（ステップＳ２）。表面Ｓを非固着性の物質２に暴露するために、非固着性の物質２の溶液を表面Ｓに噴霧してもよいし、非固着性の物質２の溶液に表面Ｓを浸してもよい。例えば、非固着性の物質２として、シリコーンを用いる場合、第１の暴露工程では、２～２０ｍｇ／ｃｍ２、６～１４ｍｇ／ｃｍ２、好ましくは８～１２ｍｇ／ｃｍ２の量のシリコーン溶液を、表面Ｓに噴霧すればよい。 Returning to FIG. 3, in the first exposure step, the surface S of the support 1 is exposed to the non-sticking substance 2 (step S2). In order to expose the surface S to the non-sticking substance 2, a solution of the non-sticking substance 2 may be sprayed on the surface S, or the surface S may be immersed in the solution of the non-sticking substance 2. . For example, when silicone is used as the non-sticking substance 2, a silicone solution in an amount of 2 to 20 mg / cm 2 , 6 to 14 mg / cm 2 , preferably 8 to 12 mg / cm 2 is used in the first exposure step. The surface S may be sprayed.
　次に、除去工程では、マスク材４を支持体１の表面Ｓから除去する（ステップＳ３）。マスク材４は、第１の暴露工程後に、一定時間経過してから除去されてもよい。マスク材４を除去後、非固着性の物質２の物性に応じて、支持体１に加熱処理を施してもよい。非固着性の物質２がシリコーンの場合、加熱処理は、例えば、１００℃で３０分間である。この結果、ステップＳ１で被覆されなかった表面Ｓの部分に非固着性の物質２の層が形成される。 Next, in the removing step, the mask material 4 is removed from the surface S of the support 1 (step S3). The mask material 4 may be removed after a lapse of a certain time after the first exposure step. After removing the mask material 4, the support 1 may be subjected to heat treatment according to the physical properties of the non-sticking substance 2. When the non-sticking substance 2 is silicone, the heat treatment is performed at 100 ° C. for 30 minutes, for example. As a result, a layer of the non-sticking substance 2 is formed on the portion of the surface S that has not been coated in step S1.
　図５は、第１の暴露工程後および除去工程後の、図２と同様の支持体１の断面の概念図である。第１の暴露工程後、非固着性の物質２は、マスク材４の上およびマスク材４で被覆されていない表面Ｓ上の部分に積層される。そして、除去工程において、マスク材４が除去されると、マスク材４とともにマスク材４の上に積層された非固着性の物質２が除去されるため、表面Ｓ上に残った非固着性の物質２は、マスク材４のパターンに応じて表面Ｓ上に間隔を置いて配置される。 FIG. 5 is a conceptual view of a cross section of the support 1 similar to FIG. 2 after the first exposure step and after the removal step. After the first exposure step, the non-sticking substance 2 is laminated on the mask material 4 and on the surface S that is not covered with the mask material 4. In the removing step, when the mask material 4 is removed, the non-adhesive substance 2 laminated on the mask material 4 together with the mask material 4 is removed, so that the non-adhesive property remaining on the surface S is removed. The substance 2 is arranged on the surface S at intervals according to the pattern of the mask material 4.
　図３に戻って、続いて、第２の暴露工程では、非固着性の物質２の表面を、創傷治癒促進剤３に暴露する（ステップＳ４）。創傷治癒促進剤３は、例えば、適切な溶媒に溶解、分散または懸濁して、非固着性の物質２を配置した支持体１の表面Ｓに噴霧される。こうすることで、非固着性の物質２の表面と、非固着性の物質２が配置されていない支持体１の表面Ｓとが創傷治癒促進剤３に暴露される。創傷治癒促進剤３としてＥＭＰを用いる場合、１～１０ｍｇ／ｃｍ２、２～８ｍｇ／ｃｍ２、好ましくは４～６ｍｇ／ｃｍ２となるようにＥＭＰエタノール水分散液を噴霧すればよい。 Returning to FIG. 3, subsequently, in the second exposure step, the surface of the non-sticking substance 2 is exposed to the wound healing promoter 3 (step S4). The wound healing promoter 3 is, for example, dissolved, dispersed or suspended in a suitable solvent and sprayed on the surface S of the support 1 on which the non-sticking substance 2 is arranged. By doing so, the surface of the non-sticking substance 2 and the surface S of the support 1 on which the non-sticking substance 2 is not disposed are exposed to the wound healing promoter 3. When EMP is used as the wound healing promoter 3, the EMP ethanol aqueous dispersion may be sprayed so as to be 1 to 10 mg / cm 2 , 2 to 8 mg / cm 2 , preferably 4 to 6 mg / cm 2 .
　なお、第２の暴露工程に続いて、必要に応じて、支持体１を加熱乾燥してもよい。こうすることで、支持体１および非固着性の物質２の表面に創傷治癒促進剤３をより確実に固定化することができる。また、創傷被覆材１００の製造方法は、上記の各工程に加え、創傷被覆材１００を滅菌する滅菌工程をさらに含んでもよい。 In addition, you may heat-dry the support body 1 as needed following a 2nd exposure process. By carrying out like this, the wound healing promoter 3 can be more reliably fixed to the surface of the support body 1 and the non-sticking substance 2. Moreover, the manufacturing method of the wound dressing material 100 may further include a sterilization process for sterilizing the wound dressing material 100 in addition to the above steps.
　以上詳細に説明したように、本実施の形態に係る創傷被覆材１００によれば、創傷治癒促進剤３が創傷面に供給されるため、速やかな創傷面の上皮化を促進することができる。また、創傷治癒促進剤３が非固着性の物質２に担持されているため、創傷治癒促進剤３が創傷面に供給されても、支持体１と創傷面との間に創傷面に対して非固着性の物質２が介在することになる。このため、創傷被覆材１００の創傷面への固着が抑制され、創傷被覆材１００を容易に剥がすことができる。これにより、創傷被覆材１００の交換時など創傷被覆材１００を剥がす際に、表皮が剥離することなどによる創傷面の損傷を極力抑えることができる。さらに、創傷被覆材１００を剥がす際の疼痛を軽減することができる。 As described above in detail, according to the wound dressing 100 according to the present embodiment, since the wound healing promoter 3 is supplied to the wound surface, rapid epithelialization of the wound surface can be promoted. In addition, since the wound healing promoter 3 is carried on the non-sticking substance 2, even if the wound healing promoter 3 is supplied to the wound surface, the wound healing promoter 3 is interposed between the support 1 and the wound surface. The non-sticking substance 2 is interposed. For this reason, sticking to the wound surface of the wound dressing 100 is suppressed, and the wound dressing 100 can be easily peeled off. Thereby, when removing the wound dressing 100, such as when the wound dressing 100 is replaced, damage to the wound surface due to peeling of the epidermis can be suppressed as much as possible. Furthermore, pain when peeling the wound dressing 100 can be reduced.
　また、本実施の形態に係る創傷被覆材１００によれば、非固着性の物質２が支持体１の表面Ｓ上に間隔を置いて配置されているため、表面Ｓが非固着性の物質２で完全に被覆されていない。これにより、創傷面からの滲出液は、非固着性の物質２が配置されていない部分から吸水性を有する支持体１に吸収され、保持される。この結果、創傷面の湿潤状態が適度に保持される。 Further, according to the wound dressing 100 according to the present embodiment, since the non-adhesive substance 2 is arranged on the surface S of the support 1 with an interval, the surface S is non-adhesive substance 2. It is not completely covered with. As a result, exudate from the wound surface is absorbed and retained by the support 1 having water absorption from the portion where the non-sticking substance 2 is not disposed. As a result, the wet state of the wound surface is appropriately maintained.
　なお、本実施の形態では、非固着性の物質２は、支持体１の表面Ｓ上に網目状に配置されてもよいこととした。非固着性の物質２を網目状に配置することで、非固着性の物質２を表面Ｓ全体に均一に、適切な間隔を置いて配置することができる。これにより、創傷治癒促進剤３を創傷面により確実に供給することができる。また、非固着性の物質２を網目状に配置することで、表面Ｓの単位面積あたりの非固着性の物質２が配置されていない部分の面積が一定になるので、創傷面全体からの滲出液を支持体１に効率よく吸収できる。 In the present embodiment, the non-sticking substance 2 may be arranged on the surface S of the support 1 in a mesh shape. By disposing the non-adhesive substance 2 in a mesh shape, the non-adhesive substance 2 can be arranged uniformly on the entire surface S with appropriate intervals. Thereby, the wound healing promoter 3 can be reliably supplied to the wound surface. In addition, by arranging the non-adhesive substance 2 in a mesh shape, the area of the portion of the surface S where the non-adhesive substance 2 is not arranged becomes constant, so that exudation from the entire wound surface The liquid can be efficiently absorbed by the support 1.
　また、本実施の形態では、非固着性の物質２が表面Ｓの面積の７０～９０％に配置されてもよいこととした。こうすることで、創傷被覆材１００の創傷面への固着抑制と創傷面の湿潤状態の保持とのバランスを好適に調整できる。 In the present embodiment, the non-sticking substance 2 may be arranged in 70 to 90% of the area of the surface S. By carrying out like this, the balance with the adhesion | attachment suppression to the wound surface of the wound dressing 100 and the maintenance of the wet state of a wound surface can be adjusted suitably.
　また、支持体１は、非固着性の物質２が配置されていない表面Ｓにおいて創傷治癒促進剤３を支持してもよいこととした。これにより、支持体１の表面Ｓで支持された創傷治癒促進剤３も創傷面に供給されるので、創傷面の上皮化をさらに促進させることができる。 Further, the support 1 may support the wound healing promoter 3 on the surface S where the non-sticking substance 2 is not disposed. Thereby, since the wound healing promoter 3 supported by the surface S of the support 1 is also supplied to the wound surface, epithelization of the wound surface can be further promoted.
　また、非固着性の物質２は、シリコーンであってもよいこととした。シリコーンは、創傷面に固着しないうえに、生体適合性も備えているため、創傷面に接触しても安全である。なお、非固着性の物質２は、創傷面に固着性がないことが知られる物質、例えばアルギン酸ゲルおよびカルボキシメチルセルロース（ＣＭＣ）ゲルなどであってもよい。 Further, the non-sticking substance 2 may be silicone. Silicone does not stick to the wound surface and is also biocompatible so it is safe to contact the wound surface. The non-adhesive substance 2 may be a substance that is known not to have adhesiveness on the wound surface, such as an alginate gel and a carboxymethyl cellulose (CMC) gel.
　また、創傷治癒促進剤３は、ＥＭＰであってもよいこととした。ＥＭＰは、各種動物試験における安全性試験および人における皮膚アレルギー性試験で安全性が確認されているため、創傷面に使用する創傷被覆材１００に好適である。また、ＥＭＰは、創傷治癒を促進する作用が認められるため、創傷治癒に有効である。 In addition, the wound healing promoter 3 may be EMP. Since EMP has been confirmed to be safe in safety tests in various animal tests and human skin allergy tests, it is suitable for the wound dressing 100 used on the wound surface. In addition, EMP is effective in wound healing because it has an effect of promoting wound healing.
　なお、創傷治癒促進剤３は、線維芽細胞増殖因子（Ｆｉｂｒｏｂｌａｓｔ　ｇｒｏｗｔｈ　ｆａｃｔｏｒｓ：ＦＧＦ）であってもよい。ＦＧＦは、線維芽細胞の増殖を促進することで、線維芽細胞によって合成されるコラーゲン、エラスチンおよびヒアルロン酸など真皮の成分の分泌を促す。ＦＧＦによって、血管伸長、創傷治癒の初期段階における肉芽組織の形成、ならびに創傷面の皮膚および粘膜組織の修復が促進される。創傷治癒促進剤３としてのＦＧＦは、例えば、酸性線維芽細胞増殖因子（ＦＧＦ１）、塩基性線維芽細胞増殖因子（ＦＧＦ２）、ケラチノサイト増殖因子（ＦＧＦ１０）および角化細胞成長因子（ＦＧＦ７）などである。 In addition, the wound healing promoter 3 may be a fibroblast growth factor (FGF). FGF promotes the proliferation of fibroblasts to promote secretion of dermal components such as collagen, elastin and hyaluronic acid synthesized by fibroblasts. FGF promotes vascular elongation, formation of granulation tissue in the early stages of wound healing, and repair of skin and mucosal tissue on the wound surface. Examples of FGF as the wound healing promoter 3 include acidic fibroblast growth factor (FGF1), basic fibroblast growth factor (FGF2), keratinocyte growth factor (FGF10), and keratinocyte growth factor (FGF7). is there.
　また、創傷治癒促進剤３は、血小板溶解液、ヒトフィブロネクチン、ツバキ葉抽出物、アロエ抽出物、抗炎症剤、カリクレインおよびコラーゲンなどであってもよい。また、創傷治癒促進剤３は、血管新生の促進に関与するＣｏｍｂ－１およびＵＮ－３などのペプチドであってもよい。 Also, the wound healing promoter 3 may be a platelet lysate, human fibronectin, camellia leaf extract, aloe extract, anti-inflammatory agent, kallikrein, collagen, and the like. In addition, the wound healing promoter 3 may be a peptide such as Comb-1 and UN-3 involved in promoting angiogenesis.
　また、本実施の形態では、支持体１が脱脂綿であってもよいこととした。脱脂綿は加工が容易で、かつ吸水性、保水性に優れるため、創傷面の湿潤状態を好適に保つことができる。また、脱脂綿の表面に毛羽押さえ加工を施すことで、創傷面との密着性を高めることができる。なお、支持体１は、脱脂綿に限らず、不織布などであってもよい。 Further, in the present embodiment, the support 1 may be absorbent cotton. Absorbent cotton is easy to process and excellent in water absorption and water retention, so that the wet state of the wound surface can be suitably maintained. Moreover, adhesiveness with a wound surface can be improved by performing a fluff pressing process on the surface of absorbent cotton. The support 1 is not limited to absorbent cotton but may be a nonwoven fabric or the like.
　また、本実施の形態では、創傷被覆材１００を、支持体１の表面Ｓを、マスク材４で被覆し、非固着性の物質２に暴露してからマスク材４を表面Ｓから除去することで、非固着性の物質２を表面Ｓ上に間隔を置いて配置した。こうすることで、所望のパターンで非固着性の物質２を簡便に、表面Ｓ上に配置することができる。 Moreover, in this Embodiment, after removing the mask material 4 from the surface S, after covering the surface S of the support body 1 with the mask material 4 and exposing the wound dressing material 100 to the non-adhesive substance 2. Then, the non-sticking substance 2 was arranged on the surface S at intervals. By doing so, the non-sticking substance 2 in a desired pattern can be easily arranged on the surface S.
　なお、創傷被覆材１００は、任意の方法で、創傷面に固定できる。例えば、創傷面に対向する支持体１の表面Ｓの周縁に、皮膚と接着する接着剤を塗布して、創傷被覆材１００を創傷面に固定してもよい。このとき、接着剤が創傷面に接触しないように、表面Ｓの面積を創傷面の面積よりも大きくするのが好ましい。また、サージカルテープなどを用いて、創傷被覆材１００を創傷面に固定してもよい。 Note that the wound dressing 100 can be fixed to the wound surface by any method. For example, the wound dressing 100 may be fixed to the wound surface by applying an adhesive that adheres to the skin to the periphery of the surface S of the support 1 facing the wound surface. At this time, the area of the surface S is preferably larger than the area of the wound surface so that the adhesive does not contact the wound surface. Further, the wound dressing 100 may be fixed to the wound surface using a surgical tape or the like.
　以下の実施例により、本発明をさらに具体的に説明するが、本発明は実施例によって限定されるものではない。 The following examples further illustrate the present invention, but the present invention is not limited to the examples.
　（実施例１：創傷被覆材の製造）
　まず、シート状の脱脂綿の表面に対し、エンボスプレスによって毛羽押さえ加工を施した。次に、脱脂綿上にマスク材を設置した。マスク材として、ステンレス製のメッシュを用いた。メッシュの目の開きは、２ｍｍとした。シリコーンの濃度が３０％となるようにシリコーンをノルマルヘキサンに溶解して調製したシリコーン溶液を、マスク材を設置した脱脂綿に１０ｍｇ／ｃｍ２となるように噴霧した。シリコーンは、東レ・ダウコーニング社製のＭＧ　７－９８５０　Ｓｏｆｔ　Ｓｋｉｎ　Ａｄｈｅｓｉｖｅ　Ｐａｒｔｓ　Ａ＆Ｂである。 (Example 1: Production of wound dressing)
First, fluff pressing processing was performed on the surface of the sheet-like absorbent cotton with an emboss press. Next, a mask material was placed on the absorbent cotton. Stainless steel mesh was used as the mask material. The mesh opening was 2 mm. A silicone solution prepared by dissolving silicone in normal hexane so as to have a silicone concentration of 30% was sprayed on absorbent cotton provided with a mask material so that the concentration was 10 mg / cm 2 . Silicone is MG 7-9850 Soft Skin Adhesive Part A & B manufactured by Toray Dow Corning.
　シリコーン溶液を噴霧後、マスク材を除去し、脱脂綿を１００℃で３０分間加熱した。これにより、脱脂綿上のマスキングされなかった部分にシリコーン層が形成された。脱脂綿の表面の面積に対して、シリコーンの面積は約８０％であった。また、脱脂綿上に、網目状に配置されたシリコーンの厚さは、１０μｍと推定される。 After spraying the silicone solution, the mask material was removed, and the absorbent cotton was heated at 100 ° C. for 30 minutes. Thereby, the silicone layer was formed in the part which was not masked on absorbent cotton. The area of silicone was about 80% with respect to the area of the surface of absorbent cotton. Moreover, the thickness of the silicone arrange | positioned on absorbent cotton at mesh shape is estimated to be 10 micrometers.
　上記シリコーンを配置した脱脂綿に対して、ＥＭＰ（キューピー社製）を含むＥＭＰエタノール水分散液を１０ｍｇ／ｃｍ２となるように噴霧した。脱脂綿を５０℃で３０分間乾燥させ、脱脂綿およびシリコーンの表面にＥＭＰを固定化することで創傷被覆材を製造した。続いて、オートクレーブを用いて、創傷被覆材を１２４℃で１５分間滅菌した。図６は、得られたＥＭＰ担持創傷被覆材（以下、「実施例１」とする）の創傷面に接触する側の表面を示す。 An EMP ethanol aqueous dispersion containing EMP (manufactured by Kewpie) was sprayed on the absorbent cotton on which the silicone was disposed so as to be 10 mg / cm 2 . The absorbent cotton was dried at 50 ° C. for 30 minutes, and the wound dressing was produced by immobilizing EMP on the absorbent cotton and silicone surfaces. Subsequently, the wound dressing was sterilized at 124 ° C. for 15 minutes using an autoclave. FIG. 6 shows the surface of the obtained EMP-carrying wound dressing (hereinafter referred to as “Example 1”) on the side in contact with the wound surface.
　なお、比較のために、上記実施例１と同様に、脱脂綿上にシリコーン層を形成し、ＥＭＰを固定化していない創傷被覆材（以下、「比較例」とする）を製造した。 For comparison, a wound dressing (hereinafter referred to as “Comparative Example”) in which a silicone layer was formed on absorbent cotton and EMP was not immobilized was produced in the same manner as in Example 1 above.
　（実施例２：創傷被覆材の有効性の評価）
　実施例１を創傷面に使用することで、創傷面の上皮化、創傷部の疼痛および湿潤状態を評価した。 (Example 2: Evaluation of effectiveness of wound dressing)
Using Example 1 on the wound surface, the epithelization of the wound surface, the pain of the wound and the wet state were evaluated.
　創傷面として、表１に示す症例に関して、分層植皮術における採皮部または難治性皮膚潰瘍の創傷面を左右の２領域に分け、一方の領域に実施例１を、他方の領域に比較例を貼り付けた。貼り付けた当日（０日目）、貼り付けた日の翌日（１日目）、３日目、７日目および１４日目に、上皮化およびびらん・潰瘍の残存の程度、創傷面の疼痛（Ｖｉｓｕａｌ　Ａｎａｌｏｇｕｅ　Ｓｃａｌｅ：ＶＡＳ）、ならびに湿潤状態を医師総合評価（Ｐｈｙｓｉｃｉａｎ　Ｇｌｏｂａｌ　Ａｓｓｅｓｓｍｅｎｔ）で評価した。なお、実施例１および比較例を１日目、３日目および７日目に交換し、交換の際に創傷面を観察した。 As the wound surface, with respect to the cases shown in Table 1, the skin area in split layer skin grafting or the wound surface of refractory skin ulcer is divided into two regions on the left and right, Example 1 in one region and Comparative example in the other region Was pasted. On the day of application (Day 0), the day after application (Day 1), Day 3, Day 7 and Day 14, degree of epithelialization, erosion / ulcer remaining, wound surface pain (Visual Analogue Scale: VAS), and the wet state were evaluated by a physician global assessment (Physician Global Assessment). In addition, Example 1 and the comparative example were exchanged on the first day, the third day, and the seventh day, and the wound surface was observed during the exchange.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
　（結果）
　図７は、症例２の創傷面を示す。（ａ）に示す貼り付け前には創傷面に見られなかった上皮が、（ｂ）に示す貼り付けから１０日目には実施例１において形成されていた。貼り付けから４ヶ月後には、比較例に対して、実施例１を貼り付けた領域において創傷治癒が明らかに促進されていた。 (result)
FIG. 7 shows the wound surface of Case 2. The epithelium that was not seen on the wound surface before the application shown in (a) was formed in Example 1 on the 10th day after the application shown in (b). Four months after application, wound healing was clearly promoted in the region where Example 1 was applied compared to the comparative example.
　図８は、症例７の創傷面を示す。（ａ）に示す創傷面に貼り付けてから１１日目には、（ｂ）に示すように、比較例よりも実施例１を貼り付けた領域において上皮化が見られた。貼り付けから４ヶ月後には、比較例に対して、実施例１を貼り付けた領域の創傷面がより回復していた。 FIG. 8 shows the wound surface of case 7. On the 11th day after being applied to the wound surface shown in (a), epithelialization was observed in the region where Example 1 was applied rather than the comparative example, as shown in (b). Four months after pasting, the wound surface in the region where Example 1 was pasted was more recovered than the comparative example.
　表２に、医師総合評価の結果を示す。ＶＡＳのかっこ内は、各症例の創傷面において実施例１を貼り付けた領域の上皮化を確認した日数を示す。１０の症例の内、著効２例を含む７例において実施例１の有効性が認められた。比較例と実施例１との間で、貼り付けた領域における上皮化で明らかな差を認めた時点は、平均１０．１日だった。また、症例７～９のように、実施例１は比較例よりも創傷面の疼痛を軽減することが示された。 Table 2 shows the results of comprehensive doctor evaluation. In the parentheses of VAS, the number of days on which the epithelialization of the region where Example 1 was pasted was confirmed on the wound surface of each case. Among 10 cases, the effectiveness of Example 1 was observed in 7 cases including 2 cases. The time when a clear difference in epithelialization in the pasted area was recognized between the comparative example and Example 1 was 10.1 days on average. In addition, as in cases 7 to 9, Example 1 was shown to reduce pain on the wound surface more than the comparative example.
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
　このように、脱脂綿およびシリコーンの表面にＥＭＰを固定化した創傷被覆材は、皮膚の再生を促進し、創傷面を綺麗に治癒するうえに、創傷面から剥がしやすいため、疼痛を軽減することが示された。また、当該創傷被覆材は、創傷面の湿潤状態も良好に維持できることが示された。 As described above, the wound dressing material in which EMP is immobilized on the surface of absorbent cotton and silicone promotes the regeneration of the skin, cleans the wound surface, and is easy to peel off from the wound surface, thereby reducing pain. Indicated. Moreover, it was shown that the said wound dressing can maintain the wet state of a wound surface favorably.
　（実施例３：創傷被覆材の安全性の評価）
　実施例１および比較例を貼り付ける前に、卵黄および卵白のプリックテストを上記全症例について実施した。また、実施例１および比較例の貼り付け前と貼り付け後１週間目に、上記全症例の患者から採血し、末梢血検査、生化学検査を行い、卵黄ＩｇＥおよび卵白ＩｇＥを評価した。 (Example 3: Evaluation of safety of wound dressing)
Prior to pasting Example 1 and Comparative Example, egg yolk and egg white prick tests were performed on all the above cases. Moreover, blood samples were collected from the patients of all the cases before and 1 week after application of Example 1 and Comparative Example, and peripheral blood test and biochemical test were performed to evaluate egg yolk IgE and egg white IgE.
　（結果）
　プリックテストは、全症例で陰性であった。また、末梢血検査、生化学検査ならびに卵黄ＩｇＥおよび卵白ＩｇＥの評価において、異常のみられた患者はいなかった。 (result)
The prick test was negative in all cases. In addition, none of the patients showed abnormalities in peripheral blood tests, biochemical tests, and egg yolk IgE and egg white IgE evaluation.
　以上より、脱脂綿およびシリコーンの表面にＥＭＰを固定化した創傷被覆材は、安全性が極めて高いことが示された。 From the above, it was shown that the wound dressing material in which EMP was immobilized on the surface of absorbent cotton and silicone was extremely high in safety.
　上述した実施の形態は、本発明を説明するためのものであり、本発明の範囲を限定するものではない。すなわち、本発明の範囲は、実施の形態ではなく、特許請求の範囲によって示される。そして、特許請求の範囲内およびそれと同等の発明の意義の範囲内で施される様々な変形が、本発明の範囲内とみなされる。 The embodiment described above is for explaining the present invention, and does not limit the scope of the present invention. In other words, the scope of the present invention is shown not by the embodiments but by the claims. Various modifications within the scope of the claims and within the scope of the equivalent invention are considered to be within the scope of the present invention.
　本出願は、２０１５年４月８日に出願された、日本国特許出願２０１５－７８８３４号に基づく。本明細書中に日本国特許出願２０１５－７８８３４号の明細書、特許請求の範囲、図面全体を参照として取り込むものとする。 This application is based on Japanese Patent Application No. 2015-78834 filed on April 8, 2015. The specification, claims, and entire drawings of Japanese Patent Application No. 2015-78834 are incorporated herein by reference.
　本発明は、創傷面の被覆および創傷面の保護に有用である。本発明に係る創傷被覆材は、皮膚の再生を促し、創傷面から剥がしやすく、安全であるため、皮膚の治療に貢献する。 The present invention is useful for covering the wound surface and protecting the wound surface. The wound dressing according to the present invention promotes skin regeneration, is easy to peel off from the wound surface, and is safe, thus contributing to skin treatment.
　１　支持体
　２　非固着性の物質
　３　創傷治癒促進剤
　４　マスク材
　１００　創傷被覆材 DESCRIPTION OF SYMBOLS 1 Support body 2 Non-adhesive substance 3 Wound healing promoter 4 Mask material 100 Wound dressing material

Claims (9)

  1. 　吸水性を有する支持体と、
    　創傷面に対向する前記支持体の表面上に間隔を置いて配置された、該創傷面に対して非固着性の物質と、
    　前記非固着性の物質に担持された創傷治癒促進剤と、
    　を備える、創傷被覆材。     A support having water absorption;
    A non-adherent substance to the wound surface, spaced apart on the surface of the support opposite the wound surface;
    A wound healing promoter carried on the non-sticking substance;
    A wound dressing comprising.
  2. 　前記非固着性の物質は、
    　前記表面上に網目状に配置されている、
    　請求項１に記載の創傷被覆材。     The non-sticking substance is
    Arranged in a mesh pattern on the surface,
    The wound dressing according to claim 1.
  3. 　前記非固着性の物質は、
    　前記表面の面積の７０～９０％に配置されている、
    　請求項１または２に記載の創傷被覆材。     The non-sticking substance is
    Arranged in 70 to 90% of the surface area,
    The wound dressing according to claim 1 or 2.
  4. 　前記支持体は、
    　前記非固着性の物質が配置されていない前記表面において創傷治癒促進剤を支持する、
    　請求項１から３のいずれか一項に記載の創傷被覆材。     The support is
    Supporting a wound healing promoter on the surface where the non-sticking substance is not disposed;
    The wound dressing according to any one of claims 1 to 3.
  5. 　前記非固着性の物質は、
    　シリコーンである、
    　請求項１から４のいずれか一項に記載の創傷被覆材。     The non-sticking substance is
    Is silicone,
    The wound dressing according to any one of claims 1 to 4.
  6. 　前記創傷治癒促進剤は、
    　卵殻膜タンパクである、
    　請求項１から５のいずれか一項に記載の創傷被覆材。     The wound healing promoter is
    Eggshell membrane protein,
    The wound dressing according to any one of claims 1 to 5.
  7. 　前記支持体は、
    　脱脂綿である、
    　請求項１から６のいずれか一項に記載の創傷被覆材。     The support is
    Cotton wool,
    The wound dressing according to any one of claims 1 to 6.
  8. 　前記脱脂綿の表面には、
    　毛羽押さえ加工が施されている、
    　請求項７に記載の創傷被覆材。     On the surface of the absorbent cotton,
    Fluff holding processing is given,
    The wound dressing according to claim 7.
  9. 　支持体の表面を、間隔を置いてマスク材で被覆する被覆工程と、
    　前記支持体の表面を、創傷面に対して非固着性の物質に暴露する第１の暴露工程と、
    　前記マスク材を前記支持体の表面から除去する除去工程と、
    　前記非固着性の物質の表面を、創傷治癒促進剤に暴露する第２の暴露工程と、
    　を含む、創傷被覆材の製造方法。     A coating process in which the surface of the support is coated with a mask material at intervals;
    A first exposure step of exposing the surface of the support to a substance that is non-adherent to the wound surface;
    A removing step of removing the mask material from the surface of the support;
    A second exposure step of exposing the surface of the non-sticking substance to a wound healing promoter;
    A method for producing a wound dressing, comprising:
PCT/JP2016/058997 2015-04-08 2016-03-22 Wound covering material and wound covering material manufacturing method WO2016163225A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08260330A (en) * 1995-03-24 1996-10-08 Japan Vilene Co Ltd Nonwoven fabric and patch substrate using the same
JP2002530157A (en) * 1998-11-24 2002-09-17 ジョンソン・アンド・ジョンソン・コンシューマー・カンパニーズ・インコーポレイテッド Absorbent bandages and effective coatings for active ingredients on bandages.
JP2009089858A (en) * 2007-10-05 2009-04-30 Kakui Kk Method of manufacturing absorbent cotton sheet for covering wound surface and absorbent cotton sheet for covering wound surface
JP2012529943A (en) * 2009-06-16 2012-11-29 バクスター・インターナショナル・インコーポレイテッド Hemostatic sponge
JP2013212412A (en) * 2007-03-06 2013-10-17 Z-Medica Llc Clay-based hemostatic agents and devices for the delivery thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2880029B1 (en) * 2004-12-23 2007-02-16 Rhodia Chimie Sa NON-YELLOWING SILICONE COMPOSITION
JP2006231068A (en) * 2006-03-28 2006-09-07 Sm Technologies Llc Porus material product

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08260330A (en) * 1995-03-24 1996-10-08 Japan Vilene Co Ltd Nonwoven fabric and patch substrate using the same
JP2002530157A (en) * 1998-11-24 2002-09-17 ジョンソン・アンド・ジョンソン・コンシューマー・カンパニーズ・インコーポレイテッド Absorbent bandages and effective coatings for active ingredients on bandages.
JP2013212412A (en) * 2007-03-06 2013-10-17 Z-Medica Llc Clay-based hemostatic agents and devices for the delivery thereof
JP2009089858A (en) * 2007-10-05 2009-04-30 Kakui Kk Method of manufacturing absorbent cotton sheet for covering wound surface and absorbent cotton sheet for covering wound surface
JP2012529943A (en) * 2009-06-16 2012-11-29 バクスター・インターナショナル・インコーポレイテッド Hemostatic sponge

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