JPS6340543B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention relates to a covering agent that promotes the repair and healing of wide-area wounds, and more specifically to a covering agent that promotes the growth of tissue cells in the wound area, absorbs body fluids from the wound area, and absorbs excess moisture. The purpose of the present invention is to provide a novel wound covering agent that evaporates the skin, prevents infection of the wound surface due to bacterial invasion from the outside, and alleviates pain. Wounds are caused by burns, skin abrasion (for skin grafts), physical injuries, etc. Burns in particular cause water to evaporate from the body, causing dehydration and sometimes even death. As a treatment method for these, a covering therapy using an ointment base containing silver nitrate, an ointment base containing a topical antibiotic, etc. is generally performed. In this therapy, the ointment is applied to the wound area to absorb exuding body fluids and prevent bacterial infection for healing. However, since this therapy does not take measures to actively promote the growth of tissue cells, it has the disadvantage that it takes a long time for complete recovery. Recently, in place of such therapy, a homograft method using human skin and a heterograft method using pig skin have been studied and adopted. However, since the homograft method uses human skin, its range of application is naturally limited, and the heterograft method also requires complicated operations such as washing and sterilizing fresh pig skin with boiling water.
There is a problem that it is difficult to obtain products of uniform quality. On the other hand, attempts have been made to use freeze-dried pig skin, and some have even undergone clinical testing, but this requires a complicated operation of aseptically soaking it in physiological saline and softening it before use. If water or the like adheres to the posterior pork skin, it will cause inconveniences such as water infiltration and delaying healing. Furthermore, as covering agents, polymethyl glutamate, polybenzyl glutamate, silicone rubber, flocs made of polyamide or polyester fibers, polyvinyl formal sponges, etc. have recently been proposed; In terms of pores, moisture permeability, etc.
The current situation is that nothing satisfactory has yet been found. Accordingly, a first object of the present invention is to provide a wound covering agent that has good adhesion to wound tissue and promotes the growth of tissue cells. A second object of the present invention is to provide a wound covering agent that absorbs body fluid exuding from a wound site, evaporates moisture appropriately, and prevents water or bacteria from entering from the outside. A third object of the present invention is to provide a wound covering agent that inhibits or kills the growth of microorganisms present in the wound. That is, the present invention provides a wound covering agent characterized in that a microporous polymer film and a biocompatible polymer film containing a physiologically active substance having antibacterial properties are laminated. According to the wound covering agent of the present invention, it has good adhesion to the wound area and promotes the growth of tissue cells, so the wound area heals quickly, and due to the action of the physiologically active substance having antibacterial properties, bacteria etc. It also has the characteristic that infection is actively prevented. The microporous polymer film used in the practice of the present invention is defined as having micropores that do not allow water or bacteria to enter from the outside and have a sufficient pore size to evaporate moisture from the surface of the wound. There are countless types of polymer films, such as microporous fluororesin films, microporous polyurethane resin films, microporous polyolefin resin films, and microporous polysulfone resin films. In particular, a microporous fluororesin film is preferred because it has particularly high water repellency and can form uniform micropores. The diameter of the micropores in the microporous polymer film is
It is in the range of 0.01 to 100 μm, preferably 0.1 to 10 μm, and if it is less than 0.01 μm, it is undesirable because it inhibits proper transpiration of moisture, and if it is more than 100 μm, it is undesirable because water etc. will enter from the outside. . Furthermore, in carrying out the present invention, a liquid-absorbing thin sheet material can be laminated as an intermediate layer of the wound covering agent, but the thin sheet material is not particularly limited as long as it absorbs body fluid exuding from the wound. Examples include gauze, nonwoven fabric, foam, etc. with a thickness of 5 to 500 μm. Furthermore, biocompatible polymer films containing physiologically active substances with antibacterial properties include thick films made of proteins such as collagen, keratin, and chitin.
Films containing bioactive substances with antibacterial properties in a dispersed and/or dissolved state in a film with a size of 2000 μm or less, preferably in the range of 10 to 500 μm can be mentioned, but films made of collagen are especially effective for the growth of tissue cells. This is preferable because it makes a large contribution. These biocompatible polymer films contain up to 50% by weight of polyhydric alcohols such as glycerin and polyethylene glycol with a molecular weight of 400 to 5000 in order to increase their flexibility and eliminate irritation to the skin. It can be blended in an amount of In addition, if the biocompatible polymer film itself is made porous, when a large amount of body fluid is secreted, it can be reliably released from the microporous polymer film through the pores (0.01 to 100 μm) of the film. Because it is transpired,
This is preferable because it speeds up healing. In addition, the biocompatible polymer film has the following ingredients to prevent it from being melted by exuding bodily fluids.
Light irradiation such as ultraviolet irradiation or acetaldehyde,
It is preferable to carry out moderate crosslinking using a compound having an aldehyde group such as formaldehyde. Physiologically active substances having antibacterial properties include antibiotics such as gentamicin sulfate, chloramphenicol, erythromycin, kanamycin sulfate, fradiomycin sulfate, and tetracycline hydrochloride; silver compounds such as colloidal silver and silver sulfadiazine;
Examples include pigments such as acrinol, nitrofurantoin, nitrofurazone, guanofracine, furazolidone, and platonin, and the physiologically active substance is preferably 0.01 to 10% by weight in order to impart antibacterial or bactericidal properties to the biocompatible polymer film. is 0.1~
It is blended in a range of 5% by weight. In this way, a wound covering agent made by combining a microporous polymer film and a biocompatible polymer film containing a physiologically active substance with antibacterial properties may contain an acidic mucopolymer that has the effect of promoting wound healing, if necessary. Saccharides such as chondroitin sulfate, hyaluronic sulfate, etc. are blended into the polymer film layer, which is cut into a desired shape and fixed to the wound site with surgical adhesive tape, or a frame is placed around the covering material piece in advance. It is used by forming a biocompatible adhesive into a shape and fixing it. Since the wound covering agent of the present invention is constructed as described above, the microporous polymer film prevents water and bacteria from entering from the outside, so that melting of the biocompatible polymer film occurs. Furthermore, the biocompatible polymer film allows exuded body fluids to be absorbed quickly and appropriately, and unnecessary water evaporates through the micropores of the microporous polymer film, further increasing the biocompatibility. The biologically active substance having antibacterial properties contained in the antibacterial polymer film suppresses the growth of microorganisms present in the wound or kills them, thereby promoting healing and speeding up the repair of the wound. Examples of the present invention will be shown below. Example 1 A pressure-sensitive adhesive was applied in spots on the surface of a microporous fluororesin film with a thickness of 80 μm and an average pore diameter of 0.45 μm.
On top of this, a collagen film (thickness:
150 μm, glycerin content: 15% by weight), and then impregnated with an aqueous solution of gentamicin sulfate from the collagen film side to obtain a wound covering agent containing 0.1% by weight of gentamicin sulfate. Example 2 Instead of the gentamicin sulfate aqueous solution of Example 1, colloidal silver was added to a collagen film in an amount of 1% by weight to obtain a wound covering agent. Example 3 Instead of the gentamicin sulfate aqueous solution of Example 1, acrinol was added to a collagen film at a concentration of 1% by weight to obtain a wound covering agent. Comparative Example A wound covering agent was obtained in the same manner as in Example 1 except that gentamicin sulfate was omitted. Test Example 1 The wound covering materials obtained in each of the Examples and Comparative Examples were sterilized with ethylene oxide gas, and freeze-dried pork skin, which had been aseptically immersed in physiological saline for 20 minutes, was used as a control sample. The anti-melting properties and skin adhesion of each sample were tested. The test was conducted by shaving the backs of 10 Sprague-Dawley rats (weighing 250-300 g), disinfecting them with alcohol, anesthetizing them, and inserting 3 cm
One centimeter square skin abrasion wound was made, each of the Examples and Comparative Examples, and the pigskin samples described above were applied at random, each covered with gauze and fixed with surgical adhesive tape. After 10 days, the anti-melting properties and adhesion of each sample were visually observed, and the results are shown in Table 1. Test Example 2 In order to evaluate the antibacterial properties of the wound covering agents obtained in each Example and Comparative Example and the pigskin used in Test Example 1, Staphylococcus was used as a test bacterium.
aureus FDA209P and Pseudomonas aeruginosa
Tested by disk method using IFO12689. 10 ⁵ to ^{10 6} cells of the above-mentioned test bacteria were dispersed on a meat extract agar medium, and each sample was placed on a flat plate. After standing at 37° C. for one day and night, the presence or absence of inhibition zone formation was observed. The results are shown in Table 2.

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Claims (1)

[Scope of Claims] 1. A wound covering agent characterized in that a microporous polymer film and a biocompatible polymer film containing a physiologically active substance having antibacterial properties are laminated. 2. The wound covering agent according to claim 1, wherein the microporous polymer film is a microporous fluororesin film. 3 The average pore diameter of the microporous polymer film is 0.01~
The wound covering agent according to any one of claims 1 to 2, which has a diameter of 100 μm. 4. The wound covering agent according to claim 1, wherein the physiologically active substance having antibacterial properties is one selected from antibiotics, silver compounds, and pigments. 5. The wound covering agent according to claim 1, wherein the biocompatible polymer film is a collagen film. 6. The wound covering agent according to claim 5, wherein the collagen film contains a polyhydric alcohol.