Disinfecting composition
Patent Information
- Application Number
- JP2025015024
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-08-06
- Filing Date
- 2025-01-31
- Publication Date
- 2025-07-29
AI Technical Summary
Existing disinfectant compositions used for skin disinfection before surgery often fail to completely remove bacteria, leading to a risk of surgical site infections (SSIs). Additionally, the addition of colorants to these compositions can reduce their disinfecting effect due to the formation of insoluble salts with fungicides, and solubility aids added to mitigate this issue can compromise the adhesive strength of in-size drapes.
A disinfectant composition containing a fungicide and a sugar alcohol, such as D-mannitol or erythritol, which enhances the adhesive strength of in-size drapes to the skin surface without adversely affecting the sterilization efficacy. The composition may also include a pressure-sensitive adhesive like polyvinyl alcohol or polyvinylpyrrolidone, further increasing the adhesive strength and sterilization power.
The disinfectant composition effectively reduces the risk of in-size drapes peeling off from the skin during surgery, thereby minimizing the risk of surgical site infections. The addition of sugar alcohols and adhesives synergistically enhances the adhesive strength and sterilization power of the composition, providing a higher preventive effect against infections caused by live bacteria like Candida albicans.
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Abstract
Description
[Technical field]
[0001] The present invention relates to a disinfectant composition containing a germicide and a sugar alcohol (hereinafter, sometimes referred to as "the disinfectant composition"). [Background technology]
[0002] Bacterial infections at the surgical site during surgery (surgical site infections (SSIs)) are often caused by bacteria that are attached to or normally present on the skin, so the skin is disinfected before surgery. However, although the number of bacteria present on the skin can be reduced by disinfecting the skin, it is difficult to completely remove the bacteria. In addition, there is a risk that normal skin bacteria will re-grow over time and contaminate the surgical field.
[0003] Therefore, the Japanese Society of Surgery has published the "Practical Guidelines for Surgical Care (Revised Edition)" (see, for example, Non-Patent Document 1). This guideline describes that incise drapes reduce the effects of resident skin bacteria, which are the cause of SSI during clean surgeries such as cardiac surgery, neurosurgery, and orthopedic surgery.
[0004] On the other hand, when disinfecting the skin before surgery, a disinfectant composition containing a coloring agent is used so that the application site can be identified. However, when a coloring agent is added to the disinfectant composition, it reacts with the active ingredient bactericide, generating an insoluble salt of the bactericide, which reduces the disinfection effect. To solve this problem, it is known to add a solubilizing agent to the disinfectant composition to suppress the generation of an insoluble salt of the bactericide. However, when a solubilizing agent is added to the disinfectant composition, the adhesive strength between the skin and the insize drape after application of the disinfectant composition is reduced.
[0005] It has been reported that mannitol is added as a plasticizer for polyvinyl alcohol to a water-soluble hot melt adhesive containing polyvinyl alcohol with a specific average polymerization degree and a specific saponification degree and water (Patent Document 1). In addition, a wet adhesive composition containing a water-soluble polymer such as polyvinyl alcohol or polyvinylpyrrolidone, a sugar alcohol such as mannitol that is compatible with the water-soluble polymer, and zeolite has been reported (Patent Document 2). However, it has not been known that the addition of mannitol to a disinfectant composition enhances the adhesive strength of an insize drape to a skin surface to which the disinfectant composition has been applied, or that the addition of mannitol and polyvinyl alcohol or polyvinylpyrrolidone to a disinfectant composition further enhances the enhancing effect and enhances the bactericidal power. [Prior art documents] [Patent documents]
[0006] [Patent Document 1] Japanese Patent Application Publication No. 6-49423 [Patent Document 2] JP 2000-159633 A [Non-patent literature]
[0007] [Non-Patent Document 1] "Practical Guidelines for Surgical Medicine", Surgical Medicine Vol. 35, Suppl., 2013 Summary of the Invention [Problem to be solved by the invention]
[0008] The object of the present invention is to provide a disinfectant composition that can reduce the risk of an incise drape peeling off from the skin without adversely affecting its bactericidal efficacy, even when the incise drape is attached to the skin surface after the disinfectant composition has been applied, and / or that exhibits more effective bactericidal activity. [Means for solving the problem]
[0009] The present inventors have been continuing their research to solve the above problems. In the process, they found that when sugar alcohol is added to a disinfectant composition containing a germicide, the adhesive strength of the incise drape to the skin surface to which the disinfectant composition has been applied is enhanced, compared to when no sugar alcohol is added or when an adhesive is added. In addition, they confirmed that when both sugar alcohol and an adhesive are added to a disinfectant composition containing a germicide, the adhesive strength of the incise drape to the skin surface to which the disinfectant composition has been applied is further enhanced, and the bactericidal power against live bacteria such as Candida albicans tends to be enhanced, compared to when sugar alcohol or an adhesive is added alone. Furthermore, they confirmed that the adhesive strength enhancing effect of the disinfectant composition in this case is exerted regardless of the type of incise drape, and that the adhesive strength effect of the disinfectant composition in this case is exerted not only when the incise drape is used but also when other medical tapes are used. The present invention has been completed based on these findings.
[0010] That is, the present invention is as follows. [1] A disinfecting composition comprising a bactericide and a sugar alcohol. [2] The disinfectant composition according to [1] above, wherein the sugar alcohol has the effect of enhancing the adhesive strength of the insize drape to the skin surface after application of the disinfectant composition. [3] The disinfectant composition according to [1] or [2] above, wherein the sugar alcohol is D-mannitol or erythritol. [4] The disinfecting composition according to any one of the above [1] to [3], further comprising an adhesive. [5] The disinfecting composition according to [4] above, wherein the adhesive has the effect of enhancing the adhesive strength of the insize drape to the skin surface after application of the disinfecting composition. [6] The disinfecting composition according to [4] or [5] above, wherein the concentration of the adhesive is 2% (w / v) or less. [7] The disinfecting composition according to any one of the above [4] to [6], wherein the adhesive is polyvinyl alcohol or polyvinylpyrrolidone. [8] The disinfecting composition according to any one of the above [1] to [7], wherein the bactericide is olanexidine gluconate.
[0011] In another embodiment of the present invention, A method for disinfecting a subject, comprising the step of applying the liquid type present disinfecting composition to a subject, the method optionally comprising the step of dissolving the non-liquid type present disinfecting composition in a solvent to prepare the liquid type present disinfecting composition; or A combination of a germicide and a sugar alcohol for use in disinfecting a subject; and The use of a germicide and a sugar alcohol in the preparation of the disinfecting composition; a method for preparing the disinfecting composition, comprising the steps of adding a sugar alcohol to a disinfectant or adding a disinfectant to a sugar alcohol to prepare the disinfecting composition; The following can be mentioned. Effect of the Invention
[0012] When a sugar alcohol is added to a disinfectant composition containing a germicide, the adhesive strength of the incise drape to the skin surface to which the disinfectant composition has been applied can be increased regardless of the type of incise drape, compared to when no sugar alcohol is added. Also, when a sugar alcohol is added to a disinfectant composition containing a germicide, the adhesive strength of the incise drape to the skin surface to which the disinfectant composition has been applied can be increased to the same or greater extent regardless of the type of incise drape, compared to when an adhesive is added. Therefore, even if an incise drape is applied after applying the disinfectant composition (especially the disinfectant composition containing a dissolving agent) and an incision surgery is performed on it, the incise drape is unlikely to peel off from the skin, making it possible to perform clean surgery with a reduced risk of SSI.
[0013] In addition, when both sugar alcohol and adhesive are added to a disinfectant composition containing a germicide, the adhesive strength of the incise drape to the skin surface to which the disinfectant composition is applied tends to be enhanced and the germicidal power tends to be increased, compared to when sugar alcohol or adhesive is added alone. Therefore, the disinfectant composition further containing an adhesive can further reduce the possibility of the incise drape peeling off from the skin, even if the incise drape is applied after the disinfectant composition is applied and an incision is performed on it, and a higher preventive effect against infectious diseases caused by live bacteria such as Candida albicans can be expected. Furthermore, by using the present disinfecting composition, the adhesive strength of medical tapes other than the incise drape (for example, surgical tape) can also be enhanced. [Brief description of the drawings]
[0014] [Figure 1] 1 is a flow chart showing the production process of an in-size drape for measurement. [Diagram 2] This is a photograph taken when the adhesive strength of a measurement incise drape was being measured. [Diagram 3] FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement incise drape to an artificial skin surface coated with four types of test disinfectants (a test disinfectant containing no D-mannitol or PVA ["-" in the figure]; a test disinfectant containing 0.5% PVA ["+PVA" in the figure]; a test disinfectant containing 5.0% D-mannitol ["+D-mannitol" in the figure]; and a test disinfectant containing 0.5% PVA and 5.0% D-mannitol ["+PVA+D-mannitol" in the figure]) in Example 1. [Figure 4] FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement incise drape to an artificial skin surface to which a test disinfectant containing D-mannitol at various concentrations (0%, 1.0%, 1.5%, or 10%) was applied in Example 1. [Diagram 5]FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement insize drape to an artificial skin surface to which a test disinfectant solution containing various concentrations (0%, 0.25%, 0.5%, or 1.0%) of PVA and 5.0% D-mannitol was applied in Example 1. [Figure 6] FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement insize drape to an artificial skin surface coated with a test disinfectant solution containing 0.5% PVA and various concentrations (0%, 1.0%, 1.5%, 2.0%, 2.5%, 5.0%, or 10%) of D-mannitol in Example 1. [Figure 7] FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement incise drape to an artificial skin surface to which a test disinfectant solution containing 0.1% PVA and various concentrations (0%, 1.0%, 1.5%, or 10%) of D-mannitol was applied in Example 1. [Figure 8] FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement insize drape to an artificial skin surface to which a test disinfectant solution containing 2.0% PVA and various concentrations (1.0%, 1.5%, 2.5%, or 10%) of D-mannitol was applied in Example 1. [Figure 9] FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement insize drape to an artificial skin surface to which a test disinfectant solution containing 3.5% PVA and various concentrations (0%, 1.0%, or 1.5%) of D-mannitol was applied in Example 1. [Figure 10]FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement incise drape to an artificial skin surface coated with five types of test disinfectants (a test disinfectant containing 5.0% D-mannitol ["+D-mannitol" in the figure], a test disinfectant containing 0.5% PVP ["+PVP" in the figure], a test disinfectant containing 0.5% PVA ["+PVA" in the figure], a test disinfectant containing 0.5% PVP and 5.0% D-mannitol ["+PVP+D-mannitol" in the figure], and a test disinfectant containing 0.5% PVA and 5.0% D-mannitol ["+PVA+D-mannitol" in the figure]) in Example 1. [Figure 11] FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of a measurement incise drape to an artificial skin surface coated with three types of test disinfectants (a test disinfectant containing no erythritol or PVA ["-" in the figure]; a test disinfectant containing 5.0% erythritol ["+erythritol" in the figure]; and a test disinfectant containing 0.5% PVA and 5.0% erythritol ["+PVA+erythritol" in the figure]) in Example 1. [Figure 12] FIG. 1 shows the results (n=3) of measuring the adhesive force (mean value ± standard deviation) of a measurement incise drape to an artificial skin surface coated with four types of test disinfectants (a test disinfectant containing no D-mannitol or PVA ["-" in the figure]; a test disinfectant containing 0.5% PVA ["+PVA" in the figure]; a test disinfectant containing 5.0% D-mannitol ["+D-mannitol" in the figure]; and a test disinfectant containing 0.5% PVA and 5.0% D-mannitol ["+PVA+D-mannitol" in the figure]) under five humidity conditions (20%, 30%, 40%, 50%, and 60%) in Example 1. [Figure 13]This figure shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of "Opsite Incise" against artificial skin surfaces coated with four types of test disinfectants (test disinfectant containing no D-mannitol or PVA ["-" in the figure]; test disinfectant containing 0.5% PVA ["+PVA" in the figure]; test disinfectant containing 5.0% D-mannitol ["+D-mannitol" in the figure]; and test disinfectant containing 0.5% PVA and 5.0% D-mannitol ["+PVA+D-mannitol" in the figure]) in Example 3. [Figure 14] FIG. 1 shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of "Opsite Incise" to artificial skin surfaces coated with test disinfectants containing various concentrations (0%, 1.0%, 1.5%, or 5.0%) of D-mannitol in Example 3. [Figure 15] In Example 3, this figure shows the results (n=3) of measuring the adhesive strength (mean ± standard deviation) of "3M Micropore S Easy Peel Silicone Tape (equivalent to "3MTM MicroporeTM S Surgical Tape" in the US, the same below)" on artificial skin surfaces coated with four types of test disinfectants (test disinfectant not containing D-mannitol and PVA ["-" in the figure]; test disinfectant containing 0.5% PVA ["+PVA" in the figure]; test disinfectant containing 5.0% D-mannitol ["+D-mannitol" in the figure]; and test disinfectant containing 0.5% PVA and 5.0% D-mannitol ["+PVA+D-mannitol" in the figure]). [Figure 16] This figure shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of "3M Micropore S Easy-Removable Silicone Tape" to artificial skin surfaces coated with test disinfectants containing various concentrations (0%, 1.0%, 1.5%, or 5.0%) of D-mannitol in Example 3. [Figure 17]In Example 3, this figure shows the results (n=3) of measuring the adhesive strength (mean value ± standard deviation) of "3M Micropore S Easy-Removable Silicone Tape" to an artificial skin surface coated with a test disinfectant solution containing 0.5% PVA and various concentrations (0%, 1.0%, 1.5%, 5.0%, or 10%) of D-mannitol. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0015] The disinfecting composition of the present invention is a composition containing a bactericide and a sugar alcohol, the use of which is specified as "for disinfection." Due to the effect of the sugar alcohol in the disinfecting composition of the present invention, even if a medical tape such as an incise drape is applied to the skin surface after the disinfecting composition is applied, the risk of the medical tape such as an incise drape peeling off from the skin can be reduced without adversely affecting the bactericidal power.
[0016] The above-mentioned bactericide may be any substance (compound) that has the effect of killing bacteria, fungi and / or viruses, and may be, for example, olanexidine gluconate, benzalkonium chloride, benzalkonium salts such as alkyl benzalkonium phosphate, benzethonium chloride, triclosan, isopropyl methylphenol, cetylpyridinium chloride, resorcin, trichlorocarbanide, chlorhexidine hydrochloride, chlorhexidine gluconate, polyhexamethylene biguanide, sodium hypochlorite, hydrogen peroxide, povidone iodine, iodine tincture, etc., and olanexidine gluconate is preferably exemplified because its effect has been demonstrated in the present embodiment described later. These bactericides may be blended alone in the present disinfecting composition, or may be blended in combination of two or more kinds. The concentration of the disinfectant may be any concentration that has sufficient disinfecting power, and is, for example, within the range of 0.01 to 20% (w / v), more preferably 0.1 to 10% (w / v), and even more preferably 1 to 5% (w / v).
[0017] The concentration of the sugar alcohol may be any concentration that can enhance the adhesive strength of the incise drape to the skin surface after application of the disinfecting composition, and examples of the lower limit of the sugar alcohol concentration include 0.01% (w / v), 0.05% (w / v), 0.1% (w / v), 0.5% (w / v), 1.0% (w / v), 1.5% (w / v), 2.0% (w / v), 2.5% (w / v), etc. Also, examples of the upper limit of the sugar alcohol concentration include 50% (w / v), 40% (w / v), 30% (w / v), 25% (w / v), 20% (w / v), 15% (w / v), 10% (w / v), etc. Therefore, the concentration range of the sugar alcohol may be, for example, 0.01-50% (w / v), 0.05% (w / v)-40% (w / v), 0.1-30% (w / v), 0.5-25% (w / v), 1.0-10% (w / v), 1.0-20% (w / v), 1.5-15% (w / v), 1.5-10% (w / v), 2.0-10% (w / v), 2.5-10% (w / v), etc., and 1.0-10% (w / v) is preferred because its effect is demonstrated in the present embodiment described later. In addition, when used in combination with an adhesive, 1.0-10% (w / v) is preferred, 1.5-10% (w / v) is more preferred, and 2.5-10% (w / v) is even more preferred.
[0018] The sugar alcohol is characterized by having an effect of enhancing the adhesive force of the incise drape to the skin surface after application of the present disinfecting composition. The sugar alcohol may be any sugar generated by reduction of the carboxyl group of aldose or ketose, such as erythritol, threitol, ribitol, arabitol, xylitol, sorbitol, galactitol, iditol, allitol, altritol, lactitol, maltitol, mannitol, sucrose, etc. The sugar alcohol may be either an α-form or a β-form, D-form or L-form, (+)-form or (-)-form, and may be any of them. It may also be a racemic form. As the sugar alcohol, D-mannitol and erythritol can be preferably exemplified because their effects have been demonstrated in the present embodiment described later. These sugar alcohols may be blended alone in the present disinfecting composition, or two or more kinds may be combined.
[0019] The sugar alcohol may have a high critical relative humidity (CRH) (i.e., low hygroscopicity). Examples of the CRH of the sugar alcohol at 25° C. include 55% or more, 60% or more, 65% or more, 70% or more, 75% or more, 80% or more, 85% or more, 86% or more, 87% or more, 88% or more, 89% or more, 90% or more, 91% or more, 92% or more, 93% or more, 94% or more, 95% or more, 96% or more, 97% or more, 98% or more, etc. The CRH can be measured by a conventional method.
[0020] As used herein, the term "critical relative humidity" refers to the relative humidity at which a sugar alcohol begins to rapidly increase in weight when the relative humidity is increased at a certain temperature (eg, 25°C).
[0021] It is preferable that the disinfecting composition further contains an adhesive in order to further enhance the adhesive strength of the insize drape to the skin surface after application of the disinfecting composition and / or to enhance the bactericidal activity against live bacteria such as Candida albicans.
[0022] The lower limit of the adhesive concentration may be any concentration that can further enhance the adhesive strength of the incise drape to the skin surface after application of the disinfecting composition and / or enhance the bactericidal activity against live bacteria such as Candida albicans, and examples of such concentrations include 0.01% (w / v), 0.03% (w / v), 0.06% (w / v), 0.1% (w / v), 0.2% (w / v), 0.25% (w / v), 0.5% (w / v), 1.0% (w / v), 1.3% (w / v), 1.6% (w / v), and the like. On the other hand, the upper limit of the concentration of the adhesive is as follows: 1) when the present disinfecting composition (containing sugar alcohol) to which a high concentration of adhesive has been added is applied to the surface of the skin, the adhesive strength of the incise drape to the skin surface may be reduced, 2) when the present disinfecting composition containing a high concentration of adhesive dries, it may form a thick film on the surface of the skin, which may reduce the adhesive strength to the skin and cause partial or total peeling of the disinfecting composition film, and 3) in the area where the disinfecting composition film has peeled off, there is no adhesive strength to the skin, and in particular, there may be no peeling of the disinfecting composition film overall. If peeling occurs, the overall adhesive strength between the incise drape and the skin may decrease, and 4) the disinfecting composition containing a high concentration of adhesive may have increased viscosity, which may result in poor application depending on the application. Therefore, from the standpoint of avoiding high concentrations, less than 3.5% (w / v) (e.g., 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, 1.6% (w / v) or less, 1.3% (w / v) or less, 1.0% (w / v) or less, etc.) is preferred, with 2.0% (w / v) or less being more preferred. Therefore, the concentration range of the pressure-sensitive adhesive is, for example, 0.01 to less than 3.5% (w / v) (e.g., 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, 1.6% (w / v) or less, 1.3% (w / v) or less, 1.0% (w / v) or less, etc.), 0.03 to less than 3.5% (w / v) (e.g., 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, 1.6% (w / v) or less, 1.3% (w / v) or less, 1.0% (w / v) or less, etc.), 0.06 to 3.Less than 5% (w / v) (e.g., 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, 1.6% (w / v) or less, 1.3% (w / v) or less, 1.0% (w / v) or less, etc.), 0.1 to less than 3.5% (w / v) (e.g., 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, 1.6% (w / v) or less, 1.3% (w / v) or less, 1.0% (w / v) or less), 0.2 to less than 3.5% (w / v) (e.g. 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, 1.6% (w / v) or less, 1.3% (w / v) or less, 1.0% (w / v) or less), 0.25 to less than 3.5% (w / v) (e.g. 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, 1.6% (w / v) or less, 1.3% (w / v) or less or less, 1.0%(w / v) or less, etc.), 0.5%(w / v) to less than 3.5%(w / v) (e.g. 3.3%(w / v) or less, 3.0%(w / v) or less, 2.6%(w / v) or less, 2.3%(w / v) or less, 2.0%(w / v) or less, 1.6%(w / v) or less, 1.3%(w / v) or less, 1.0%(w / v) or less, etc.), 1.0%(w / v) to less than 3.5%(w / v) (e.g. 3.3%(w / v) or less, 3.0%(w / v) or less, 2.6%(w / v) or less, 2.3%(w / v) or less, 2.0%(w / v) or less) , 1.6% (w / v) or less, 1.3% (w / v) or less, etc.), 1.3% (w / v) to less than 3.5% (w / v) (for example, 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, 1.6% (w / v) or less, etc.), 1.6% (w / v) to less than 3.5% (w / v) (for example, 3.3% (w / v) or less, 3.0% (w / v) or less, 2.6% (w / v) or less, 2.3% (w / v) or less, 2.0% (w / v) or less, etc.).
[0023] The adhesive is characterized by having an effect of enhancing the adhesive strength of the incise drape to the skin surface after application of the disinfecting composition of the present invention. Examples of the adhesive include vinyl-based polymer compounds, acrylic-based polymer compounds, and cellulose-based polymer compounds.
[0024] In this specification, the term "vinyl polymer" refers to a polymer (vinyl polymer) obtained by polymerizing a monomer compound having a vinyl group and saponifying it as necessary. Examples of vinyl polymer compounds include polyvinyl alcohol (PVA) (completely or partially saponified), polyvinylpyrrolidone (PVP), polyvinyl acetate, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polymethyl methacrylate, polyacrylic acid, carboxyvinyl polymer, polyvinyl acetal, polyvinylidene chloride, PVA / PVP copolymer, etc., and PVA and PVP are preferred examples because their effects have been demonstrated in the present embodiment described below.
[0025] The molecular weight of the vinyl polymer compound cannot be specified in general because it varies depending on the type of constituent monomer, but is usually 10,000 to 2.5 million, preferably 5,000 to 2 million, and more preferably 10,000 to 1.5 million in weight average molecular weight. More specifically, when the vinyl polymer compound is polyvinyl alcohol, the average degree of polymerization of polyvinyl alcohol measured in accordance with JIS K-6726 is usually within the range of 100 to 4000, preferably 200 to 3000, and more preferably 300 to 2000. When the vinyl polymer compound is polyvinylpyrrolidone, the K value [viscosity characteristic value] of polyvinylpyrrolidone by the Fikentscher method is usually 10 to 120, preferably 30 to 110, more preferably 60 to 100, and more preferably 80 to 100.
[0026] In this specification, the term "acrylic polymer compound" refers to a polymer containing a monomer unit derived from a (meth)acrylic monomer in the polymer structure, and typically refers to a polymer containing a monomer unit derived from a (meth)acrylic monomer at a ratio of more than 50% by weight. Examples of the acrylic polymer compound include polyacrylic acid, sodium polyacrylate, carboxyvinyl polymer, polyacrylamide, polyacrylamide / acrylate copolymer, etc.
[0027] In this specification, the term "cellulose-based polymer compound" refers to cellulose (cellulose-based polymer) in which some or all of the hydroxyl groups of cellulose have been substituted. Examples of the cellulose-based polymer compound include ethyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose, nitrocellulose, and cationic cellulose. The adhesive may be incorporated alone or in combination of two or more kinds in the disinfecting composition of the present invention.
[0028] The lower limit of the weight ratio of the adhesive to the sugar alcohol in the present disinfecting composition further containing an adhesive can be, for example, 1:0.5, 1:0.75, 1:1, 1:1.2, 1:1.25, 1:1.5, 1:2, 1:2.5, 1:3.0, etc. The upper limit of the weight ratio of the adhesive to the sugar alcohol in the present disinfecting composition further containing an adhesive can be, for example, 1:40, 1:36, 1:33, 1:30, 1:26, 1:23, 1:20, 1:16, 1:13, 1:10, etc. Therefore, the range of the weight ratio of the adhesive to the sugar alcohol in the disinfecting composition of the present invention further containing an adhesive is, for example, 1:0.5 to 1:40, 1:0.5 to 1:36, 1:0.5 to 1:33, 1:0.5 to 1:30, 1:0.5 to 1:26, 1:0.5 to 1:23, 1:0.5 to 1:20, 1:0.5 to 1:16, 1:0.5 to 1:13, 1:0.5 to 1:10, 1:0.75 to 1:40, 1:0.75~1:36, 1:0.75~1:33, 1:0.75~1:30, 1:0.75~1:26, 1:0.75~1:23, 1:0.75~1:20, 1:0.75~1:16, 1:0.75~1:13, 1:0.75~1:10, 1:1~1:40, 1:1~1:36, 1:1~1:33, 1:1~1:30, 1:1~1:26, 1:1~1:23, 1:1~1:20, 1:1~1: 16, 1:1~1:13, 1:1~1:10, 1:1.2~1:40, 1:1.2~1:36, 1:1.2~1:33, 1:1.2~1:30, 1:1.2~1:26, 1:1.2~1:23, 1:1.2~1:20, 1:1.2~1:16, 1:1.2~1:13, 1:1.2~1:10, 1:1.25~1:40, 1:1.25~1:36, 1:1.25~1:33, 1:1.25~1:3 0, 1:1.25-1:26, 1:1.25-1:23, 1:1.25-1:20, 1:1.25-1:16, 1:1.25-1:13, 1:1.25-1:10, 1:1.5-1:40, 1:1.5-1:36, 1:1.5-1:33, 1:1.5-1:30, 1:1.5-1:26, 1:1.5-1:23, 1:1.5-1:20, 1:1.5-1:16, 1:1.5-1:13, 1:1.5~1:10, 1:2~1:40, 1:2~1:36, 1:2~1:33, 1:2~1:30, 1:2~1:26, 1:2~1:23, 1:2~1:20, 1:2~1:16, 1:2~1:13, 1:2~1:10, 1:2.5~1:40, 1:2.5~1:36, 1:2.5~1:33, 1:2.5~1:30, 1:2.5~1:26, 1: Examples include 2.5 to 1:23, 1:2.5 to 1:20, 1:2.5 to 1:16, 1:2.5 to 1:13, 1:2.5 to 1:10, 1:3 to 1:40, 1:3 to 1:36, 1:3 to 1:33, 1:3 to 1:30, 1:3 to 1:26, 1:3 to 1:23, 1:3 to 1:20, 1:3 to 1:16, 1:3 to 1:13, and 1:3 to 1:10.
[0029] In this specification, the term "incise drape" refers to a film drape for incision that is applied to the skin of a patient and used for the purpose of preventing SSI (e.g., infection due to skin flora, bacteria, fungi, viruses, etc.) during a surgical procedure (incision procedure) performed on the skin. Incise drapes are usually waterproof, conform to the patient's body shape, have moderate water vapor permeability, and are coated with an adhesive. Incise drapes are commercially available, such as "3M (registered trademark) Steri-Drape (registered trademark)", "3M Ioban (registered trademark) Special Incise Drape" (all manufactured by 3M), and "Opsite (registered trademark) Incise" (manufactured by Smith & Nephew).
[0030] The disinfecting composition of the present invention may further contain optional components in addition to the germicide and sugar alcohol. In this specification, the "optional components" include, for example, isotonic agents (e.g., glucose, sorbitol, mannitol, lactose, sodium chloride), chelating agents (e.g., EDTA, EGTA, citric acid, salicylate), solubilizing agents, coloring agents, preservatives, antioxidants, amino acids (e.g., proline, glutamine), buffers (e.g., CAPS, bicine, glycine, tricine, tris, HEPPS, TAPS, bicine), phospholipids (e.g., lysophosphatidic acid [LPA; Lysophosphatidic acid]), and pH adjusters (e.g., glucono-δ-lactone, sodium hydroxide, sodium bicarbonate). In this specification, the term "optional components" refers to components that may or may not be included.
[0031] The disinfecting composition of the present invention may contain a coloring agent to identify the location where the disinfecting composition has been applied. In this case, a solubilizing agent is usually further contained to suppress the reaction between the coloring agent and the germicide and to suppress the generation of insoluble salts.
[0032] Examples of the solubilizing agent include surfactants (nonionic surfactants, ionic surfactants), ethylenediamine, sodium benzoate, nicotinic acid amide, cyclodextrin, ethanol, benzyl alcohol, propylene glycol, etc. Examples of the ionic surfactant include alkyl dimethylamine oxides such as oleyl dimethylamine oxide, stearyl dimethylamine oxide, palmityl dimethylamine oxide, myristyl dimethylamine oxide, lauryl dimethylamine oxide, and coconut oil alkyl dimethylamine oxide, among which lauryl dimethylamine oxide is preferred. Examples of the nonionic surfactant include sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene alkyl ethers, polyoxyethylene polyoxypropylene alkyl ethers, polyoxyethylene polyoxypropylene glycols, polyglycerin fatty acid esters, polyoxyethylene hydrogenated castor oil, and sucrose fatty acid esters, among which polyoxyethylene polyoxypropylene glycols, polyoxyethylene alkyl ethers, and polyoxyethylene polyoxypropylene alkyl ethers are preferred.Polyoxyethylene polyoxypropylene glycols include polyoxyethylene (42) polyoxypropylene (67) glycol (Pluronic P-123), polyoxyethylene (54) polyoxypropylene (39) glycol (Pluronic P-85), polyoxyethylene (196) polyoxypropylene (67) glycol (Pluronic F-127), polyoxyethylene (42) polyoxypropylene (67) glycol (Pluronic P-123), polyoxyethylene (3) polyoxypropylene (17) glycol (Pluronic L-31), polyoxyethylene (20) polyoxypropylene (20) glycol (Pluronic L-44), polyoxyethylene (120) polyoxypropylene (40) glycol (Pluronic F-87), polyoxyethylene (160) polyoxypropylene (30) glycol (Pluronic F-68), among which polyoxyethylene (20) polyoxypropylene (20) glycol (Pluronic L-44) is preferred. Examples of polyoxyethylene alkyl ethers include polyoxyethylene cetyl ether, polyoxyethylene oleyl ether, polyoxyethylene lauryl ether (lauromacrogol), and the like, with polyoxyethylene lauryl ether (lauromacrogol) being particularly preferred. Examples of polyoxyethylene polyoxypropylene alkyl ethers include polyoxyethylene (20) polyoxypropylene (4) cetyl ether, polyoxyethylene (30) polyoxypropylene (6) decyl tetradecyl ether, polyoxyethylene (25) polyoxypropylene (25) lauryl ether, and the like, with polyoxyethylene (20) polyoxypropylene (4) cetyl ether being particularly preferred. These solubilizing agents may be incorporated alone in the disinfecting composition of the present invention, or two or more kinds may be incorporated in combination. The concentration of the solubilizing agent may be any concentration that prevents precipitation of the bactericide and does not reduce the bactericidal activity, and is usually used at a concentration of 0.1 to 30% (w / v), preferably 0.5 to 15% (w / v), and more preferably 1 to 8% (w / v).
[0033] The coloring agent may be any coloring agent that is not toxic to living organisms, and examples thereof include tar dyes (e.g., Red No. 2 [amaranth], Red No. 3 [erythrosine], Red No. 102 [new coccine], Red No. 201 [lysol rubin B], Yellow No. 4 [tartrazine], Yellow No. 5 [sunset yellow], Green No. 3 [fast green], Blue No. 1 [brilliant blue], Blue No. 2 [indigo carmine], Blue No. 205 [alphazurin FG], Blue No. 403 [sudan blue B], Purple No. 201 [arizurin purple SS], Purple No. 401 [arizurol purple], etc.). The concentration of the coloring agent is usually within the range of 0.001 to 1.0% (w / v), and preferably 0.005 to 0.5% (w / v).
[0034] The disinfecting composition of the present invention may be a non-liquid type, but is preferably a liquid type (disinfecting liquid). When the non-liquid type disinfecting composition of the present invention, which contains a germicide such as a powder and a sugar alcohol, is dissolved in a solvent, the liquid type disinfecting composition of the present invention can be prepared. Examples of the "solvent" in this specification include deionized water, distilled water, physiological saline, PBS (Phosphate Buffered Saline), and TBS (Tris Buffered Saline). In addition, when the disinfecting composition of the present invention is a non-liquid type, the concentrations of the germicide, sugar alcohol, and adhesive in the disinfecting composition of the present invention are the concentrations of the germicide, sugar alcohol, and adhesive when the non-liquid type disinfecting composition of the present invention is dissolved in a solvent to prepare the liquid type disinfecting composition of the present invention, and the weight ratio of the adhesive and sugar alcohol in the disinfecting composition of the present invention is the weight ratio of the adhesive and sugar alcohol when the non-liquid type disinfecting composition of the present invention is dissolved in a solvent to prepare the liquid type disinfecting composition of the present invention.
[0035] The subject to which the present disinfecting composition is applied may be any subject that requires disinfection, and examples thereof include subjects (patients) having a wound; such subjects having a wound and who further require the application of a transparent dressing (transparent wound covering material) to the site to which the present liquid disinfecting composition has been applied; subjects (patients) requiring surgery (e.g., neurosurgery, cardiovascular surgery, digestive system (e.g., stomach, large intestine, liver, pancreas) surgery, cosmetic surgery); subjects requiring such surgery and who require the application of an incise drape to the site to which the present liquid disinfecting composition has been applied; and the like. The subject requiring surgery and who requires the application of an incise drape to the site to which the present liquid disinfecting composition has been applied is preferred.
[0036] The application site of the present disinfectant composition is, for example, the wound site when the subject to which the present disinfectant composition is applied has a wound, and the surgical site (usually the skin) when the subject requires surgery. When the application site of the present disinfectant composition is the skin (e.g., the skin surface, subcutaneous tissue), the application method is normal application. Examples of the method of application to the subject's skin include a method of application using the present disinfectant composition of liquid type impregnated in a substrate such as paper, cloth, nonwoven fabric, cotton swab, absorbent cotton, etc., a method of application using the present disinfectant composition of liquid type filled in an applicator for application, and a method of application using the present disinfectant composition of liquid type as a rubbing agent or scrubbing agent.
[0037] The conditions such as temperature and humidity when applying the present disinfecting composition are not particularly limited. The temperature is, for example, room temperature (for example, within a range of 15 to 35°C, preferably 15 to 30°C, more preferably 18 to 28°C, and even more preferably 20 to 26°C), and the humidity is, for example, within a range of 10 to 90%, preferably 20 to 80%, more preferably 30 to 70%, and even more preferably 40 to 60%.
[0038] The present invention will be described in more detail below with reference to examples, but the technical scope of the present invention is not limited to these examples. EXAMPLES
[0039] Example 1. Measurement of the adhesive strength of an incise drape to a skin surface to which the disinfectant composition of the present invention has been applied (1) 1. Materials and Methods 1-1 Test disinfectant The test disinfectants were prepared by adding various concentrations of PVA (Gohsenol EG-05P, average degree of polymerization: approximately 500, partially saponified, manufactured by Mitsubishi Chemical Corporation) or PVP (polyvinylpyrrolidone K90, K value: 90, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) to the Olanedine disinfectant solution (1) shown in Table 1 below, and various concentrations of D-mannitol (PEARLITOL 160C, manufactured by Roquette) or erythritol (meso-erythritol, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.).
[0040] [Table 1]
[0041] 1-2 Preparation of incise drape for measurement 3M Ioban Special Insize Drape (overall size: 15cm x 20cm, adhesive part size: 10cm x 20cm) (6035, 3M) was cut to a width of 4cm (overall size: 15cm x 4cm, adhesive part size: 10cm x 4cm). Masking tape was attached to both ends of the long side and folded back (with tabs of approximately 10cm and approximately 3cm) so that the size of the adhesive part was 4cm x 4-5cm. The tabs of approximately 10cm were used as gripping points to prepare the insize drape for measurement (see Figure 1).
[0042] 1-3 Measurement of adhesive strength of incise drape for measurement The adhesive strength of the measurement insize drape to the artificial skin surface to which the test disinfectant had been applied was measured according to the following steps [1] to [7] (see Figure 2). [1] 100 μL of the test disinfectant was dropped onto the surface of artificial skin (Bio Skin Plate (50 mm square), product number: No. 64, size: 50 mm x 50 mm x 5T mm, manufactured by Beaulax), spread over the entire surface of the artificial skin using a platinum loop, and air-dried at room temperature (23 ± 3 ° C) for approximately 30 minutes. [2] The incise drape for measurement was lightly attached to the surface of the artificial skin coated with the test disinfectant, and then pressed with a manual pressing device (pressure roller for peeling test) (manufactured by Imada Co., Ltd.) by reciprocating twice at a speed of about 10 mm per second. At this time, it was confirmed that the manual pressing device did not touch the adhesive surface of the incise drape for measurement, that there were no wrinkles in the incise drape, and that there was no air between the artificial skin and the incise drape for measurement. After pressing, it was left to stand at room temperature. [3] After about 30 minutes, the backs of the incise drapes for measurement were overlapped and the gripping portion was folded 180°, and the artificial skin was fixed to the flat chuck on the top of the measuring device (digital force gauge system [a digital force gauge (model: ZTS-5N) was attached to a vertical motorized measuring stand (model: MX2-500N) and connected to a computer, and a flat chuck (model: GC-1200) was attached to the measuring axis of the digital force gauge]) (manufactured by Imada Co., Ltd.). [4] With the artificial skin and the measurement insize drape floating, the load of the measuring instrument was reset to zero. [5] The gripping edge of the incise drape for measurement was lowered vertically and fixed to the bottom of the measuring device. [6] The artificial skin was raised at 100 mm / sec and the incise drape for measurement was peeled off at 180°. The load at the time of peeling was measured and recorded using Force Recorder Standard (load-time graph creation software) (manufactured by Imada Co., Ltd.). The recording rate was 0.005 sec. The measurement was completed when the incise drape for measurement was completely peeled off from the artificial skin. [7] The adhesive strength (N / cm) per 1 cm width of the incise drape for each artificial skin was determined. The adhesive strength was determined by taking the time (seconds) 25% after the start of the measurement as point 1, and the time (seconds) 50% of the length of the peeled off length as point 2, and taking the average value of the load between point 1 and point 2 (see the literature "17th Revised Japanese Pharmacopoeia Commentary: Adhesive Strength Test Method. Tokyo: Hirokawa Shoten; 2016. p. B-664-71."). The values of point 1 (= total load measurement time x 0.25) and point 2 (point 1 + [total load measurement time - point 1] x 0.5), calculated to one decimal place, were entered into the Force Recorder Standard to calculate the adhesive strength. The total load measurement time was calculated as the recording rate (0.005 seconds) x the number of data. It should be noted that this disinfectant composition is intended to be used in an operating room, and the humidity in the operating room is usually controlled at around 50%. For this reason, adhesive strength measurements were performed at a humidity of 50 (% RH) except for "2-7" below. Also, since there was a large difference in adhesive strength between tests and it was not possible to properly compare adhesive strength between different tests, it was decided to compare adhesive strength between the same tests.
[0043] 2.Results 2-1 The effect of sugar alcohol in the disinfectant composition in question and the effect of the disinfectant composition in question with the addition of an adhesive In order to confirm the effect of the sugar alcohol in this disinfectant composition and the effect of this disinfectant composition to which an adhesive has been added, the adhesive strength of a test insize drape was measured using the four types of test disinfectant shown in Table 2.
[0044] As a result, it was shown that when the measurement insize drape was applied to artificial skin coated with a test disinfectant containing D-mannitol, the adhesive strength of the measurement insize drape was enhanced compared to when it was applied to artificial skin coated with a test disinfectant containing neither D-mannitol nor PVA, or a test disinfectant containing PVA (see Table 2 and Figure 3). These results show that the disinfecting composition of the present invention (i.e., a disinfecting composition containing a sugar alcohol [D-mannitol]) provides greater adhesion of the insize drape to the skin surface to which the disinfecting composition has been applied, compared to a disinfecting composition that does not contain a sugar alcohol (D-mannitol) or a disinfecting composition that contains an adhesive (PVA).
[0045] In addition, when the measurement insize drape was applied to artificial skin coated with a test disinfectant containing both PVA and D-mannitol, it was shown that the adhesive strength of the measurement insize drape was synergistically enhanced compared to when it was applied to artificial skin coated with a test disinfectant containing either PVA or D-mannitol alone (see Table 2 and Figure 3).
[0046] These results show that the disinfecting composition of the present invention to which an adhesive (PVA) has been added (i.e., a disinfecting composition containing a sugar alcohol [D-mannitol]) synergistically enhances the adhesive strength of the incise drape to the skin surface to which the disinfecting composition has been applied, compared to disinfecting compositions containing either the sugar alcohol (D-mannitol) or the adhesive (PVA) alone.
[0047] [Table 2]
[0048] 2-2 Examination of the sugar alcohol concentration in the present disinfectant composition In order to examine the concentration of sugar alcohol in the present disinfectant composition, the adhesive strength of a test incise drape was measured using the four types of test disinfectants shown in Table 3.
[0049] As a result, it was shown that when the measurement insize drape was applied to artificial skin coated with a test disinfectant containing 1.0 to 10% D-mannitol, the adhesive strength of the measurement insize drape was enhanced compared to when it was applied to artificial skin coated with a test disinfectant not containing D-mannitol (see Table 3 and Figure 4).
[0050] These results show that when the concentration of sugar alcohol (D-mannitol) in the disinfectant composition is adjusted to be at least 1.0 to 10%, the adhesive strength of the insize drape to the skin surface to which the disinfectant composition has been applied is enhanced compared to when a disinfectant composition not containing sugar alcohol (D-mannitol) is used.
[0051] [Table 3]
[0052] 2-3 Examination of the concentration of adhesive to be added to the present disinfectant composition In order to examine the concentration of adhesive to be added to the present disinfectant composition, the adhesive strength of a test incise drape was measured using the four types of test disinfectants shown in Table 4.
[0053] As a result, it was shown that when the measurement insize drape was applied to artificial skin coated with a test disinfectant containing 0.25 to 1.0% PVA and 5% D-mannitol, the adhesive strength of the measurement insize drape was enhanced compared to when it was applied to artificial skin coated with a test disinfectant containing only 5% D-mannitol (see Table 4 and Figure 5).
[0054] This result shows that adding an adhesive (PVA), especially when the adhesive is added to the present disinfecting composition (i.e., a disinfecting composition containing sugar alcohol [D-mannitol]) at 0.25-1.0%, can further increase the adhesive strength of the incise drape to the skin surface to which the disinfecting composition is applied, compared to the present disinfecting composition not containing the adhesive (PVA). Furthermore, when the adhesive (PVA) was 0.25-1.0%, no serious problems such as film peeling occurred.
[0055] [Table 4]
[0056] 2-4 Examination of the concentration of sugar alcohol in the present disinfectant composition with added adhesive In order to examine the concentration of sugar alcohol in the present disinfectant composition containing an adhesive, the adhesive strength of a test insize drape was measured using the seven types of test disinfectants shown in Table 5.
[0057] As a result, it was shown that the adhesive strength of the incise drape for measurement was increased by applying it to the artificial skin coated with the test disinfectant containing 0.5% PVA and 1.0 to 10.0% D-mannitol. In particular, when the incise drape for measurement was applied to the artificial skin coated with the test disinfectant containing 0.5% PVA and 1.5 to 10% D-mannitol, the adhesive strength of the incise drape for measurement was sharply increased compared to when it was applied to the artificial skin coated with the test disinfectant containing only 0.5% PVA or when it was applied to the artificial skin coated with the test disinfectant containing 0.5% PVA and 1% D-mannitol (see Table 5 and Figure 6).
[0058] This result shows that when the concentration of sugar alcohol (D-mannitol) in the present disinfecting composition containing 0.5% adhesive (PVA) is adjusted to 1.5-10%, the adhesive strength of the incise drape to the skin surface to which the disinfecting composition is applied is enhanced, compared with the case where the sugar alcohol (D-mannitol) concentration is adjusted to 1.0% or the case where a disinfecting composition containing an adhesive (PVA) without sugar alcohol (D-mannitol) is used. Furthermore, no serious problems such as film peeling occurred in this study (adhesive concentration 0.5%).
[0059] [Table 5]
[0060] 2-5 Examination of the concentration of adhesive in the disinfectant composition containing adhesive (1) In order to examine whether results similar to those in "2-4" above (i.e., the adhesive strength enhancement effect due to a specific concentration of sugar alcohol) could be obtained even if the concentration of the adhesive in the present disinfecting composition to which an adhesive was added was adjusted to a value other than 0.5%, the adhesive strength of a test insize drape was measured using the four types of test disinfectants shown in Table 6.
[0061] As a result, it was shown that the adhesive strength of the incise drape for measurement was increased by applying it to artificial skin coated with a test disinfectant containing 0.1% PVA and 1.0 to 10.0% D-mannitol. In particular, when the incise drape for measurement was applied to artificial skin coated with a test disinfectant containing 0.1% PVA and 1.5 to 10% D-mannitol, the adhesive strength of the incise drape for measurement was sharply increased compared to when it was applied to artificial skin coated with a test disinfectant containing only 0.1% PVA or when it was applied to artificial skin coated with a test disinfectant containing 0.1% PVA and 1% D-mannitol (see Table 6 and Figure 7).
[0062] This result shows that when the concentration of sugar alcohol (D-mannitol) in the present disinfecting composition containing 0.1% adhesive (PVA) is adjusted to 1.5-10%, the adhesive strength of the incise drape to the skin surface to which the disinfecting composition is applied is enhanced, compared with the case where the sugar alcohol (D-mannitol) concentration is adjusted to 1.0% or the case where a disinfecting composition containing an adhesive (PVA) without sugar alcohol (D-mannitol) is used, and supports the result of "2-4" above. Note that no serious problems such as film peeling occurred in this study (adhesive concentration 0.1%).
[0063] [Table 6]
[0064] 2-6 Examination of the concentration of adhesive in the disinfectant composition containing adhesive (2) In order to examine whether results similar to those of "2-4" and "2-5" above (i.e., the adhesive strength enhancement effect due to a specific concentration of sugar alcohol) could be obtained even if the concentration of the adhesive in the present disinfecting composition containing an adhesive was adjusted to a value other than 0.1% and 0.5%, the adhesive strength of the measurement insize drape was measured using the four types of test disinfectants shown in Table 7.
[0065] As a result, it was shown that when the measurement insize drape was applied to artificial skin coated with a test disinfectant containing 2.0% PVA and 1.5 to 10% D-mannitol, the adhesive strength of the measurement insize drape was enhanced compared to when it was applied to artificial skin coated with a test disinfectant containing 2.0% PVA and 1.0% D-mannitol (see Table 7 and Figure 8).
[0066] This result shows that when the concentration of sugar alcohol (D-mannitol) in the present disinfecting composition to which 2.0% adhesive (PVA) is added is adjusted to 1.5-10%, the adhesive strength of the incise drape to the skin surface to which the disinfecting composition is applied is enhanced compared to when the sugar alcohol (D-mannitol) concentration is adjusted to 1.0%, supporting the results of "2-4" and "2-5" above. Note that no serious problems such as film peeling occurred in this study (adhesive concentration 2.0%).
[0067] Taking the results of "2-4", "2-5", and "2-6" above together, it is shown that when the concentration of sugar alcohol (D-mannitol) in the disinfectant composition of the present invention to which 0.1 to 2.0% adhesive (PVA) has been added is adjusted to 1.5 to 10%, the adhesive strength of the incise drape to the skin surface to which the disinfectant composition has been applied is enhanced, compared to when the sugar alcohol (D-mannitol) concentration is adjusted to 1.0% or when a disinfectant composition containing an adhesive (PVA) without sugar alcohol (D-mannitol) is used.
[0068] [Table 7]
[0069] 2-7 Confirmation that the disinfectant composition in question, which contains a high concentration of adhesive, is inappropriate as a disinfectant composition In order to confirm that the disinfecting composition in question, which contains a high concentration of adhesive, is unsuitable as a disinfecting composition, the adhesive strength of the measurement insize drape was measured using the three types of test disinfectant shown in Table 8.
[0070] As a result, it was shown that when the measurement insize drape was applied to artificial skin coated with a test disinfectant containing 3.5% PVA and 1.0% or 1.5% D-mannitol, the adhesive strength of the measurement insize drape tended to decrease depending on the concentration of D-mannitol compared to when it was applied to artificial skin coated with a test disinfectant containing only 3.5% PVA (see Table 8 and Figure 9).
[0071] This result shows that the present disinfectant composition containing a high concentration (e.g., 3.5%) of adhesive is different from the present disinfectant composition containing a low concentration (e.g., 0.1 to 2.0%) of adhesive, and contains sugar alcohol, which reduces the adhesive strength of the incise drape to the skin surface to which the disinfectant composition is applied. In addition, the test disinfectant solution containing 3.5% PVA has a high adhesive strength of the incise drape, but the amount of PVA applied is large, and as a result of forming a thick film on the skin surface when dried, the disinfectant composition film partially peeled off. Naturally, even if the incise drape is attached to the peeled disinfectant composition film, there is no adhesive strength between the incise drape and the skin, so that in particular, when the disinfectant composition film peels off overall, the overall adhesive strength between the incise drape and the skin may decrease. In addition, if the adhesive is present in the disinfectant composition at a high concentration, the viscosity of the disinfectant composition increases, and depending on the application, it is considered that the applicability of the disinfectant composition may be deteriorated. Furthermore, if the adhesive is present in a high concentration in the disinfecting composition, it may have the adverse effect of taking a long time to dry after application of the disinfecting composition. Therefore, when adding an adhesive to the disinfecting composition of the present invention, it is preferable to adjust the concentration of the adhesive so that it does not become too high.
[0072] [Table 8]
[0073] 2-8 Consideration of adhesives other than PVA to be added to the disinfectant composition in question In order to examine adhesives other than PVA that can be added to the present disinfectant composition, the adhesive strength of a test incise drape was measured using the five types of test disinfectants shown in Table 9.
[0074] As a result, it was shown that when the measurement insize drape was applied to artificial skin coated with a test disinfectant containing 0.5% PVP and 5.0% D-mannitol, the adhesive strength of the measurement insize drape was enhanced compared to when it was applied to artificial skin coated with a test disinfectant containing 0.5% PVP (see Table 9 and Figure 10).
[0075] These results also show that the disinfectant composition of the present invention, which contains an adhesive other than PVA (PVP), can further enhance the adhesive strength of the incise drape to the skin surface to which the disinfectant composition has been applied, compared to the disinfectant composition of the present invention that does not contain an adhesive (PVP).
[0076] [Table 9]
[0077] 2-9 Examination of sugar alcohols other than D-mannitol in the present disinfectant composition In order to examine sugar alcohols other than D-mannitol in the present disinfectant composition, the adhesive strength of a test incise drape was measured using the three types of test disinfectants shown in Table 10.
[0078] As a result, it was shown that when the incise drape for measurement was applied to artificial skin coated with a test disinfectant containing 5.0% erythritol, the adhesive strength of the incise drape for measurement was enhanced compared to when it was applied to artificial skin coated with a test disinfectant not containing erythritol (a test disinfectant not containing erythritol and PVA) (see Table 10 and Figure 11).In addition, it was shown that when it was applied to artificial skin coated with a test disinfectant containing 0.5% PVA and 5.0% erythritol, the adhesive strength of the incise drape for measurement was further enhanced compared to when it was applied to artificial skin coated with a test disinfectant containing 5.0% erythritol (see Table 10 and Figure 11).
[0079] These results show that even if a sugar alcohol other than D-mannitol is selected as the sugar alcohol in the disinfecting composition of the present invention, the adhesive strength of the incise drape to the skin surface to which the disinfecting composition has been applied can be increased. In addition, since both D-mannitol and erythritol are sugar alcohols with relatively high CRH (specifically, the CRH of D-mannitol is about 98 and the CRH of erythritol is about 90) and relatively low hygroscopicity, it is considered that one of the possibilities is that these sugar alcohols contribute to maintaining the dry state of the skin surface after the application of the disinfecting composition of the present invention, resulting in the adhesive strength of the incise drape being further increased.
[0080] [Table 10]
[0081] 2-10 Effect of sugar alcohols in the disinfectant composition under various humidity conditions In order to confirm that the effect of D-mannitol in the disinfecting composition of the present invention is observed even under conditions other than 50% humidity, the adhesive strength of the incise drape for measurement was measured under five humidity conditions (20%, 30%, 40%, 50%, and 60%) using the four types of test disinfectants shown in Table 11. In this test, the width of the incise drape was 5 cm, the amount of the test disinfectant applied was 270 μL, the application area on the artificial skin was 610 mm × 620 mm, the test disinfectant was applied using a spatula, the resting time after the incise drape was pressed was 3 minutes, the measuring instrument for the tensile test was a Tensilon universal testing machine (model: RTG-1225, manufactured by A & D Co., Ltd.), and the tensile speed was 5.0 mm / sec.
[0082] As a result, it was shown that when the incise drape for measurement was applied to artificial skin coated with a test disinfectant containing D-mannitol, the adhesive strength of the incise drape for measurement was increased under all humidity conditions compared to when it was applied to artificial skin coated with a test disinfectant not containing D-mannitol, and the decrease in adhesive strength due to an increase in humidity was reduced compared to when it was applied to artificial skin coated with a test disinfectant containing PVA (see Table 11 and Figure 12). In addition, it was shown that when the incise drape for measurement was applied to artificial skin coated with a test disinfectant containing both PVA and D-mannitol, the decrease in adhesive strength due to an increase in humidity was further reduced compared to when it was applied to artificial skin coated with a test disinfectant containing D-mannitol alone or a test disinfectant containing PVA alone. These results show that the effects of the sugar alcohol (D-mannitol) in the disinfectant composition and the effects of the disinfectant composition with added adhesive (PVA) are exhibited even under various humidity conditions.
[0083] [Table 11]
[0084] Example 2. Evaluation of the bactericidal activity of the present disinfecting composition In order to investigate the effect on the bactericidal activity of this disinfectant composition and this disinfectant composition to which an adhesive has been added, the bactericidal activity against bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) and fungi (Candida albicans) known to cause infectious diseases was evaluated using D-mannitol as the sugar alcohol and PVA as the adhesive.
[0085] 1. Materials and Methods 1-1 Test disinfectant The test disinfectants were prepared by adding various concentrations (1.0%, 2.0%, or 5.0%) of D-mannitol (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.), various concentrations (1.0% or 2.0%) of PVA (500) (average degree of polymerization: approximately 500, partially saponified product; manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.), or various concentrations (0.5%, 1.0%, or 2.0%) of PVA (1500) (average degree of polymerization: approximately 1500, partially saponified product; manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) to the oranidine disinfectant solution (2) shown in Table 12 below.
[0086] [Table 12]
[0087] 1-2 Culture medium 1-2-1 SCD flat plate 1000 mL of pure water was added to 40 g of SCD agar medium "Daigo" (product number: 396-00175, manufactured by Nippon Pharmaceutical Co., Ltd.) and stirred. This was sterilized by high-pressure steam (121°C, 20 minutes). Before the agar solidified, approximately 20 mL was dispensed into petri dishes and allowed to solidify to prepare SCD plates. These were stored at room temperature until use.
[0088] 1-2-2 SCDLP medium 48.0 g of SCDLP agar medium "Daigo" (product code: 398-00255, manufactured by Nippon Pharmaceutical Co., Ltd.) was weighed into a glass Erlenmeyer flask, and 1000 mL of pure water was added and stirred. This was sterilized by high-pressure steam (121°C, 20 minutes) to prepare SCDLP medium. It was stored in a hot bath set at 47°C until use.
[0089] 1-2-3 SAB flat plate 1000 mL of pure water was added to 65 g of Sabouraud Agar Medium "Nissui" (product number: 05701, manufactured by Nissui Pharmaceutical Co., Ltd.) and stirred. This was sterilized by high-pressure steam (121°C, 20 minutes). Before the agar solidified, approximately 20 mL was dispensed into petri dishes and allowed to solidify to prepare SAB plates. These were stored at room temperature until use.
[0090] 1-2-4 SABLP medium 73.0 g of Sabouraud Glucose LP Agar Medium "Daigo" (product code: 392-01875, manufactured by Nippon Pharmaceutical Co., Ltd.) was weighed into a glass Erlenmeyer flask, 1000 mL of pure water was added, and the flask was stirred. This was sterilized with high-pressure steam (121°C, 20 minutes) to prepare SABLP medium. The medium was stored in a water bath set at 47°C until use.
[0091] 1-3 Reagents 1-3-1 PBS Approximately 50 mL of distilled water was added to 3.4 g of potassium dihydrogen phosphate and dissolved. Sodium hydroxide solution was added to adjust the pH to 7.2±0.2, and distilled water was added to make the total volume 100 mL. This was used as the phosphate buffer stock solution. 2.5 mL of the phosphate buffer stock solution and approximately 1800 mL of distilled water were added to 17.5 g of sodium chloride and dissolved. Distilled water was added to make the total volume 2000 mL, and then the mixture was sterilized with high-pressure steam (121°C, 20 minutes) to prepare PBS. The mixture was stored at room temperature until use.
[0092] 1-3-2 Neutralizer Approximately 800 mL of distilled water was added to 100 g of polysorbate 80 and stirred. 5.0 g of sodium thiosulfate hydrate, 0.4 g of potassium dihydrogen phosphate, 1 mL of Triton X-100, 10.1 g of anhydrous sodium monohydrogen phosphate, and 11.7 g of soybean lecithin were added and stirred. Furthermore, 10.0 g of Tamol (registered trademark) NN8906 was added, and the mixture was heated and stirred until dissolved. After dissolution, the mixture was cooled to room temperature, and then 1 mol / L sodium hydroxide solution was added to adjust the pH to 7.8 to 7.9. Distilled water was added until the total volume was 1000 mL, and the mixture was transferred to a medium bottle and sterilized by high-pressure steam. After sterilization, the mixture was removed from the high-pressure steam sterilizer while still hot, and cooled to room temperature while stirring to prepare a neutralizing agent.
[0093] 1-4 Pre-culture of test bacteria and preparation of test bacteria suspension The test bacteria were Staphylococcus aureus ATCC29213, epidermis Staphylococcus epidermidis ATCC12228, Pseudomonas aeruginosa ATCC27853, and fungus Candida albicans ATCC90028 were used. Each test bacteria was cultured on SCD plates (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) or SAB plates (Candida albicans), and then suspended in distilled water to prepare a 5-fold diluted solution of McFarland 1 (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) or a test bacteria suspension of McFarland 5 (Candida albicans).
[0094] 1-5 Bactericidal activity evaluation test 1-5-1 Measurement of the number of live bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) before the action of the test disinfectant The number of viable bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) was measured before the action of the test disinfectant according to the following steps [1] to [6]. [1] 150 μL of a suspension of test bacteria, Staphylococcus aureus, Staphylococcus epidermidis, or Pseudomonas aeruginosa, was added to 3 mL of PBS and mixed. [2] Immediately, 500 μL of the bacterial mixture was added to 4.5 mL of neutralizing agent and mixed. 1 This was a 2-fold diluted solution. [3] 10 1 The diluted solution was diluted 10 times with a neutralizer. Dilution was then repeated to make a 10-fold dilution series (10 1 ~10 5 A total of five dilutions (up to 200% diluted) were prepared. [4] 10 3 ~10 5 1 mL of each double dilution was dispensed into a petri dish, and about 20 mL of SCDLP medium stored in a warm bath was added to prepare a pour plate. [5] After the pour plate solidified, it was inverted and incubated aerobically at 35±2°C for 2 days. [6] The colonies that grew on the pour plate were visually counted, and the viable bacterial count (CFU / mL) was calculated by multiplying the colony count by the dilution factor (n=3).
[0095] 1-5-2 Measurement of the number of viable bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) after the action of the test disinfectant The number of viable bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) after the action of the test disinfectant was measured according to the following steps [1] to [5]. [1] 10 types of test disinfectants (test disinfectant containing 2.0% PVA (500); test disinfectant containing 1.0% PVA (500); test disinfectant containing 2.0% PVA (1500); test disinfectant containing 1.0% PVA (1500); test disinfectant containing 0.5% PVA (1500); test disinfectant containing 5.0% D-mannitol; test disinfectant containing 2.0% D-mannitol; test disinfectant containing 1.0% D-mannitol; test disinfectant containing 2.0% PVA (500) and 5.0% D-mannitol; and test disinfectant containing 1.0% PVA (1500) and 5.0% D-mannitol) were added to 3 mL of Staphylococcus aureus, Staphylococcus epidermidis, or Pseudomonas aeruginosa test bacteria suspension and mixed. This was used as the reaction solution, and the reaction was carried out at room temperature. [2] After reacting for a specified time (30 seconds or 60 seconds), 500 μL of the reaction solution was extracted and added to 4.5 mL of neutralizing agent and mixed. 1 This was a 2-fold diluted solution. [3] 10 1 1 mL of each double dilution was dispensed into a petri dish, and about 20 mL of SCDLP medium stored in a warm bath was added to prepare a pour plate. [4] After the pour plate solidified, it was inverted and incubated aerobically at 35±2°C for 2 days. [5] The colonies that grew on the pour plate were visually counted, and the viable bacterial count (CFU / mL) was calculated by multiplying the colony count by the dilution factor (n=3).
[0096] 1-5-3 Measurement of the number of viable bacteria (Candida albicans) before the action of the test disinfectant The number of viable bacteria (Candida albicans) before the action of the test disinfectant was measured according to the following procedures (1) to (6). [1] 150 μL of Candida albicans test bacteria suspension was added to 3 mL of PBS and mixed. [2] Immediately, 500 μL of the bacterial mixture was added to 4.5 mL of neutralizing agent and mixed. 1 This was a 2-fold diluted solution. [3] 10 1 The diluted solution was diluted 10 times with a neutralizer. Dilution was then repeated to make a 10-fold dilution series (10 1 ~10 4 A total of four dilutions (up to 200% diluted) were prepared. [4] 10 2 ~10 4 1 mL of each of the two-fold diluted solutions was dispensed into petri dishes, and about 20 mL of SABLP medium that had been stored in a warm bath was added to prepare pour plates. [5] After the pour plate solidified, it was inverted and incubated aerobically at 35±2°C for 2 days. [6] The colonies that grew on the pour plate were visually counted, and the viable bacterial count (CFU / mL) was calculated by multiplying the colony count by the dilution factor (n=3).
[0097] 1-5-4 Measurement of the number of viable bacteria (Candida albicans) after the action of the test disinfectant The number of viable bacteria (Candida albicans) after the action of the test disinfectant was measured according to the following procedures (1) to (6). [1] 150μL of the Candida albicans test bacteria suspension was added to 3mL of the above 10 types of test disinfectants and mixed. This was used as the reaction solution, and the reaction was carried out at room temperature. [2] After reacting for a specified time (30 seconds or 60 seconds), 500 μL of the reaction solution was extracted and added to 4.5 mL of neutralizing agent and mixed. 1 This was a 2-fold diluted solution. [3] 10 1 The diluted solution was diluted 10 times with a neutralizer. Dilution was then repeated to make a 10-fold dilution series (10 1 ~10 3 A total of three dilutions (up to 200% diluted) were prepared. [4] 10 2 , 10 3 1 mL of each of the two-fold diluted solutions was dispensed into petri dishes, and about 20 mL of SABLP medium that had been stored in a warm bath was added to prepare pour plates. [5] After the pour plate solidified, it was inverted and incubated aerobically at 35±2°C for 2 days. [6] The colonies that grew on the pour plate were visually counted, and the viable bacterial count (CFU / mL) was calculated by multiplying the colony count by the dilution factor (n = 3 times).
[0098] 1-5-5 Calculation of bactericidal activity When no colonies were detected after the action of the test disinfectant, the detection limit was set at 10 CFU / mL for Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa, and 100 CFU / mL for Candida albicans. The common logarithm was calculated for the number of viable bacteria (CFU / mL) before the action of the test disinfectant and the number of viable bacteria after the action of the test disinfectant for each reaction time (30 seconds or 60 seconds), and the bactericidal activity was expressed as a relative value with the number of colonies not detected being set at 1 (see the following formula). Bactericidal power=(AB)÷(AC) A: Average number of viable bacteria (common logarithm) before the action of the test disinfectant B: Number of viable bacteria after the action of the test disinfectant (common logarithm value) C: Common logarithm of the detection limit (the number of viable bacteria when no colonies are detected)
[0099] 2.Results When three types of disinfectant compositions of the present invention (a test disinfectant containing 1.0% D-mannitol, a test disinfectant containing 2.0% D-mannitol, and a test disinfectant containing 5.0% D-mannitol) and two types of disinfectant compositions of the present invention with added adhesive (a test disinfectant containing 2.0% PVA (500) and 5.0% D-mannitol, and a test disinfectant containing 1.0% PVA (1500) and 5.0% D-mannitol) were reacted with three strains of bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) for 30 seconds and 60 seconds, no residual bacteria were detected for any of the bacteria (see Tables 13 to 15). In addition, when two types of the disinfectant compositions of the present invention containing an adhesive were reacted with fungus (Candida albicans) for 30 and 60 seconds, it was shown that the bactericidal activity tended to be stronger than when a test disinfectant containing only PVA(500) or PVA(1500) was used or when three types of the disinfectant compositions of the present invention were used (see Table 16). These results show that the sugar alcohol in the disinfectant composition and the adhesive added to the disinfectant composition do not adversely affect the bactericidal activity of the disinfectant composition, and also show that the addition of an adhesive to the disinfectant composition tends to increase the bactericidal activity compared to when no adhesive is added. In particular, Candida albicans is known to be the bacterium with the highest risk of hospital-acquired infections, and the recognition of the enhanced bactericidal activity against Candida albicans is considered to be of great clinical significance.
[0100] [Table 13]
[0101] [Table 14]
[0102] [Table 15]
[0103] [Table 16]
[0104] Example 3. Measurement of adhesion of an incise drape to a skin surface to which the disinfectant composition of the present invention has been applied (2) In Example 1, "3M Ioban Special Incise Drape" was used as the incise drape for measurement. In order to confirm that the adhesive strength enhancing effect of the present disinfecting composition is exerted regardless of the type of incise drape, an analysis was carried out according to the method described in Example 1 using "Opsite Incise" (manufactured by Smith & Nephew), an incise drape other than "3M Ioban Special Incise Drape". In addition, since "3M Ioban Special Incise Drape" and "Opsite Incise" are both acrylic adhesives, in order to confirm that the adhesive strength enhancing effect of the present disinfecting composition is exerted even when a medical tape other than an acrylic adhesive is used, "3M Micropore S Gentle Peel Silicone Tape" ("3M Micropore S" in the U.S.), a surgical tape with a silicone adhesive, was used. TM Micropore TM A similar analysis was also performed on "3M Micropore S Easy-Removable Silicone Tape" (equivalent to "3M Micropore S Surgical Tape" manufactured by 3M). Note that measurements were performed on a 2.5 cm width instead of a 4 cm width for "3M Micropore S Easy-Removable Silicone Tape."
[0105] The adhesive strength of "Opsite Incise" was measured using the four types of test disinfectants shown in Table 17. As a result, it was shown that the disinfectant composition in question (i.e., a disinfectant composition containing a sugar alcohol [D-mannitol]) had a higher adhesive strength of "Opsite Incise" to the skin surface to which the disinfectant composition was applied than a disinfectant composition that did not contain a sugar alcohol (D-mannitol), and that the adhesive strength increased to the same level as when a disinfectant composition containing an adhesive (PVA) was used (see Table 17 and Figure 13). In addition, when Opsite Incise was applied to artificial skin coated with a test disinfectant containing both PVA and D-mannitol, the adhesive strength of Opsite Incise was shown to be enhanced compared to when it was applied to artificial skin coated with a test disinfectant containing either PVA or D-mannitol alone (see Table 17 and Figure 13).
[0106] [Table 17]
[0107] In addition, the adhesive strength of "Opsite Incise" was measured using the four types of test disinfectants shown in Table 18. The results showed that when "Opsite Incise" was applied to artificial skin coated with a test disinfectant containing 1.0 to 5% D-mannitol, the adhesive strength of "Opsite Incise" was enhanced compared to when it was applied to artificial skin coated with a test disinfectant not containing D-mannitol (see Table 18 and Figure 14).
[0108] [Table 18]
[0109] In addition, the adhesive strength of "3M Micropore S Easy-to-Remove Silicone Tape" was measured using the four types of test disinfectants shown in Table 19. The results showed that the disinfectant composition in question (i.e., a disinfectant composition containing a sugar alcohol [D-mannitol]) enhanced the adhesive strength of "3M Micropore S Easy-to-Remove Silicone Tape" to the skin surface to which the disinfectant composition had been applied, compared to disinfectant compositions containing either the sugar alcohol (D-mannitol) or the adhesive (PVA) alone (see Table 19 and Figure 15). In addition, when "3M Micropore S Easy-Removable Silicone Tape" was applied to artificial skin coated with a test disinfectant containing both PVA and D-mannitol, the adhesive strength of "3M Micropore S Easy-Removable Silicone Tape" was shown to be enhanced compared to when it was applied to artificial skin coated with a test disinfectant containing either PVA or D-mannitol alone (see Table 19 and Figure 15).
[0110] [Table 19]
[0111] In addition, the adhesive strength of "3M Micropore S Easy-to-Remove Silicone Tape" was measured using the four types of test disinfectants shown in Table 20. The results showed that when "3M Micropore S Easy-to-Remove Silicone Tape" was applied to artificial skin coated with a test disinfectant containing 1.0-5% D-mannitol, the adhesive strength of "3M Micropore S Easy-to-Remove Silicone Tape" was enhanced compared to when it was applied to artificial skin coated with a test disinfectant not containing D-mannitol (see Table 20 and Figure 16).
[0112] [Table 20]
[0113] In addition, the adhesive strength of "3M Micropore S Easy-to-Remove Silicone Tape" was measured using the five types of test disinfectants shown in Table 21. The results showed that the adhesive strength of "3M Micropore S Easy-to-Remove Silicone Tape" was enhanced when it was applied to artificial skin coated with a test disinfectant containing 0.5% PVA and 1.5 to 10.0% D-mannitol (see Table 21 and Figure 17).
[0114] [Table 21]
[0115] The above results show that the effect of enhancing the adhesive strength of an incise drape by the disinfecting composition of the present invention is exerted regardless of the type of incise drape. [Industrial Applicability]
[0116] The present invention contributes to the prevention of infections (eg, infections caused by bacteria, fungi, viruses, etc.) at wound sites and at surgical sites during surgery.
Claims
Claim 1 A disinfecting composition comprising a bactericide (excluding iodine) and a sugar alcohol. The disinfecting composition according to claim 1, wherein the sugar alcohol has an effect of enhancing the adhesion of an incised drape to the skin surface after application of the disinfecting composition. The disinfecting composition according to claim 1 or 2, wherein the sugar alcohol is D-mannitol or erythritol. The disinfecting composition according to claim 1 or 2, further comprising an adhesive. The disinfecting composition according to claim 4, wherein the adhesive has an effect of enhancing the adhesion of an incised drape to the skin surface after application of the disinfecting composition. The disinfecting composition according to claim 4, wherein the concentration of the adhesive is 2% (w / v) or less. The disinfecting composition according to claim 4, wherein the adhesive is polyvinyl alcohol or polyvinylpyrrolidone. The disinfecting composition according to claim 1 or 2, wherein the bactericide is chlorhexidine gluconate.