JPH0563446B2 - - Google Patents

Description

[Detailed description of the invention]

(Industrial Application Field) The present invention relates to a medical disinfectant composition suitable for disinfecting hands and fingers. (Conventional technology) Hospital nursing station, ward entrance, ICU
Traditionally, basin-shaped containers (basins) containing an aqueous solution of disinfectant have been installed at entrances, etc., and the basin method has been adopted, in which both hands are immersed in this to disinfect the fingers. However, recently, regarding this basin method, there is a risk that if the drug concentration drops below a certain level, the basin itself may become a pool of bacteria, resistant bacteria may appear due to long-term use of the same drug, and There is a possibility of recontamination from towels, etc. Many problems have been pointed out. Therefore, quick-drying disinfectants such as ethanol solutions of suitable disinfectants are being investigated. Examples of quick-drying disinfectants include ethanol solutions of chlorhexidine gluconate. This disinfectant is a pharmacopoeial disinfectant ethanol (76.9
~81.4v/v% ethanol aqueous solution) by adding chlorhexidine gluconate at a rate of 0.1 to 0.5% w/v. This disinfectant is quick-drying, and the ethanol and chlorhexidine gluconate that it contains have an additive bactericidal effect, so it is used for disinfecting the skin during surgery and disinfecting medical equipment in emergencies. . However, when the solvent ethanol comes into contact with the skin, it has the effect of denaturing skin constituent proteins such as keratin, causing skin roughness (skin disorders). Therefore, it is not generally used as a frequently used disinfectant such as disinfecting hands and fingers. It is conceivable to suppress skin damage by adding an emollient agent that protects the skin to such a disinfectant solution whose main component is ethanol as a solvent. However, it is known that the bactericidal activity of chlorhexidine gluconate decreases due to the presence of various coexisting substances. For example, serum [Journal of Infectious Diseases 53 , 292
(1979)], Polysaccharides [J.Periodont.Res. 8,
Suppl. 12 , 61 (1973)], nonionic surfactants [Okayama Medical Journal, 91 , 251 (1979)], various organic compounds such as powdered milk, dried bovine serum, and fish meal [Journal.
of Applied Bacteriology (J.Appl.
Bacteriol.), 54 , 243 (1983)] has been reported to reduce bactericidal activity. Since most of the emollients used in cosmetics are nonionic surfactants or higher alcohols, it is thought that the bactericidal activity of chlorhexidine gluconate is reduced when these are added. Thus, at present, a quick-drying hand disinfectant composition that has sufficient bactericidal activity and is less likely to cause skin damage has not been obtained. (Problems to be Solved by the Invention) The present invention is intended to solve the above-mentioned conventional problems, and its purpose is to provide a product that has sufficient sterilizing power, is quick drying, and is used frequently. It is an object of the present invention to provide a hand disinfectant composition that is less likely to cause skin damage. Another object of the present invention is to use chlorhexidine gluconate ethanol solution as the main component,
The object of the present invention is to provide a hand disinfectant composition having the above-mentioned excellent properties. (Means and effects for solving the problem) The inventors, while considering an emollient agent that does not reduce the bactericidal activity of chlorhexidine gluconate,
The present inventors discovered an emollient that improves the bactericidal activity of chlorhexidine gluconate by coexisting with chlorhexidine gluconate, leading to the completion of this invention. The hand disinfection composition of the present invention is a hand disinfection composition containing disinfectant ethanol, chlorhexidine gluconate, and an emollient.
The emollient is at least one selected from the group consisting of diisopropyl adipate, diisobutyl adipate, higher fatty acid polyoxyethylene glyceryl, and polyglycerin, thereby achieving the above object. here,
"Hand disinfection composition" is used not only for disinfecting hands but also for disinfecting skin during surgery and disinfecting medical instruments.
Refers to disinfectant compositions that can be widely used for medical purposes. Among the emollients contained in the hand disinfection composition of the present invention, higher fatty acid polyoxyethylene glyceryl has fatty acids constituting the molecule having 8 to 18 carbon atoms. Such fatty acid polyoxyethylene glyceryl is a compound in which one molecule of glycerin is condensed with the above fatty acid and 1 to 30 ethyne oxides are added, and has the following formula ()
Indicated by: Here, R is an alkyl group having 7 to 17 carbon atoms, and n is an integer of 1 to 30. Compounds in which R has different carbon numbers may be mixed. For example, the main component is lauric acid, and C8
Using coconut oil fatty acids containing ~18 fatty acids, mixtures of compounds () with different numbers of carbon atoms in R are obtained. Among the emollient agents, polyglycerin is a compound obtained by dehydration condensation of 2 to 15 glycerins, and two or more types of polyglycerin having different numbers of condensed glycerins may be used as a mixture. All of the emollients in the composition of the present invention function as skin softeners and sebum component replenishers, and suppress skin disorders such as skin irritation and rough skin caused by ethanol components. At the same time, it also has the function of enhancing the bactericidal power of chlorhexidine gluconate contained in the composition. Although the detailed mechanism of bactericidal activity enhancement has not been fully elucidated, it is thought that the action of chlorhexidine gluconate on bacterial cell walls is enhanced due to the synergistic effect of these emollients and chlorhexidine gluconate. These emollients are contained in the composition at 0.1 to 1.0 wt/v%,
It is preferably contained in a proportion of 0.2 to 0.4 wt/v%. If the amount is too low, the above effect cannot be obtained. If used in excess, the emollient will leave a sticky feeling on the skin surface. The concentration of chlorhexidine gluconate in the composition of the present invention is approximately 0.02 to 0.5wt/1, based on the usual chlorhexidine gluconate-sterilizing ethanol composition.
v%, preferably 0.1 to 0.5wt/v%. The ethanol for disinfection may be any ethanol solution having sterilizing power, and usually an aqueous ethanol solution of about 50 to 95% v/v is used. For example, pharmacopoeial disinfectant ethanol (76.9 to 81.4 v/v%) is preferably used. The hand disinfectant composition of the present invention is obtained by dissolving chlorhexidine gluconate and an emollient in an ethanol aqueous solution of approximately 80 v/v%, such as pharmacopoeial disinfectant ethanol. When hands and fingers are immersed in this composition (disinfectant), the bactericidal effects of both chlorhexidine gluconate and ethanol are obtained, and the action of chlorhexidine gluconate is further enhanced by the emollient. It goes without saying that the action of this emollient agent suppresses skin roughness. Since this disinfectant is quick-drying, it dries quickly, so there is no need to use a hand towel or the like, and there is no risk of re-contamination from the hand towel. Even after drying, the chlorhexidine gluconate and emollient agent remain attached to the skin surface, so they have a sufficient bactericidal effect. The composition of the present invention can be widely used for medical purposes such as hand disinfection and medical instrument disinfection. (Experimental Example) The present invention will be explained below using an example. Experimental example 1 As an emollient agent soluble in a disinfectant ethanol solution of chlorhexidine gluconate, 80v/v
Emollients that can be dissolved in % ethanol aqueous solution
Thirteen species (No. ~ in Table 1) were selected and their influence on the bactericidal activity of chlorhexidine gluconate was investigated. Add emollient No. ~ shown in Table 1 to 80v/v% aqueous ethanol solution containing chlorhexidine gluconate at 0.2wt/v% at 0.2wt/v%.
13 types of sample solutions were prepared. Separately, use serum instead of emollient.
A sample solution added at a ratio of 0.2 wt/v% was also prepared (No.). A glass cylindrical tube (diameter 25 mm, height 65 mm) was fixed to the inner bottom of a 100 ml glass beaker, and a chromatographic paper (Toyo Ro Paper No. 50) (20×
25mm) was placed. A 50μ drop of the sample solution (one of the above sample solutions) was placed in the center of the paper, covered with a glass lid (diameter 75 mm), and dried for 2 hours. 20μ of Staphylococcus aureus suspension (cultivated in liquid broth medium at 37°C for 16 hours) was dropped onto the area in the center of the paper where the sample solution had dried, and the suspension was covered with a lid and left at room temperature for 10 minutes. This paper was mixed with 20 g of sterilized glass beads (particle size 3 mm) and bacteria recovery liquid (50 g).
ml) and shaken vigorously up and down for 45 seconds to collect bacteria. The number of viable bacteria was measured using pour culture for this bacterial recovery solution. The bacteria recovery liquid is a 0.3% aqueous solution of cocoamide ether sulfate, and the cocoamide ether sulfate has the function of inactivating chlorhexidine gluconate brought in during bacteria recovery. The experiment was repeated three times for each sample solution containing each emollient, the sample solution containing serum, and the control solution containing no emollient.
Experiments were also conducted on untreated fingers to which no sample solution was added. Table 1 shows the number of viable bacteria per 500μ of each bacterial recovery solution, and FIG. 1 shows the results of an analysis of variance of the logarithm of the number of viable bacteria in 1 ml of the bacteria recovery solution.

【table】

[Table] From Table 1 and Figure 1, when serum was added to an 80v/v% ethanol aqueous solution of chlorhexidine gluconate, the bactericidal activity of chlorhexidine gluconate decreased, but when the above 13 types of emollients were added. It is clear that the bactericidal activity does not decrease in this case. Furthermore, according to Figure 1, the number of viable bacteria in the control (R) to which no emollient was added was 2×
10 ⁴ , whereas when diisopropyl adipate (DIPA) and polyglycerin (PG) were added, it was 5 × 10 ³ , respectively.
It can be seen that when coconut oil fatty acid polyoxyethylene glyceryl (GC; the number of added moles of ethylene oxide is 7) is added, the amount is 2×10 ³ , and when diisopropyl adipate (DIBA) is added, it is 7×10 ² . In this way, there is a significant difference with a hazard rate of P<0.01 when GC or DIBA is added compared to when no emollient is added.
There is a significant difference at P<0.05 when DIPA or PG is added. In other words, when these emollients are added, the number of viable bacteria is reduced to 1/10 to 1/100, and it is clear that the emollients of the present invention enhance the bactericidal activity of chlorhexidine gluconate. Contains no emollients and contains chlorhexidine gluconate at a rate of 0.4wt/v%
When a similar experiment was carried out using an 80 v/v % ethanol aqueous solution, its bactericidal activity was almost the same as in the above experimental example in which 0.2 wt/v % of the emollient of the present invention was added. Example 2 Experimental Example 1 using Pseudomonas aeruginosa instead of Staphylococcus aureus
The number of viable bacteria was measured according to the procedure described in . The results of the analysis of variance of the logarithm of the number of viable bacteria are shown in Figure 2. It is clear from FIG. 2 that these emollients do not reduce the bactericidal effect of chlorhexidine gluconate against P. aeruginosa. In particular, DIBA used in the present invention enhances the bactericidal activity against chlorhexidine gluconate (number of viable bacteria: 1 x 10 ³ ), and has a hazard rate P<0.01 compared to when no emollient is added (number of viable bacteria: 4 x 10 ³ ). A significant difference was observed. Experimental example 3 Serratia cerevisiae was used instead of Staphylococcus aureus.
marcescens) as an emollient.
The number of viable bacteria was measured using GC and DIBA in accordance with Experimental Example 1. The results of the analysis of variance of the logarithm of the number of viable bacteria are shown in FIG. From Figure 3, the number of viable bacteria in the control (R) to which no emollient was added was 5 x 10 ³ , while in the case of GC and 3 x 10 ³ when DIBA was added. It shows a clearly low value of 2×10 ³ . In either case, the risk rate P<
A significant difference was observed at 0.01, which is used in the present invention.
It is clear that GC or DIBA enhances the bactericidal effect of chlorhexidine gluconate against S. marcescens. Experimental Example 4 The effect of using two types of emollients in combination was investigated. Chlorhexidine gluconate 0.2wt/v
As shown in Table 2, GC was added at a rate of 0 to 0.4wt/v% and DIPA was added at a rate of 0 to 4wtv% to an 80v/v% ethanol aqueous solution containing a 80v/v% aqueous solution containing 16 types of sample solutions. did. Using this, the operation was performed according to Experimental Example 1, and the number of viable bacteria per 500μ of the bacteria recovery liquid was measured. The experiment was repeated twice.
The results are shown in Table 2.

[Table] It is clear from Table 2 that GC and DIPA mutually enhance the bactericidal activity of chlorhexidine gluconate in each concentration range. Experimental Example 5 GC was dissolved in an 80v/v% ethanol solution at a ratio of 0.2wt/v%. This was used as a sample solution and operated according to Experimental Example 1 to measure the number of viable Staphylococcus aureus bacteria per 500μ of the bacteria recovery liquid. Similar experiments were conducted using DIBA, DIPA, and PG instead of GC. The results are shown in Table 3.

[Table] From Table 3, it can be seen that the emollient agent alone has no bactericidal effect at all. (Effects of the Invention) According to the present invention, a hand disinfectant composition that has sufficient sterilizing power, dries quickly, and does not easily cause skin damage even when used frequently can be obtained. The bactericidal power of chlorhexidine gluconate contained in the composition is enhanced by the action of a specific emollient added to the composition.
Even with a small amount of chlorhexidine gluconate, the same effect as conventional products can be obtained. Such compositions are widely used for medical purposes, such as disinfecting hands in hospitals, disinfecting skin during surgery, and disinfecting medical instruments.

[Brief explanation of the drawing]

Figure 1 is a graph showing the results of measuring the bactericidal activity of chlorhexidine gluconate in the presence of various emollients using Staphylococcus aureus, and Figures 2 and 3 are graphs showing the results of measuring the bactericidal activity of chlorhexidine gluconate in the presence of various emollients, and Figures 2 and 3 show the results of measuring the bactericidal activity of chlorhexidine gluconate in the presence of various emollients. It is a graph which shows the result measured using.

Claims (1)

[Scope of Claims] 1. A hand disinfection composition containing disinfectant ethanol, chlorhexidine gluconate, and an emollient, wherein the emollient is diisopropyl adipate, diisobutyl adipate, or higher fatty acid polyoxyethylene. A hand disinfectant composition comprising at least one member selected from the group consisting of glyceryl and polyglycerin. 2. The higher fatty acid constituting the higher fatty acid polyoxyethylene glyceryl has 8 to 18 carbon atoms, and each molecule of the higher fatty acid polyoxyethylene glyceryl contains 1 to 30 added ethylene oxides. Composition according to item 1. 3. The composition according to claim 1, wherein the polyglycerin is a condensate of 2 to 15 glycerins. 4. The composition according to claim 1, wherein the emollient agent is contained in a proportion of 0.1 to 1.0% by weight.