JP7626424B2 - Skin disinfectant composition - Google Patents

Description

Detailed Description of the Invention

The present invention relates to a skin disinfectant composition that is effective against both viruses and food poisoning bacteria.

In recent years, food poisoning caused by norovirus has become a problem. Due to its high infectiousness, the number of cases is increasing and it has caused large-scale food poisoning incidents. It was believed that food poisoning caused by norovirus was caused by eating bivalve mollusks such as oysters, but it has recently been discovered that the main cause of food poisoning is secondary contamination, where the norovirus contained in food, feces, and vomit spreads from person to person, and further spreads by contact with clean surfaces via contaminated food or water.

To prevent this secondary contamination, it is important to sterilize cooking utensils and equipment such as cutting boards and knives, clean doorknobs and other entrances, dispose of vomit, and disinfect hands.

By the way, "norovirus" is an RNA virus belonging to the Norovirus genus of the Caliciviridae family. The RNA is surrounded by a protein shell called a capsid, and it does not have a membrane made of sugar and lipids called an envelope.

Generally, enveloped viruses can be inactivated by easily destroying their envelope with drugs, which prevents them from binding to receptors on host cells. However, noroviruses do not have this envelope and are therefore resistant to drugs.

A method using a sodium hypochlorite solution is known as a method for inactivating norovirus (Non-Patent Document 1). However, this method cannot be used to disinfect hands and fingers due to its irritating properties. As an alternative method, a method using a disinfectant composition containing alcohol as a main component is known.

For example, JP 2014-19659 A (Patent Document 1) discloses an alcohol-based disinfectant having an excellent disinfecting effect against norovirus, the alcohol-based disinfectant containing (A) 50 to 70% by weight of ethanol and (B) 0.05 to 4.50% by weight of at least one selected from the group consisting of organic acids, organic acid salts, and ethanolamines and having a pH of 6 to 12, and a disinfection method using the alcohol-based disinfectant.

JP 2014-19659 A

"Report on the Investigation of Inactivation Conditions for Norovirus in FY2015," Food Sanitation Control Division, National Institute of Health Sciences, November 18, 2016

However, although existing alcohol-based disinfectant compositions have an inactivating effect on norovirus, there is a problem in that they cause rough skin when used to disinfect the skin of hands and fingers, etc.

As a result of extensive research by the inventors to solve the above problems, the inventors have completed the following invention.
[1] A skin disinfectant composition comprising the following components (A) to (E) in the following proportions relative to the total composition, water, and a pH (JIS Z-8802:2011 "pH measurement method") of 8 to 11 at 25°C:
(A) 0.01 to 5% by mass of a cationic surfactant,
(B) 35 to 60% by mass of a lower alcohol,
(C) 0.01 to 2 mass% of at least one selected from the group consisting of organic acids and alkali metal salts thereof,
(D) 0.1 to 5 mass% of an inorganic alkaline substance,
(E) Moisturizer: 0.001 to 2% by mass.
[2] The skin disinfectant composition according to [1], wherein the component (A) is at least one selected from the group consisting of benzalkonium chloride, benzethonium chloride, dioctyldimethylammonium chloride, octyldecyldimethylammonium chloride, didecyldimethylammonium chloride, didecyldimethylammonium methosulfate, polyhexamethylene biguanide hydrochloride, and alkyldimethylhydroxyethylammonium chloride.
[3] The skin disinfectant composition according to [1] or [2], wherein the component (B) is at least one selected from ethyl alcohol and isopropanol.
[4] The skin disinfectant composition according to any one of [1] to [3], wherein the component (C) is at least one selected from the group consisting of citric acid, malic acid, gluconic acid, succinic acid, tartaric acid, lactic acid, and alkali metal salts thereof.
[5] The skin disinfectant composition according to any one of [1] to [4], wherein the component (D) is at least one selected from an alkali metal hydrogen carbonate, potassium carbonate, and an alkali metal hydroxide.
[6] The skin disinfectant composition according to any one of [1] to [5], wherein the component (E) is at least one selected from glycerin, sodium hyaluronate, diisopropyl adipate, allantoin, and isopropyl myristate.

In other words, the present invention can provide a disinfectant composition that exhibits an inactivating effect or bactericidal effect on both viruses and food poisoning bacteria, and that has little effect on the skin when applied to the skin of the hands, fingers, etc.

Next, the best mode for carrying out the present invention will be described in detail.

The skin disinfectant composition of the present invention can be obtained using (A) a cationic surfactant, (B) a lower alcohol, (C) an organic acid and an alkali metal salt thereof, (D) an inorganic alkaline substance, (E) a moisturizer, and water.

Examples of the cationic surfactant of component (A) used in the skin disinfectant composition of the present invention include benzalkonium chloride, benzethonium chloride, dioctyldimethylammonium chloride, octyldecyldimethylammonium chloride, didecyldimethylammonium chloride, didecyldimethylammonium methosulfate, polyhexamethylene biguanide hydrochloride, alkyldimethylhydroxyethylammonium chloride, cetylpyridium chloride, alkyltrimethylammonium chloride, etc. These may be used alone or in combination of two or more kinds.

The cationic surfactant of the component (A) can be contained in the skin disinfectant composition in the range of 0.01 to 5% by mass. From the viewpoint of bactericidal properties and storage stability, it is preferably set to the range of 0.02 to 2% by mass, and more preferably to the range of 0.05 to 1% by mass. The more cationic surfactant, the higher the bactericidal effect and virus inactivation effect, but if it is too much, skin irritation increases. In addition, it is disadvantageous in terms of the balance of the entire composition, and the storage stability is reduced and the bactericidal effect and virus inactivation effect are close to the upper limit, which may not be economically advantageous.

Examples of the lower alcohol of the component (B) used in the skin disinfectant composition of the present invention include ethyl alcohol, isopropyl alcohol, and denatured alcohol. Examples of the denatured alcohol include geraniol, octaacetylated sucrose, phenylethyl alcohol, brucine, linalool, diethyl phthalate, linalyl acetate, benzyl acetate, 10% by mass denatonium benzoate alcohol solution, and various denatured ethyl alcohols denatured with denaturants such as flavor H-No. 11 and H-13. These may be used alone or in combination of two or more. In addition, if it is a commercially available product, one having an alcohol concentration of 60 to 100% by mass is preferably used. In particular, ethyl alcohol is preferably used from the viewpoints of safety and toxicity.

The lower alcohol of the component (B) can be contained in the skin disinfectant composition in the range of 35 to 60% by mass. From the viewpoints of bactericidal effect, virus inactivation effect, effect on skin, and storage stability, it is preferably set to 37 to 54% by mass, and more preferably set to the range of 39 to 49% by mass. If the content is small, the effect on skin is small, but the bactericidal effect and virus inactivation effect are poor, and drying properties are also poor, making it difficult to use. If the content is large, the bactericidal effect and especially the virus inactivation effect are improved, but the effect on skin is large, and other blended components are precipitated, leading to a decrease in storage stability.

The organic acid and its alkali metal salt of the component (C) is at least one selected from citric acid, malic acid, gluconic acid, succinic acid, tartaric acid, lactic acid, and alkali metal salts thereof, and examples of the alkali metal salt include sodium salts and potassium salts. More specifically, examples of the alkali metal salt include citric acid, malic acid, gluconic acid, succinic acid, tartaric acid, lactic acid, sodium citrate, potassium citrate, sodium malate, sodium gluconate, potassium gluconate, sodium succinate, sodium tartrate, sodium lactate, etc. These may be used alone or in combination of two or more.

The organic acid and its alkali metal salt of component (C) may be contained in the skin disinfectant composition in an amount ranging from 0.01 to 2% by mass. From the viewpoints of virus inactivation effect and storage stability, it is preferable to set the amount to the range of 0.1 to 1% by mass. If the amount is too small, the virus inactivation effect is poor, and if the amount is too large, storage stability is reduced.

Examples of the inorganic alkaline substance of the component (D) include alkali metal hydroxides, alkali metal silicates, alkali metal carbonates, and alkali metal hydrogen carbonates. More specifically, sodium hydroxide, potassium hydroxide, sodium silicate, potassium silicate, sodium carbonate, potassium carbonate, sodium hydrogen carbonate, and potassium hydrogen carbonate can be mentioned. These may be used alone or in combination of two or more. From the viewpoint of storage stability, alkali metal hydrogen carbonates, potassium carbonate, and alkali metal hydroxides are preferred, and the combination of sodium hydrogen carbonate and potassium hydroxide is particularly suitable from the viewpoints of virus inactivation, storage stability, and skin irritation.

The inorganic alkaline substance of component (D) may be contained in the range of 0.1 to 5% by mass. From the viewpoints of virus inactivation, storage stability, and skin irritation, the content is preferably 0.3 to 3% by mass, and more preferably 0.5 to 1.5% by mass. If the content is too low, the virus inactivation effect is poor, and if the content is too high, the storage stability decreases and the effect on the skin becomes significant, which is disadvantageous.

Examples of the moisturizing agent of the component (E) include glycerin, sodium hyaluronate, diisopropyl adipate, allantoin, isopropyl myristate, diglycerin, erythritol, xylitol, ribitol, arabitol, galactitol, sorbitol, iditol, mannitol, palatinite, maltitol, lactitol, maltotriitol, isomaltotriitol, maltotetritoitol, isomaltotetritoitol, oligosaccharides, polysaccharides, polyethylene glycol, propylene glycol, butylene glycol, dipropylene glycol, aloe extract, and loofah extract.

The moisturizing agent of component (E) may be contained in the range of 0.001 to 2% by mass. From the viewpoints of mitigating skin irritation, storage stability, and usability, the content is preferably 0.1 to 1% by mass. If the content is too low, the mitigating effect on skin irritation is poor, and if the content is too high, the storage stability is reduced and the skin may feel uncomfortable after application to the hands and fingers.

The pH (JIS Z-8802:2011 "pH measurement method") of the undiluted solution of the skin disinfectant composition of the present invention is preferably in the range of 8 to 11 at 25° C., and particularly preferably in the range of 8.5 to 10.5 from the viewpoints of bactericidal effect, virus inactivation effect, and effect on the skin. If the pH is too low, the bactericidal effect and virus inactivation effect are inferior, and if the pH is too high, it is disadvantageous from the viewpoint of effect on the skin. In particular, a pH in the range of 8.8 to 10.5 is preferable because a virus inactivation effect can be obtained even in the presence of organic soil.

The water used in the skin disinfectant composition of the present invention may be tap water, soft water, ion-exchanged water, pure water, purified water, etc., but from the viewpoint of the storage stability of the composition, it is preferable to use soft water, ion-exchanged water, pure water, purified water, etc.

In the skin disinfectant composition of the present invention, water is blended in an amount necessary to make the total of the other components in the skin disinfectant composition of the present invention 100% by mass, with the remaining amount being % by mass.

Furthermore, the skin disinfectant composition of the present invention may contain, if necessary, surfactants other than cationic surfactants, dyes, fragrances, metal corrosion inhibitors, antioxidants, viscosity adjusters such as water-soluble thickeners, and the like.

The skin disinfectant composition of the present invention is generally prepared by mixing and stirring when each component is liquid, or by first dissolving a solid component in water and then adding and stirring the other liquid components when the composition contains solid components. However, depending on the composition, the order of addition and dissolution of each component, and the manufacturing procedure such as heating/cooling as necessary are not particularly limited.

The skin disinfectant composition of the present invention can be used by any suitable method, for example, by spraying the surface of the hands, fingers, etc. with a sprayer or the like, and leaving it for about 30 seconds to 2 minutes after a predetermined time, and drying it. Specifically, a dedicated dispenser containing the undiluted solution of the skin disinfectant composition of the present invention is placed in a kitchen, a kitchen area, an entranceway, etc., and the hands, fingers, etc. can be sterilized and disinfected by spraying the undiluted solution at a rate of about 6 to 12 ml/ ^m2 each time it is used. After spraying the skin disinfectant composition of the present invention on the hands, fingers, etc., rubbing the areas to which the skin disinfectant composition has adhered accelerates the drying of the skin disinfectant composition.

The skin disinfectant composition of the present invention may be provided in a plastic container, a container with a pump, a pouch, a tube, etc. It may also be provided in an amount equivalent to that required for one-time use, individually packaged, for portability.

The skin disinfectant composition of the present invention can be used to disinfect objects to which viruses or food poisoning bacteria are attached. Here, the "virus" includes calicivirus, preferably norovirus. The "food poisoning bacteria" includes Staphylococcus aureus, pathogenic Escherichia coli, Salmonella, Campylobacter, Vibrio parahaemolyticus, Clostridium botulinum, Clostridium perfringens, etc., preferably bacteria such as Staphylococcus aureus and pathogenic Escherichia coli. "Sterilization" means inactivation of viruses and/or sterilization/elimination of bacteria.

Next, examples will be described together with comparative examples. The present invention is not limited to these. In the following description, "%" means mass %.

Skin disinfectant compositions of Examples 1 to 27 and Comparative Examples 1 to 10 (hereinafter also referred to as test compositions) were prepared according to the compositions shown in Tables 1 to 7 below. The obtained test skin disinfectant compositions were evaluated for the test items of inactivation activity against viruses, bactericidal activity against food poisoning bacteria, pH, storage stability, and skin moisture content (effect on skin) according to the following test methods and criteria, and the results are shown in Tables 1 to 7 below.

(1) pH
The pH of the undiluted solution of the test agent was measured using a pH meter (model: pH METER F-12, manufactured by Horiba, Ltd.) in accordance with JIS Z-8802:2011 "pH measurement method."

(2) Storage stability [Test method]
The test preparations were placed in 100 mL transparent plastic bottles and stored in a thermostatic chamber (type: freezer-refrigerator HRF, manufactured by Hoshizaki Corporation) under an atmosphere of 0°C for 3 weeks, after which the appearance was visually observed and evaluated according to the following criteria.
〔Judgment criteria〕
○: No precipitation, deposition or separation occurs. △: Some precipitation, deposition or separation occurs. ×: A lot of precipitation, deposition or separation occurs.

(3) Skin moisture content (effect on skin)
[Test Method]
2 ml of the test preparation was placed on the palm of the hand and spread evenly over the fingers. After 10 minutes, the moisture content was measured using a moisture meter ASA-M2/S (manufactured by Asahi Biomed Co., Ltd.) and compared with the moisture content measured before the test to calculate the rate of change in moisture content.
〔Judgment criteria〕
⊚: Change rate is 200% or more; ◯: Change rate is 150% or more but less than 200%; Δ: Change rate is 100% or more but less than 150%; ×: Change rate is less than 100%. If the moisture content change rate is 100% or more, it was determined that there was a moisturizing effect (little effect on the skin).

(4) Usability [Test Method]
2 ml of the test preparation was placed on the palm of the hand and spread evenly over the fingers. After 1 minute, the feel of the skin on the hands was evaluated sensorily based on the following criteria.
〔Judgment criteria〕
◎: Almost no stickiness or roughness is felt. ○: Either stickiness or roughness is felt slightly. ×: Either stickiness or roughness is felt significantly.

(5) Feline calicivirus (FCV)
Inactivation test 1. Test method Using FCV, a surrogate virus for norovirus, a test was conducted to determine the norovirus inactivation effect of the skin disinfectant compositions of the Examples and Comparative Examples. The test method was based on known methods (Food Hygiene Inspection Guidelines: Microorganisms (2015) "Virus Inactivation Test";"Report on the Investigation of Inactivation Conditions for Norovirus in FY2015" Food Hygiene Management Department, National Institute of Health Sciences, etc.).

That is, the virus solution (FCV F9 strain) and each of the skin disinfectant compositions of the Examples and Comparative Examples were mixed in a ratio of 1:9, left at room temperature for 30 seconds, and then diluted 7-fold with DMEM medium supplemented with 2% FBS to stop the reaction. Then, 7-fold serial dilutions were performed, and each dilution was inoculated into feline kidney-derived cells (CRFK cells), and the amount of viable virus was quantified by the 50% infection endpoint method ( _TCID50 /ml).

To conduct an organic load test simulating organic contamination, equal amounts of MEM medium supplemented with 10% meat extract (Nacalai Tesque) and the virus solution were mixed to prepare a virus solution containing 5% meat extract. The same procedure as above was carried out on this virus solution, and the amount of viable virus was quantified.

In assessing efficacy, since the virus was diluted 7-fold in steps after the reaction, the actual measured value (log ₇ ) was converted to log ₁₀ , and the efficacy was assessed based on the converted value. The inactivation effect was assessed based on the reduction in the infectivity titer, and the efficacy was assessed according to the difference in the infectivity titer from the inoculated virus (log ₁₀ converted value) as follows: ◎: sufficient effect (reduction in infectivity titer of 4 log ₁₀ or more), ○: effective (reduction in infectivity titer of 2 log ₁₀ or more and less than 4 log ₁₀ ), and ×: ineffective (reduction in infectivity titer of less than 2 log ₁₀ ).

(6) Bactericidal test against food poisoning bacteria [Test method]
The test was conducted according to the sanitizer test method of the Association of Official Agricultural Chemists (AOAC). Specifically, 0.1 ml of a bacterial solution adjusted to 10 ⁸ to 10 ⁹ in Nutrient Broth (NB) medium (MERCK) was added to 9.9 ml of the original test agent solution. After 30 seconds of contact, 1 ml of the solution was added to 9 ml of phosphate buffer containing an inactivating agent, and then immediately serially diluted. The mixture was mixed with Plate Count Agar (PCA) medium (MERCK), and the number of surviving bacteria was measured after 48 hours of culture at 37°C. Log Reduction was calculated from the logarithmic difference between the number of inoculated bacteria and the number of surviving bacteria, and evaluated according to the following criteria.
The test bacteria used were Escherichia coli (NBRC-3972) and Staphylococcus aureus (NBRC-12732).
〔Judgment criteria〕
○: LogReduction is 5 or more ×: LogReduction is less than 5

The details of the components shown in Tables 1 to 7 are as follows. However, in these tables, the numbers indicating the composition of each component are shown as pure contents.

(A) Ingredients BAC: Benzalkonium chloride Product name: GEM, manufactured by Sanyo Chemical Industries, active ingredient 50%
BZC: Benzethonium chloride Product name: Hyamine 1622-I, manufactured by Lonza, 100% active ingredient
DOAC: Dioctyldimethylammonium chloride Product name: Bardac LF-80, manufactured by Lonza, active ingredient 80%
DDAS: Didecyldimethylammonium methosulfate Product name: Lipoguard 210-80MSPG,
Manufactured by Lion Specialty Chemicals, 80% active ingredient
DHAC: alkyldimethylhydroxyethylammonium chloride Product name: Plapagen HY, Clariant, active ingredient 40%

(B) Ingredient: Ethanol Product name: Traceable 95 Grade 1, manufactured by Japan Alcohol Sales Co., Ltd.
Active ingredient content: 95%
IPA: Isopropyl alcohol Product name: Isopropyl alcohol, manufactured by Kanto Chemical Co., Ltd. (reagent grade 1),
Active ingredient content: 99%

(C) Ingredient: Citric acid Product name: Citric acid (anhydrous), manufactured by Fuso Chemical Co., Ltd., active ingredient content 100%
Sodium lactate Product name: Fermented sodium lactate 50%, Corbion, active ingredient content 50%
Sodium gluconate Product name: Healthy A, manufactured by Fuso Chemical Industry Co., Ltd., active ingredient content 100%

(D) Ingredients: Sodium bicarbonate Product name: Sodium bicarbonate official grade E, manufactured by Tokuyama Corporation, active ingredient content 100%
・Potassium carbonate Product name: Potassium carbonate, manufactured by AGC, 100% active ingredient
・Sodium carbonate Product name: Soda ash (dense), manufactured by Tokuyama Corporation, active ingredient content 100%
・Potassium hydroxide Product name: Potassium hydroxide, Kanto Chemical Co., Ltd., active ingredient 85%
・Sodium hydroxide Product name: Sodium hydroxide, Kanto Chemical Co., Ltd., active ingredient 95%

(E) Ingredients/Moisturizer 1: Glycerin Product name: Concentrated glycerin, manufactured by Miyoshi Oil Co., Ltd., 100% active ingredient
Moisturizer 2: Sodium hyaluronate Product name: Hyaluronic acid liquid HA-LQH1P, manufactured by Kewpie Corporation, active ingredient 1%
Moisturizer 3: Diisopropyl adipate Product name: NIKKOL DID, manufactured by Nikko Chemicals, 100% active ingredient
Moisturizer 4: Allantoin Product name: Allantoin, manufactured by Kawaken Fine Chemicals, 100% active ingredient
Moisturizer 5: Isopropyl myristate Product name: NIKKOL IPM-100, manufactured by Nikko Chemicals Co., Ltd.
100% active ingredients

・Purified water (official)

比較例９：室温で配合した時点で析出したので、ｐＨの測定を実施していない。

Comparative Example 9: Precipitation occurred when blended at room temperature, so pH was not measured.

From the evaluation results in Tables 1 to 7, it can be seen that Examples 1 to 27 obtained almost good results in all items. All of them obtained the effect of inactivating FCV and the effect of killing food poisoning bacteria, and it was confirmed that not only was excellent in storage stability, but also that they had a moisturizing effect, which maintained the moisture content of the skin and reduced the impact on the skin. In contrast, it can be seen that Comparative Examples 1 to 10 had practical problems in at least some items.

Claims (6)

A skin disinfectant composition comprising the following components (A) to (E) in the following proportions relative to the total composition, water, a pH (JIS Z-8802:2011 "pH measurement method") of 8 to 11 at 25°C , and a ratio (C/D) of the following component (C) to the following component (D) of 0.1111 to 0.625 :
(A) 0.01 to 5% by mass of a cationic surfactant,
(B) 35 to 60% by mass of a lower alcohol,
(C) 0.01 to 2 mass% of at least one selected from the group consisting of organic acids and alkali metal salts thereof,
(D) 0.1 to 5 mass% of an inorganic alkaline substance,
(E) Moisturizer: 0.001 to 2% by mass. The skin disinfectant composition according to claim 1, characterized in that the component (A) is at least one selected from benzalkonium chloride, benzethonium chloride, dioctyldimethylammonium chloride, octyldecyldimethylammonium chloride, didecyldimethylammonium chloride, didecyldimethylammonium methosulfate, polyhexamethylene biguanide hydrochloride, and alkyldimethylhydroxyethylammonium chloride. The skin disinfectant composition according to claim 1 or 2, characterized in that the component (B) is at least one selected from ethyl alcohol and isopropanol. The skin disinfectant composition according to any one of claims 1 to 3, characterized in that the component (C) is at least one selected from citric acid, malic acid, gluconic acid, succinic acid, tartaric acid, lactic acid, and alkali metal salts thereof. The skin disinfectant composition according to any one of claims 1 to 4, characterized in that the component (D) is at least one selected from an alkali metal hydrogen carbonate, potassium carbonate, and an alkali metal hydroxide. The skin disinfectant composition according to any one of claims 1 to 5, characterized in that the component (E) is at least one selected from the group consisting of glycerin, sodium hyaluronate, diisopropyl adipate, allantoin, and isopropyl myristate.