WO2007061028A1

WO2007061028A1 - Gel composition for sterilization

Info

Publication number: WO2007061028A1
Application number: PCT/JP2006/323391
Authority: WO
Inventors: Yuichi Teratani; Tomoko Izumi; Yuko Itsuji; Manabu Soga; Kaoru Nagata
Original assignee: Maruishi Pharmaceutical Co., Ltd.
Priority date: 2005-11-25
Filing date: 2006-11-24
Publication date: 2007-05-31
Also published as: JPWO2007061028A1; TW200727785A

Abstract

(i) A gel composition for sterilization containing 0.2-0.55 w/v% of at least one substance selected from the group consisting of chlorhexidine and salts thereof, 50-99 v/v% of a hydrocarbon alcohol having 2-3 carbon atoms, a thickening agent and a wetting agent, while having a viscosity of 10-1000 mPs. (ii) A gel composition for sterilization containing 0.2-0.55 w/v% of at least one substance selected from the group consisting of chlorhexidine and salts thereof, 50-99 v/v% of a hydrocarbon alcohol having 2-3 carbon atoms, 0.05-10 w/v% of a thickening agent and 0.15-10 w/v% of a wetting agent.

Description

Specification

Gel composition for sterilization

Technical field

[0001] The present invention relates to a gel composition for sterilization and disinfection of human fingers and skin, which has a sustained disinfecting effect.

Background art

[0002] Chlorhexidine dalconate is a strong antibacterial strong basic substance developed in the UK in 1954. Chlorhexidine dalconate damages bacterial cell membranes at relatively low concentrations, causing irreversible leakage of cytoplasmic components and enzyme inhibition, and at relatively high concentrations causing intracellular protein and nucleic acid deposition. Shows antibacterial action (bactericidal action). At present, chlorhexidine dalconate is included in many hand hygiene products and is used in aqueous or ethanol solutions depending on the application, such as hand disinfection of the skin, skin disinfection of surgical sites, disinfection of medical devices, etc. (Refer to the 14th revised Japanese Pharmacopoeia Manual, edited by the Japanese Pharmacopoeia Manual, Tokyo, Hirokawa Shoten, 2001, p. 1225-1229).

[0003] Also, according to the Guidelines for Hand Hygiene in Medical Facilities (CDC Guidelines) published by the Center for Epidemiology and Prevention (CDC) in 2002, chlorhexidine dalconate was used immediately after rubbing. It has been reported as a highly active hand disinfectant that effectively reduces the number of bacteria on the skin (Centers for Disease Control and d Prevention., Guideline for Hand Hygiene in Health— Care Settin gs: Morbidity and Mortality Weekly Report, 2002, 51 (see No. RR—16)).

[0004] In recent years, due to improvements in surgical methods and the like, it has become possible to perform surgery on patients who have been difficult to perform surgery, and operations that require a long time are increasing. As described above, when surgery is performed for a long time, there is a problem that bacteria may flow into the surgical field of the patient, such as pinholes, etc. generated in the rubber gloves of the surgeon and the like, causing bacterial contamination. Under these circumstances, in the United States, handwash products using disinfectants for health care workers are regulated by the U.S. Food and Drug Administration (FDA) mass medicine department, and handwash products and surgery for healthcare professionals. To hand sanitizer Requirement for in vitro and in vivo testing as outlined in FDA's “Medical Hand Sanitizer Product Provisional Final Criteria”. Among them, hand sanitizers during surgery greatly reduce microorganisms on intact skin, contain anti-irritant antibacterial agents, have a broad spectrum action, and are fast-acting and durable. (See Food and Drug Administration, Tentative Final Monograph for Health—Care Antiseptic Drug Products; Proposed Rules: Federal Register, 1994; 59: P31401-52.) In addition, according to the CDC guidelines, the effects of surgical hand sanitizers are as follows: (1) Immediately after hand sanitization (immediate effect), (2) After wearing surgical gloves for 6 hours (sustained effect), (3) 5 days Are evaluated based on their ability to reduce bacterial release from the fingers after multiple rubs (cumulative effects), especially immediate and sustained effects are considered the most important in determining product efficacy ing. Furthermore, according to the CDC guidelines, adding 0.5% or 1.0% chlorhexidine dalconate to alcohol-based formulations may provide a better bactericidal effect than alcohol alone. (See Centers for Disease Control and Prevention., Guideline for Hand Hygiene Health Care Care: Morbidity and Mortality Weekly Report, 2 002; 51 (No. RR-16)).

[0005] As a disinfectant containing chlorhexidine darconate and alcohol, Japanese Patent No. 3515 821 contains ethyl alcohol having a concentration of 50% by weight or more, chlorhexidine darconate, and an organic acid, and has a pH of Teaches disinfecting compositions that are 3 to 4.5. Patent No. 3592080 publication Viscous quick-drying disinfectant containing one or more alcohols selected from methyl alcohol, ethyl alcohol and isopropyl alcohol, chlorhexidine dalconate, and hydrophobized hydroxypropylmethylcellulose Disinfectants having a hydrophobized hydroxypropylmethylcellulose content of 0.1 to 20% by weight relative to the total weight of the disinfectant are disclosed. However, none of them have practically sufficient sustainability of the bactericidal effect.

Disclosure of the invention

Problems to be solved by the invention

[0006] The present invention includes chlorhexidine or a salt thereof and an alcohol, and has a sustained bactericidal effect. Relates to a gel composition for sterilization and disinfection.

Means for solving the problem

[0007] As a result of intensive studies to solve the above problems, the present inventors have found that chlorhexidine or Z and a salt thereof are about 0.2 to 0.55 wZv% and carbonized with 2 to 3 carbon atoms. Hydrogen alcohol contains 50 ~ 99vZv%, thickener and wetting agent, viscosity is about SlO ~ 1000mPs (millipascal second), and the bactericidal effect approved by the inspection method by hand disinfection evaluation method We have found that a composition that lasts at least 6 hours can solve the above problems.

[0008] Further, chlorhexidine or Z and a salt thereof are about 0.2 to 0.55 WZV%, a hydrocarbon alcohol having 2 to 3 carbon atoms is about 50 to 99 vZv%, and a thickener is 0.05 to: LOwZv It was also found that a gel composition containing about 0.1% to 50 wZv% of a wetting agent and the sterilizing effect approved by the hand disinfection evaluation method lasts for a long time.

The present invention has been completed based on the above findings.

That is, the present invention

Item 1. At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 wZv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, a thickener, and a wetting agent. A gel composition for disinfecting and disinfecting, characterized in that it contains an agent, has a viscosity of 10 to: LOOOmPs, and has a disinfecting effect that is approved by the inspection method by the hand disinfection evaluation method for at least 6 hours.

Item 2. The composition according to Item 1, wherein the hand sanitization evaluation method is a glove juice method, a gnome stamp method, or a finger-streak method.

Item 3. The composition according to Item 1, wherein the thickener is at least one selected from the group consisting of cellulose derivatives and salts of cellulose derivatives.

Item 4. The composition according to Item 1, wherein the content of the thickener is 0.05-: L0wZv%. Item 5. The composition according to item 1, wherein the wetting agent is at least one polyhydric alcohol. Item 6. The composition according to Item 1, wherein the content of the wetting agent is 0.15 to 50 wZv%. Item 7. The composition according to Item 1, wherein the content ratio of the thickening agent to the wetting agent is 3 parts by weight of the wetting agent to 1 part by weight of the thickening agent. Item 8. The composition according to Item 1, further comprising a humectant.

Item 9. The composition according to item 8, wherein the humectant is at least one selected from the group consisting of silicone oil and fatty acid ester.

Item 10. At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 wZv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, a thickener, and a wetting agent. Disinfection method that disinfects human fingers or skin by applying a composition that contains 10 to 10 and has a viscosity of 10 to: LOOOmPs and has a sterilization effect that is approved by the inspection method by the hand disinfection evaluation method for at least 6 hours .

Item 11. At least one selected from the group consisting of chlorhexidine and its salt strength is 0.2 to 0.55 wZv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, a thickener, and a wetting agent. And a viscosity of 10 to: LOOOmPs, and a composition having a sterilizing effect that is approved by the inspection method by the hand sanitization evaluation method for at least 6 hours, is used as a disinfectant.

Item 12. At least one selected from the group consisting of chlorhexidine and its salt strength is 0.2 to 0.55 wZv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, and a thickener is 0.05. ~: L0wZv% and a wetting agent 0.15 ~: Gel composition for sterilization and disinfection containing L0wZv%.

Item 13. The composition according to Item 12, wherein the viscosity is 10 to: LOOOmPs.

Item 14. The composition according to Item 12, wherein the thickener is at least one selected from the group consisting of cellulose derivatives and salts of cellulose derivatives.

Item 15. The composition according to Item 12, wherein the wetting agent is at least one polyhydric alcohol. Item 16. The composition according to Item 12, wherein the content ratio of the thickening agent to the wetting agent is 3 parts by weight of the wetting agent to 1 part by weight of the thickening agent.

Item 17. The composition according to Item 12, further comprising a humectant.

Item 18. The composition according to Item 17, wherein the humectant is at least one selected from the group consisting of silicone oil and fatty acid ester.

Item 19. At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 wZv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, and a thickener is 0. 05 ~: L0wZv% and a humectant 0.15 ~: A sterilization method for disinfecting human fingers or skin by applying a composition containing L0wZv%.

Item 20. At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 wZv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, and a thickener is 0.05. ~: Use of a composition containing L0wZv% and a wetting agent 0.15 ~: L0wZv% as a disinfectant.

I will provide a.

The invention's effect

[ooio] The sterilizing and disinfecting gel composition of the present invention has an immediate sterilizing power equivalent to that of a conventional sterilizing and disinfecting agent containing chlorhexidine or Z and its salt and alcohol, and its sterilizing effect. Persists for a long time. In the composition of the present invention, the bactericidal effect approved by the hand disinfection evaluation method lasts at least 6 hours after disinfection. For this reason, for example, when a pinhole or the like is damaged in a rubber glove of an operator or the like due to a long operation, it is possible to suppress the outflow of bacteria to the patient's operative field.

[0011] In addition, since the gel composition for sterilization and disinfection of the present invention has moisture retention, it is possible to prevent rough hands due to frequent use of bactericides by medical personnel. Furthermore, the gel composition for sterilization and disinfection of the present invention has an appropriate viscosity, has an appropriate moist feeling and moist feeling, and can suppress the occurrence of erosion. Anyone can be prevented, and disinfection work will not be hindered!

Brief Description of Drawings

[0012] [FIG. 1] FIG. 1 shows formulation examples 1 based on the glove juice method, 0.2 wZv% chlorhexidine alcohol lotion, 0.5 wZv% chlorhexidine alcohol lotion, and 1. OwZv% chlor. It is a figure which shows the time-dependent change of RF value from immediately after disinfection of a xidine alcoholic emulsion to 6 hours after disinfection.

[Fig. 2] Fig. 2 is a graph showing changes over time in the rate of decrease in the number of bacteria after disinfection of Formulation Example 1 based on the palm stamp method and 0.2 WZV% chlorhexidine alcohol lotion. In the figure, the country represents 0.2 WZV% chlorhexidine alcohol lotion, and the mouth represents Formulation Example 1. [Fig. 3] Fig. 3 is a graph showing the bacterial count reduction rate 6 hours after disinfection of Formulation Example 1, Avagard, and Hexac Handgel based on the finger streak method.

BEST MODE FOR CARRYING OUT THE INVENTION

[0013] (1) Xiao ffl gel

In the first sterilizing and disinfecting gel composition of the present invention, at least one selected from the group consisting of chlorhexidine and its salt power is about 0.2 to 0.55 wZv% and a hydrocarbon alcohol having 2 to 3 carbon atoms. Contains about 50-99vZv%, thickener and wetting agent, has a viscosity of about 10-: LOO OmPs, and lasts at least 6 hours for the bactericidal effect approved by the hand sanitization evaluation method. It is a composition.

[0014] Chlorhexidine and its salt

Chlorhexidine used in the present invention is a known compound having a chemical name of 1,1 hexamethylenebis [5- (4 chlorophenol) biguanide] developed in the United Kingdom in 1954. It is a compound with a broad antimicrobial spectrum, that is, a compound that exhibits bactericidal disinfection action against a wide range of microorganisms. Examples of the salt of chlorhexidine include inorganic acid salts or organic acid salts. Specifically, for example, hydrochloride, dalconate or acetate is preferable, and in particular, dalconate (chlorhexidine dalconate). Is preferred. Darconic acid and its salts can be used singly or in combination of two or more.

[0015] The concentration of chlorhexidine or Z and a salt thereof in the germicidal disinfectant gel composition of the present invention is about 0.2 to 0.55 wZv% with respect to the whole composition, preferably about 0.5. It is 2 to 0.5 wZv%, more preferably about 0.4 to 0.5 w / v%. By setting the concentration of chlorhexidine and / or its salt within the above range, the bactericidal effect approved by the hand sanitization evaluation method can be maintained for a long time, for example, at least 6 hours. In addition, irritation to the skin and the like can be suppressed.

[0016] Lower hydrocarbon alcohol

Examples of the hydrocarbon alcohol having 2 to 3 carbon atoms include ethanol, propanol, and isopropanol, and ethanol or isopropanol is preferable. The hydrocarbon alcohol having 2 to 3 carbon atoms can be used alone or in combination of two or more. The alcohol may be mixed with methanol-modified alcohol or the like. By including chlorhexidine or z and a salt thereof and alcohol, the antimicrobial spectrum of the germicidal disinfectant gel composition of the present invention can be broadened. The concentration of the alcohol in the gel composition is about 50 to 99 vZv%, preferably about 60 to 90 vZv% with respect to the whole composition from the viewpoint of achieving a concentration that exhibits an antimicrobial effect (bactericidal effect). More preferred <is about 76-82vZv%.

[0017] Glaze

Examples of the thickener used in the gel composition for sterilization and disinfection of the present invention include polyacrylic acid, sodium polyacrylate, crosslinked branched polyacrylic acid, crosslinked branched sodium polyacrylate, potassium polyacrylate, and polyacrylic. Polyacrylic acid or its salts such as acid monoethanolamine, polyacrylic acid diethanolamine, polyacrylic acid triethanolamine, polyacrylic acid ammonium; acrylic acid starch graft copolymer cross-linked product; -Luacetoamide Z Copolymers comprising acrylic acid or its salt as sodium acrylate copolymer as one of the constituents; hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropino methenorescenellose, hydrophobic匕 Hydroxypropinoremethinoresenorose, methyl Loose, cellulose derivatives such as sodium carboxymethylcellulose or salts thereof (hereinafter sometimes referred to as cellulose thickener); polybulal alcohol; polybulurpyrrolidone; polyethylene oxide; methylvinyl ether maleic anhydride copolymer; Examples thereof include polyacrylamide; alginic acid; sodium alginate; propylene glycol ester alginate; gelatin; gum arabic; tragacanth gum; locust bean gum; gua gum; tamarind gum; The salt is a non-toxic salt, and examples thereof include a sodium salt and a potassium salt. Thickeners can be used alone or in combination of two or more.

[0018] Among these, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, and hydrophobized hydroxypropyl methylcellulose are preferred, and cellulose derivatives or salts thereof are more preferred Hydrophobic hydroxypropyl methylcellulose. As the hydrophobized hydroxypropylmethylcellulose, for example, those substituted with a modifier having a hydroxyl group long chain (about 6 to 26 carbon atoms) alkyl group of hydroxypropylmethylcellulose are preferable (Japanese Patent Laid-Open No. 3-151330, Or patent No. 3592080). Specifically, for example, hydrophobic hydroxypropylmethylcellulose in which a stearyloxyhydroxypropoxy group or the like is introduced into the hydroxyl group of hydroxypropylmethylcellulose is preferred. Examples of commercially available hydrophobized hydroxypropyl methylcellulose include Sangelose 60L, 60M, 60H, 90L, 90M, and 90H manufactured by Nisshin Kasei Co., Ltd., and any of them can be preferably used.

[0019] The concentration of the thickening agent in the gel composition is about 0.05 to about 0.05: L0wZv% is preferred, about 0.1 to 5wZv% is more preferred. 2 ~ lwZv% is even more preferred. When the thickener concentration is in the above range, a sufficient viscosity can be obtained and no swell occurs.

[0020] Wetting agent

The wetting agent used in the gel composition for sterilization and sterilization of the present invention is preferably a polyhydric alcohol such as sodium oleate or polyhydric alcohol. Examples of the polyhydric alcohol include ethylene glycol, propylene glycol, 1,3-butylene glycol, glycerin (including concentrated glycerin defined in the Japanese Pharmacopoeia), trimethylol propane, pentaerythritol, mannitol, sorbitol, xylitol, pentanetril. Examples include all or hexanetriol, and propylene glycol, 1,3-butylene glycol or glycerin is particularly preferable. As the wetting agent, one kind can be used alone, or two or more kinds can be mixed and used.

[0021] The concentration of the wetting agent in the gel composition is from about 1.0 to about 15 to 50 wZv%, more preferably about 0.3 to 20 wZv%, based on the entire composition. 10wZv% is even more preferred. When the wetting agent concentration is in the above range, rough hand, rough skin, and unpleasant crispness due to the gel composition for sterilization and disinfection of the present invention can be suppressed. In addition, when the concentration of the wetting agent is in the above-described range, an unpleasant stickiness that does not dry quickly after use is prevented.

[0022] The ratio of the thickener and the wetting agent contained in the gel composition for sterilization and disinfection of the present invention is, for example, about 3 to: LOO parts by weight of the wetting agent with respect to 1 part by weight of the thickener. It is preferably about 3 to 30 parts by mass, more preferably about 5 to 15 parts by mass. If it is the said range, sufficient viscosity will be obtained and a wrinkle will not arise. In addition, after the use, it is within the above range. There is a feeling of stickiness and can prevent rough hands

[0023] The gel composition for sterilization and disinfection of the present invention preferably further contains a humectant. The humectant may be any commonly used sterilizing agent such as silicone oil, fatty acid ester, pyrrolidone carboxylic acid, sodium pyrrolidone carboxylate, sodium lactate, hyaluronic acid, sodium hyaluronate, dl-pyrrolidone. Examples thereof include sodium carboxylate and urea. Examples of the silicone oil include dimethyl silicone oil, methylphenol silicone oil, and methylhydrogen silicone oil. Examples of the fatty acid ester include isopropyl myristate, isopropyl palmitate, isopropyl stearate, isobutyl oleate, and isobutyl maleate. The humectant is preferably silicol oil and Z or a fatty acid ester. The humectants can be used alone or in admixture of two or more.

[0024] The concentration of the humectant is more preferably about 0.2 to 5 wZv%, preferably about 0.1 to: LOwZv% with respect to the total amount of the composition. When the content of the humectant is within the above range, it is possible to suppress rough hands and rough skin caused by the gel composition for sterilization and disinfection of the present invention, as with the humectant. In addition to the effect as a moisturizing agent, silicone oil also has the effect of making it easy to attach and detach surgical gloves, for example.

[0025] Other ingredients

The sterilizing / disinfecting gel composition of the present invention may contain other sterilizing / disinfecting agents. Other disinfectants include atalinol, salt benzenton, salt benzalkonium, cetyl phosphorylated benzalkonium, cetylpyridinum chloride, methyl rosaniline chloride, iodine, yowi potassium, povidone Examples include Jodh Honore, Jodh Honolem, Mercurochrome, alkylpolyaminoethylglycine, thimerosal, pronopol, resorcin, hinokitiol, triclosan or phenol and their derivatives. These other disinfectants can be used alone or in combination of two or more.

[0026] The gel composition for sterilization and disinfection of the present invention comprises a glycyrrhizic acid or a derivative thereof, a drug such as vitamin E, vitamin E acetate or vitamin B, a non-ionic surface activity, if necessary.

6

Agents, amino acids and derivatives thereof, diisobutyl adipate or allantoin, and the like. These components can be used alone or in combination of two or more. [0027] Viscosity of the composition

The viscosity of the first composition of the present invention is about 10-1000 mPa, more preferably about 20-60 mPs, preferably about 10-200 mPs. The viscosity of the gel composition for sterilization and disinfection of the present invention is a value measured using a cone-plate rotational viscometer under the conditions of 20 ° C., 100 rpm, and a shear rate of 383se _C - ¹ .

[0028] When the viscosity of the first composition of the present invention is in the above range, the sterilizing and disinfecting effect can be maintained or extended, and dripping during use can be suppressed.

[0029] Sustained bactericidal effect

The first sterilizing and disinfecting gel composition of the present invention has the effect of hand disinfectant during operation according to CDC infection control guidelines, in particular, (1) immediate effect of reducing bacterial release from the hand immediately after hand disinfection, And (2) has a lasting effect of reducing bacterial release of finger strength after 6 hours of wearing surgical gloves. Specifically, the bactericidal effect approved by the inspection method based on the hand sanitization evaluation method lasts for at least 6 hours.

[0030] Finger disinfection evaluation methods include glove juice method, palm 'stamp method or finger

'Streak method and the like. The first composition of the present invention preferably has a bactericidal effect approved by any of these evaluation methods for 6 hours or longer. Among them, those having a bactericidal effect approved by the global juice method lasting for at least 6 hours are preferable.

[0031] <Glove Juice Method>

The glove juice test is a test method recommended by the FDA as an effective test method for hand washing products for medical professionals and Surgical hand Scrub. The Glove Juice Act is Federal Register, 39, (179): 3 3137 (1974), Federal Register, 43, (4): 1242 (1978) and Federal Register ゝ 59, (116): 31444 (1994) ) OTC (Over-the-Counter) topical disinfectant FDA proposal or “Surgery”, April 1982, pp. 513-518. The contents are roughly divided into the measurement of baseline values and the main tests (hand washing, disinfection effect tests).

[0032] To measure the baseline value, first select a subject, wash the hands with a sarcophagus, wear sterilized rubber gloves, and then use a sampling solution (0.4 g potassium hydrogen phosphate, 2 sodium hydrogen phosphate 10 lg and TritonX—A solution made by dissolving 100 lg in distilled water 1. OL. Put pH 7.8) into a 50mL glove, massage for 1 minute from the top of the glove, and remove a certain amount (lmL) of the sampling solution. Dilute the sampled solution, incubate, calculate the number of colonies, and convert to the number of bacteria per 50 mL of sampled solution. In terms of dilution, the sampled solution collected is collected in a sterile spitz containing an equal amount of neutralizing agent (for example, a solution prepared by dissolving 10 g of Tween80 and 3 g of lecithin in lOOmL of distilled water) and mixed well. It is preferable to dilute the mixed solution (hereinafter referred to as a stock solution) to a concentration at which the number of bacteria can be counted using a diluent, for example, 10 times, 100 times and 1000 times. As a diluting solution, for example, a solution prepared by dissolving 26.22 g of potassium hydrogen phosphate and 7.78 g of sodium carbonate in lOOOmL of distilled water is used. For culturing, the stock solution and the diluted solution are applied to an agar medium [eg, TSA (Trypticase Soy Agar) plate] with, for example, a congeal rod, and cultured at 30 ° C. for 24 hours, for example. Calculate the number of colonies that have grown on the agar after incubation and convert to the number of bacteria per 50 mL of the sampling solution. The measurement is performed twice, for example, and the average value is obtained. The average value is taken as the baseline value (the number of bacteria before disinfection) for each subject.

[0033] This test is a method for testing the bactericidal effect immediately after disinfection and the bactericidal effect after an arbitrary time. Specifically, after performing surgical hand washing with the sterilizing and disinfecting gel composition of the present invention, sterilized rubber gloves are put on. Immediately after putting on the glove, add 50 mL of the same sampling solution used to measure the baseline value into one glove. As with the baseline measurement, the glove's upper force is also subjected to a marsage for 1 minute, and a certain amount (lmL) of the sampling solution is withdrawn (hereinafter this operation is called sampling). Dilute and culture the extracted sampling solution in the same way as the baseline value above, calculate the number of bacteria, calculate the number of bacteria per 50 mL of the sampling solution, and calculate the total number of bacteria in one hand. Sampling the other hand is performed in the same manner as above except that the sample is taken 6 hours after wearing the glove. Diluting and culturing the sampled solution, and calculating the total number of bacteria.

[0034] The disinfection effect (disinfection evaluation) is usually performed by determining the rate of decrease in the number of bacteria before and after disinfection and comparing the disinfection effect. The comparison is performed based on, for example, the index decrease rate (RF value) of the number of bacteria. The RF value is a value calculated by the following formula.

[0035] [Equation 1] RF ii = I og (the number of bacteria before disinfection) — log (the number of bacteria after disinfection)-log (the number of bacteria before disinfection Z the number of bacteria after disinfection) In the above inspection method, when the RF value is 1.2 or more, the present invention The bactericidal effect in is recognized. A preferred RF value is 1.5 or higher.

[0036] <Nome 'stamp method>

In the Palm 'stamp method, instead of sampling in the above-mentioned glove juice method, bacteria are collected by pressing the entire palm of one hand against a hand-printed medium (eg, SCD medium, SCDLP medium for palms, etc.) immediately after disinfection with both hands using a disinfectant. After 6 hours of disinfection, the other palm is pressed against the bill medium to collect bacteria, and the collected bacteria are cultured at approximately 35 ° C for approximately 18 hours. This is a method for evaluating disinfection. The number of bacteria in the palm before disinfection is measured in the same way as above and set as the baseline.

[0037] In addition to the index reduction rate, the disinfection evaluation can also be performed by, for example, the rate of reduction of the number of bacteria after disinfection relative to the number of bacteria before disinfection. The rate of decrease in the number of bacteria

[0038] [Equation 2] decrease: seeking by _n ^ disinfected before the number of bacteria vanishing '¾ ^ Xiao of bactericidal effect is admitted when reduction ratio is 80% or more.

[0039] Ku-finger-streak method>

In the finger streak method, instead of sampling in the above-mentioned glove juice method, the thumb and pinky fingers of one hand are placed on an agar medium for viable count (for example, SCDLP medium) immediately after disinfection with both hands using a disinfectant. Place the three removed fingertips, move them forward, scrape the surface of the medium, attach three parallel streaks to collect the bacteria, and disinfect the other finger's thumb and little fingers after 6 hours Place three fingertips excluding, move to the front and rub the surface of the culture medium. Add three parallel streaks to collect the bacteria, and collect the bacteria from the culture medium at about 35 ° C for about 18 hours. This is a method for evaluating disinfection by culturing for a time and measuring the number of bacteria after the cultivation. The number of bacteria on the three fingertips excluding the thumb and pinky before disinfection is also measured in the same way as described above and set as the baseline.

[0040] In addition to the index reduction rate, the disinfection evaluation is performed by, for example, reducing the number of bacteria after disinfection with respect to the number of bacteria before disinfection. It can also be performed at a small rate. The rate of decrease in the number of bacteria

[0041] [Equation 3] Small Number of bacteria before disinfection-Number of bacteria after disinfection

= ^ Bactericidal effect is approved when the rate of decrease is 80% or more, as determined by the number of bacteria before poisoning ^{X 1 0 0} .

[0042] (ii) Second gel composition for sterilization

The second sterilizing and disinfecting gel composition of the present invention comprises at least one selected from the group consisting of chlorhexidine and its salt strength, 0.2 to 0.55 wZv%, and a hydrocarbon alcohol having 2 to 3 carbon atoms. 50 to 99 vZv%, thickener 0.05 to LOwZv%, and wetting agent 0.15 to LOw Zv%.

[0043] The viscosity of the second composition is more preferably about 20 to 60 mPs, more preferably about 10 to 200 mPs, more preferably about 10 to 1000 mPas. The viscosity is a value measured using a conical plate type rotational viscometer under the conditions of 20 ° C, 100 rpm, and a shear rate of 383 sec- ¹ . If the viscosity is within the above range, the sterilizing and disinfecting effect can be maintained or extended, and dripping during use can be suppressed.

[0044] Types and concentrations of chlorhexidine and its salts, types and concentrations of hydrocarbon alcohols having 2 to 3 carbon atoms, types and preferred concentrations of thickeners, types and preferred concentrations of wetting agents, and thickeners The ratio of the amount used with the wetting agent, other components, the reason for limiting the numerical values, etc. are as described for the first disinfectant composition of the present invention.

[0045] By having the above composition, the second composition of the present invention is excellent in sustainability of the bactericidal effect.

[0046] Preparation of composition

The first and second sterilizing and disinfecting gel compositions of the present invention can be produced by mixing the above-mentioned components to obtain a gel composition. For example, chlorohexidine or / and a salt thereof, a thickener, and a wetting agent are mixed and dissolved in a hydrocarbon alcohol having 2 to 3 carbon atoms by a known means such as stirring, and a humectant is added as necessary. It can be produced from the material by dissolving it by adding other ingredients such as.

0047] (ii) M ^ The disinfection method of the present invention is a method of disinfection by applying the above-described first or second composition of the present invention to human fingers or skin.

[0048] The gel composition for sterilization and disinfection of the present invention can be preferably used as a disinfectant for disinfection of fingers, skin and the like, and can also be used for disinfection of machines, instruments and the environment. For disinfection, either disinfection method can be used. Usually, disinfection can be performed by applying the composition of the present invention to fingers or skin. Examples of the disinfection method by application include a subbing method (wiping method) or a rubbing method (rubbing method). The disinfection by the subbing method can be carried out by including the composition of the present invention in a gauze or a cotton swab and wiping the skin surface with a gauze or a cotton swab soaked with the gel composition. Disinfection by rubbing can be performed by taking the composition of the present invention in the palm and rubbing it into the skin until it is dry. Two or more disinfection methods may be combined.

[0049] An appropriate amount of the gel composition for sterilization and disinfection of the present invention is used. The specific amount varies depending on the disinfection site, disinfection area, etc., and is not particularly limited, but is usually about 3 to: LOmL. When disinfecting fingers, 8 ~: LOmL is preferred. The sterilizing effect of the gel composition for sterilization and disinfection of the present invention can usually be maintained for 6 hours or more. However, if it is desired to maintain the sterilization effect for a long time of 6 hours or more, the sterilization and disinfection of the present invention is performed every 6 hours. Preferably, the gel composition for use is about 3 to: LOmL each.

[0050] (ΠΙ) use

The use of the present invention is the use of the above-described first or second composition of the present invention as a disinfectant.

Example

[0051] Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to these examples.

[0052] “Shelves ί,

After mixing the components shown in Table 1 below in the mixing ratios shown in Table 1, adjusting ρΗ to 6 with a ρΗ adjuster, the total amount is made up to lOOmL with purified water, and 0.5 wZv% chlorhexidine dulconate-containing disinfectant A poison gel composition (hereinafter abbreviated as Formulation Example 1) was produced. The viscosity of Formulation Example 1 obtained was 30 mPs (conical plate type rotational viscometer (Tokimek, TVE-20H) at 20 ° C, 100 rpm, The average value measured three times at a shear rate of 383 sec- ¹ .

[0053] [Table 1]

[0054] "Test, Test Example 1" Evaluation of fungal efficacy by glove juice method

The test preparation is as follows.

Formulation Example 1: Listed in Table 1 above

Comparative Example 1: 0.2 wZv% Chlorhexidine Alcohol Lotion [Well-up (manufactured by Maruishi Pharmaceutical Co., Ltd.); In lOOmL, 0.2 g (0.2 w / v%) of chlorhexidine darconate was contained. ]

Comparative Example 2: 0.5 wZv% Chlorhexidine Alcohol Lotion [Muskin 'ethanol (manufactured by Maruishi Pharmaceutical Co., Ltd.); Contains 0.5 g (0.5 w / v%) chlorhexidine darconate in lOOmL]

Comparative Example 3: 1. Ow / v% chlorhexidine alcoholic emulsion [Avagard (manufactured by 3M); contains 10 g of chlorhexidine dalhexate lg (lwZw%)]

[0055] The test was carried out according to the following procedure! By measuring the number of bacteria before disinfection (baseline value), the number of bacteria immediately after disinfection, and the number of bacteria after 6 hours of disinfection.

[0056] (1) Measurement of hand bacteria before disinfection (baseline measurement)

After washing both hands of the subject with sarcophagus, the moisture was wiped off with a sterilized towel and sterilized rubber gloves (powder-free) were worn on both hands. Next, inject the sample solution 50mL (disodium hydrogen phosphate 10.lg, potassium hydrogen phosphate 0.4g and TritonX-lOO lg dissolved in distilled water lOOOmL) into the right glove. After allowing the liquid to blend in over the entire surface, the left hand held the upper part of the glove with the left hand to prevent the liquid from flowing out, and the helper was massaged for 1 minute. Next, remove the rubber bag so that the sampling solution is collected on the fingertips, mix well, and then collect lmL of the sample solution in the gloves in a sterile spitz. It was. The same operation was performed on the left hand. Sampling solution collected in sterile Spitz is diluted 10-fold and 100-fold with diluent (solution prepared by dissolving 26.22 g of potassium hydrogen phosphate and 7.78 g of sodium carbonate in lOOOmL of distilled water) 0.1 mL each of the stock solution, 10-fold diluted solution and 100-fold diluted solution was applied to two Trypticase soy agar (TSA) plates with a congeal rod. Each plate was cultured at 30 ° C for 24 hours, the number of colonies was calculated, and converted to the number of bacteria per 50 mL of the sampling solution. The number of bacteria before disinfection of the left and right fingers in each subject was the average of the number of bacteria in two baseline measurements.

[0057] (2) Measurement of hand bacteria count after disinfection

Formulation Example 1, 3 mL of 0.2 wZv% chlorhexidine alcohol lotion, 0.5 WZV% chlorhexidine alcohol lotion, or 1.0 w / v% chlorhexidine alcoholic emulsion in each subject's hands 3 After rubbing the hands and disinfecting the fingers, the subject's hands were put on sterile rubber gloves (powder-free). Next, 50 mL of the sampling solution used in (1) above was injected into the right glove, and the same operation as the baseline measurement was performed. Thereafter, ImL of the sampling solution in the gloves was collected in a sterilized spitz containing an equal amount of neutralizing agent (a solution of 10g of Tween80 and 3g of lecithin in lOOmL of distilled water) and mixed well. The left hand was left for 6 hours with gloves on and the same operation as the right hand was performed. Sampling solution collected in sterile Spitz is diluted 10-fold and 100-fold with diluent, and 0.1 mL each of stock solution, 10-fold dilution, and 100-fold dilution is mixed onto two TSA plates. It was applied with a stick. Each plate was cultured at 30 ° C for 24 hours, the number of colonies was calculated, and converted to the number of bacteria per 50 mL of the sampling solution.

[0058] Formulation Example 1, 0.2 wZv% Chlorhexidine Alcohol Lotion, 0.5 wZv% Chlorhexidine Alcohol Lotion and 1. OwZv% Chlorhexidine Alcohol Emulsion is evaluated for bactericidal effect Based on the results, the index decrease value (RF value) was calculated from the number of bacteria immediately after disinfection relative to the number of bacteria before disinfection or the number of bacteria after 6 hours of disinfection (the following formula).

[0059] [Equation 4] R "Value = I og (Bacteria count before disinfection) — log (Bacteria count after disinfection)-log (Bacteria count before disinfection)

[0060] Also, using the RF value after 6 hours of hand disinfection, t-tests for Formulation Example 1 and other test formulations

The difference between disinfectants was tested by (Student's t test). The bactericidal effect immediately after disinfection with each disinfectant (RF value; Table 2) and the bactericidal effect after 6 hours of disinfection (RF value; Table 3) are shown. Figure 1 shows the time course of RF values when using each disinfectant.

[0061] RF value immediately after disinfection

[¾2]

(In the table, N.S. indicates no significant difference.)

[0062] There was no significant difference in the RF value immediately after disinfection between Formulation Example 1 and 0.5 wZv% chlorhexidine alcohol lotion.

[0063] Disappearance RF 6 hours later

3]

[0064] The RF value of Formulation Example 1 was about 1.6 even after 6 hours from disinfection, and it was confirmed that a sufficient bactericidal effect was maintained. On the other hand, it does not contain thickeners and wetting agents. 0.2 w / vo / ₀ chronolehexidine phenolic lotion, 0.5 wZv% chronolehexidine alcoholic lotion and 1. Ow / v% chlorhexidine alcohol In the case of allergic emulsions, the RF value decreased to 1.2 or less, and the bactericidal efficacy was greatly reduced from immediately after disinfection.

[0065] "Test Example 2" Evaluation of bactericidal confectionery by palm 'stamp method Based on the palm stamp method, the bactericidal effect of Formulation Example 1 was evaluated by comparing it with the bactericidal effect of 0.2 wZv% chlorhexidine alcohol lotion (Comparative Example 2). The preparatory operations and various conditions for evaluating the bactericidal effect were the same as those performed by the glove juice method. The bacteria were collected by pressing the entire palm against a hand-printed medium (Hand Petan Check (registered trademark) by Eiken Kikai Co., Ltd.). The hand culture medium after pressing the palm was cultured at 35 ° C for 18 hours. Colonies were counted after incubation. The number of bacteria before disinfection was counted and the average value was used as the baseline. Evaluation was made by measuring the number of bacteria in the palm before disinfection (baseline), the number of bacteria in the palm immediately after disinfection, 3 hours after disinfection, and 6 hours after disinfection, and calculating the rate of decrease in the number of bacteria after disinfection relative to the baseline. . The result is shown in Fig.2.

[0066] As shown in Fig. 2, 0.2 wZv% chlorhexidine alcohol lotion maintained the bactericidal effect up to 3 hours after disinfection, but the rate of bacteria reduction decreased 6 hours after disinfection, Bacterial growth was observed in the palm. On the other hand, in Formulation Example 1, no fungal growth was observed even after 6 hours of disinfection, and a sustained bactericidal effect was observed.

[0067] “Trial, Test 3” Evaluation of fungal efficacy by finger streak method

Based on the finger 'streak method, the bactericidal effect of Formulation Example 1 was obtained by combining Avagard (manufactured by 3M; 1. OwZv% chlorhexidine dalconate) and Hexac Handgel (manufactured by Yoshida Pharmaceutical Co., Ltd .; 0.2 wZv% Evaluation was made by comparing with the bactericidal effect of chlorhexidine dalconate). The preparatory operations and various conditions for measuring the bactericidal effect were the same as those performed by the above-mentioned globe juice method. To collect bacteria, remove the thumb and little finger, place 3 fingers on the SCDLP medium (Nippon Pharmaceutical Co., Ltd.), move it forward, and scrape the surface of the medium to make 3 parallel streaks. It was. In the evaluation, the number of bacteria before disinfection (baseline) and the number of bacteria after 6 hours of disinfection were measured, and the rate of decrease in the number of bacteria after disinfection relative to the baseline was calculated. The results are shown in Figure 3.

[0068] As shown in Fig. 3, formulation example 1 has the sterilizing effect of formulation example 1 even after 6 hours of disinfection, even though the content of chlorhexidine dalconate is 1V2 of Avagar d. It was equivalent to Avagard. In addition, it was confirmed that the bactericidal effect of Formulation Example 1 was superior to Hexac Hand Gel.

Industrial applicability Since the gel composition for sterilization and disinfection of the present invention has a broad antimicrobial spectrum, it is useful as a disinfectant for fingers, skin, instruments or machines. In particular, the gel composition for sterilization and disinfection of the present invention maintains a sterilization effect for at least 6 hours in the sterilization determination by the hand disinfection evaluation method, and thus is particularly suitable as a disinfectant for hand disinfection of an operator in a long-time operation. Can be used.

Claims

The scope of the claims

[I] At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 w Zv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, a thickener, and a wetting agent A gel composition for sterilization and disinfection, characterized in that it contains an agent, has a viscosity of 10 to: LOOOmPs, and has a sterilization effect that is approved by the inspection method by the hand sanitization evaluation method for at least 6 hours.

[2] The composition according to claim 1, wherein the hand disinfection evaluation method is a glove juice method, a palm stamp method, or a finger 'strike method.

[3] The composition according to claim 1, wherein the thickener is at least one selected from the group consisting of a cellulose derivative and a salt strength of the cellulose derivative.

[4] The composition according to claim 1, wherein the content of the thickener is 0.05 to L0wZv%.

5. The composition according to claim 1, wherein the wetting agent is at least one polyhydric alcohol.

6. The composition according to claim 1, wherein the content of the wetting agent is 0.15 to 50 wZv%.

[7] The composition according to claim 1, wherein the content ratio of the thickener to the wetting agent is from 3 parts by weight of the wetting agent to 1 part by weight of the thickener.

8. The composition according to claim 1, further comprising a humectant.

9. The composition according to claim 8, wherein the humectant is at least one selected from the group consisting of silicone oil and fatty acid ester power.

[10] At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 w Zv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, a thickener, and a wet agent. Disinfectant that disinfects human hands or skin by applying a composition that contains an agent, has a viscosity of 10 to: LOOOmPs, and has a sterilizing effect that is approved by the inspection method by the hand sanitization evaluation method for at least 6 hours Method.

[II] At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 w Zv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, a thickener, and a wetting agent Use as a disinfectant of a composition containing an agent and having a viscosity of 10 to: LOOOmPs and having a bactericidal effect that is approved by the inspection method by hand disinfection evaluation method for at least 6 hours

[12] At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 w Zv%, a hydrocarbon alcohol having 2 to 3 carbon atoms is 50 to 99 vZv%, and a thickener is 0. 05-: Gel composition for sterilization and disinfection containing L0 wZv% and wetting agent 0.15-: L0wZv%.

13. The composition according to claim 12, wherein the viscosity is 10 to: LOOOmPs.

14. The composition according to claim 12, wherein the thickener is at least one selected from the group consisting of cellulose derivatives and the salt strength of cellulose derivatives.

15. The composition according to claim 12, wherein the wetting agent is at least one polyhydric alcohol.

[16] The composition according to claim 12, wherein the content ratio of the thickener to the wetting agent is from 3 parts by weight of the wetting agent to 1 part by weight of the thickener.

17. The composition according to claim 12, further comprising a humectant.

18. The composition according to claim 17, wherein the humectant is at least one selected from the group consisting of silicone oil and fatty acid ester power.

[19] At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 w.

Applying a composition containing Zv%, C2-C3 hydrocarbon alcohol 50-99vZv%, thickener 0.05-L0 wZv%, and wetting agent 0.15-L0wZv% A disinfectant method that disinfects the fingers or skin.

[20] At least one selected from the group consisting of chlorhexidine and a salt thereof is 0.2 to 0.55 w.

Sterilization and disinfection of a composition containing Zv%, 50 to 99 vZv% of a hydrocarbon alcohol having 2 to 3 carbon atoms, a thickener of 0.05 to L0 wZv%, and a wetting agent of 0.15 to L0wZv% Use as an agent.