EP2952213A1 - Kit zum färben desinfizierter regionen einer oberfläche - Google Patents

Kit zum färben desinfizierter regionen einer oberfläche Download PDF

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Publication number
EP2952213A1
EP2952213A1 EP15164321.0A EP15164321A EP2952213A1 EP 2952213 A1 EP2952213 A1 EP 2952213A1 EP 15164321 A EP15164321 A EP 15164321A EP 2952213 A1 EP2952213 A1 EP 2952213A1
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EP
European Patent Office
Prior art keywords
swab
disinfectant
dye
dyes
kit according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP15164321.0A
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English (en)
French (fr)
Inventor
Sabine Behrends
Mona Hahn
Nicole Steinhorst
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Schuelke and Mayr GmbH
Original Assignee
Schuelke and Mayr GmbH
Air Liquide SA
LAir Liquide SA pour lEtude et lExploitation des Procedes Georges Claude
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schuelke and Mayr GmbH, Air Liquide SA, LAir Liquide SA pour lEtude et lExploitation des Procedes Georges Claude filed Critical Schuelke and Mayr GmbH
Publication of EP2952213A1 publication Critical patent/EP2952213A1/de
Withdrawn legal-status Critical Current

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Classifications

    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/40Dyes ; Pigments
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D17/00Detergent materials or soaps characterised by their shape or physical properties
    • C11D17/04Detergent materials or soaps characterised by their shape or physical properties combined with or containing other objects
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/48Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions

Definitions

  • the invention relates to a kit for colouring disinfected regions of a surface, comprising a) at least one dry and coloured swab made of absorbent gauze, and b) liquid disinfectant.
  • the invention further relates to the kit for use in a method for disinfecting skin or mucous membrane.
  • the invention relates, moreover, to a dry and coloured swab made of absorbent gauze and to the corresponding use of a liquid disinfectant.
  • a coloured identification of the treated surface is desirable, as for example prior to a surgical intervention, such as an operation for example.
  • DE 199 01 526 A1 discloses an antiseptic particularly for the control of HIV and HBV, this antiseptic comprising defined amounts of 1-propanol, 2-propanol and ethanol. The optional presence of dyes is additionally envisaged.
  • alcoholic antiseptics which contain 50 or more wt% of alcohol having 1 to 3 carbon atoms, dye and optionally further active antimicrobial ingredients. Alongside a broad multiplicity of dyes, a broad multiplicity of the optional antimicrobial additives is disclosed.
  • WO 2007/062306 A2 describes methods for coating surfaces.
  • a composition which comprises antimicrobial agent is cured on the surface by means of heat, and the composition may include a dye.
  • the surface is typically an inanimate surface (the surface of a medical device, for example).
  • WO2009/058144 A1 discloses an antiseptic solution which comprises a micellar complex and an active cationic antiseptic ingredient, the complex being composed of cationic auxiliary and anionic dye.
  • cationic auxiliaries are quaternary ammonium compounds.
  • the solution is applied using an applicator.
  • WO02/082907 A1 as well describes complexes of antiseptics with dyes: described by way of example therein are compositions with chlorhexidine, which to be effective must be employed at a comparatively high concentration.
  • WO97/46622 A2 describes the use of natural or nature-identical synthetic dyes for the marking or colouring of materials, and mentions the marking of operation sites by means of dye-containing disinfecting solution or using marker pens.
  • WO02/091832 A1 describes two-component disinfecting systems where the first component comprises chlorite and the second component comprises acid and optionally oxidizable dye.
  • the use of two-component disinfectants is costly and inconvenient, and in the hospital sector the use of agents which release chlorine is also fundamentally inappropriate.
  • WO2006/077616 A1 addresses a system for visualizing contaminated regions, using a film with controlled release of coloured substances.
  • WO2007/100654 A2 discloses a method for monitoring microorganisms, in which a surface is coated with a removable composition that forms an antimicrobial film.
  • WO2008/032212 A2 is concerned with coloured or colourable, foamable liquid compositions for topical application, where the colouring of the composition differs from that of the foam produced from it.
  • WO2009/138890 A2 describes a wipe made of fibrous material, with beads being included in the fibrous material, the beads enclosing an active ingredient. When the beads are moistened, they rupture and release the active ingredient.
  • chlorhexidine digluconate (hereinafter “chlorhexidine") in combination with 70% 2-propanol (e.g. the product ChloraPrep ® ).
  • concentration of the cationic active ingredient chlorhexidine in ChloraPrep ® is 2 wt%.
  • the ChloraPrep ® product is applied by means of an applicator. There is an uncoloured version and a coloured version.
  • a glass ampoule with the chlorhexidine-containing disinfectant is located in a plastic tube.
  • a felt which is coloured with the dye Yellow Orange S (E 110).
  • E 110 Yellow Orange S
  • the glass ampoule is destroyed by exertion of pressure on the plastic tube laterally.
  • the disinfectant then flows through the coloured felt, which delivers the dye to the disinfectant and also retains glass fragments.
  • the coloured disinfectant then impregnates the foam material and is delivered from it again in order to disinfect skin or mucous membrane, and to provide disinfected regions with coloured identification, before and during an operation.
  • applicators of this kind have to be disposed of after use, they are disadvantageous to use on environmental grounds. Furthermore, a comparatively large amount of disinfectant remains in the plastic tube and in the foam material and is therefore not used. Accordingly, an applicator of this kind is unsuitable for those disinfectants which include a lower concentration of active antiseptic ingredient than ChloraPrep ® . With the applicator described, moreover, it is not possible to influence the concentration of the dye and hence the intensity of the colouring of the disinfectant emerging from the applicator, depending on the natural colour of the patient's skin and on the lighting within the operating theatre. Lastly, for measures to be implemented aseptically, the applicators, which are comparatively large, must be sterile and hence packaged in a fully sterile manner prior to application, and consequently there is also a lot of packaging waste.
  • WO2014/043354 A1 US2014/0081222 A1
  • an antiseptic based on chlorhexidine or octenidine is applied with the aid of a hydrophilic, solid (polyurethane) foam.
  • the solid (polyurethane) foam is hydrophobic.
  • the antiseptic may be coloured, or may become coloured by dye included within the foam.
  • the use of polyurethane foams, however, is not in line with the routine procedure for skin disinfection.
  • the problem addressed by the present invention was therefore that of providing a system with which disinfected regions can be colouringly identified in a simple way.
  • the system ought to be applicable to a large number of different active ingredients, and active ingredients used in different concentrations, in disinfectants, and for a multiplicity of different dyes.
  • the system moreover, ought not automatically to lead to excessive waste (including packaging waste).
  • kit for colouring disinfected regions of a surface that comprises:
  • kits can be compiled in such a way that commercial swabs made of absorbent gauze can be coloured and that the dye then leaches when the disinfectant is used, to give a coloured disinfectant.
  • the coloured disinfectant is then applied in a usual way, with the impregnated swab, to the area that is to be disinfected.
  • the swab hence serves both as a carrier for the dye and as a carrier for the subsequent application of the (coloured) disinfectant for disinfecting.
  • the kit comprises a) at least one swab made of absorbent gauze.
  • the absorbent gauze is preferably in accordance with EN 14079:2003, i.e. the absorbent gauze is designed in a manner defined in EN 14079:2003.
  • the absorbent gauze is therefore preferably made from woven fabric, in contrast to the coloured material of the Chlora-Prep ® applicators (which is made from felt: an unordered fibre material which is difficult to separate, i.e. a nonwoven textile).
  • the woven fabric of the absorbent gauze comprises cotton, and hence for the absorbent gauze to be designed in the manner defined specifically in EN 14079:2003 as per 3.1.
  • the woven fabric consists essentially of cotton, and preferably consists of cotton.
  • the dye is further preferred for the dye to be adsorbed on the fibres of the swab.
  • the dye is therefore in particular not contained in beads (cf. WO2009/138890 A2 ).
  • Typical swab sizes are pea-sized, hazelnut-sized, walnut-sized, plum-sized, egg-sized, extra-sized or fist-sized.
  • Typical packaging units vary in size and contain 4, 5, 10, 20, 100, 250, 500 or even 1000 swabs per packaging unit.
  • the skilled person should ensure by appropriate selection that the dyes employed permit sterilization. This means that the nature of the coloured swabs (i.e. the swab material and the dye) must be such that they are not altered or destroyed by typical sterilizing techniques. Examples of sterilizing techniques are sterilization with gamma radiation, electron beams or ethylene oxide.
  • the at least one swab a) is packaged separated, with the swab preferably having been sterilized with the packaging, and the packaging also ensuring the sterility.
  • the dry swab contains no active antimicrobial ingredient.
  • the dye of the swab is preferably selected from a1) xanthene dyes, a2) azo dyes, a3) polyterpene compounds, a4) triarylmethane dyes, a5) quinophthalone dyes and mixtures thereof, where the dye is preferably selected from a1) xanthene dyes, a2) azo dyes, a3) polyterpene compounds and mixtures thereof.
  • Xanthene is a tricyclic ether.
  • the xanthene dyes for example the rhodamines, fluorescein and also eosin B and eosin Y, have the xanthene parent structure:
  • Uranine is the sodium salt of fluorescein.
  • D&C RED 27 is 2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein (2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-spiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one).
  • D&C Orange 5 is 4',5'-dibromofluorescein (4,5-dibromo-3,6-dihydroxy-spiro[isobenzofuran-1(3H),9-[9H]xanthen]-3-one).
  • the xanthene dye is preferably selected from erythrosine, eosin, uranine, D&C Orange 5, D&C Red 27 and phloxine B; very preferably, component b) is erythrosine.
  • the azo dye is preferably a monoazo dye, and the monoazo dye is preferably selected from D&C Orange 4, Fastyellow and D&C Red 33; more particularly component b) is D&C Orange 4.
  • the polyterpene compound is preferably an isoprenoid, more particularly a carotenoid, and the carotenoid in turn is preferably selected from carotene dyes and xanthophyll dyes.
  • Carotenes are pure hydrocarbons; xanthophylls are hydrocarbons oxidized with oxygen. Frequently occurring primary carotenoids are ⁇ -carotene, a representative of the carotenes, and also lutein, violaxanthin and neoxanthin as representatives of the xanthophylls.
  • the xanthophyll dye is selected for example from lutein and the annatto dyes cis- or trans-bixin and cis- or transnorbixin, with component b) being more particularly lutein (4-[18-(4-hydroxy-2,6,6-trimethylcyclohex-2-enyl)-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaenyl]3,5,5-trimethyl-cyclohex-3-enol, E161b).
  • Norbixin (a xanthophyll) is a natural dye which is obtained by extraction from the seeds of the roucou or achiote plant annatto (Bixa orellana).
  • Norbixin can be obtained by removing the outer layer of the prepared seeds of the annatto tree (Bixa orellana) by grinding down of the seeds in cold water and subsequent extraction through solvents such as acetone, methanol or hexane, for example.
  • the solution resulting from this process is acidified bixin (this being the methyl ester of the acid norbixin), which is then filtered and dried, with the precipitate being ground.
  • the precipitate contains primarily cis- and trans-bixin, with the principal dye being cis-bixin.
  • norbixin can be obtained as the corresponding salt, where again it is cis-norbixin which is the principal dye.
  • the dye is E160b (annatto, bixin, norbixin), it is preferably stabilized (for example with propylene glycol and Polysorbat 80, Annatto ® AS).
  • the carotene dye is selected for example from beta-carotene and 8'-apo-beta-caroten-8'-al.
  • 8'-Apo- ⁇ -caroten-8'-al is a carotenoid. It occurs naturally, for example, in oranges, vegetables and liver, but is nowadays principally synthesized. In the EU it is approved as a food additive, with the number E 160e.
  • the carotene dye is an annatto dye.
  • the dye is a triarylmethane dye, it is preferably selected from Patent Blue V, Fast Green FCF, Bromocresol Green, Brillant Blue G and Bromothymol Blue.
  • a preferred quinophthalone dye is Quinoline Yellow.
  • the dye is selected from i) annatto dyes, ii) a mixture of D&C Orange 4 with erythrosin and iii) a mixture of annatto dyes with D&C Orange 4 and erythrosin.
  • the dye is applied to the absorbent gauze swab in a conventional way, as for example from an aqueous solution.
  • the swab is impregnated with the aqueous dye solution and dried, and then is optionally treated with the selected sterilization method.
  • the skilled person is aware of a multiplicity of dyes which are compatible with absorbent gauze made from cotton, for example.
  • the skilled person is also able without problems, and where appropriate with minimal experimental effort, to identify those dyes which are compatible with a particular sterilization method.
  • the at least one swab prefferably has an X-ray contrast thread.
  • X-ray contrast threads of this kind are known and serve for subsequent identification of swabs which have mistakenly remained inside a closed operation wound, and which can then be removed.
  • the at least one X-ray contrast thread prefferably be coloured and for the colour of the X-ray contrast thread to differ from the colour of the swab, thereby facilitating the identification of the swab during the operation as well.
  • One exemplary X-ray contrast agent which is preferred and is present in the X-ray contrast thread is barium sulphate.
  • the carrier material of the X-ray contrast thread may differ from the material of the absorbent gauze (preferably cotton), and a typical material for the X-ray contrast thread is a synthetic polymer such as polypropylene or polyester.
  • the dry swab preferably contains no active antimicrobial ingredient; in other words, the swab consists wholly of cotton, optionally with the added X-ray contrast thread.
  • the kit further and necessarily comprises b) liquid disinfectant.
  • suitable disinfectants The skilled person is aware of suitable disinfectants.
  • the disinfectant comprises preferably b1) one or more alcohols selected from aliphatic and aromatic alcohols and mixtures thereof.
  • Typical and preferred as component b1) are one or more aliphatic alcohols.
  • the aliphatic alcohol is preferably a C 2 to C 6 alkyl alcohol, such as, for example, ethanol, propanol, butanol and mixtures thereof, more particularly ethanol and propanol and mixtures thereof.
  • the concentration of the aliphatic alcohol in the disinfectant is typically at least 5 wt%, preferably at least 30 wt%, more preferably at least 40 wt%, more particularly 50 to 90 wt%. In the case of n-propanol, even the low concentrations from 10 wt% up are very effective (more particularly between 30 and 50 wt%).
  • the disinfectant frequently comprises mixtures of aliphatic alcohols as b1).
  • a preferred amount in the disinfectant of the invention is at least 30 wt%, preferably at least 40 wt%, more particularly at least 60 wt%, as for example at least 80 wt%.
  • the amount of ethanol in the disinfectant is preferably not more than 90 wt%, more preferably not more than 80 wt%, with an amount of ethanol of 60 wt% being the most preferred.
  • the preferred amount in the disinfectant is at least 10 wt%, more preferably at least 30 wt%.
  • the concentration is preferably at least 4 wt%, more preferably at least 10 wt%, more particularly at least 20 wt%.
  • the disinfectant comprises a mixture of ethanol and isopropanol as aliphatic alcohol.
  • Preferred concentrations of ethanol are 60 to 85 wt%, more preferably 65 to 80 wt%, more particularly 70 to 80 wt%.
  • Preferred concentrations of isopropanol are 1 to 15 wt%, such as 2 to 12 wt%.
  • the disinfectant comprises a mixture of isopropanol and n-propanol as aliphatic alcohol.
  • concentration of isopropanol is preferably 5 to 55 wt%, more preferably 15 to 50 wt%, more particularly 25 to 50 wt%, such as 28 to 48 wt%.
  • amount of n-propanol is 5 to 50 wt%, preferably 10 to 45 wt%, more particularly 20 to 35 wt%.
  • mixtures of ethanol and n-propanol are used as component b1) in the disinfectant.
  • a preferred concentration of ethanol in the disinfectant is 10 to 50 wt%, more preferably 20 to 30 wt%, such as, for example, about 25 wt%.
  • a preferred concentration of n-propanol is 30 to 50 wt%, preferably 35 to 45 wt%.
  • Mixtures of ethanol with isopropanol and n-propanol as component b1) are especially preferred.
  • a preferred concentration of ethanol is 10 to 30 wt%, such as about 20 wt%.
  • a preferred amount of isopropanol is 20 to 40 wt%, such as about 30 wt%.
  • Preferably the amount of n-propanol is 15 to 35 wt%, such as about 25 wt%.
  • a preferred aliphatic alcohol is propanol, i.e. n-propanol, isopropanol and mixtures thereof.
  • one or more aromatic alcohols it is possible for one or more aromatic alcohols to be present as component b1) in the disinfectant of the invention.
  • Aromatic alcohol Aromatic alcohol
  • the aromatic alcohol (or the optionally two or more aromatic alcohols) preferably comprises (i) aryloxyalkanol (i.e. glycol monoaryl ether) or (ii) arylalkanol.
  • Preferred aryloxyalkanols (i) are selected from phenoxyethanol and phenoxypropanol, preferably phenoxyethanol.
  • Preferred arylalkanols (ii) are selected from 3-phenylpropan-1-ol, phenethyl alcohol, veratryl alcohol, benzyl alcohol or 2-methyl-1-phenyl-2-propanol, preferably 3-phenylpropan-1-ol, phenethyl alcohol, veratryl alcohol or 2-methyl-1-phenyl-2-propanol, more particularly phenethyl alcohol.
  • aromatic alcohol in all embodiments of the invention it is preferred for the aromatic alcohol to be selected from benzyl alcohol, phenoxyethanol and phenethyl alcohol; more particularly preferred as component b) are phenethyl alcohol or phenoxyethanol.
  • the aromatic alcohol is not benzyl alcohol, since in certain circumstances an odour may develop over time as a result of formation of benzaldehyde (since benzyl alcohol is sensitive to oxidation).
  • the composition of the invention is free from benzyl alcohol.
  • benzyl alcohol if benzyl alcohol is present, there is (are) additionally one (or more) different aromatic alcohol(s), i.e. aromatic alcohol(s) different from benzyl alcohol.
  • the disinfectant comprises b2) at least one active antiseptic ingredient selected from peroxide compounds, quaternary ammonium salts, phenolic compounds, hexetidine and mixtures thereof.
  • the peroxide compound is preferably hydrogen peroxide.
  • the quaternary ammonium salt is preferably selected from benzalkonium chloride, bispyridiniumalkanes (preferably octenidine dihydrochloride, hereinafter “octenidine”), chlorhexidine and polyhexamethylenebiguanide (hereinafter “polyhexanide”).
  • bispyridiniumalkane here encompasses the bis [4-(substituted amino)-1-pyridinium]alkanes that are disclosed in DE 27 08 331 C2 , of the general formulae (I) or (II) in which Y is an alkylene group having 4 to 18 carbon atoms, R is an alkyl group having 6 to 18 carbon atoms or a cycloalkyl group having 5 to 7 carbon atoms or the phenyl radical, which is substituted by a halogen atom, and A is an anion or a plurality of anions.
  • A can of course also be a multivalent anion, e.g. phosphate or orthosilicate.
  • bispyridiniumalkane further encompasses the various prototropes of the compounds of the formula (I), as is disclosed in DE 196 47 692 A1 , for example.
  • the active ingredient b1) is octenidine.
  • quaternary ammonium salts are a suitable active antiseptic ingredient.
  • quaternary ammonium compound is preferably a dialkyldimethylammonium salt.
  • Quaternary ammonium salts used in accordance with the invention are represented for example by the formula [R 1 R 2 R 3 (CH 3 ) N] + [X] - , where R 1 to R 3 may be identical or different and are selected from C 1 to C 30 alkyl, aralkyl, alkenyl and mixed groups, which may have one or more atoms selected from 0, S, N and P, where R 1 to R 3 for example are C 8 to C 18 alkyl, benzyl or methyl, preferably C 9 to C 18 alkyl, benzyl or methyl, such as C 16 alkyl, benzyl or methyl.
  • X is an anion (of an organic or inorganic acid). Both anion and cation of the quaternary ammonium salt here may be multivalent ions, resulting in a stoichiometry [A (n+) ] m [K (m+) ] n .
  • Suitable quaternary ammonium salts in accordance with the invention are all quaternary ammonium salts known in the prior art and of the formula above, of the kind that are disclosed, for example, in WO 00/63337 A , hereby referenced. Preference, however, is given to using dialkyldimethylammonium salts, as for example dialkyldimethylammonium chlorides, whose alkyl chains are selected independently of one another from C 8 to C 18 alkyl, preferably C 9 to C 18 alkyl, such as C 16 alkyl.
  • dialkyldimethylammonium salts one of the methyl groups may be an alkoxylated, for example ethoxylated, hydromethyl group.
  • Quaternary ammonium salts used preferably in accordance with the invention are compounds of the formulae [R 1 N(CH 3 )3] + [X] - , [R 1 R 2 N(CH 3 ) 2 ] + [X] - and [R 1 R 2 R 3 (CH 3 )N] + [X] - , where R 1 to R 3 are selected independently of one another from C 8 to C 18 alkyl and -(CH 2 -CHR 4 O) n -R 5 , where n is a number from 1 to 20, preferably 1 to 5, and R 4 and R 5 , which may be identical or different, are H and/or C 1 to C 4 alkyl, preferably H.
  • Exemplary anions and classes of anions of the stated quaternary ammonium salts are hydroxide, sulphate, hydrogen sulphate, methosulphate, ethosulphate, lauryl sulphate, lauryl ether sulphate, cellulose sulphate, sulfamate, halide (fluoride, chloride, bromide, iodide), nitrite, nitrate, carbonate, hydrogencarbonate, phosphate, alkyl phosphate, metaphosphate, polyphosphate, thiocyanate (rhodanide), carboxylic salt such as benzoate, lactate, acetate, propionate, citrate, succinate, glutarate, adipate, toluenesulfonate (tosylate) and salicylate. Particularly preferred anions are chloride and propionate.
  • surfactants are the quaternary ammonium salts mecetroniumetilsulfat (hexadecyl(ethyl)dimethylammonium ethylsulphate) and benzalkonium chloride.
  • Preferred amounts of component b2) in the disinfectant are 0.005 to 1.0 wt%, preferably 0.01 to 0.5 wt%, more preferably 0.03 to 0.3 wt%, even more preferably 0.04 to 0.2 wt%, such as 0.05 to 0.15 wt%, for example about 0.1 wt%, based in each case on the total weight of the disinfectant, especially so when component b2) comprises one or more quaternary ammonium salts; especially preferred as active antiseptic ingredient b2) is octenidine.
  • the phenolic compound is preferably o-phenylphenol.
  • the disinfectant b) preferably contains no added dye, and more preferably the disinfectant has no inherent colour.
  • the disinfectant of the invention in one preferred embodiment, comprises one or more of the following optional components b3):
  • anionic, amphoteric and/or nonionic surfactants preferably amphoteric or nonionic surfactants. Particularly if they are present in a comparatively small amount, these surfactants may have a supporting effect for the activity of the active antiseptic ingredient. If they are present at higher use concentrations in the disinfectant, then these surfactants may have an antimicrobial activity or may contribute substantially to such activity.
  • Nonionic surfactant used may comprise all suitable nonionic surfactants, with (i) (fatty) alcohol ethoxylates, (ii) sorbitan esters, (iii) alkylglycosides (more particularly alkylpolyglucosides), (iv) amine oxides and (v) ethylene oxide/propylene oxide block copolymers being preferred.
  • the (i) alcohol polyalkoxylates include fatty alcohol alkoxylates, e.g. isodecyl ethoxylates with different fractions of ethylene oxide, isotridecyl ethoxylates, polyethylene glycol ethers of stearyl alcohol, of lauryl alcohol and of cetyl alcohol and of oleyl alcohol.
  • the alcohols here may have been alkoxylated with ethylene oxide, propylene oxide or any desired mixtures of ethylene oxide and propylene oxide.
  • Alcohol polyalkoxylates are known by names including the designations Lutensol ® , Marlipal ® , Marlox ® , Brij ® and Plurafac ® . Particularly preferred as nonionic surfactant are lauryl alcohol ethoxylates.
  • nonionic surfactants are sorbitan esters, which are mostly present as oleates, stearates, laurates and palmitates and which are referred to as polysorbates (e.g. Tween ® ).
  • the nonionic surfactant may be an (iii) alkylglycoside, such as an alkylglucoside (i.e. an alkylglycoside of glucose), more preferably a C 8 to C 20 alkylpolyglucose, more particularly a C 8 to C 16 alkylpolyglucose of a fatty alcohol, with preference being given to a laurylpolyglucose, a decylpolyglucose or a mixture thereof.
  • an alkylglucoside i.e. an alkylglycoside of glucose
  • a C 8 to C 20 alkylpolyglucose more particularly a C 8 to C 16 alkylpolyglucose of a fatty alcohol
  • the C chain length is 8 to 16 atoms in the case of the cocoylpolyglucose, 12 to 16 C atoms in the case of the laurylpolyglucose, and likewise 8 to 16 C atoms in the case of the decylpolyglucose.
  • a typical amount of alkylglycoside is 0.03 to 10 wt%, preferably 0.06 to 5 wt%, more particularly 0.1 to 2 wt%.
  • amine oxide As (iv) amine oxide it is possible in accordance with the invention to use in principle all suitable amine oxides.
  • the amine oxides which are N-oxides of tertiary amines, include aliphatic amine oxides, cyclic amine oxides (such as N-alkylmorpholine oxide) and aromatic amine oxides (such as pyridine N-oxides).
  • the amine oxide possesses the general formula R 1 R 2 R 3 N-O, in which R 1 is methyl, ethyl or 2-hydroxyethyl, R 2 is methyl, ethyl or 2-hydroxyethyl, R 1 and R 2 together may be morpholine, R 3 is alkyl having 8 to 18 carbon atoms or R 4 CONH(CH 2 ) n , where R 4 is alkyl having 8 to 18 carbon atoms and n is in the range from 1 to 10, preferably 1 to 5, more preferably 2 to 4, and more particularly 3, and 2-hydroxyethyl may be condensed with 1 to 2000 ethylene oxide, ethylene oxide/propylene oxide or propylene oxide units.
  • Exemplary amine oxides are cocamidopropylamine oxide, N-cocomorpholine oxide, decyldimethylamine oxide, dimethylcetylamine oxide, dimethylcocamine oxide, dimethyl-hydrogenated tallow-amine oxide, dimethyllaurylamine oxide, dimethylmyristylamine oxide, (2-hydroxyethyl)cocamine oxide and oleamine oxide; see also " International Cosmetic Ingredient Dictionary and Handbook", 10th edition 2004, Volume 3, pages 2268-2275 (Surfactants-Cleansing Agents).
  • This product is sold as Rewominox B 204 by Evonik, Federal Republic of Germany.
  • a typical amount of amine oxide is 0.03 to 10 wt%, preferably 0.06 to 5 wt%, more particularly 0.1 to 2 wt%.
  • amphoteric surfactants examples being betaines.
  • Suitable betaines are described in EP 560 114 A2 .
  • Particularly preferred is cocamidopropyl betaine.
  • a typical amount of betaine is 0.03 to 10 wt%, preferably 0.06 to 5 wt%, more particularly 0.1 to 2 wt%.
  • the disinfectant optionally comprises solvents.
  • Preferred solvents are glycols and water and also mixtures thereof.
  • a preferred solvent is water.
  • active ingredients and/or auxiliaries which may optionally be present in disinfectants of the invention are skincare additives, refatting agents, perfumes, fragrances, thickeners, pH regulators and humectants. These include:
  • optional active ingredients and/or auxiliaries are preferably the following constituents:
  • the disinfectant of the invention is liquid. It is preferably an aqueous, an aqueous-alcoholic or an alcoholic solution.
  • the disinfectant wets the swab immediately on contact and dissolves the dye that is present in the swab, this dissolution being at least partial and preferably substantially complete.
  • the disinfectant used in accordance with the invention not to contain any added dye.
  • Exemplary formulations for disinfectants 1 to 4 used in accordance with the invention are listed below (amounts in wt%): Component b1) Component b2) 1 - 10 to 65%, preferably 20 to 55%, such as about 45% of isopropanol, and 0.02 to 0.5%, preferably 0.05 to 0.2%, such as about 0.1% of octenidine - 10 to 50%, preferably 20 to 40%, such as about 30% of n-propanol 2 - 10 to 65%, preferably 20 to 55%, such as about 45% of isopropanol, and 0.05 to 1%, preferably 0.1 to 0.5%, such as about 0.2% of o-phenylphenol, and 0.01 to 1%, preferably 0.05 to 0.25%, such as about 0.10% of hydrogen peroxide - 3 to 20%, preferably 5 to 15%, such as about 10% of n-propanol 3 40 to 85%, preferably 50 to 75%, such as about 63% of isopropanol 0.005
  • the kit of the invention comprises a) swab and b) disinfectant. These constituents a) and b) need not necessarily be present together in packaged form. The disinfectant b) may therefore be present separately from constituent a), i.e. a) and b) may also be present in physically separate form.
  • coloured swabs a) being present in packaged form, preferably at least two coloured swabs, more preferably at least three coloured swabs, more particularly at least five coloured swabs, as for example at least ten coloured swabs, at least 20 coloured swabs or at least 50 coloured swabs, which are packaged jointly (and preferably are sterile-packaged jointly), and additionally the use of the swabs together with a disinfectant is recommended or described in an in-pack leaflet, a usage recommendation or the like, without, therefore, disinfectant being present physically combined with the swab or swabs.
  • the invention further relates to the kit for use in a method for disinfecting skin or mucous membrane, more particularly in humans.
  • the method is preferably a pre-operative measure and/or a measure prior to puncture or injection, with the disinfection preferably being followed by a surgical intervention and/or by puncture or injection.
  • kit of the invention in the case of pre-operative disinfection of skin or mucous membrane in hospitals, or in vessel puncture or injections) is therefore as follows:
  • dye is dissolved from the absorbent gauze, without any need for mechanical extraction of the dye from the absorbent gauze (mechanical action is necessary, for example, for the beads of WO2009/138890 A2 with enclosed active ingredients, since the beads have to be broken open).
  • the dye therefore detaches from the fibres of the absorbent gauze when the swab is immersed (optionally a number of times) into the disinfectant.
  • the impregnated sterile swabs are removed from the solution using dressing forceps, a clamp or another device and placed onto the area of skin/mucous membrane that is to be disinfected; subsequently, disinfection is carried out with the impregnated swabs, with the coloured disinfectant drawn up into the impregnated swab being applied to the skin/mucous membrane regions that are to be disinfected. It may be necessary to repeat the procedure a number of times (each time with a fresh swab). The exposure time is governed by the specification of the disinfectant manufacturer for skin/mucous membrane disinfection. The required number of swabs and quantity of liquid is guided by the size of the area to be disinfected.
  • the skin/mucous membrane area to be disinfected is coloured as a result of the colouring of the swabs and consequently of the skin/mucous membrane disinfectant. After use, the swabs and the excess disinfectant solution are discarded.
  • the invention relates to a dry swab made of absorbent gauze, which is coloured with dye, with the dye, when the swab is contacted with liquid disinfectant, being at least partly leached from the swab.
  • the invention further relates to a liquid disinfectant for use in a method for disinfecting skin or mucous membrane, where the method includes the colouring of disinfected regions of the skin or mucous membrane with a dye and where this dye is at least partly leached from a swab made of absorbent gauze.
  • the intensity of the colouring of the disinfectant can be controlled through the amount of coloured swabs used.
EP15164321.0A 2014-05-26 2015-04-20 Kit zum färben desinfizierter regionen einer oberfläche Withdrawn EP2952213A1 (de)

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WO2017102849A1 (en) * 2015-12-18 2017-06-22 Schülke & Mayr GmbH Alcoholic disinfectant for virus control
WO2017102850A1 (en) * 2015-12-18 2017-06-22 Schülke & Mayr GmbH Alcoholic compositions with a content of octenidine dihydrochloride
JP2018535798A (ja) * 2015-09-21 2018-12-06 ヘルムント、ロベルトHELLMUNDT,Robert 表面および/または皮膚を消毒する薬剤を貯蔵および投与するための消毒剤ディスペンサ、消毒剤、および人の消毒状態を公衆に通知するための方法
JP2019182902A (ja) * 2018-04-02 2019-10-24 ライオン株式会社 液体漂白剤組成物
CN114259004A (zh) * 2021-12-16 2022-04-01 上海交通大学 一种抗菌透明微乳液水剂及其制备与应用

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CN112023088A (zh) * 2020-09-29 2020-12-04 湖北君言医疗科技有限公司 一种医用透明敷料加工用消毒工艺

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Cited By (9)

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Publication number Priority date Publication date Assignee Title
JP2018535798A (ja) * 2015-09-21 2018-12-06 ヘルムント、ロベルトHELLMUNDT,Robert 表面および/または皮膚を消毒する薬剤を貯蔵および投与するための消毒剤ディスペンサ、消毒剤、および人の消毒状態を公衆に通知するための方法
WO2017102849A1 (en) * 2015-12-18 2017-06-22 Schülke & Mayr GmbH Alcoholic disinfectant for virus control
WO2017102850A1 (en) * 2015-12-18 2017-06-22 Schülke & Mayr GmbH Alcoholic compositions with a content of octenidine dihydrochloride
CN108495552A (zh) * 2015-12-18 2018-09-04 奇科迈尔有限公司 具有一定含量的奥替尼啶二盐酸盐的醇组合物
AU2016372336B2 (en) * 2015-12-18 2019-10-31 Schülke & Mayr GmbH Alcoholic compositions with a content of octenidine dihydrochloride
JP2019182902A (ja) * 2018-04-02 2019-10-24 ライオン株式会社 液体漂白剤組成物
JP7063688B2 (ja) 2018-04-02 2022-05-09 ライオン株式会社 液体漂白剤組成物
CN114259004A (zh) * 2021-12-16 2022-04-01 上海交通大学 一种抗菌透明微乳液水剂及其制备与应用
CN114259004B (zh) * 2021-12-16 2023-12-22 上海交通大学 一种抗菌透明微乳液水剂及其制备与应用

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