DE202013003661U1 - disinfectant - Google Patents

Abstract

A disinfectant, characterized in that it contains glycolic acid, at least one C 1 -C 6 alcohol, at least one quaternary ammonium compound from the group comprising C 8 -C 16 -alkylbenzyldimethylammonium chloride, C 8 -C 16 -alkyldimethylammonium chloride and di (C 8 -C 16 -alkyl) dimethylammonium chloride.

Description

Technical area

The technical solution relates to a disinfectant with a broad spectrum of activity against microbes and viruses, suitable in particular for small areas and medical resources.

State of the art

The most commonly used disinfectants in hospitals and healthcare are spray-based alcohol-based products for small areas. These are the disinfection of medical devices, small cars, handlebars, pawls, equipment, etc. At these points, the highest transmission of nosocomial infections occurs and therefore a high microbial efficiency of the disinfectants to be tested under load conditions is emphasized.

Alcohols are the most commonly used disinfectants for several reasons. Compared with the other active ingredients, they are not financially intensive, non-corrosive, leave no residual residue on the disinfected surfaces and have a broad bactericidal spectrum of microbial activity. However, it is known that they are less effective on certain types of mold and enveloped viruses, are ineffective against non-enveloped viruses, and that the mycobacteria multiply in the presence of alcohol. A disadvantage of the alcohols is that they damage polymers and plastics and are easily combustible.

Quaternary ammonium compounds (KAS), such as. As benzalkonium chloride or alkyldimethylammonium chloride, have no significant effect on the inactivation of microorganisms, but in combination with alcohols, they are effective against bacteria, pathogenic molds and enveloped viruses. A less good effect is recorded against mycobacteria. The combination of alcohol and KAS is the most widely used in commercial products, but they are insufficient for use in areas of high risk of infection.

One of the variants to increase the effectiveness of previous intended for spraying alcohol disinfections for small areas, namely by achieving the full virucidal effect, is the addition of aldehydes (today most commonly the combination of glutaraldehyde, glyoxal). Their application will in future only on the glutaraldehyde limited, because the glyoxal from the list of approved biocides according to regulation BPD (Biocidal Product Directive) should be excluded. In general, there is a trend of gradual decline in the use of aldehydes because they may be carcinogenic or potentially carcinogenic, bacterial resistance to glutaraldehyde has been noted, and recent reports indicate that they cause severe asthma and other health conditions.

A scientific one Article from Brazilian Journal of Pharmaceutical Sciences, vol. 45, n. 2, abr./jun., 2009 , cites the maximum inhibitory concentrations (MIC) of disinfecting and / or sterilizing agents, but mentions neither the glycolic acid nor its disinfecting action. US 4,346,043 describes the microbial activity of derivatives (esters, ester amides) of glycolic acid, but does not mention the actual glycolic acid.

US 2010/0151046 and US 7,144,846 describe the glycolic acid as one of the many variants for the pH-treatment of the solution. However, according to the authors, it is not even the first choice for pH treatment.

US 6,368,610 describes an antimicrobial cleaning and disinfecting agent for food, brewing or dairy plants containing inorganic acid (or a mixture), an organic acid of 30 to 70%, e.g. Glycolic acid, or from 70 to 30% acetic acid which is active against Gram + and Gram bacteria as well as yeasts. The use in the medical and hospital facilities for surface and surface disinfection is not mentioned, the effect against viruses, mycobacteria and the TBC strain is not mentioned.

Technical solution

The present technical solution has a disinfectant subject, which is particularly suitable for small areas, surfaces and medical products, the essence of which is that it is the glycolic acid, at least one C ₁ -C ₆ alcohol, at least one quaternary ammonium compound from the Group comprising C ₈ -C ₁₆ -alkylbenzyldimethylammonium chloride, C ₈ -C ₁₆ -alkyldimethylammonium chloride and di (C ₈ -C ₁₆ -alkyl) dimethylammonium chloride.

The advantage of the technical solution lies in the increase of the microbial and virucidal efficiency of commercial products and thereby in the extension of the scope of the disinfectant in areas with a high risk of infection without having to use problematic aldehydes. It has surprisingly been found that the glycolic acid contributes to ensuring the full virucidal activity.

Preferably, the disinfectant contains 50 to 88 wt .-%, advantageously 55 to 80 wt .-% of a C ₁ -C ₆ alcohol or a mixture of C ₁ -C ₆ alcohols. Advantageously, the C ₁ -C ₆ alcohol is selected from the group comprising ethanol, 1-propanol, 2-propanol.

Further, the disinfectant preferably contains 0.1 to 5 wt .-%, preferably 0.5 to 2 wt .-% of the quaternary ammonium compounds or a mixture of quaternary ammonium compounds. Preferably, the quaternary ammonium compound is selected from the group of substances such as N, N-didecyl-N, N-dimethylammonium chloride (Bardac 22) and its differently concentrated variants, N, N-dimethyl-N, N-dioctylammonium chloride (Bardac LF), mixture of N-benzyl-N (C 12 -C 16 alkyl) -N, N-dimethyl ammonium chloride (Barquat CB), mixture of N-benzyl-N (C 12 -C 16 alkyl) -N, N-dimethyl ammonium chloride (Barquat DM), mixture of N-benzyl-N (C 12 -C 16 alkyl) -N, N-dimethyl ammonium chloride (Barquat MB) and mixture of N-benzyl-N (C 12 -C 16 alkyl) -N, N-dimethyl ammonium chloride (Barquat BB) (all from Lonza) or a mixture of N-benzyl-N (C 12 -C 16 -alkyl) -N, N-dimethylammonium chloride (Protectol KLC-50, BASF).

To increase the microbial and virucidal efficiency, the disinfectant contains advantageously 7 to 12 wt .-%, more preferably 7 to 10 wt .-% glycoric acid.

The remainder of the disinfectant up to 100% by weight is water.

The technical solution formula contains the C ₁ -C ₆ alcohol as one of the basic antimicrobial components. The addition of the quaternary ammonium compound thus deepens the microbial effect of the alcohols and increases the activity against pathogenic molds and enveloped viruses (eg HIV, HBV etc.). In addition, it has a good cleaning and wetting ability. To ensure a full virucidal effect, the content of glycolic acid is essential.

As further additives can be used for the disinfectant auxiliaries such as perfumes, in the case of the formation of gel structure gel-forming reagents and associated neutralizing agents due to a high alcohol content, and also coloring components and solvents for flavor compositions or perfume compositions, or even others for use in the disinfectants suitable adjuvants are used.

Examples of the execution of the technical solution

Examples 1-7: Preparation and composition of disinfectants All raw materials have a liquid state, are soluble in cold water. The raw materials were mixed under laboratory temperature, resulting in a homogeneous, finely yellowish solution characterized by an alcoholic odor. raw material example 1 2 3 4 5 6 7 Ethanol [g] 45 45 80 45 - - - 1-Propanol [g] - - - - 45 45 55 2-propanol [g] 35 35 - 25 30 30 - Didecyldimethylammonium chloride [g] - - 1 - 1 1 1 C ₁₂ -C ₁₆ dimethyl benzyl ammonium chloride [g] 0.5 - - 0.5 1 - - C ₁₂ -C ₁₈ dimethylbenzylammonium chloride [g] - 0.5 - - - - - Glycolic acid [g] 10 10 10 10 7 10 10 water up to 100 g

Example 8: Microbiological Testing

The testing was carried out under the auspices of the State Health Institute in Prague in the accredited laboratory Chemila. The preparations were tested both with the suspension method and with the method of disinfecting contaminated carriers according to the actual conditions of use. The summary of the results can be found in Tab. 1 .: Values of Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC), Table 2: Results for the preparation of the composition according to Example 6 and Tab. 3. : Results for the preparation of composition according to Example 7.

Test methods of the efficiency of disinfectants with the suspension methods and on solid surfaces (carrier method), used microbes:

A. Evaluation of the bactericidal, fungicidal (microscopic yeast-like fungi) and sporicidal action of the preparation

• a. The suspension micro-method determines the minimum inhibitory concentration (MIC), the minimum bactericidal concentration at exposure to ice-white at exposure of 10 min. (MBC-B) and the minimum bactericidal concentration in water solution at different exposures (MBC).
• b. With the standard suspension method, the fungicidal (MFC - microscopic yeast-like fungi) and sporicidal (MSC) effects of the substances in the water solution are also evaluated for protein exposure at different exposures and the bactericidal effect (MBC) at different temperature of the working solution and protein load. ( ČSN EN 1650 (66 5203 ): Chemical disinfectants and antiseptics quantitative test under suspension application for the determination of the fungicidal activity or activity against yeasts of chemical disinfectants and antiseptics for use in the food, industrial, household and public facilities test method and requirements (Phase 2 / Stage 1)).
• c. The method with artificially contaminated carriers simulates the practical use of the agents in disinfecting by dipping, wiping and spraying. Glass or metal supports of dimensions 25 × 25 mm are mixed with a bouillon suspension of the bacteria St. aureus, E. coli. and C. alcicans. After drying, the disinfection is carried out by dipping in the solution to be tested or by wiping or by spraying with this solution. Surviving microbes are detected by imprinting the carriers onto the agar plate and subsequent culturing. The number of microbial colonies grown on the impression is evaluated in relation to the control prints of non-disinfected carriers.

During testing, strains from the National Type Culture Collection (CNCTC) are used at the State Health Institute in Prague: Staphylococcus aureus Mau 43/60 SG 511 Escherichia coli Bc 324/70 NCTC 8196 Pseudomonas aeruginosa Ps 79/70 NCTC 6749, ATCC 19582 Proteus vulgarit PrO 10/52 Serratia marcescens Sm 29/80 JF 246 Enterococcus faecium Str. 6/58 FDA M19, ATCC 10541 Candida albicans 49/64 SC 1539 Bacillus subtilis (spores) Bs 4/42

Bioindicators for hot air sterilization

Bacillus subtilis (10 ⁶ CFU / ml) ATTC 9372

The density of bacterial suspensions is 10 ^8-9 CFU / ml. (CFU - coliforms).

The samples to be tested are considered 100% and are diluted to desired concentrations before use with sterile distilled water. In tracking the effects of egg white, the samples are diluted with 20% bovine serum or nutrient broth. As appropriate, a decrease of CFU / 1 ml by 5 to 6 digits is considered. A neutralizing agent is added to the growth medium: Tween 80 (3%), cysteine (0.1%), lecithin (0.3%), sodium thiosulfate (0.5%).

B. Evaluation of the virucidal activity of the preparation

• a. With the suspension method of direct action of the disinfectant on the suspension of the model virus, the MVC value (minimum virucidal substance concentration) is determined, which is necessary for inactivating the virus in the aqueous or protein environment.
• b. The method with contaminated carriers simulates the use of the preparation in practice. The carriers of different materials (glass, metal, etc.) are contaminated with the virus suspension, and after disinfecting by wiping, dipping or spraying, the efficiency of the preparation is evaluated by the plaque method.

In the testing, strains from the National Type Culture Collection (CNCTC) are used at the State Health Institute in Prague: E. coli bacteriophage phi X 174 (NCTC 13706-B1 detected in host E. coli (NCTC 13706/427/84) One titer of the virus suspension used is 10 ^7-8 PFU / ml. (PFU plaque forming unit).

The samples to be tested are considered 100% and are diluted to desired concentrations before use with sterile distilled water. In tracking the effects of egg white, the samples are diluted with 20% bovine serum. As appropriate, a decrease of CFU / 1 ml by 4 to 5 digits is considered.

C. Evaluation of the fungicidal activity of the preparation on microscopic filamentous fungi

Modified suspension method, wherein 0.1 ml fungal spore suspension mixed with 10 ml of the solutions to be tested and inoculated after time exposure in the liquid and solid medium after 0.1 ml. The fungal growth is evaluated in the sporulation on the surface skin of the liquid medium and the growth of colonies on the solid medium.

During testing, strains from the mycological culture collection of the Faculty of Natural Sciences of Charles University in Prague are used:

Aspergillus niger

Penicillium aurantiogriseum

The spore count in the suspension is about 10 ⁶ CFU / ml. (CFU - coliforms). As appropriate, a decrease of CFU / 1 ml by 5 to 6 digits is considered.

The stated percentages correspond to the dilution of preparations of the composition according to Example 6 or 7 with water. Table 1: MIC and MBC values Composition according to Example 6: Composition according to Example 7: MIC 0.12% 0.12% MBC 3.3% 3.3% Tab. 2 .: Results for the preparation of the composition according to Example 6 microbe suspension test Disinfection of contaminated carriers Min. Concentration / exposure Min. Concentration / exposure Staphylococcus aureus 3.3% / 10 min. * 100% -50% / 5 min. Escherichia coli 3.3% / 10 min. * 100% -50% / 5 min. Pseudomonas aeruginosa 3.3% / 10 min. * not tested Proteus vulgaris 3.3% / 10 min. * not tested Seratia marcescens 3.3% / 10 min. * not tested Candida albicans 100% -50% / 4 min. * 100% -50% / 5 min. Aspergillus niger 100% -50% / 5 min. * 100% -50% / 5 min. Penicillium aurantiogriesum 100% -50% / 5 min. * 100% -50% / 5 min. Mycobacterium terrae 100% / 5 min. * not tested Mycobacterium avium 100% / 5 min. * not tested E. coli bacteriophage Φ174 100% / 4 min. * 100% / 5 min. * tested in egg white medium Table 3 .: Results for the preparation of the composition according to Example 7 microbe suspension test Disinfection of contaminated carriers Min. Concentration / exposure Min. Concentration / exposure Staphylococcus aureus 3.3% / 10 min. * 100% -50% / 5 min. Escherichia coli 3.3% / 10 min. * 100% -50% / 5 min. Pseudomonas aeruginosa 3.3% / 10 min. * not tested Proteus vulgaris 3.3% / 10 min. * not tested Seratia marcescens 3.3% / 10 min. * not tested Candida albicans 100% -50% / 4 min. * 100% -50% / 5 min. Aspergillus niger 100% -50% / 5 min. * 100% -50% / 5 min. Penicillium aurantiogriesum 100% -50% / 5 min. * 100% -50% / 5 min. E. coli bacteriophage 0174 100% / 4 minutes * 100% / 5 min. * tested in the protein medium

Example 9-11: Comparative Examples of Microbiological Testing

The comparison of the efficiency of three samples of disinfectants was carried out:

Example 9: Alcohol

Example 10: Alcohol + KAS

Example 11: Alcohol + KAS + Glycolic Acid

The samples were prepared by mixing components at laboratory temperature.

The results were obtained by the method of disinfecting contaminated carriers, at 100% concentration of the preparation, with exposure time of 5 min. raw material example 9 10 11 1-Propanol [g] 45 45 45 2-propanol [g] 25 25 30 Didecyldimethylammonium chloride [g] - 1 1 Glycolic acid [g] - - 10 water up to 100 g up to 100 g up to 100 g tribe example 9 10 11 Staphylococcus aureus + + + Escherichia coli + + + Candida albicans + + + Aspergillus niger + / 15 min + + Penicillium aurantiogriesum + / 15 min + + E. coli bacteriophage Φ174 - - +

Industrial Applicability

The present disinfectant can be used in liquid form for small areas for spraying with efficacy even for small non-enveloped viruses. It finds application especially in highly endangered infection areas, such as the intensive care unit, the anesthesia resuscitation department, the ambulance, the ambulance service, all surgical specialties (neurosurgery, urology, gynecology, etc.), the burn center, neonatal and the like. a. m. are. The preparation can be used, among others, in all hospital and medical institutions, in retirement homes, laboratories, in the veterinary and food industry and in other institutions.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 4346043 [0006]
• US 2010/0151046 [0007]
• US 7144846 [0007]
• US 6368610 [0008]

Cited non-patent literature

• Article from Brazilian Journal of Pharmaceutical Sciences, vol. 45, n. 2, abr./jun., 2009 [0006]
• ČSN EN 1650 (66 5203 [0019]

Claims (3)

Disinfectant, characterized in that it comprises glycolic acid, at least one C ₁ -C ₆ -alcohol, at least one quaternary ammonium compound selected from the group consisting of C ₈ -C ₁₆ -alkylbenzyldimethylammonium chloride, C ₈ -C ₁₆ -alkyldimethylammonium chloride and di (C ₈ -C ₁₆ alkyl) dimethyl ammonium chloride. Disinfectant according to claim 1, characterized in that it contains 50 to 88 wt .-% of a C ₁ -C ₆ alcohol or a mixture of C ₁ -C ₆ alcohols, 0.1 to 5 wt .-% of a quaternary ammonium compound or a mixture of quaternary ammonium compounds, 7 to 12 wt .-% glycolic acid and water. Disinfectant according to one of the preceding claims, characterized in that it further contains components from the group comprising auxiliaries, gel-forming reagents, neutralizing agents, coloring components and solvents for flavoring compositions or perfume compositions.