SK281353B6 - Self-sterilizing wide-spectral disinfection and antiseptic preparations - Google Patents

Abstract

The combined broad-spectrum disinfectant and antiseptic preparations contain an organic ammonium salt, chlorhexidine, amine oxide and hydrogen peroxide in an aqueous solution of isopropyl alcohol combining high microbicidal efficacy in a short exposure time against a wide range of microorganisms, the ability to overcome the negative effects of organic pollution, autosterilization - killing vegetative cells and bacterial spores entering the preparation during manufacture or subsequent handling. The composition of the formulation utilizes the potentiation of the positive properties of its components, resulting in a broad antimicrobial spectrum, rapid onset of action and residual effect upon evaporation of the vehicle. The quantitative representation of the components in the formulation is as follows: 0.5 to 1.0 wt. % hydrogen peroxide, 0.5 to 1.0 wt. % alkyldimethylamine oxide, 0.5 to 1.0 wt. % dialkyldimethylammonium salt and 0.1 to 1.0 wt. chlorhexidine digluconate dissolved in an aqueous solution of isopropyl alcohol at a concentration of 30 to 95% by weight.

Description

Technical field

The present invention relates to combined disinfectants and antiseptic agents based on isopropyl alcohol, containing surface-active antimicrobial active compounds soluble in its aqueous solution and hydrogen peroxide. These preparations are intended for use as disinfectants and antiseptics for intact skin (e.g. before invasive procedures) or as disinfectants for minor injuries. The sphere of use is health and veterinary, communal hygiene, as well as other areas where a rapid and reliable decontamination effect is required, eliminating the risk of possible survival of the most resistant microorganisms in the preparation itself, as documented in the literature.

BACKGROUND OF THE INVENTION

With the exception of an amine oxide whose composition is original and the effects have been proven by us as a matter of priority, they are components of known efficacy, having their limits both in spectrum and in the dynamics of antimicrobial activity. They are used in practice individually or in two-, three-component combination preparations, in which the desired properties are significantly improved, but they do not take full advantage of the individual components. In particular, it is an unsatisfactory spectrum of action, not sufficient dynamics of action, particularly on bacterial spores, and the negative effect of organic contaminants on the efficacy of the formulation.

The ability of bacterial spores to survive in some and concentrated disinfectants makes them a potential source of nosocomial infections, an unacceptable risk that can be avoided by using appropriate combinations of formulation components with defined properties and activity.

One of the basic ingredients of the isopropyl alcohol preparation is itself antimicrobial and is considered to be one of the most preferred compounds for disinfecting and antiseptic skin preparation. as well as surface active compounds, in this case organic ammonium salts and branched alkyldimethylamine oxide having a number of carbon atoms in the C10-C18 chain, as well as chlorhexidine, greatly extending the spectrum of antimicrobial activity of the preparation. Hydrogen peroxide provides a rapid autosterilizing effect of this combination, which ensures that the preparation is already ab initio deprived of eventually. germs that cause nosocomial infections.

SUMMARY OF THE INVENTION

It is based on the autosterilizing ability and potentiated antimicrobial efficacy of a unique, yet unused combination of known antimicrobial compounds supplemented with the original amine oxide. The individual components are characterized by relatively low toxicity and negligible occurrence of adverse reactions as well as intrinsic biological effects (defined spectrum of antimicrobial effect, onset dynamics, residual effect, ability to penetrate or remove barriers of contaminating organic substances) and physicochemical properties. They are compatible and mutually potent. In this combination, the spectrum of their antimicrobial activity is broadly broadened, the onset of action is virtually instantaneous (within 1 min), they have a cleaning effect and the effect of organic contaminants on their activity is negligible. After evaporation of the vehicle, the residual effect of antimicrobial surfactants and chlorhexidine persists. The combination is able to inactivate in a short time in addition to the virtually immediate destruction of vegetative forms of microorganisms or. massive contamination with the most resistant bacterial spores, which guarantees the product autosterilizing ability.

The solution of the invention is an optimal combination of ingredients in a composition intended for disinfecting various materials and for topical application to the skin prior to invasive surgery or which has not been massively damaged by injury. The composition is comprised of 0.5 to 1.0 wt. amine oxide of formula (I)

CH ₃

R — N — O ¹ ) '

₃ H wherein R is a straight or branched alkyl chain having a carbon number from 10 to 18, further 0.5 to 1.0% by weight. an organic ammonium salt of formula (II)

CH

Wherein R 1 represents a linear or branched substituted or unsubstituted alkyl chain having a carbon number of 12 to 16 and R ₂ represents either a methyl or benzyl radical and X 'represents a halide anion, further 0.1 to 1.0 wt. % of chlorhexidine and finally 0.5 to 1 wt. % hydrogen peroxide in 70 wt. aqueous isopropanol solution. The individual components have their own spectrum of antimicrobial activity and other specific properties. The presence of hydrogen peroxide provides an immediate autosterilizing effect after contamination of the formulation during use. They are mutually compatible compounds and their combination makes optimal use of their advantages and at the same time removes their individual deficiencies. On the one hand, their spectrum of action extends to Gram-positive and Gram-negative bacteria, microscopic fungi and enveloped viruses, while at the same time achieving a synergistic increase in the efficacy of the whole formulation, which is ultimately higher than that of the individual components. The surface activity of some of them provides, in addition to the antimicrobial effect, also a cleaning effect and the significant residual antimicrobial effect remains even after the isopropyl alcohol evaporation. Due to the presence of isopropyl alcohol, the preparation has a very rapid onset of action (from a microbiological point of view, the onset of action is almost immediate). The preparation also acts on those microorganisms to which the aqueous solutions of its individual components are not effective.

DETAILED DESCRIPTION OF THE INVENTION

Aqueous solutions of chlorhexidine digluconate (e.g. 20% by weight), an organic ammonium salt, e.g. carbetopendecinium bromide (e.g., 10 wt.%), an antimicrobically active aliphatic amine oxide, e.g. % (1-methyldodecyl) dimethylamine oxide (e.g. 10 wt.%) And mixed with pure isopropyl alcohol (ca. 99 wt.%). To be completed

% By volume of 33 wt. % aqueous hydrogen peroxide solution and the concentration of the solution is adjusted with distilled water to achieve a final isopropyl alcohol concentration of 70% by weight.

To illustrate the efficacy, the tables show the results of the antimicrobial activity tests:

Tab. 1

Effective microbicidal concentrations of the preparation in the suspension test within 1 min. effect in% (vol.)

Staphylococcus aureus 0,03% Bacillus subtilis 0.2% Escherichia coli 0,06% Salmonella typhimurium 0.2% Proteus vulgaris 0.3% Pseudomonas aeruginosa 0.2% Candida albicans 0.2%

Tab. 2

Minimum microbicidal concentrations in the carrier test in% (v / v)

exposure time 1 min 2 min. 5 min. Staphylococcus. aureus 0,06% 0.05% 0.05% Escherichia coli 1% 1% 0.3% Candida albicans 1% 0.5% 0.3%

Tab. 3

Fungicidal efficacy of the preparation (concentrations necessary to kill microorganisms within 1 min of exposure in pg / cm ³ )

Candida albicans 100 Scopulariopsis brevicularis 100 Aspergillus flavus 100 Aspergillus niger 100 Microsporum canis 20 Trichophyton mentagrophytes 20 Trichophyton rubrum 100 Trichophyton quinckeanum 100

wherein R represents a linear or branched alkyl chain having a carbon number of 10 to 18.0.5 to 1 wt. dialkyldimethylammonium salt of formula (II)

(Π) where R | % represents a linear or branched substituted or unsubstituted alkyl chain having a carbon number of 12 to 16 and R ₅ represents either a methyl or benzyl residue and X 'represents a halide anion and 0.1 to 1 wt. % of chlorhexidine in the form of digluconate dissolved in 30 to 95 wt. aqueous isopropanol solution.

Disinfectant and antiseptic composition according to claim 1, characterized in that it contains 0.5 wt. % alkyldimethylamine N-oxide having 14 carbon atoms in the alkyl chain; % dialkyldimethylammonium salts with equal number of carbons in both alkyl chains and bromide anion, 0.4 wt. % of chlorhexidine digluconate and 0.5 wt. hydrogen peroxide in 70% aqueous isopropyl alcohol.

End of document

Tab. 4

Germicidal efficacy of the preparation on Bacillus subtilis spores CNCTC 4/42

dilution time to kill 1: 100 1 min 1: 200 4 min. 1: 300 6 min. 1: 400 30 min.

Claims (1)

PATENT CLAIMS Disinfectant and antiseptic broad spectrum preparation, characterized in that it contains 0.5 to 1% by weight of a disinfectant. % hydrogen peroxide, 0.5 to 1 wt. alkyldimethylamine oxide of formula (I)