RU2297444C2 - Agent for disinfections and presterilization treatment with detergent action - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: claimed agent contains alkyldimethylbenzylammonium chloride, urotropin, surfactant, alcohol, and water. As low molecular mono- or triatomic low toxic alcohol it contains ethanol or isopropanol, additionally it may contain flavor or colorant.

EFFECT: agent with bactericidal and anti-tuberculosis activity.

3 cl, 1 tbl, 1 ex

Description

The invention is intended for medicine and can be used in the disinfection of surfaces of premises, apparatus, devices, furnishings, disinfection of special tools and equipment, work clothes, neutralization of storage tanks of autonomous and dry closets, waste collection equipment, disinfection of tableware and laboratory glassware, presterilization cleaning of dental instruments in a mechanized way , fight against bacterial and fungal infections.

Known rinsing composition described in US Pat. US No. 5837644 (Cl. C11D 1/08, 1998), designed to remove impurities from the surfaces of showers, rooms, accessories and give them a pleasant shine without a scraper or a hard brush and additional wiping. This composition contains, wt.%: 0.5 ÷ 3.0 anionic surfactants, 1 ÷ 8 glycerol, the rest is water. Trilon B can be used as an anionic surfactant in this composition. To inhibit the growth of microorganisms, such as bacteria, fungi and mold, which multiply rapidly at room temperature and high humidity, a quaternary ammonium compound, alkyl dimethylbenzylammonium chloride, is additionally introduced into the composition. This composition is close to the claimed in qualitative-quantitative composition, but has a different purpose, does not have a wide spectrum of action, its effectiveness as a disinfectant is not large enough, especially against bacteria and viruses.

Known detergent and disinfectant described in US Pat. RU No. 2214452 (Cl. C11D 3/48, 2003), containing, wt.%: Alkali metal salt - 7.0 ÷ 10.0, Catamine AB - 4.0 ÷ 6.5, thiourea - 0.9 ÷ 4 , 0, dimethyldialkylammonium salt - 4.0 ÷ 5.0, complexing agent (Trilon B) - 0.5 ÷ 1.0, water - the rest. It is characterized by increased bactericidal action, low toxicity, environmentally friendly. The disadvantage of this tool is that it does not have a wide spectrum of action and is used mainly for processing food and medical equipment, as well as the working surfaces of veterinary clinics. In addition, this composition is ineffective for killing viruses.

Known antiseptic drug described in US Pat. RU No. 21113862 (Cl. A61L 2/18, 1998), intended for the treatment of the skin of the hands of personnel. This preparation contains, wt.%: Ethyl alcohol - 77.0 ÷ 81.0, glycerin - 0.2 ÷ 0.5, castor oil - 0.15 ÷ 0.25, alkyldimethylbenzylammonium chloride - 0.08 ÷ 0.12 , water - the rest; low toxicity, does not irritate the skin. Its disadvantages include the fact that it does not have a wide spectrum of action, is not intended for disinfection of large surfaces.

Known facial skin care product described in US Pat. RU No. 2036636 (class A61K 7/00, 1995), containing, wt.%: Urotropin - 35.0 ÷ 40.0, glycerin - 1.0 ÷ 1.5, perfume - 0.1 ÷ 0.2, water is the rest. In this composition, urotropin is an antimicrobial and anti-inflammatory agent that improves the permeability of the composition into the pores of the skin, and glycerin softens it. This composition does not irritate the skin and is effective for the treatment of acne, but it does not have a wide spectrum of action and cannot be used to treat large areas as a disinfectant.

Known disinfectant "Lysafin" described in US Pat. RU No. 2145238 (class A61L 2/18, 2000), which has a wide spectrum of action. It contains the following ingredients, wt.%: Alkyldimethylbenzylammonium chloride - 25.0 ÷ 35.0, glutaraldehyde - 0.3 ÷ 0.7, glyoxal - 3.5 ÷ 6.5, nonionic surfactant - 4.0 ÷ 8, 0, ethyl alcohol - 6.0 ÷ 10.0, Trilon B - 0.08 ÷ 0.12, water - the rest. This tool has a satisfactory disinfecting effect, it can be used repeatedly without changing the appearance of the solution. The disadvantage of this tool is the presence of very toxic glutaraldehyde and glyoxal. The disinfecting properties of this drug are based primarily on the toxicity of these particular components. Another significant drawback of this drug is that it has fixing properties.

Closest to the claimed is a washing and disinfecting composition described in US Pat. US No. 4455250 (Cl. C11D 1/835, 1984), containing, wt.%: Alkyldimethylbenzylammonium chloride - 2.5 ÷ 4.0, nonionic surfactant - 1.0 ÷ 10.0, Trilon B - 2.0 ÷ 5 , 0, ethyl alcohol - 1.0 ÷ 6.0, water - the rest. This tool can be used to disinfect surfaces, but is unacceptable for the treatment of medical instruments, anti-virus processing. Therefore, with the significant advantages of this composition, its main disadvantage is the insufficiently wide spectrum of action.

The objective of the present invention is to provide a disinfectant, devoid of the disadvantages of the above analogues and combining their advantages, namely having a wide spectrum of action, high activity against bacteria, viruses and fungi, satisfying the established standards for toxicity, not containing toxic components.

This is achieved by the fact that the proposed tool "DIABAK" contains the following ingredients, wt.%:

alkyldimethylbenzylammonium chloride 1,0 ÷ 30,0 surfactant 0.3 ÷ 15.0 low molecular weight single or low alcohol triatomic alcohol 0.2 ÷ 15.0 urotropin 0.3 ÷ 24.0 water rest

The claimed composition may additionally contain 0.5 ÷ 5.0 wt.% Complexing agents, as well as perfumes and / or dyes. The number of the latter is not fundamental and is determined only by organoleptic and aesthetic considerations, as well as the specific conditions of use. The complexing agent improves the washing properties of the claimed composition, wettability, contributes to its additional stabilization.

Alkyldimethylbenzylammonium chloride is the main active ingredient in the claimed composition. As follows from the above analogues, its use in disinfectant, antiseptic and detergent compositions is well known. When its content in the claimed composition in an amount of less than 1 wt.% Narrows the spectrum of the drug. An increase of more than 30 wt.% Is impractical, because there is no noticeable increase in activity.

Urotropin is a colorless crystal, readily soluble in water. This drug is widely used for medicinal purposes in the form of a solution as an antiseptic, deodorizing and disinfectant. However, the use of urotropine as a component of disinfectants with a wide spectrum of action is not known from the prior art. In addition, it was unexpectedly discovered that urotropine dramatically enhances the activity of alkyldimethylbenzylammonium chloride. This, in turn, allows to reduce the content of the latter, despite the fact that the overall disinfecting effect and activity of the claimed composition is enhanced. This is not known in the art. With the introduction of urotropine in an amount of less than 0.3 wt.%, An increase in the activity of alkyldimethylbenzylammonium chloride is not observed. An increase in the content of urotropine in the composition of more than 24 wt.% Is impractical, because its disinfectant and antibacterial properties do not improve.

Introduction to the claimed composition of a low molecular weight mono- or triatomic low-toxic alcohol can stabilize the composition, improve the antimicrobial effect. As the specified alcohol, well-known ethyl or isopropyl alcohol, as well as glycerin, are used. It is important to note that the use of glycerin in such compositions is not known from the prior art, while providing additional benefits: the absence of a sharp characteristic odor and an additional reduction in the toxicity of the composition as a whole. When the alcohol content in the amount of less than 0.2 wt.% Can not significantly stabilize the composition and improve the antimicrobial effect. An increase in the amount of alcohol of more than 15 wt.% Is impractical because does not give a noticeable improvement in the characteristics of the claimed composition.

Surfactants are necessary for the washing effect, and any can be used. When the amount of surfactant is less than 0.3 wt.%, The drug has unsatisfactory washing properties and, as a result, low antimicrobial effect. An increase in surfactant content of more than 15 wt.% Leads to difficulties associated with the removal of the composition from the treated surface, in particular to additional washing and rinsing, which increases labor costs.

DIABAC is an odorless, clear, violet liquid that mixes well with water and has a pH of 9.8 ± 1.0. Its shelf life with unopened packaging is 5 years. An important advantage of this tool is that it retains all its useful properties during freezing and thawing, so it can be stored in unheated rooms, which is especially important for the northern regions. In addition, the claimed tool does not cause corrosion of metals, does not spoil the treated surfaces, does not discolor fabrics, does not fix organic pollution, destroys stains and deposits of grease, oil, soot, protein deposits from surfaces of any materials (glass, mirrors, metals, ceramics, carpets, leather, chromed products, concrete, tile, rubber, plastics, vinyl, porcelain, earthenware, porous products). Working solutions have a pH of 6.0 ÷ 11.0. The product is incompatible with soaps and anionic surfactants.

According to the parameters of acute toxicity when introduced into the stomach, the proposed agent belongs to the 3rd class of moderately hazardous substances, when applied to the skin - to the 4th class there are few hazardous substances according to the classification GOST 12.1.007-76. When introduced into the peritoneum, it belongs to practically non-toxic substances (Grade 5 according to K.K.Sidorov). With inhalation exposure in the form of vapors according to the degree of volatility (C ₂₀ ), this agent is also low-hazard. In the form of an aerosol, it has a general toxic effect corresponding to the threshold of acute single action. The concentrate "DIABAK" has a distinct irritant effect on contact with the skin and conjunctival eyes. Working solutions with a single exposure do not have a local irritant effect on contact with the skin and cause not pronounced irritation of the mucous membrane of the eyes, do not have a general toxic effect on contact with the skin and the effect of sensitization.

When preparing the claimed product, there is no need for special equipment and conditions, which is also its important advantage over the known analogues. The DIABAC tool is prepared by mixing all the components at room temperature in a conventional reactor equipped with a stirrer. The sequence of administration of the components is also not particularly significant.

An example of obtaining a concentrate of DIABAC.

Surfactants, for example, Neonol, in an amount of 4 wt.%, Are placed in a reactor equipped with a stirrer. 40 wt.% Water is added there. Stir until complete dissolution of Neonol. After that, 5 wt.% Of alkyldimethylbenzylammonium chloride is introduced and mixed again until a homogeneous mixture is obtained. Then, 4.9 wt.% Of urotropine is introduced, it is kept under stirring until it is completely dissolved, and 10 wt.% Of low molecular weight one- or triatomic low-toxic alcohol, for example, isopropyl alcohol, is added. After that, a complexing agent, for example, Trilon B, in an amount of 1 wt.% Can be added to the composition and mixed again until a homogeneous mixture is obtained. At the last stage, water is added to 100 wt.%, Mixed until a homogeneous mixture is obtained.

Means "DIABAK" is used in the form of 0.25 ÷ 3.0% aqueous solution for bacterial infections, including tuberculosis; with viral infections, including hepatitis B, HIV - in the form of 3.5 ÷ 9.0% aqueous solution; with candidiasis and dermaphitia - in the form of 1.0 ÷ 12.0% aqueous solution; during pre-sterilization treatment of medical equipment and instruments - in the form of 1.0 ÷ 9.0% aqueous solution with a temperature of at least 18 ° C; during the disinfection of objects with especially dangerous infections - plague, cholera - in the form of 0.5 ÷ 3.0% aqueous solution; when processing from molds - in the form of 1.0 ÷ 4.0% aqueous solution; during general cleaning in medical and child care facilities - in the form of 0.25 ÷ 8.0% aqueous solution; during disinfection of autonomous storage tanks and dry closets - in the form of a 5.0% aqueous solution.

Safety and efficacy indicators are determined in accordance with the “Test methods for disinfectants to assess their safety and effectiveness”, Moscow, Ministry of Health of the Russian Federation, 1996, part 1, and in accordance with the standards listed in the list “Normative indicators of safety and efficacy of disinfectants to be controlled when conducting mandatory certification "No. 01-12 / 75 of 1997

The quality of the pre-sterilization cleaning of medical devices is monitored by placing an azopyram test for the presence of residual blood, a phenolphthalein sample for the presence of residual alkaline components of the solution of the product and a sample with Sudan III and methylene blue for the remainder of fatty contaminants. Sample production procedures are described in the Methodological Instructions for Presterilizing Cleaning of Medical Products (No. 28-6 / 13 of 06/08/82), in the Methodological Instructions for Quality Control of Presterilizing Cleaning of Medical Products with Azopyram Reagent (No. 28- 6/13 of 05.26.88 g) and "Instructions for use of the sample with Sudan III and methylene blue."

Control is subject to 1% of simultaneously processed products of the same name, but not less than three products. If blood residues, greasy contaminants, residual amounts of alkaline components of the product are detected (positive sample), the entire group of products from which the products were taken for control should be re-processed until a negative result is obtained.

The table provides comparative data on the activity of the claimed composition and Catamine AB.

From the data presented in the table, the following can be seen:

one). The bactericidal activity of DIABAK is at least 5 times higher than that of Catamine AB with the same concentration of active ingredient - alkyldimethylbenzylammonium chloride. The tuberculicidal activity of the claimed composition is at least 10 times higher than that of Catamine AB.

2) Means "DIABAK" is active against viruses, while in Catamine AB it is absent.

3) With a minimum content of components, the bactericidal and tuberculicidal activity of the claimed composition is lower than that of Catamine AB, but at the same time, anti-virus activity is absent in Catamine AB. This indicates a wider spectrum of action of the claimed composition.

The following components are optimal, wt.%: Alkyldimethylbenzylammonium chloride - 4.0 ÷ 15.0; Surfactant - 3.0 ÷ 10.0; alcohol - 3.0 ÷ 15.0; urotropin - 5.0 ÷ 20. Within these limits, the claimed composition has the best properties.

Additional advantages of the claimed composition should include the fact that the invention can significantly reduce the consumption of the working solution with the same activity with known means. Possessing activity and spectrum of activity comparable with Lizafin, DIABAK is less toxic and has better detergent properties, the same processing quality is achieved at a lower consumption of DIABAC.

Claims (3)

1. A means for disinfection and pre-sterilization cleaning, containing alkyldimethylbenzylammonium chloride, a surfactant, alcohol and water, characterized in that it additionally contains urotropine in the following components, wt.%: Alkyldimethylbenzylammonium chloride 1.0-30.0 Urotropin 0.3-24.0 Surface-active substance 0.3-15.0 Alcohol 0.2-15.0 Water Rest 2. The tool according to claim 1, characterized in that the alcohol used is a low molecular weight mono- or tri-atom low-toxic alcohol, for example, ethyl alcohol or isopropyl alcohol. 3. The tool according to claim 1, characterized in that it further comprises a fragrance and / or dye.