Tableted antimicrobial composition

FIELD: medicine.

SUBSTANCE: tableted antimicrobial composition contains polyhexamethylene guanidine hydrochloride (PHMH) in a combination with at least one ingredient specified in a group: quaternary ammonium compound (QAC), N,N-bis-(3-aminopropyl)dodecylamine and persol, as well as with an alkaline metal iodide and ammonium iodide. The antimicrobial composition has the following ratio of ingredients: PHMH - 10 to 70 wt %; QAC, N,N-bis(3-aminopropyl)dodecylamine and/or persol - 1 to 30 wt %; an alkaline metal iodide and ammonium iodide - 0.1 to 20 wt %.

EFFECT: using the invention provides the fast-acting tableted antimicrobial composition having a wide antimicrobial spectrum and a higher level of biocidal activity.

5 cl, 2 tbl, 2 ex

 

The technical FIELD TO WHICH the INVENTION RELATES.

The invention relates to the field of medicine, sanitation and hygiene, and in particular to means for disinfection of surfaces of medical devices and other items in medical institutions, in the infectious foci, sanitary transport, food industry, public catering enterprises, utilities and other

The LEVEL of TECHNOLOGY

Known tablets disinfectants "Absolute hydroxy" and "PFC-T active substance which is peroxyde of potassium fluoride (see http://www.infodez.ru/product/33_absolyutsid_oksi.html, . Tablets of Absoluted hydroxy contain 24÷34% peroksigidrat potassium fluoride and dissolved in water at room temperature for 20÷22 minutes. Tablets PFC-T" contain 28÷38% of peroksigidrat potassium fluoride and dissolved within 15 minutes.

It is also known tablets disinfectant "designback-super (http://desinbak.ru/index.php?doc&id=1,6,8). It contains a stabilized mixture of peroxide compounds (26÷32%, in terms of hydrogen peroxide). In addition, the product contains a stabilizer (0,1÷0,3% alkyldimethylbenzylammonium), pH Adjuster (0,4÷0,8% borax), washing additive and flavoring. The tool is dissolved in water at room temperature for 22±2 minutes.

Despite the convenient consumer who Orme, all these tools have a strong corrosive properties and lack of antimicrobial activity, particularly against viruses.

Known tablets disinfectant means "Velta", representing almost pure clathrate Quaternary ammonium compounds with urea (see instructions for use http://www.dezreestr.ru/instr/Veltab.html). In contrast to the above means, it is recommended not only for disinfection of various objects, but also for the sterilization of medical products. The tool is dissolved in water at room temperature for 20÷22 minutes.

The modes of application of the tool shown in the above instructions should be critically evaluated because it is well known that Quaternary ammonium compounds have high activity against gram-positive bacteria, is much less active against gram-negative bacteria, mycobacteria and fungi, even less active against viruses (particularly ineffective against polioviruses) and are not sporocidal, i.e. unsuitable as sterilants (http://cmr.asm.org/content/1211/147.full.pdf+html). In addition, a significant drawback of all funds on the basis of a single Quaternary ammonium compound is the rapid emergence of resistant to strains of pathogenic microorganisms.

izvestno tablets disinfectant, containing as active substance polyhexamethylene guanidine hydrochloride (phmg), characterized in that it additionally contains a mixture of alkaline and acidic components in the following ratio of components: pgmg from 1 to 99 wt.%, the mixture alkaline and acidic components from 99 to 1 wt.% (RF patent for the invention №2452513). The alkaline component are alkali metal salts of carbonic acid, and the acid component selected from citric, tartaric, fumaric maleic, adipic, malic, sulfamic, oxalic, and (or) of boric acid. The mixture alkaline and acidic components can accelerate the dissolving tablets, facilitates the efficient dispersion of particles pgmg and their soopermexican with water, provides a neutral level of pH of the resulting solution (6,5÷7,0) due to selection of the desired ratio of components. The likely implementation of this patent is the "Notabs"containing 52% phmg (http://www.dezreestr.ru/instr/Neotbs.html'). It is soluble in water at room temperature for 5÷6 minutes.

The lack of funds from the Russian patent for invention №2452513, you should consider the sensitivity to moisture of the air, as moisture initiates a chemical reaction between the alkaline and acidic components, resulting in the destruction of the tablets. When specified in the patent States that the use of PGMs ru is et to get the disinfectant with high activity against a broad spectrum of microorganisms, including their spore forms. This contradicts the common opinion that all known biocidal derivatives of guanidine low activity against mycobacteria, fungi, and especially viruses (some viruses such as the virus of foot and mouth disease - resistant pgmg) and do not have spores at room temperature (http://cmr.asm.Org/content/l12/1/147.full.pdf+html, http://www.infodez.ru/product/163_bior_1.html. http://www.infodez.ru/product/1311_polisept.html).

Although in example 4 of this patent States that when the concentration of PGMs in the working solution of 0.02% 100%destruction of tubercle bacilli occurs within 5 min, this information is questionable, as in other known disinfectants based on pgmg as the only active substance, such as Policept" and "BIOR-1", a similar result is achieved for 120 minutes at a concentration of PGMs 2%, or 30 minutes at a concentration of PGMs 5% (http://www.infodez.ru/product/1311_polisept.html, http://www.infodez.ru/product/l163_bior_1.html). Obviously, adding to pgmg such auxiliary components, as sodium bicarbonate and fumaric acid, cannot serve as a reason for such significant differences in tuberkulocide activity means to example 4 of the patent of the Russian Federation 2452513 and means "bear-1" and "Policept".

The modes of sterilization of medical devices described in the aforementioned application instructions "of Newtabs" vig is yadyat improbable: 60 min at a concentration of pgmg 0,04%, 30 min at a concentration of 0.05%, 15 min at a concentration of 0.1% and 5 min at a concentration of 0.2%, such as sporicidal activity does not possess even the drugs peracetic acid. Experimental verification showed that in fact "Notabs" does not provide for the sterilization of medical products.

DISCLOSURE of INVENTIONS

The objective of the invention is to provide a fast-acting antimicrobial compositions in the form of tablets, devoid of the above disadvantages of the known disinfectants and with a broad antimicrobial spectrum.

The problem is solved in that the inventive composition includes a synergistic complex of pgmg in combination with at least one component selected from the group of substances with antimicrobial activity:

- Quaternary ammonium compound (QAC),

- N,N-bis-(3-aminopropyl)dodecylamine,

- Persol,

and at least one mineral salt selected from the group:

iodide of an alkali metal,

iodide of ammonium,

in the following ratio of components:

- Pgmg from 1 to 70 wt.%;

HOURS, N,N-bis(3-aminopropyl)dodecylamine and/or Persol - from 1 to 30 wt.%;

iodide of an alkali metal and/or ammonium iodide is from 0.1 to 20 wt.%.

Non-limiting examples of the HOUR include, in particular, the pyridinium chloride, alkyldimethylbenzylammonium one chloride, alkyldimethyl(active compounds)ammonium chloride, didecylammonium chloride, didecylammonium bromide and pyridinium bromide. As percale can be used peroxyde urea and/or procovery mineral salts, such as perborate sodium, potassium persulfate, percarbonate sodium, peroxyde potassium fluoride or peroxyde of ammonium fluoride.

Source phmg is introduced into the formulation in the form of a fine powder of HOURS in individual form or in the form of clathrates with urea.

The compositions may also contain other ingredients, including detergent additives, stabilizers, corrosion inhibitors, complexing agents, pH regulators, dyes and flavoring.

In the patent literature describes a liquid antimicrobial composition comprising synergistic complexes pgmg+H (patent RU 2275193 C2), pgmg+N,N-bis-(3-aminopropyl)dodecylamine (patent RU 2172637 C1), pgmg+H+N,N-bis-(3-amino-propyl)dodecylamine (patent RU 2317950 C1) and pgmg+hydrogen peroxide (patent RU 2337714 S1). The iodides of alkali metals and ammonium iodide has not previously been used in the composition of disinfectants (the only exception is iodine tincture, which includes potassium iodide as a functional additive; see http://www.altermed.bv/index.php?item=prep&g=%D2&p=1521&ps=392877').

Not wishing to be limited to any particular theory is th, we assume that the addition of iodide turns pgmg and the aforementioned chloride and bromide Watch in appropriate iodine derivatives, molecules which have a greater positive charge of the cation, contributing to their adsorption on the negatively charged surface of microbial cells, and possess significantly greater lipophilicity, which facilitates their diffusion through the cell wall of microorganisms and enhances hydrophobic interactions with phospholipids and proteins of the cytoplasmic membrane. In addition, it is possible that oxidative enzymes of microorganisms transform ideny anion to molecular iodine (I2), which is a more powerful antiseptic than pgmg and Watch (http://wwwn.cdc.gov/publiccomrnents/comments/guidelines-for-the-prevention-of-intravascular-catheter-related-infections/2021.ashx).

The claimed composition was prepared by thorough mixing of all components, followed by pelletizing the mixture. The tablets are completely dissolved in water at room temperature for 12÷15 minutes.

The advantages of the proposed composition become apparent from the examples below.

The IMPLEMENTATION of the INVENTION

The following examples are given only to illustrate the inventive idea. Nothing in this section the description should not be construed as limiting the scope of the claims. It should be clear that the average person, the sign of the nd with the ideas of the present invention, can use its main features and to make equivalent replacements to achieve the target and without deviating from the spirit and scope of the present invention.

The tests were carried out by the method described in "Methods of testing disinfectants to assess their safety and effectiveness", M, 1998, am 2, near-real conditions of use of funds. As models were selected as the most resistant to cationic disinfectants types of microorganisms Mycobacterium tuberculosis and polio virus.

EXAMPLE 1

Used a tablet composition containing 40% pgmg, 40% of clathrate didecylammonium chloride, 8% N,N-bis(3-aminopropyl)dodecylamine, 5% ammonium iodide, 2% of the trylon B and 5% detergent additives. On cleansed and sterilized medical instruments caused a cell culture of Mycobacterium tuberculosis, and then process them by wiping with a solution containing 2 tablets of the claimed composition by mass of 1 g in 10 l of water. After 5 minutes registered 100%cell death B5.

Table 1 provides comparative data on tuberkulocide activity of this composition in comparison with the "Westbam" and "Neoteam".

The name means
TABLE 1
The concentration of working solution that provides 100%cell death within 5 minutes, g/l (in preparation)
The composition according to example 10,2
"Welcab"2,0
"Notabs"0,5

EXAMPLE 2

On cleansed and sterilized medical instruments struck a culture of polio virus, and then process them by wiping with a solution containing 2 tablets of the claimed composition by mass of 1 g in 10 l of water. Each tablet contained 45% pgmg, 12% of pyridinium chloride, 20% percarbonate sodium, 15% potassium iodide, 1% of the trylon B, 5% corrosion inhibitors and 2% detergent additives. After 10 minutes registered 100%destruction of the virus.

Table 2 shows comparative data for virucidal activity of this composition in comparison with the "Westbam" and "Neoteam".

TABLE 2
The name meansThe concentration of working solution that provides 100%destruction of the virus in 10 minutes g/l (in preparation)
The composition according to example 2 izobreteny the 0,2
"Welcab"2,5
"Notabs"0,7

Tableted compositions of examples 1 and 2 do not disintegrate with prolonged stay in the open air, at least for 3 months and do not have strong corrosive properties.

Thus, the technical result of the invention is to provide a fast-acting antimicrobial compositions in the form of tablets, with a broad antimicrobial spectrum and a higher level of biocidal activity than the known tablets disinfectant.

1. Antimicrobial agent in the form of tablets containing polyhexamethylene guanidine hydrochloride (phmg)at least one antimicrobial substance is selected from the group consisting of Quaternary ammonium compounds (QAC), N,N-bis-(3-aminopropyl)dodecylamine and Persol, at least one iodide selected from the group consisting of alkali metal iodide and ammonium iodide, in the following ratio of components (wt.%): Pgmg - 1,0÷70, an antimicrobial substance - 1,0÷30, iodide - 0,1÷20.

2. The tool according to claim 1, in which the HOURS selected from the group consisting of pyridinium chloride, alkyldimethylbenzylammonium chloride, alkyldimethyl(active compounds)ammonium chlorine is IDA, didecylammonium chloride, didecylammonium bromide and pyridinium bromide.

3. A tool according to any one of claims 1 or 2, in which Persol selected from the group consisting of procalert urea, sodium perborate, potassium persulfate, percarbonate sodium, procalert fluoride of potassium and procalert of ammonium fluoride.

4. A tool according to any one of claims 1 or 2, additionally comprising at least one substance selected from the group consisting of detergent additives, stabilizers, corrosion inhibitors, complexing agents, pH regulators, dyes and fragrances.

5. The tool according to claim 3, additionally comprising at least one substance selected from the group consisting of detergent additives, stabilizers, corrosion inhibitors, complexing agents, pH regulators, dyes and fragrances.



 

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