RU2423149C1 - Method of obtaining antimicrobial composition - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to medicine, namely, to method of obtaining antimicrobial composition for disinfection and sterilisation of products of medical purpose by mixing water base solution, which contains 1-5 wt % of hydrogen peroxide and 5.2-9 wt % of stabilising agent, which represents mixture of aminophosphate, phosphonate and phosphate taken in weight ratio 1:2:4, and solution of activator, containing 40-60 wt % of N-acetyl-caprolactam and 5-15 wt % of morpholine carbonitrile.

EFFECT: terms of storage of ready composition increases to 60 days.

6 cl, 2 tbl, 1 ex

Description

The invention relates to medicine, namely to a method for producing an antimicrobial composition intended for disinfection and sterilization of medical devices, for example endoscopes. Currently known disinfectant compositions consisting of solutions of aldehydes, for example glutaral, succinic, formic, with antimicrobial efficacy.

Known means for the disinfection and sterilization of medical supplies (RF Patent No. 2218185), containing (wt.%): 2.3-2.7 glutaraldehyde, 0.2-0.33 phosphoric acid salts of potassium and sodium, 0, 02-0.2 benzotriazole, the rest is water.

The tool retained high bactericidal and sporicidal activity for a long time up to 1.5 years. However, glutaraldehyde has extreme volatility, which helps to reduce its concentration in the solution and to reduce the effectiveness of the disinfectant properties of the solution, and also has undesirable effects on medical personnel. The tool also has a long exposure. The disinfection time for medical materials is 45 minutes, the sterilization time is 10 hours.

Known means for sterilizing medical equipment (RF Patent No. 2077890), containing the following components (wt.%): Peracetic acid 6.5-10, acetic acid 13-18, hydrogen peroxide 25-30, ethylenediaminetetra-acetic acid 0.005-0, 3, water - the rest.

The stability of the disinfectant is achieved when the pH value is less than 2, which leads to its high aggressiveness with respect to materials made of metal, plastic and rubber, that is, its application is very limited.

Work with such a composition is possible only in protective equipment because of the sharp smell of acetic acid, which affects the respiratory organs of the nursing staff.

Known antimicrobial composition (RF Patent No. 2210386) obtained by mixing solutions at the time of its application, and the method of its application. The base solution contains 0.25-35 wt.% Hydrogen peroxide, anti-corrosion agents, pH regulators, alcohols. The second activator solution contains 1-80 wt.% N-acetylcaprolactam.

The mixing of the two solutions provides a weakly acidic or slightly alkaline antimicrobial composition, the pH of which is in the range from 6 to 8, which makes it possible to use it for any materials, in particular for ferrous and non-ferrous metals.

The composition has a wide spectrum of antimicrobial activity against bacteria, fungi, viruses and spores; It can be used for disinfection and sterilization of all types of medical devices, including endoscopes.

However, the prepared composition retains its activity for no more than 21 days; the exposure time during sterilization of medical devices is at least 30 minutes.

The objective of the present invention is to remedy these disadvantages.

The technical result of the claimed invention is to reduce the exposure time during sterilization of medical materials and maintaining high stability of the antimicrobial composition during storage.

This is achieved by the fact that a method for producing an antimicrobial composition by mixing a base solution containing 1-5 wt.% Hydrogen peroxide and an activator solution containing 40-60% wt. N-acetyl-caprolactam and 5-10 wt.% Morpholinocarbonitrile.

Such an amount of active components provides a high sporocidal activity of the composition.

The perhydrolysis reaction of N-acetylcaprolactam produces caprolactam and peracetic acid (NAA). During the perhydrolysis of morpholinocarbonitrile, iminomorpholinomethyl hydroperoxide (a derivative of perimidic acid) is formed. Both compounds are organic peracids with antibacterial properties due to the presence of active oxygen atoms in their structure. The reduction in exposure time during sterilization of medical devices is due to the synergistic effect of the interaction of these peracids.

The second important parameter that determines the effectiveness of the application of the working solution of the antimicrobial composition is the preservation of the high stability of the antimicrobial composition during storage. The concentration of peracetic acid at the time of receipt of the working solution is 0.15 wt.%. During storage of the working solution, the concentration of peracetic acid decreases as a result of its decomposition into acetic acid and oxygen. The decrease in the concentration of peracetic acid less than 0.1% wt. leads to the loss of sporocidal activity of the working solution of this composition. Maintaining the necessary concentration of acetic acid is achieved by introducing into the composition a mixture consisting of aminophosphonate, phosphonate and phosphate, which stabilizes the concentration of peracetic acid in the required range.

The inventive method prepare the antimicrobial composition of a two-component system consisting of a base solution and an activator.

The base solution contains 1-5 wt.% Hydrogen peroxide and 5.2-9 wt.% A stabilizer containing a mixture of aminophosphonate, phosphonate and phosphate taken in a mass ratio of 1: 2: 4. The shelf life of the base solution is 2 years.

A mixture of aminophosphonate, phosphonate, for example, alkyl (aryl) phosphonic acid, mainly hydroxyethylene diphosphonic acid, and phosphate, for example trisodium phosphate, acts as a stabilizer of hydrogen peroxide and peroxides (peracetic and perimidic) formed during the reaction of hydrogen peroxide with activator components. They bind metal ions that are present in water and can affect the stability of peroxides. At the same time, they provide a high buffer capacity of this system, which makes it possible to maintain a pH of 6–8 not only for the base solution, but also after the activator is introduced into it, that is, for the working solution of the agent — the antimicrobial composition. The activator contains 40-60% N-acetylcaprolactam, 5-15 wt.% Morpholinocarbonitrile, and may also contain nonionic surfactants, a corrosion inhibitor (e.g. benzotriazole) and propylene glycol.

Propylene glycol acts as a solvent for the components of the activator. Shelf life of the activator is 2 years. Surfactants belonging to the class of nonionic surfactants, in particular derivatives of fatty alcohols, play the role of auxiliary components: they dissolve contaminants on medical devices, thereby facilitating the access of active components to the surface of instruments.

Example 1

Stock solution (1 kg)

60 g of a mixture containing 8.6 g of aminophosphonate, 17.1 g of phosphonate and 34.3 g of phosphate are dissolved in 840 g of water. The components of the mixture with stirring dissolve well in water at room temperature. To the resulting solution, 100 g of 30% hydrogen peroxide are added with stirring.

Activator (9 g)

3.36 g of propylene glycol are mixed with 0.45 g of a corrosion inhibitor (benzoriazole) and 0.54 g of a nonionic surfactant, the resulting mixture is heated to 45 ° C and stirred until the corrosion inhibitor is completely dissolved. The mixture is cooled to a temperature of 25 ° C and 4.2 g of N-acetylcaprolactam and 0.45 g of morpholinocarbonitrile are introduced into it with stirring.

The activator thus prepared is poured into a container with a base solution, mixed and a working solution of the antimicrobial composition is obtained, which is used to treat medical devices infected with bacterial spores. During the experiment, determine the time at which the complete disinfection of products.

Tables 1, 2 below give specific examples 1-14 of the composition of the antimicrobial composition prepared according to the method described above according to the invention, and indicators on the time of sterilization of medical devices and the stability of the working solution while maintaining antimicrobial activity during long-term storage.

Table 1 shows the sterilization time of medical devices with the claimed antimicrobial composition and the composition according to Patent 2210386 (prototype).

Table 1 Prototype Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Example 8 Example 9 Base solution 1 kg The content of hydrogen peroxide,% 3.0 3.0 3.0 3.0 3.0 3.0 0.5 5,0 7.0 5,0 The stabilizer content,%, including: 6.0 6.0 6.0 5.2 6.0 6.0 6.0 6.0 9.0 aminophosphonate 0.86 0.86 0.86 0.71 0.86 0.86 0.86 0.86 1.28 phosphonate 1.71 1.71 1.71 1.41 1.71 1.71 1.71 1.71 2,57 phosphate 3.43 3.43 3.43 2.98 3.43 3.43 3.43 3.43 5.15 Activator, g 8.4 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 N-acetylcaprolactam,% fifty 46.7 46.7 46.7 46.7 46.7 60 40 60 46.7 Morpholinocarbonitrile,% - 0,0 3.0 5,0 10.0 15.0 5,0 7.0 10.0 5,0 Sterilization time for medical devices providing disinfection efficiency of 100%, min thirty thirty 25 twenty fifteen 10 fifteen eighteen 10 twenty

From the table it follows that the introduction of the composition of the proposed composition of morpholinocarbonitrile enhances its antimicrobial properties and reduces the time of sterilization of medical devices by 1.5-3 times.

Table 2 shows the effect of the amount of stabilizer on the stability of the working solution of the antimicrobial composition.

table 2 Composition of solutions Prototype Example 10 Example 11 Example 12 Example 13 Example 14 one 2 3 four 5 6 7 Base solution 1 kg The content of hydrogen peroxide,% 3.0 3.0 3.0 3.0 3.0 3.0 The stabilizer content,%, including: 0,0 4.0 5.2 9.0 10.0 aminophosphonate 0,0 0.57 0.71 1.28 1.43 Phosphonate 0,0 1.14 1.41 2,57 2.86 Phosphate 0,0 2.29 2.98 5.15 5.71 Activator, g 8.4 9.0 9.0 9.0 9.0 9.0 N-acetylcaprolactam,% fifty 46.7 46.7 46.7 46.7 46.7 Morpholinocarbonitrile,% - 5,0 5,0 5,0 5,0 5,0 The content of NUK,%, in the composition after mixing through: 15 minutes 0.14 0.15 0.15 0.15 0.15 0.15 2 hours 0.15 0.15 0.15 0.15 0.15 0.15 1 day 0.15 0.13 0.15 0.15 0.15 0.15 15 days 0.12 0.08 0.15 0.15 0.15 0.15 20 days 0.09 0.14 0.15 0.15 0.15 25 days 0,07 0.13 0.15 0.15 0.15 40 days 0.08 0.15 0.15 0.15 60 days 0.15 0.15 0.15

The data shown in table 2, confirm the effect of the introduction of the stabilizer, as claimed in this invention and expressed in maintaining a constant concentration of peracetic acid in the working solution of the antimicrobial composition for at least 60 days, which is three times higher than the data for the prototype.

Claims (6)

1. A method of obtaining an antimicrobial composition by mixing an aqueous base solution and an activator solution, characterized in that the aqueous base solution contains 1-5 wt.% Hydrogen peroxide and 5.2-9 wt.% Stabilizer, which is a mixture of aminophosphate, phosphonate and phosphate and the activator solution contains 40-60 wt.% N-acetyl-caprolactam and 5-15 wt.% morpholinocarbonitrile. 2. The method according to claim 1, characterized in that the mass ratio of aminophosphate, phosphonate and phosphate is 1: 2: 4, respectively. 3. The method according to claim 1 or 2, characterized in that the activator solution further comprises a corrosion inhibitor and a nonionic surfactant, and as a solvent, opylene glycol. 4. The method according to claim 3, characterized in that benzotriazole is used as a corrosion inhibitor. 5. The method according to claim 1 or 2, characterized in that the pH of the antimicrobial composition is in the range from 6 to 8. 6. The method according to claim 1 or 2, characterized in that the mixing of the base solution and the activator solution is carried out at the time of use, and when mixed, peracetic acid and a pyrimidic acid derivative are formed.