KR20210085075A - Peracetic acid disinfectant composition for medical devices with improved stability - Google Patents

Abstract

The present invention relates to a peracetic acid disinfectant composition for a medical device with improved stability, which contains citric acid and orthophthalaldehyde. The peracetic acid disinfectant composition containing citric acid and orthophthalaldehyde suppresses the decomposition of the peracetic acid to maintain sterilizing power for a long period of time, and allows sterilization effect to continue even after the peracetic acid is decomposed due to the sterilizing power of the orthophthalaldehyde.

Description

Peracetic acid disinfectant composition for medical devices with improved stability {PERACETIC ACID DISINFECTANT COMPOSITION FOR MEDICAL DEVICES WITH IMPROVED STABILITY}

The present invention relates to a peracetic acid disinfectant composition for medical devices with improved stability, and more particularly, because it contains citric acid and orthophthalaldehyde to inhibit the decomposition of peracetic acid, not only maintains sterilization power for a long period of time, but also orthophthalaldehyde It relates to a peracetic acid disinfectant composition for medical devices with improved stability, which exhibits a bactericidal effect that persists even after peracetic acid is decomposed due to its sterilizing power.

Recently, the frequency of endoscopy is rapidly increasing, the proportion of the elderly population and immunocompromised patients is also increasing, and the use of invasive endoscopes is also increasing with the development of therapeutic endoscopes, increasing the risk of bacterial infection through endoscopy.

The endoscopic scope belongs to semi-critical according to the classification of Spaulding, and it contains proliferative bacteria, part of bacterial spores (effective only when in contact with disinfectants for a long time), viruses, fungi, and mycobacteria. It requires a high level of disinfection to remove, and for this purpose, various chemical disinfectants are used.

Conventionally, commercially available disinfectant products are divided into products that directly dilute peracetic acid and products that generate peracetic acid by mixing tetraacetylethylenediamine (TAED, Tetraacetylethylenediamine) and peroxide.

In general, peracetic acid is highly corrosive because it has a high pH, and in the case of a peracetic acid disinfectant product using tetraacetylethylenediamine, it is neutral and relatively less corrosive. The pH at which peracetic acid shows stability is in the range of 2 to 5, When out of the above range, there was a problem that the peracetic acid was rapidly decomposed and the sterilizing power of the disinfectant could not be maintained.

Korean Patent No. 10-0363896 (January 1, 2002) Korean Patent No. 10-0426937 (2004.03.31)

An object of the present invention is not only to maintain sterilization power for a long period of time because citric acid and orthophthalaldehyde are contained to suppress the decomposition of peracetic acid, but also to maintain the sterilization effect even after peracetic acid is decomposed due to the sterilization power of orthophthalaldehyde. It is to provide a peracetic acid disinfectant composition for medical devices with improved stability that exhibits the effect of being

An object of the present invention is achieved by providing a peracetic acid disinfectant composition for medical devices with improved stability, characterized in that it contains citric acid and orthophthalaldehyde.

According to a preferred feature of the present invention, the peracetic acid disinfectant composition for medical devices with improved stability is an aqueous peracetic acid solution, an aqueous hydrogen peroxide solution, sodium peroxide borate, citric acid, orthophthalaldehyde and purified water.

According to a more preferred feature of the present invention, the peracetic acid disinfectant composition for medical devices with improved stability is sodium peroxide, citric acid, orthophthalaldehyde, tetraacetylethylenediamine, benzotriazole, sodium pyrophosphate and purified water.

According to a more preferred feature of the present invention, the peracetic acid disinfectant composition for medical devices with improved stability contains 0.01 to 1% by weight of citric acid and 0.35 to 0.75% by weight of orthophthalaldehyde.

According to an even more preferred feature of the present invention, the peracetic acid disinfectant composition for medical devices with improved stability is 4 to 6% by weight of an aqueous peracetic acid solution having a mass concentration of 5%, 6 to 7% by weight of an aqueous hydrogen peroxide solution having a mass concentration of 35%, It shall consist of 1 to 3% by weight of sodium peroxide borate, 0.01 to 1% by weight of citric acid, 0.35 to 0.75% by weight of orthophthalaldehyde, and the remaining amount of purified water.

According to an even more preferred feature of the present invention, the peracetic acid disinfectant composition for medical devices with improved stability is 0.5 to 1% by weight of sodium peroxide, 0.01 to 1% by weight of citric acid, 0.35 to 0.75% by weight of orthophthalaldehyde, tetraacetylethylene Diamine 0.05 to 0.15% by weight, benzotriazole 0.05 to 0.15% by weight, sodium pyrophosphate 0.05 to 0.15% by weight and the remaining amount of purified water.

The peracetic acid disinfectant composition for medical devices with improved stability according to the present invention contains citric acid and orthophthalaldehyde to suppress the decomposition of peracetic acid, thereby exhibiting an excellent effect of maintaining sterilization power for a long time.

In addition, due to the sterilizing power of orthophthalaldehyde, the sterilizing effect continues even after peracetic acid is decomposed.

1 is a photograph showing a storage container in which a peracetic acid disinfectant composition for medical devices prepared in Example 1 and Comparative Example 1 of the present invention is stored.
2 is a graph showing the concentration of peracetic acid in a transparent storage container containing a peracetic acid disinfectant composition for medical devices prepared in Example 1 and Comparative Example 1 of the present invention as time passes.
3 is a photograph showing the storage container containing the peracetic acid disinfectant composition for medical devices prepared in Example 2 and Comparative Example 2 of the present invention.
4 to 6 are results of measuring and showing the sterilization performance of the peracetic acid disinfectant composition for medical devices prepared in Example 1 and Comparative Example 1 of the present invention against Bacillus subtilis (BGA, Bacillus subtilis).
7 to 10 are results of measuring and showing the sterilization performance of Enterococcus hirae ( KCTC 2012) of the peracetic acid disinfectant composition for medical devices prepared in Examples 1 to 2 and Comparative Example 1 of the present invention.
11 to 15 are results obtained by measuring the sterilization performance of the peracetic acid disinfectant composition for medical devices prepared in Examples 1 to 2 and Comparative Example 1 of the present invention against Escherichia coli (KCTC 2441).

Hereinafter, a preferred embodiment of the present invention and the physical properties of each component will be described in detail, which is intended to describe in detail enough that a person of ordinary skill in the art to which the present invention pertains can easily carry out the invention, This does not mean that the technical spirit and scope of the present invention is limited.

The peracetic acid disinfectant composition for medical devices with improved stability according to the present invention contains citric acid and orthophthalaldehyde, 0.01 to 1% by weight of citric acid and 0.35 to 0.75% by weight of orthophthalaldehyde It is preferable to contain.

Since the citric acid and the orthophthalaldehyde are water-soluble and serve as a buffer solution to inhibit the decomposition of peracetic acid components, it is possible to suppress the decomposition of peracetic acid to stabilize it, and to provide a peracetic acid disinfectant composition that maintains sterilization power for a long time do.

In addition, since orthophthalaldehyde itself exhibits a sterilizing effect, it serves to sustain the sterilization effect even after the peracetic acid contained in the peracetic acid disinfectant composition for medical devices with improved stability according to the present invention is decomposed.

When the content of the citric acid is less than 0.01% by weight or the content of orthophthalaldehyde is less than 0.35% by weight, the above effect is insignificant, and the content of the citric acid exceeds 1% by weight or the content of orthophthalaldehyde is When it exceeds 0.75% by weight, the sterilizing power of the disinfectant composition may be reduced because the content of peracetic acid contained in the peracetic acid disinfectant composition is relatively reduced without significantly improving the above effect.

The peracetic acid disinfectant composition according to the present invention can be applied to both a product prepared by diluting peracetic acid and a product produced by mixing tetraacetylethylenediamine (TAED, tetraacetylethylenediamine) and peroxide to produce peracetic acid.

At this time, when the peracetic acid disinfectant composition is prepared by diluting the peracetic acid, it consists of an aqueous peracetic acid solution, an aqueous hydrogen peroxide solution, sodium peroxide, citric acid, orthophthalaldehyde and purified water, and a peracetic acid aqueous solution having a mass concentration of 5% 4 to 6% by weight, 6 to 7% by weight of an aqueous hydrogen peroxide solution having a mass concentration of 35%, 1 to 3% by weight of sodium peroxide borate, 0.01 to 1% by weight of citric acid, 0.35 to 0.75% by weight of orthophthalaldehyde, and the remaining amount of purified water desirable.

In addition, in the case of a peracetic acid disinfectant composition prepared by mixing tetraacetylethylenediamine and peroxide, sodium peroxide, citric acid, orthophthalaldehyde, tetraacetylethylenediamine, benzotriazole, sodium pyrophosphate, and purified water consist of, 0.5 to 1% by weight of sodium borate, 0.01 to 1% by weight of citric acid, 0.35 to 0.75% by weight of orthophthalaldehyde, 0.05 to 0.15% by weight of tetraacetylethylenediamine, 0.05 to 0.15% by weight of benzotriazole, 0.05 to 0.15% by weight of sodium pyrophosphate It is preferable that it consists of weight% and the remainder of purified water.

When tetraacetylethylenediamine and peroxide are mixed and reacted as described above, peracetic acid is produced at a predetermined equilibrium concentration.

Hereinafter, a method for producing a peracetic acid disinfectant composition for medical devices with improved stability according to the present invention and physical properties of the peracetic acid disinfectant composition prepared through the production method will be described with reference to examples.

<Example 1>

5.2 g of aqueous peracetic acid solution having a mass concentration of 5%, 6.43 g of aqueous hydrogen peroxide solution having a mass concentration of 35%, 2 g of sodium peroxide borate, 0.1 g of citric acid, 0.55 g of orthophthalaldehyde and 85.72 g of purified water are put into the stirrer, and the speed of 150 rpm A peracetic acid disinfectant composition for medical devices was prepared by stirring for 5 minutes.

<Example 2>

0.81 g of sodium peroxide borate, 0.1 g of citric acid, 0.55 g of orthophthalaldehyde, 0.1 g of tetraacetylethylenediamine, 0.1 g of benzotriazole, 0.1 g of sodium pyrophosphate and 98.24 g of purified water were put into a reactor equipped with a stirrer and placed at 40°C. A peracetic acid disinfectant composition for medical devices was prepared by reacting for 20 minutes at a temperature of 150rpm.

<Comparative Example 1>

5.2 g of an aqueous solution of peracetic acid having a mass concentration of 5%, 6.43 g of an aqueous solution of hydrogen peroxide having a mass concentration of 35%, 2 g of sodium peroxide borate and 86.37 g of purified water are put into a stirrer and stirred at a speed of 150 rpm for 5 minutes to obtain a peracetic acid disinfectant for medical devices A composition was prepared.

<Comparative Example 2>

0.81 g of sodium peroxide borate, 0.1 g of citric acid, 0.1 g of tetraacetylethylenediamine, 0.1 g of benzotriazole, 0.1 g of sodium pyrophosphate and 98.79 g of purified water were put into a reactor equipped with a stirrer, and the temperature of 40° C. and the speed of 150 rpm By reacting for 20 minutes, a peracetic acid disinfectant composition for medical devices was prepared.

The transparent storage container containing the peracetic acid disinfectant composition for medical devices prepared in Example 1 and Comparative Example 1 was photographed and shown in FIG. 1 below.

As shown in Figure 1 below, in general, in the case of peracetic acid, when the pH is out of the range of 2 to 5, it begins to decompose while generating oxygen bubbles. This will create bubbles.

It can be seen that the transparent storage container containing the peracetic acid disinfectant composition for medical devices prepared in Example 1 of the present invention does not generate bubbles, thereby exhibiting excellent stability.

In addition, the concentration of peracetic acid in the transparent storage container containing the peracetic acid disinfectant composition for medical devices prepared in Examples 1 to 2 and Comparative Example 1 was measured over time and shown in FIG. 2 below.

As shown in FIG. 2 below, in the case of the peracetic acid disinfectant composition prepared in Examples 1 and 2 of the present invention, the concentration of peracetic acid is maintained for a long period of time compared to the peracetic acid disinfectant composition prepared in Comparative Example 1. can

In addition, after 10 minutes of the peracetic acid disinfectant composition for medical devices prepared in Example 2 and Comparative Example 2, pH and content of peracetic acid were measured and shown in Table 1 below.

<Table 1>

As shown in Table 1, in the case of the peracetic acid disinfectant composition for medical devices prepared in Example 2 of the present invention, the peracetic acid remains without decomposition even over time, whereas the peracetic acid for medical devices prepared through Comparative Example 2 In the case of the acetic acid disinfectant composition, it can be seen that all peracetic acid is decomposed.

In addition, the storage container containing the peracetic acid disinfectant composition for medical devices prepared in Example 2 and Comparative Example 2 was photographed and shown in FIG. 3 below.

As shown in FIG. 3 below, in the case of the peracetic acid disinfectant composition prepared in Example 2 of the present invention, there was no foaming, whereas in the case of the peracetic acid disinfectant composition prepared in Comparative Example 2, bubbles were generated and decomposition of peracetic acid can be seen that is occurring.

In addition, the sterilization performance against Bacillus subtilis (BGA, Bacillus subtilis) of the peracetic acid disinfectant composition for medical devices prepared in Example 1 and Comparative Example 1 was measured and shown in FIGS. 4 to 6 below.

{However, the test strain is Bacillus subtilis (BGA) spore suspension (Merck 110649) 10 ⁷ CFU/ml (8×10 ⁶ ~ 5×10 ⁷ CFU/mg), and the control group uses a diluent, but EN13727 5.2 A dilution was prepared according to .2.4. Specifically, 900 μL of Diluent was dispensed into each of 6 1.5 mL tubes, and 100 μL of Bac.subtilis (Merck 1.10649) was put into one tube, followed by Serial Dilution 10 ^-4 , 10 ^-5 and 10 ^-6 dilutions were prepared.

100 μL of the prepared 10 ^-4 , 10 ^-5 , 10 ^-6 diluted solution was dispensed into a petri dish, liquid TSB (+ Agar) was poured and mixed, and then solidified to make a plate medium. After incubation for 24 hours in an incubator at 37 °C, the number of colonies for each dilution concentration was measured.

In addition, for sterilization performance , 100 μL of Bac.subtilis (Merck 1.10649) and 100 μL of an interference substance (BSA, 0.3 g/L) were added to two 1.5 mL tubes and mixed for 2 minutes. Then, 800 μL of the disinfectant composition was added to each tube and mixed for 3 minutes to expose the strain to the disinfectant. In order to stop the activity of the disinfectant, 100 µL of the peracetic acid disinfectant composition for medical devices of the previous process was put into a 1.5 mL tube containing 800 µL of a neutralizing substance (1.25% Sodium Metabisulfate) and 100 µL of sterile distilled water, and neutralized for 10 seconds.

^{A 10 -1} dilution was prepared by dispensing 100 μL of the neutralized solution into 2 petri dishes for each tube, and 50 μL of the neutralizing material (1.25% Sodium Metabisulfate) into a 1.5 mL tube containing 450 μL.

100 μL of each 10 ^-1 dilution was dispensed into 2 petri dishes per tube, and 50 μL was dispensed into a 1.5 mL tube containing 450 μL of a neutralizing substance (1.25% Sodium Metabisulfate) to prepare ^{a 10 -2 dilution.}

10 ^-2 dilutions were dispensed in each tube by 100 μL in 2 petri dishes. After that, liquid TSB (+ Agar) was poured into each petri dish, mixed well, and solidified to make a plate medium. After culturing for 1 day in a 37°C incubator, the number of each colony was measured.}

Bac.subtilis (Merck 1.10649) ^{was diluted to 10 -4} , 10 ^-5 , 10 ^-6 , dispensed and cultured in 100 μl, and the results measured in colonies are shown in Table 2 below.

<Table 2>

Figure 4 below is the sterilization performance for Bacillus subtilis diluted solution, Figure 5 is the result of treating Bacillus subtilis with the peracetic acid disinfectant composition for medical devices of Comparative Example 1, and Figure 6 is the treatment of Bacillus subtilis with the peracetic acid disinfectant composition for medical devices of Example 1 is a result

As shown in FIGS. 4 to 6 below, it can be seen that the peracetic acid disinfectant composition for medical devices prepared in Example 1 of the present invention exhibits excellent sterilization performance against Bacillus subtilis.

In addition, the sterilization performance against Enterococcus hirae ( KCTC 2012) of the peracetic acid disinfectant composition for medical devices prepared in Examples 1 to 2 and Comparative Example 1 was measured and shown in Table 3 and FIGS. 7 to 10 below.

{However, for sterilization performance, the EN 13727 suspension test method was used,

Diluent was prepared according to EN13727 5.2.2.4 for bacterial count measurement. After dispensing 5 mL of diluent into a 15 mL conical tube, the Enetrococcus hirae (KCTC 2012) strain cultured on the BHI plate medium was sufficiently buried in the loop and released into the diluent. After measuring A600 (1.741) using 1 mL of the culture stock solution, 1.3 mL of the solution and 3.7 mL of Diluent were mixed to adjust the A600 of the test solution to 0.415.

Dispense 900 μL of Diluent into 8 1.5 mL tubes, put 100 μL of A600 = 0.415 test solution into one tube, and proceed with serial dilution to prepare 10 ^-5 , 10 ^-6 , 10 ^-7 , 10 ^-8 dilutions.

200 μL of the 10 ^-5 , 10 ^-6 , 10 ^-7 , 10 ^-8 diluted solution was dispensed into a petri dish, poured with liquid BHI (+ Agar), mixed well, and solidified to make a plate medium. Thereafter, after culturing for 24 hours in an incubator at 36 °C, the number of colonies at each dilution concentration was measured.

In addition, for the sterilization test , 100 μL of Enterococcus hirae (KCTC 2012) test solution (A600 = 0.415) and 100 μL of an interference substance (BSA, 0.3 g/L) were added to a 1.5 mL tube and mixed for 2 minutes. Then, 800 μL of the composition for sterilization was added, and the strain was exposed to the composition for sterilization by mixing for 3 minutes. In order to stop the activity of the sterilization composition, 800 µL of a neutralizing material (1.25% Sodium Metabisulfate) and 100 µL of sterile distilled water were placed in a 1.5 mL tube containing 100 µL of the sterilization composition + strain mixture from the previous process and neutralized for 10 seconds.

100 μL of the neutralized solution was dispensed into each of 4 petri dishes, and 50 μL was dispensed into a 1.5 mL tube containing 450 μL of a neutralizing substance (1.25% Sodium Metabisulfate) to prepare ^{a 10 -1 dilution.}

100 μL of each 10 ^-1 dilution was dispensed into 4 petri dishes, and 50 μL was dispensed into a 1.5 mL tube containing 450 μL of a neutralizing substance (1.25% Sodium Metabisulfate) to prepare ^{a 10 -2 dilution.}

100 μL of each 10 ^-2 dilution was dispensed into 4 petri dishes. After that, liquid BHI (+ Agar) was poured into each petri dish, mixed well, and solidified to make a flat plate. Then, after culturing for 24 hours in a 36 ℃ incubator, the number of each colony was measured.}

The strain was scraped off from the BHI (+ Agar) plate medium in which Enterococcus hirae (KCTC 2012) was cultured, diluted in diluent, and the absorbance (A600) was adjusted to 0.415 to prepare a dilution solution. Table 3 below shows the results of measuring the number of bacteria by diluting this to 10 ^-5 , 10 ^-6 , 10 ^-7 , 10 ^{-8, aliquoting 200 μl, culturing, and then colony measurement.}

<Table 3>

7 below shows the results of Serial Dilution (10 ^-5 , 10 ^-6 , 10 ^-7 , 10 ^-8 ) of an OD = 0.415 culture medium (about 1.9×10 ⁷ cfu/mL) of Enterococcus hirae (KCTC 2012). ,

8 is a result of treatment the culture medium of the Enterococcus hirae (KCTC 2012) as a comparative example of a composition for the disinfection of 1 is a result of treatment the culture medium of the Enterococcus hirae (KCTC 2012), 9 is carried out disinfection composition of the example 1, 10 is a result of treating the culture solution of Enterococcus hirae ( KCTC 2012) with the disinfecting composition of Example 2.

As shown in Table 3 and FIGS. 7 to 10 below, it was found that the peracetic acid disinfectant composition for medical devices with improved stability prepared through Examples 1 and 2 of the present invention exhibited excellent sterilization performance against Enterococcus hirae (KCTC 2012). can

In addition, the sterilization performance against Escherichia coli ( KCTC 2441) of the peracetic acid disinfectant composition for medical devices prepared in Examples 1 to 2 and Comparative Example 1 was measured and shown in FIGS. 11 to 15 below.

{However, to measure the number of bacteria, scrape the strain from the NB plate medium in which Escherichia coli ( KCTC 2441) is cultured, dilute it in diluent, adjust the absorbance (A600) to 0.432, and prepare a diluted solution, which is 10 ^-5 , 10 ^-6 , 10 ^After diluting with -7, 200 μl was dispensed, cultured, and colony measurement was used, and 117, 15, and 1 were identified, respectively, as shown in FIG. 11 below.}

In addition, when 100 μl of A600 = 0.432 culture solution (about 8 million cells) was exposed to 800 μl of test solution (disinfectant composition prepared in Examples 1-2 and Comparative Example 1) for 3 minutes, the results are shown in FIGS. 13 to 13 to 15, the control is a peracetic acid solution having a mass concentration of 1%, and the results of treatment with the peracetic acid solution having the mass concentration are shown in FIG. 12 below.

At this time, Sample A is a disinfectant composition prepared through Comparative Example 1, Sample B is Example 1, and Sample C is Example 2.

As shown in FIGS. 11 to 15 below, it can be seen that the peracetic acid disinfectant composition for medical devices prepared in Examples 1 and 2 of the present invention exhibits excellent sterilization performance.

Therefore, the peracetic acid disinfectant composition for medical devices with improved stability according to the present invention contains citric acid and orthophthalaldehyde to suppress the decomposition of peracetic acid, so that the sterilizing power is maintained for a long time.

Claims (6)

Peracetic acid disinfectant composition for medical devices with improved stability, characterized in that it contains citric acid and orthophthalaldehyde.
The method according to claim 1,
The peracetic acid disinfectant composition for medical devices with improved stability is a peracetic acid disinfectant composition for medical devices with improved stability, characterized in that it consists of an aqueous peracetic acid solution, an aqueous hydrogen peroxide solution, sodium peroxide, citric acid, orthophthalaldehyde and purified water.
The method according to claim 1,
The peracetic acid disinfectant composition for medical devices with improved stability is a peracetic acid disinfectant for medical devices with improved stability, characterized in that it consists of sodium peroxide, citric acid, orthophthalaldehyde, tetraacetylethylenediamine, benzotriazole, sodium pyrophosphate and purified water. composition.
4. The method according to any one of claims 1 to 3,
The peracetic acid disinfectant composition for medical devices with improved stability is a peracetic acid disinfectant composition for medical devices with improved stability, characterized in that it contains 0.01 to 1% by weight of citric acid and 0.35 to 0.75% by weight of orthophthalaldehyde.
The method according to claim 1 or 2,
The peracetic acid disinfectant composition for medical devices with improved stability is 4 to 6% by weight of an aqueous peracetic acid solution having a mass concentration of 5%, 6 to 7% by weight of an aqueous hydrogen peroxide solution having a mass concentration of 35%, 1 to 3% by weight of sodium peroxide borate, citric acid Peracetic acid disinfectant composition for medical devices with improved stability, characterized in that it consists of 0.01 to 1% by weight, 0.35 to 0.75% by weight of orthophthalaldehyde and the remaining amount of purified water.
4. The method of claim 1 or 3,
The peracetic acid disinfectant composition for medical devices with improved stability is sodium peroxide 0.5 to 1% by weight, citric acid 0.01 to 1% by weight, orthophthalaldehyde 0.35 to 0.75% by weight, tetraacetylethylenediamine 0.05 to 0.15% by weight, benzotriazole Peracetic acid disinfectant composition for medical devices with improved stability, characterized in that it consists of 0.05 to 0.15 wt%, sodium pyrophosphate 0.05 to 0.15 wt%, and the remaining amount of purified water.

Images