KR102416911B1 - Detergent composition for medical device with excellent biofilm removal effect - Google Patents

Abstract

The present invention relates to a detergent composition for medical devices having an excellent biofilm removal effect, and is composed of octenidine hydrochloride, a corrosion inhibitor, a surfactant, an enzyme, and purified water. The detergent composition for medical devices comprising the above components exhibits an excellent removal effect on biofilms generated on medical devices and also exhibits an effect of inhibiting corrosion of medical devices.

Description

Medical device cleaning composition with excellent biofilm removal effect {DETERGENT COMPOSITION FOR MEDICAL DEVICE WITH EXCELLENT BIOFILM REMOVAL EFFECT}

The present invention relates to a cleaning composition for medical devices having an excellent biofilm removal effect, and more particularly, a biofilm removal effect showing an effect of inhibiting corrosion of medical devices while exhibiting an excellent removal effect on biofilms generated on medical devices relates to an excellent cleaning composition for medical devices.

Although medical devices are made of stainless steel, corrosion occurs during cleaning, disinfection and sterilization. In particular, dental medical devices have a high carbon content and are generally more prone to corrosion.

In addition, in the case of some medical devices, surface corrosion may proceed only under the condition of undergoing a desalination process for a long time, and a cleaning agent for medical devices containing a rust preventive agent is used to solve this problem.

On the other hand, in recent years, medical devices have become more sophisticated and advanced electronically with the development of electronic technology and medical procedures, leading to many developments in the use of devices and treatment of patients. As it is directly related to the qualitative management of the patient's level of care, hospitals tend to have their own management and a minimum of professional manpower.

In addition, the importance of cleaning, sterilization and disinfection of medical devices has recently become more important, and accordingly, cleaning agents, disinfectants and disinfectants directly related to the level of medical care are inevitably used.

However, conventionally used cleaning agents for medical devices have a problem in that they have low cleaning power against biofilms generated in surgical instruments and tubular-type medical devices, and also cause corrosion in medical devices to reduce performance.

Korean Patent Registration No. 10-0978822 (2010.08.24.) Korean Patent Registration No. 10-1796892 (2017.11.06.)

SUMMARY OF THE INVENTION It is an object of the present invention to provide a cleaning composition for medical devices having an excellent biofilm removal effect that exhibits an effect of inhibiting corrosion of medical devices while exhibiting an excellent removal effect on biofilms generated on medical devices.

An object of the present invention is achieved by providing a cleaning composition for medical devices with excellent biofilm removal effect, comprising octenidine hydrochloride, a corrosion inhibitor, a surfactant, an enzyme and purified water.

According to a preferred feature of the present invention, the cleaning composition for medical devices having an excellent biofilm removal effect is 0.01 to 0.5% by weight of octenidine hydrochloride, 0.5 to 5% by weight of a corrosion inhibitor, 0.05 to 10% by weight of a surfactant, 0.1 to 1 of an enzyme It shall consist of weight % and the remaining amount of purified water.

According to a more preferred feature of the present invention, the octenidine hydrochloride is made of octenidine dihydrochloride.

According to a more preferred feature of the present invention, the corrosion inhibitor is trimethylenephosphonic acid, aminotrimethylenephosphonate, etidronic acid, etidronic acid salt, diethylenetriaminepentamethylenephosphonic acid, ethylenebisnitrilodimethylenetetraphos phonic acid, nitrilotriacetic acid, tiludronate, pamidronate, alendronate, ibandronate, risedronate, zoledronate, citric acid, citrate, glycolic acid and ethylenediaminetetraacetic acid and ethylenediaminetetraacetic acid It shall consist of one or more selected from the group consisting of.

According to an even more preferred feature of the present invention, the surfactant is made of at least one selected from the group consisting of lauramine oxide, decylamine oxide, sorbitan oleate and lauryl sulfate.

According to an even more preferred feature of the present invention, the enzyme is made of at least one selected from the group consisting of amylase, lipase, protease and cellulase.

The cleaning composition for medical devices having an excellent biofilm removal effect according to the present invention exhibits an excellent effect of inhibiting corrosion of medical devices while exhibiting an excellent removal effect on biofilms generated on medical devices.

1 is a photograph showing the corrosion inhibitory effect of the cleaning composition prepared through Example 1 and Comparative Examples 1 to 3 of the present invention.
2 to 3 are photographs showing the biofilm removal effect of the cleaning composition prepared in Example 1 of the present invention by measuring it.
4 is a photograph showing the biofilm removal effect of the cleaning composition prepared in Example 1 of the present invention in comparison with other products.

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 cleaning composition for medical devices having an excellent biofilm removal effect according to the present invention consists of octenidine hydrochloride, a corrosion inhibitor, a surfactant, an enzyme and purified water, 0.01 to 0.5 wt% of octenidine hydrochloride, 0.5 to 5 wt% of a corrosion inhibitor , It is preferable to consist of 0.05 to 10% by weight of a surfactant, 0.1 to 1% by weight of an enzyme, and the remaining amount of purified water.

The octenidine hydrochloride is contained in an amount of 0.01 to 0.5% by weight. It is also a zwitterionic surfactant and is a kind of bis-(dihydropyridinyl)-decane] derivative in chemical structure and has 10 carbons It is a very long-ring line surfactant with both chains having octylaminopyridine derivatives on both side chains of decane alkyl containing

In addition, octenidine hydrochloride exhibits an excellent removal effect on biofilms generated on medical devices due to its strong cleaning power as well as sterilization and disinfection power, and it can exhibit excellent cleaning power without applying physical force to medical devices in the form of tubes. In this case, the octenidine hydrochloride is preferably composed of octenidine dihydrochloride.

When the content of the octenidine hydrochloride is less than 0.01% by weight, the cleaning power and the biofilm removal effect of the cleaning composition according to the present invention are reduced, and when the content of the octenidine hydrochloride exceeds 0.5% by weight, the effect is greatly increased Skin toxicity is increased without improvement.

Octenidine dihydrochloride, which is octenidine hydrochloride used in the present invention, is shown in Structural Formula 1 below.

<Structural formula 1>

The corrosion inhibitor is contained in an amount of 0.5 to 5% by weight, and serves to impart an anticorrosive effect to the cleaning composition according to the present invention. A phosphoric acid-based corrosion inhibitor or an organic acid-based corrosion inhibitor may be used, and trimethylenephosphonic acid (Trimethylene) phosphonic acid), aminotrimethylenephosphonate, etidronic acid, etidronic acid, diethylenetriamine pentamethylenephosphonic acid (Diethylenetriamine penta(methylene phosphonic acid)), ethylenebis(nitrilodimethylene)tetraphosphonic acid )tetraphosphonicacid), Nitrilotriacetic acid, Tiludronate, Pamidronate, Alendronate, Ibandronate, Risedronate, Zoledronate (Zoledronate), citric acid, citrate, glycolic acid, and preferably composed of at least one selected from the group consisting of ethylenediaminetetraacetic acid and ethylenediaminetetraacetic acid.

When the content of the corrosion inhibitor is less than 0.5% by weight, the above effect is insignificant, and when the content of the corrosion inhibitor exceeds 5% by weight, the effect is not significantly improved and relatively octenidine hydrochloride, surfactant and As the content of enzymes is reduced, the cleaning power or the biofilm removal effect of the cleaning composition may be reduced.

The surfactant is contained in an amount of 0.05 to 10% by weight, and the sterilization power and sterilization rate can be improved without mixing an alcohol component such as phenoxyethanol in the detergent composition according to the present invention, and the detergent composition according to the present invention It serves to form this stable bubble.

At this time, the surfactant is preferably made of at least one selected from the group consisting of lauramine oxide, decylamine oxide, sorbitan oleate and lauryl sulfate. In this case, as a component of the surfactant, decylamine oxide or lauramine oxide When used, the detergent composition forms stable air bubbles without being sprayed into the air to provide the form of foam.

When the detergent composition forms stable bubbles and maintains the form of the foam without spraying, it is possible to provide a detergent composition with low lung toxicity.

When the content of the surfactant is less than 0.05% by weight, the above effect is insignificant, and when the content of the surfactant exceeds 10% by weight, the effect is not significantly improved and relatively octenidine hydrochloride, a corrosion inhibitor, etc. It is not preferable because the content of is excessively reduced.

The enzyme is contained in an amount of 0.1 to 1% by weight, and serves to further improve the cleaning power of the cleaning composition according to the present invention.

When the content of the enzyme is less than 0.1% by weight, the above effect is insignificant, and when the content of the enzyme exceeds 1% by weight, the effect is not significantly improved, and the content of octenidine hydrochloride and a preservative This is undesirable because it is excessively reduced.

Hereinafter, a method for manufacturing a cleaning composition for medical devices having excellent biofilm removal effect according to the present invention and physical properties of the cleaning composition prepared by the method will be described with reference to Examples.

<Example 1>

Octenidine hydrochloride (octenidine dihydrochloride) 0.2 wt%, corrosion inhibitor (ethidronic acid) 2 wt%, surfactant (lauramine oxide, Miwon Chemical MINOX L) 4 wt%, enzyme (protease) 0.5 wt% and The remaining amount of purified water was put into a mixing device equipped with a stirrer and stirred at a speed of 150 rpm for 10 minutes to prepare a cleaning composition for medical devices with excellent biofilm removal effect.

<Comparative Example 1>

A cleaning composition for medical devices was prepared in the same manner as in Example 1, but without using a corrosion inhibitor.

<Comparative Example 2>

A cleaning composition for medical devices was prepared in the same manner as in Example 1, except that 0.1 wt% of a corrosion inhibitor was used.

<Comparative Example 3>

The detergent composition described in Korean Patent Registration No. 10-1130643.

The corrosion inhibitory effect of the cleaning compositions prepared in Example 1 and Comparative Examples 1 to 3 was measured and shown in FIG. 1 below.

(However, for the corrosion inhibitory effect, the method of confirming the invention of rust by spraying the cleaning composition onto the medical device and checking the appearance after 72 hours was used.)

As shown in Figure 1 below, the cleaning composition prepared in Example 1 did not corrode the medical device even after 72 hours, whereas the medical device to which the cleaning composition of Comparative Example 1 was applied had a large amount of rust, Comparative Examples 2 and 3 In the case of , it was not visible with the naked eye, but a small amount of rust occurred.

In addition, the biofilm removal effect of the cleaning composition prepared in Example 1 was measured and shown in FIGS. 2 to 3 below.

{However, the biofilm removal effect of the cleaning composition prepared in Example 1 was compared with an aqueous solution of isopropyl alcohol (70% by mass) and purified water conventionally used to remove the biofilm, P. aeruginosa and S. aureus strains were cultured at 37 °C in a coverglass bottom dish to form a biofilm, then exposed to a detergent composition, isopropyl alcohol aqueous solution and purified water for a set time, and then stained with 2.5 μM SYTO and 5 μM propidium iodide. Afterwards, a method was used to confirm the living and dead cells by observing them with a fluorescence microscope.

In this case, as the biofilm, a S. aureus biofilm and a P.aeruginsa biofilm were used, and the surviving bacteria are green and the dead bacteria are red.}

As shown in FIG. 2 below, it can be seen that the S. aureus biofilm is immediately removed when the cleaning composition prepared in Example 1 is applied.

On the other hand, in the case of isopropyl alcohol (IPA, Isopropyl alcohol) aqueous solution, some surviving bacteria were detected up to 1 and 5 minutes, and a large amount of dead bacteria were detected at 10 and 20 minutes. is shown, and therefore, there is a possibility that living bacteria exist inside the dead bacteria.

In addition, as shown in FIG. 3 below, it can be seen that the P. aeruginsa biofilm is immediately removed when the cleaning composition prepared in Example 1 is applied.

In the case of P.aeruginsa biofilm, it forms a sticky biofilm while generating a lot of various extracellular polymeric substances (EPS). It can be seen that a considerable part remains without being removed.

In addition, the biofilm removal effect of the cleaning composition prepared in Example 1 and Comparative Example 3 was measured and shown in FIG. 4 below.

{However, the biofilm removal effect of the cleaning composition prepared in Example 1 was compared with the cleaning composition and purified water of Comparative Example 3 that are conventionally used to remove the biofilm, and P. aeruginosa and S. aureus strain was cultured at 37 °C in a coverglass bottom dish to generate a biofilm, and then exposed to the detergent composition of Example 1, the detergent composition of Comparative Example 3, and purified water for 30 minutes, 2.5 µM SYTO and 5 µM propidium iodide After staining, a method was used to confirm by observing live and dead cells with a fluorescence microscope.

In this case, as the biofilm, a S. aureus biofilm and a P.aeruginsa biofilm were used, and the surviving bacteria are green and the dead bacteria are red.}

As shown in Figure 4 below, it can be seen that the S. aureus biofilm is removed within 30 minutes when the cleaning composition prepared in Example 1 is applied.

On the other hand, it can be seen that in the detergent composition of Comparative Example 3, a significant level of surviving bacteria was detected, and in the case of purified water, there was almost no cleaning effect.

In addition, in the case of P. aeruginsa biofilm, a sticky biofilm is formed while generating a lot of various extracellular polymeric substances (EPS). It can be seen that it is completely removed within minutes.

Therefore, the cleaning composition for medical devices having an excellent biofilm removal effect according to the present invention suppresses corrosion of medical devices while exhibiting an excellent removal effect on biofilms generated on medical devices.

Although the present invention has been described in detail with reference to the embodiments above, it is obvious to those skilled in the art that various changes and modifications can be made within the scope of the technical spirit of the present invention, and it is natural that such variations and modifications fall within the scope of the appended claims.

Claims (6)

It consists of 0.01 to 0.5% by weight of octenidine hydrochloride, 0.5 to 5% by weight of a preservative, 0.05 to 10% by weight of a surfactant, 0.1 to 1% by weight of an enzyme, and the remaining amount of purified water,
The corrosion inhibitor consists of at least one selected from the group consisting of tiludronate, pamidronate, alendronate, ibandronate, risedronate, zoledronate, citric acid, citrate and glycolic acid,
The surfactant is a cleaning composition for medical devices with excellent biofilm removal effect, characterized in that it consists of decylamine oxide.
delete The method according to claim 1,
The octenidine hydrochloride is a cleaning composition for medical devices with excellent biofilm removal effect, characterized in that it consists of octenidine dihydrochloride.
delete delete The method according to claim 1,
The enzyme is an amylase, lipase, protease and a cleaning composition for medical devices with excellent biofilm removal effect, characterized in that consisting of at least one selected from the group consisting of cellulase.

Images