WO2023171868A1 - Medical device detergent composition having excellent biofilm removal effect - Google Patents

Abstract

The present invention relates to a medical device detergent composition having an excellent biofilm removal effect, and comprises octenidine hydrochloride, a corrosion inhibitor, a surfactant, an enzyme and purified water. The medical device detergent composition comprising the ingredients inhibits the corrosion of a medical device while exhibiting an excellent removal effect on a biofilm formed on the medical device.

Description

Cleaning composition for medical devices with excellent biofilm removal effect

The present invention relates to a cleaning composition for medical devices with excellent biofilm removal effect, and more specifically, to a biofilm removal effect that exhibits an excellent removal effect for biofilms generated on medical devices while suppressing corrosion of medical devices. It relates to an excellent cleaning composition for medical devices.

Even though medical devices are made of stainless steel, corrosion occurs during the cleaning, disinfection, and sterilization process. In particular, dental medical devices have a high carbon content, so corrosion generally occurs more easily.

In addition, in the case of some medical devices, surface corrosion may occur simply under the condition of undergoing a long-term soaking process. To solve this problem, medical device cleaning agents containing rust inhibitors are used.

Meanwhile, in recent years, with the advancement of electronic technology and medical procedures, the trend towards precision and advanced electronics in medical devices has been prominent, bringing about great advancements in the use of devices and treatment of patients. In parallel, the correct use of medical devices and thorough follow-up management are essential. As it is directly related to the quality management of the patient's treatment level, hospitals are tending to maintain a minimum level of professional manpower along with their own management.

In addition, the importance of cleaning, sterilizing, and disinfecting medical devices has become more important in recent years, and accordingly, cleaners, disinfectants, and disinfectants that are directly related to the level of medical care are being used as a necessity.

However, conventionally used cleaners for medical devices not only have a low cleaning power against biofilms generated from surgical instruments and tubular-type medical devices, but also cause corrosion in medical devices, deteriorating their performance.

[Prior art literature]

[Patent Document]

(Patent Document 1) Republic of Korea Patent Registration No. 10-0978822 (2010.08.24.)

(Patent Document 2) Republic of Korea Patent Registration No. 10-1796892 (2017.11.06.)

The purpose of the present invention is to provide a cleaning composition for medical devices with excellent biofilm removal effect, which exhibits an excellent removal effect on biofilms generated on medical devices while also suppressing corrosion of medical devices.

The object of the present invention is achieved by providing a cleaning composition for medical devices with excellent biofilm removal effect, which is composed of 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 excellent biofilm removal effect includes 0.01 to 0.5% by weight of octenidine hydrochloride, 0.5 to 5% by weight of corrosion inhibitor, 0.05 to 10% by weight of surfactant, and 0.1 to 1% by weight of enzyme. It shall be composed of weight percent and remaining amount of purified water.

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

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

According to an even more preferred feature of the present invention, the surfactant is composed of one or more 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 composed of one or more selected from the group consisting of amylase, lipase, protease, and cellulase.

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

Figure 1 is a photograph showing the corrosion inhibition effect of the detergent composition prepared through Example 1 and Comparative Examples 1 to 3 of the present invention.

Figures 2 and 3 are photographs showing the biofilm removal effect of the detergent composition prepared in Example 1 of the present invention.

Figure 4 is a photograph showing the biofilm removal effect of the detergent composition prepared in Example 1 of the present invention compared with other products.

Below, preferred embodiments of the present invention and the physical properties of each component are described in detail, but are intended to be described in detail so that those skilled in the art can easily practice the invention. This does not mean that the technical idea and scope of the present invention are limited.

The cleaning composition for medical devices with excellent biofilm removal effect according to the present invention consists of octenidine hydrochloride, a corrosion inhibitor, a surfactant, an enzyme, and purified water, including 0.01 to 0.5% by weight of octenidine hydrochloride and 0.5 to 5% by weight of a corrosion inhibitor. , it is preferably composed of 0.05 to 10% by weight of surfactant, 0.1 to 1% by weight of enzyme, and the balance of purified water.

The octenidine hydrochloride contains 0.01 to 0.5% by weight, and is also a zwitterionic surfactant. In terms of chemical structure, it is a type of bis-(dihydropyridinyl)-decane derivative and contains 10 carbon atoms. It is a very long cyclic surfactant with both chains having octylaminopyridine derivatives on both side chains of the decane alkyl containing , and at the same time, it exhibits strong sterilizing and disinfecting power.

In addition, octenidine hydrochloride not only has sterilization and disinfection power, but also has an excellent cleaning effect on biofilms generated on medical devices due to its strong cleaning power. It can also show excellent cleaning power on tubular medical devices without applying physical force. It serves to ensure that the octenidine hydrochloride is preferably octenidine dihydrochloride.

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

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

<Structural Formula 1>

The corrosion inhibitor contains 0.5 to 5% by weight and serves to impart a corrosion prevention 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 trimethylene phosphonic acid (Trimethylene) phosphonic acid), aminotrimethylenephosphonate, etidronic acid, etidronic acid, diethylenetriamine penta(methylene phosphonic acid), ethylenebis(nitrilodimethylene) )tetraphosphonicacid), Nitrilotriacetic acid, Tiludronate, Pamidronate, Alendronate, Ibandronate, Risedronate, Zoledronate (Zoledronate), citric acid, citrate, glycolic acid, and ethylenediaminetetraacetic acid and ethylenediaminetetraacetate.

If the content of the corrosion inhibitor is less than 0.5% by weight, the effect is minimal, and if the content of the corrosion inhibitor exceeds 5% by weight, the effect is not significantly improved and is relatively more effective than octenidine hydrochloride, surfactant and As the content of enzymes, etc. is reduced, the cleaning power or biofilm removal effect of the detergent composition may be reduced.

The surfactant contains 0.05 to 10% by weight, and not only improves sterilizing power and sterilization speed without mixing alcohol components such as phenoxyethanol in the detergent composition according to the present invention, but also improves the detergent composition according to the present invention. It plays a role in forming stable bubbles.

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

If 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 pulmonary toxicity.

If the content of the surfactant is less than 0.05% by weight, the above effect is minimal, and if the content of the surfactant exceeds 10% by weight, the effect is not significantly improved and is relatively more effective than octenidine hydrochloride, corrosion inhibitors, etc. It is undesirable because the content 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 detergent composition according to the present invention, and is preferably composed of one or more selected from the group consisting of amylase, lipase, protease, and cellulase.

If the enzyme content is less than 0.1% by weight, the effect is minimal, and if the enzyme content exceeds 1% by weight, the effect is not significantly improved, but the content of octenidine hydrochloride and corrosion inhibitor is relatively high. This is undesirable because it decreases excessively.

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

<Example 1>

Octenidine hydrochloride (octenidine dihydrochloride) 0.2% by weight, corrosion inhibitor (ethidronic acid) 2% by weight, surfactant (lauramine oxide, Miwon Chemical MINOX L) 4% by weight, enzyme (protease) 0.5% by weight, and The remaining amount of purified water was put into a mixing device equipped with a stirrer and stirred for 10 minutes at a speed of 150 rpm 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, but using 0.1% by weight of a corrosion inhibitor.

<Comparative Example 3>

Cleanser composition described in Korean Patent Registration No. 10-1130643.

The corrosion inhibition effect of the detergent composition prepared through Example 1 and Comparative Examples 1 to 3 was measured and shown in Figure 1 below.

(However, the corrosion inhibition effect was determined by spraying the cleaning composition on the medical device and checking the appearance 72 hours later to check whether rust had occurred.)

As shown in Figure 1 below, the detergent composition prepared in Example 1 did not corrode medical devices even after 72 hours, while the medical device to which the detergent composition of Comparative Example 1 was applied showed a large amount of rust, and Comparative Examples 2 and 3 In the case of , a small amount of rust occurred, although it was not clearly visible to the naked eye.

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

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

At this time, S.aureus biofilm and P.aeruginsa biofilm were used as the biofilm, with surviving bacteria in green and dead bacteria in red.}

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

On the other hand, in the case of isopropyl alcohol (IPA) aqueous solution, some surviving bacteria were detected at 1 and 5 minutes, and a large amount of dead bacteria were detected at 10 and 20 minutes, which indicates that the biofilm was killed after considerable growth. It is visible, and therefore there is a possibility that surviving bacteria exist inside the killed bacteria.

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

In the case of P.aeruginsa biofilm, it produces a lot of various extracellular polymer substances (EPS, Extracellular Polymeric Substance) and forms a sticky biofilm. In the case of isopropyl alcohol (IPA) aqueous solution, P.aeruginsa biofilm is immediately formed. You can see that it cannot be removed and a significant portion remains.

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

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

At this time, S.aureus biofilm and P.aeruginsa biofilm were used as the biofilm, with surviving bacteria in green and dead bacteria in red.}

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

On the other hand, a significant level of surviving bacteria was detected in the detergent composition of Comparative Example 3, and purified water had almost no cleaning effect.

In addition, in the case of P. aeruginsa biofilm, it produces a lot of various extracellular polymeric substances (EPS, Extracellular Polymeric Substance) and forms a sticky biofilm. The detergent composition prepared in Example 1 makes P. aeruginsa biofilm 30%. You can see that it is completely removed within minutes.

Therefore, the cleaning composition for medical devices with excellent biofilm removal effect according to the present invention exhibits excellent removal effect for biofilms generated on medical devices while suppressing corrosion of medical devices.

In the above, the present invention has been described in detail focusing on the embodiments, but it is obvious to those skilled in the art that various changes and modifications are possible within the technical scope of the present invention, and it is natural that such changes and modifications fall within the scope of the appended patent claims.

Claims (3)

1. It consists of 0.01 to 0.5% by weight of octenidine hydrochloride, 0.5 to 5% by weight of corrosion inhibitor, 0.05 to 10% by weight of surfactant, 0.1 to 1% by weight of enzyme, and the balance of purified water,

   The corrosion inhibitor consists of one or more selected from the group consisting of tiludronate, pamidronate, alendronate, ibandronate, risedronate, zoledronate, citric acid, citrate salt, and glycolic acid,

   A cleaning composition for medical devices with excellent biofilm removal effect, wherein the surfactant consists of decylamine oxide.
2. In claim 1,

   A cleaning composition for medical devices with excellent biofilm removal effect, wherein the octenidine hydrochloride is comprised of octenidine dihydrochloride.
3. In claim 1,

   A cleaning composition for medical devices with excellent biofilm removal effect, wherein the enzyme consists of one or more selected from the group consisting of amylase, lipase, protease, and cellulase.

Images