KR100515928B1 - A composition for disinfecting and washing medical instruments comprising a surfactant having alcohol groups at the both terminals and a process for the preparation thereof 1 - Google Patents

Abstract

The present invention relates to a peracetic acid-based medical device disinfecting detergent comprising a surfactant having an alcoholic group at both ends, specifically, 0.08 to 0.35 wt% peracetic acid, 0.1 to 20 wt% acetic acid, 1 to 6 wt% hydrogen peroxide 0.1 to 20% by weight of phosphoric acid, 0.1 to 5% by weight of 1,1-diphosphonic acid, 0.001 to 10% by weight of at least one surfactant having a structure of Formula 1, and 0.001 to 5% by weight of a corrosion inhibitor, The remainder relates to a medical device disinfecting cleaning agent consisting of purified water, reverse osmosis water, or deionized purified water, and a method of manufacturing the same.

              One

Wherein l, m and n are each an integer of 1 to 50, and the sum of l and n is 2 to 50.

Description

A composition for disinfecting and washing medical instruments comprising a surfactant having alcohol groups at the both terminals and a process for the preparation Ya 1

The present invention relates to a peracetic acid type medical device disinfecting detergent comprising a surfactant having an alcoholic group at both ends and a corrosion inhibitor, and a method of manufacturing the same.

Since the endoscopy was implemented in the 1970s, with the development of modern science and technology, the development of endoscopy equipment has been expanded to various medical fields. As the number of endoscopic examinations is gradually increasing, it is important for the safe and efficient endoscopy to be preventive measures against hospital infections due to endoscopy as well as the ability and skills of endoscopy, the function of endoscopy equipment.

The glutaraldehyde-based disinfectants developed in the 1960s have a high level of recognition in terms of effectiveness and are still used. However, as the safety and environmental problems for users are reported, their use is increasingly limited. In recent years, the possibility of hospital infection by endoscopy is increasing for a variety of reasons, and in reality, there are many hospitals and clinics that examine several people in a row with one endoscope in Korea. It is very urgent. Around 1980, the United States, the United Kingdom, and Japan began to recognize the severity of hospital infections by endoscopy, providing institutional support for endoscopy disinfection, the assignment of dedicated personnel, and guidelines for how to disinfect endoscopy instruments. The search for continued. Endoscopic infections include infections not only of patients but also of endoscopy workers, including endoscopists, and thus require new awareness of hospital infections (eg, Helicobacter pylori, tuberculosis, etc.).

In addition to the endoscope device as described above, it is also essential to prevent hospital infection through sufficient cleaning in surgical instruments, general medical instruments, anesthesia, respirators or their peripheral devices, gynecological instruments, dental instruments, or herbal medical instruments. This can be called.

Conventional disinfectants (eg, glutaraldehyde, etc.), which have been used for cleaning the medical device in the past, have problems with fastness, efficacy of disinfection (previous sterilization level of 10 hours or more) and time problems (previous sterilization level). Is 30 minutes or more).

Meanwhile, peracetic acid-based medical device disinfectant cleaners containing peracetic acid, acetic acid, and hydrogen peroxide have been developed (WO 88/08667, WO 93/07909, WO WO). 94/14321, European Patent Publication No. EP 193,426, European Patent Publication No. EP 596493, US Patent No. US 6168,808, Korean Patent Publication No. 2000-49667, and the like.

The conventional peracetic acid-based medical device disinfectant cleaners contain peracetic acid, acetic acid, hydrogen peroxide, and purified water, and nonionic interfaces such as stabilizers such as phosphoric acid and phosphonic acid, sorbitan monopalmitate, and polyoxyethylene cetyl ether. Active agents, or amine oxides.

However, the peracetic acid disinfectant cleaner may be referred to as a product suitable for automatic washing and hand washing with fast disinfection, but in the case of a disinfectant detergent having a low peracetic acid content (for example, less than 1 wt%), Low cleaning power against contamination of organic matter is limited to its use. In addition, disinfectant cleaners with low peracetic acid content are mainly used for endoscopy instruments, forceps, and surgical instruments. Some of these instruments contain copper and zinc compounds, causing corrosion problems caused by peracetic acid disinfectant cleaners. do.

In addition, in the case of using a disinfectant detergent added with a surfactant in the conventional peracetic acid-based medical disinfectant detergent, bubbles are generated because bubbles are not sufficiently suppressed, and when bubbles are generated, contact between the disinfectant detergent and the medical device is generated. There is a problem that the sufficient disinfection and cleaning is not made by preventing the.

Accordingly, the present inventors have conducted a study to solve the problem in the low content peracetic acid-containing medical device disinfectant detergents, by adding a surfactant having a alcoholic group at both ends and a constant corrosion inhibitor to the peracetic acid disinfectant detergent When used, the present invention has been found to be able to minimize cleaning problems and corrosion problems, as well as to improve cleaning power.

Accordingly, an object of the present invention is to provide a medical device disinfecting cleaning agent containing a specific surfactant, while exhibiting high cleaning and sterilizing power, and minimizing the problems of bubble generation and corrosion.

It is also an object of the present invention to provide a method for producing the medical device disinfectant cleaner.

Medical device disinfectant cleaning agent of the present invention is 0.08 to 0.35% by weight peracetic acid, 0.1 to 20% by weight acetic acid, 1 to 6% by weight hydrogen peroxide, 0.1 to 20% by weight phosphoric acid, 0.1 to 5% by weight 1,1-diphosphonic acid, 0.001 to 10% by weight of at least one surfactant having a structure of Formula 1, and 0.001 to 5% by weight of a corrosion inhibitor, and the rest is a medical device disinfecting cleanser consisting of purified water, reverse osmosis water, or deionized purified water.

Wherein l, m and n are each an integer of 1 to 50, and the sum of l and n is 2 to 50.

The peracetic acid and hydrogen peroxide are components directly involved in the sterilization function which is a function of the disinfectant cleaner of the present invention, and each of these components will exist in an equilibrium state in the disinfectant cleaner of the present invention.

The phosphoric acid (phosphoric acid) and 1,1-diphosphonic acid (1,1-diphosphonic acid) is a mixed stabilizer, each structure is as follows.

Such, phosphoric acid and 1,1-diphosphonic acid has the effect of improving the scale removal ability of calcium carbonate, calcium sulfate, etc. in addition to stabilizing the peracetic acid and hydrogen peroxide in the disinfecting cleaning agent of the present invention. In addition, the disinfectant cleaning agent of the present invention gives an acidity for removing the scale of calcium carbonate, potassium carbonate and the like effectively by mixing phosphoric acid as a stabilizer. Therefore, the mixed stabilizer used in the present invention enables to prepare not only the effect as a stabilizer but also the acidity of the disinfectant cleaning agent in a preferable range.

In addition, any surfactant that is characteristically used in the present invention may be used as long as it has the structure of Formula 1.

              One

(Wherein l, m, and n are each an integer of 1 to 50, and the sum of l and n is 2 to 50).

Preferably, the surfactant is l + n, that is, the content of the ethylene oxide moiety is about 4 to 50 moles, and m, that is, the content of the propylene oxide moiety is about 5 to 40 moles. In addition, the molecular weight of the surfactant is preferably 1500 to 3000, more preferably about 2,500. In addition, as the surfactant usable in the present invention, commercially available surfactants having the above requirements, for example, polyoxyethylene and oxypropylene block copolymers such as the brand name Koremul-PE62 (ultra-concentrated) may be used.

The surfactants characteristically used in the disinfectant cleaner of the present invention have stability, low foaming ability, detergency and low toxicity to peroxides. Therefore, even if it contains a low content of peracetic acid can improve the cleaning power of the medical device disinfectant cleaner. In addition, since the surfactant has low surface tension and fewer bubbles generated during cleaning of the medical device, problems with the environment of the conventional medical device cleaning agent generated by using the antifoaming agent can be effectively solved.

Corrosion inhibitors that can be used in the medical device disinfecting cleaning agents of the present invention include aluminum silica, copper, and one or more selected from the group consisting of sodium silicate, sodium nitrate, sodium benzoate, benzotriazole, and polyacrylate copolymers. It is preferable because it has corrosion protection against zinc compounds and the like. Here, as the polyacrylate copolymer, a copolymer having a molecular weight of 50,000 to 100,000 is preferably a copolymer of pH 2-3, and commercially available acrysol (Acrysol, Rohm & Hass), Sokalan (Sokalan, BASF), TPA 50 (TPA50, Taechang Products) etc. can also be used.

The medical device disinfectant cleaning agent of the present invention may use water as a solvent, preferably purified water that is close to pure water and uncontaminated, and more preferably reverse osmosis water or deionized distilled water.

The content of all components contained in the medical device disinfecting detergent of the present invention indicates the content of the final disinfecting detergent in equilibrium.

That is, the content of the peracetic acid is 0.08 to 0.35% by weight, the acetic acid is 0.1 to 20% by weight, and the hydrogen peroxide is preferably 1 to 6% by weight in the disinfecting detergent in equilibrium. Of course, these contents may deviate slightly from the above range for the purpose of sufficient cleaning power and sterilization power, but it should be interpreted as being included in the scope of the medical device disinfecting cleaning liquid of the present invention.

In addition, it is preferable that phosphoric acid and 1,1-diphosphonic acid contained as a stabilizer and a descaling agent are contained in 0.1-20 weight% and 0.1-5 weight%, respectively. Of course, these contents may also slightly out of the above range for the purpose of sufficient stabilization and descaling effect, it should be construed to fall within the scope of the medical device disinfecting cleaning agent of the present invention.

As content of surfactant which has the structure of Formula (1) characteristically contained in this invention, 0.001-10 weight% is preferable, and 0.5-5 weight% is more preferable.

The corrosion inhibitor contained in the medical device disinfecting cleaning agent of the present invention is preferably 0.001 to 5% by weight. Of course, the content may be slightly out of the above range for the purpose of sufficient corrosion protection, it should be construed to fall within the scope of the medical device disinfecting cleaning agent of the present invention.

The content of purified water, reverse osmosis water, or deionized purified water used as a solvent or diluent in the disinfectant cleaner of the present invention is used in an amount suitable to satisfy the content of the above components in the final composition and to adjust the remaining amount to 100%.

Medical devices that can be cleaned using the medical device disinfectant cleaning agent of the present invention is not particularly limited, but endoscope equipment, surgical instruments, general medical equipment, anesthesia, respirator or peripherals thereof, obstetrics, dental, dental It is preferable to use the apparatus or the herbal medical apparatus.

The present invention includes a method for producing the medical device disinfectant cleaner.

That is, the present invention is a step of mixing purified water, more preferably reverse osmosis water or deionized purified water, 79 to 80% by weight and phosphoric acid and 1,1-diphosphonic acid, respectively 0.1 to 1.0% by weight, 0.1 to 10% by weight ;

Mixing 0.2 to 2.0 wt% acetic acid;

Mixing 5-7 wt% hydrogen peroxide to form peracetic acid;

Incubating the mixture at 35 to 45 ° C. for 4 to 7 hours and then aging at room temperature;

Mixing 0.001 to 5% by weight of one or more preservatives selected from the group consisting of sodium silicate, sodium nitrate, sodium benzoate, benzotriazole, polyacrylate copolymer; And

It includes a method for producing a medical device disinfecting cleaning agent comprising the step of mixing at least 0.001 to 10% by weight of at least one surfactant having a structure of formula (1).

In the preparation method, the warming step is for promoting the reaction of hydrogen peroxide and acetic acid, and the aging step is preferably a step of adjusting the content of hydrogen peroxide to an appropriate level, for example, 6 wt% or less, for about three days.

The medical device disinfectant cleaning agent uses a contact time of about 5 to 10 minutes, so that the endoscopic device, surgical instrument, general medical device, anesthesia machine, respirator or its peripheral device, gynecological device, dental device or oriental medical device It is possible to effectively clean such medical devices. Of course, the contact time can be reduced or increased as needed. The low concentration peracetic acid-containing disinfecting detergent according to the present invention does not need to be diluted separately, but may be used if appropriately diluted within the allowable range in the art if necessary. As a diluent, an aqueous solvent, Preferably purified water, reverse osmosis water, deionized purified water, etc. are preferable.

Hereinafter, the present invention will be described in more detail with reference to Examples. However, these Examples are intended to illustrate the present invention more specifically, but the scope of the present invention is not limited to these Examples.

Example 1 Preparation Example of Medical Device Disinfecting Cleanser of the Present Invention

Reverse osmosis water 88.3 g, phosphoric acid and 1,1-diphosphonic acid were mixed 1.0 g and 0.1 g, respectively, followed by 1 g of acetic acid. 6 g of hydrogen peroxide was mixed thereto to form peracetic acid, and kept at 35 to 45 ° C. for 7 hours. After aging by stirring at room temperature, 0.5 g of TPA 50 (TPA50, Taechang Products) was added, followed by 0.2 g of sodium benzoate, 0.2 g of benzotriazole, 0.5 g of sodium nitrate, and 0.1 g of sodium silicate. Thereafter, 2 g of polyoxyethylene and oxypropylene block copolymers of Koremul-PE62 (hyperconcentrate) were added to prepare a disinfectant cleaner for medical devices. The concentrations of peracetic acid and hydrogen peroxide in the obtained disinfecting detergents were 0.35% and 2.02%, respectively.

Example 2: Preparation of Medical Device Disinfecting Cleanser of the Present Invention

Except that 0.3g of acetic acid was used, a medical device disinfecting detergent was prepared in the same manner as in Example 1, and the concentrations of peracetic acid and hydrogen peroxide in the obtained disinfecting detergent were 0.20% and 2.10%, respectively.

Example 3: Preparation of Medical Device Disinfecting Cleanser of the Present Invention

Except that 0.1g of acetic acid was used, the medical device disinfecting detergent was prepared in the same manner as in Example 1, and the concentrations of peracetic acid and hydrogen peroxide were 0.09% and 2.20%, respectively.

Example 4 Preparation of Medical Device Disinfecting Cleanser of the Present Invention

A medical device disinfectant cleaner was prepared in the same manner as in Example 1 except that 0.3 g of acetic acid and 3.0 g of hydrogen peroxide were used, and the concentrations of peracetic acid and hydrogen peroxide in the disinfectant cleaners obtained were 0.18% and 1.01%, respectively.

Example 5 Preparation of Medical Device Disinfecting Cleanser of the Present Invention

Medical device disinfectant cleaners were prepared in the same manner as in Example 1, except that 0.1 g of acetic acid and 3.0 g of hydrogen peroxide were used, and the concentrations of peracetic acid and hydrogen peroxide were 0.08% and 1.05%, respectively.

Example 6 Corrosion Test (1)

After removing the corrosion products and impurities using the 70% nitric acid on the surface of the aluminum test piece, contact with the disinfectant detergent prepared in Example 1 for 5 hours, and after weighing the weight of the corrosion piece, the corrosion rate by the following formula Obtained.

Corrosion Rate = 534X (Weight Loss) / {(Density g / cm ³ ) X (Area of Corrosion Pieces in ² ) X (hour)}

The corrosion rate measured according to the above formula was 1.67 mm / yr. Accordingly, it can be seen that the disinfectant cleaner of the present invention significantly reduced the problem of corrosion as compared with the corrosion rate of 2.68 mm / yr of the conventional peracetic acid disinfectant cleaner.

Example 7 Corrosion Test (2)

The surface of the brass test piece was removed using 20% hydrochloric acid to remove the corrosion product and impurities, and then contacted with the disinfectant cleaner prepared in Example 1 for 30 minutes, and then the weight of the corrosion piece was measured. The corrosion rate was found to be 5.25 mm / yr. Accordingly, it can be seen that the disinfectant cleaner of the present invention significantly reduced the problem of corrosion as compared to the corrosion rate of 109.37 mm / yr of the conventional peracetic acid disinfectant cleaner.

Example 8 Wash / Disinfection Test

While using a commercially available endoscope (manufacturer: Olympus and Model No .: GIF-P20) for about one month, the sterilization power was tested by washing with the disinfecting detergent prepared in Example 1.

Sterilization and cleaning were performed based on the guidelines used by the Gastrointestinal Endoscopy Society. Samples and cultures were taken from two sites per endoscope for the disinfection of the endoscope.

While slowly injecting 30 ml of physiological saline into the suction channel through the biopsy hole using a 50 ml syringe, water falling to the end of the insert was collected in a sterile tube (S-1 sample). In addition, between the end of the endoscope insertion portion and the body connecting portion was smeared with a cotton swab soaked with saline (S-2 sample). In order to confirm the bacterial contamination of the endoscope auto washer itself, 100 ml of the rinse solution passed through the filter was collected twice.

Samples obtained from the rinse solution of the S-1 probe and the endoscope auto washer were passed through a 0.22 μm cellulose nitrate membrane filter under negative pressure and immediately lifted a membrane filter and spread evenly on the blood agar medium. S-2 samples from cotton swabs were evenly inoculated directly into blood agar medium. The test results of bactericidal power are shown in Table 1 below.

S-1 sample S-2 sample Before disinfection After disinfection Before disinfection After disinfection 2.7 X 10 ³ - 5.3 X 10 ³ -

As can be seen in Table 1, it can be seen that the disinfectant cleaning agent of the present invention can effectively disinfect and clean the endoscope device, it was possible to effectively clean the endoscope device without foaming, and no problems of corrosion occurred. .

Example 9: Sterilization Test

The bactericidal activity against bacteria and fungi was tested as follows.

1. Bacterial bactericidal test

0.1 ml of the bacterial solution incubated in Nutrient broth and Tryptic soy broth for 24 hours and 10 ml of the disinfectant wash prepared in Example 1 were shaken and reacted for 1 minute. After 1 minute, 1 ml of the reaction solution was immediately added with 9 ml of neutralizing agent (4.26% sodium phosphate dibasic, 3% Tween, 0.5% sodium thiosulfate pentahydrate, 0.3% L-α-lecithin, and 0.1% L- Histidine). 1 ml of the mixture was taken and diluted 10-fold with peptone water. Each of the stock solution of the mixed solution and the diluted solution diluted 10-fold were prepared in advance and plated at least two by 0.1 ml in the solidified plate medium. After culturing for 3 days at 30-35 ° C. incubator, the number of colonies in each plate was measured and summed, and then divided by the number of used plates to calculate the average number of colonies per plate.

2. Fungal Sterilization Test

0.1 ml of the bacterial solution incubated in yeast malt broth for 48 hours and 10 ml of the disinfectant cleaner prepared in Example 1 were shaken and reacted for 10 minutes. After 10 minutes, 1 ml of the reaction was immediately added to 9 ml of neutralizing agent (4.26% sodium phosphate dibasic, 3% Tween, 0.5% sodium thiosulfate pentahydrate, 0.3% L-α-lecithin, and 0.1% L- Histidine). 1 ml of the mixture was taken and diluted 10-fold with peptone water. Each stock and 10-fold dilutions of the mixed solution were prepared in advance and plated with two or more 0.1 ml plates of solidified plate medium. After culturing for 7 days at 20 to 25 ° C. incubator, the number of colonies in each plate was measured and summed, and then divided by the number of plates used to calculate the average number of colonies per plate.

The bactericidal power test results for the bacteria and fungi are shown in Table 2 below.

Strain Initial strain Contact time (minutes) Final strain Staphylococcus Areus ATCC 6538 2.6 X 10 ⁷ One - Candida Albicans ATCC 10251 1.7 X 10 ⁶ 10 - MLS 3.4 X 10 ⁶ One - Escherichia coli ATCC 2592 5.6 X 10 ⁷ One - Pseudomonas eroginosa ATCC 9027 2.6 X 10 ⁶ One - Creep Sierra Funonia ATCC 10051 1.9 X 10 ⁷ One

As can be seen in Table 2, it can be seen that the disinfectant cleaner of the present invention has an effective bactericidal power against bacteria and fungi.

According to the medical device disinfecting cleaning agent of the present invention, it is possible to effectively increase the cleaning power without reducing the disinfecting power, as well as to minimize the problems caused by bubbles and corrosion problems.

Claims (6)

0.08 to 0.35% by weight peracetic acid, 0.1 to 20% by weight acetic acid, 1 to 6% by weight hydrogen peroxide, 0.1 to 20% by weight phosphoric acid, 0.1 to 5% by weight 1,1-diphosphonic acid, at least 1 having a structure of formula (1) A disinfectant cleaning agent comprising 0.001 to 10% by weight of surfactant, and 0.001 to 5% by weight of corrosion inhibitor, the remainder consisting of purified water, reverse osmosis water, or deionized purified water:               One Wherein l, m and n are each an integer of 1 to 50, and the sum of l and n is 2 to 50. The medical device disinfecting cleaning agent according to claim 1, wherein the average molecular weight of the surfactant is 1500 to 3000. The medical device disinfecting cleaning agent according to claim 2, wherein the average molecular weight of the surfactant is 2,500. The medical device disinfection according to claim 1, wherein the medical device is an endoscope device, a surgical instrument, a general medical device, an anesthesia device, a respirator or a peripheral device thereof, an gynecological device, a dental device, or a herbal medical device. cleaning solution. The medical device according to any one of claims 1 to 4, wherein the corrosion inhibitor is at least one selected from the group consisting of sodium silicate, sodium nitrate, sodium benzoate, benzotriazole and polyacrylate copolymer. Disinfectant Cleanser. Mixing 0.1-1.0 wt% and 0.1-10 wt% of purified water, reverse osmosis water, or deionized purified water, 79 to 80 wt% with phosphoric acid and 1,1-diphosphonic acid, respectively; Mixing 0.2 to 2.0 wt% acetic acid; Mixing 5-7 wt% hydrogen peroxide to form peracetic acid; Incubating the mixture at 35 to 45 ° C. for 4 to 7 hours and then aging at room temperature; Mixing 0.001 to 5% by weight of one or more preservatives selected from the group consisting of sodium silicate, sodium nitrate, sodium benzoate, benzotriazole, polyacrylate copolymer; And Method for producing a medical device disinfecting cleaning agent comprising the step of mixing at least 0.001 to 10% by weight of at least one surfactant having a structure of formula:               One In the above, l, m, and n are each an integer of 1-50, and the sum of l and n is 2-50.