KR20040019569A - 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 - Google Patents

Abstract

PURPOSE: A medical instrument disinfectant containing the surfactant having an alcohol group at both terminals and its preparation method are provided, to prevent the problems due to the generation of bubbles without deterioration of the washing power. CONSTITUTION: The medical instrument disinfectant comprises 1.0-1.6 wt% of peracetic acid; 0.1-20 wt% of acetic acid; 1-6 wt% of hydrogen peroxide; 0.1-20 wt% of phosphoric acid; 0.1-5 wt% of 1,1-diphosphonic acid; 0.001-10 wt% of at least one surfactant represented by the formula 1; 0.001-5 wt% of a corrosion inhibitor; and the balance of purified water, reverse osmosis water or deionized water, wherein l, m and n are independently an integer of 1-50 and l+n is 2-50. Preferably the medical instrument is a hemodialysis unit or its peripheral device.

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 etc.

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

Since domestic hospitals perform dialysis twice or three times a day, the time for disinfection and cleaning of the device is short, and the possibility of contamination is very high. In particular, in the case of hemodialysis devices that are most widely used in Korea, the use of glucose-containing dialysis fluid is continuously increasing, so that the special sensors installed in the device are often contaminated, which makes it difficult to maintain the device. there was.

It is essential to use a disinfecting detergent for removing various hemodialysis apparatuses and scales generated inside the pipes and for peeling off biofilms. Currently, sodium hypochlorite is mainly used as a disinfectant cleaner for this purpose, and additionally citric acid, formalin or acetic acid is used once or twice a week. However, although sodium hypochlorite and acetic acid have some degree of bactericidal and descaling power, the high concentration of acetic acid used for descaling together with sodium hypochlorite is a major cause of instrument corrosion. In addition, the corrosion causes frequent breakdowns of the device, which results in shortening the life of the medical device. Moreover, not only waste of time, electricity and water, but also a problem of generating secondary environmental pollution by formalin and sodium hypochlorite occurs. In addition, there is still a problem that can not remove the scale, biofilm and bacterial spores, etc. in the dialysis apparatus pipe, there is a disadvantage that disinfection and cleaning is not completely made.

Meanwhile, a peracetic acid-based medical device disinfectant cleaner has been developed as a new detergent to solve the above problems (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, when sorbitan monopalmitate, polyoxyethylene cetyl ether, or the like is used in the conventional peracetic acid medical device disinfecting detergent, bubbles are generated because bubbles are not sufficiently suppressed, and bubbles are generated. In this case, there is a problem that sufficient disinfection is not achieved by preventing contact between the disinfectant and the medical device.

Therefore, the present inventors have conducted a study to prevent the disadvantages caused by the bubble generation, as a result, when used with a surfactant having an alcoholic group at both ends to the peracetic acid disinfecting detergent, there is no bubble during use at all The present invention has been completed by discovering that problems caused by bubble generation in a disinfectant cleaner can be solved.

Accordingly, an object of the present invention is to provide a medical device disinfecting cleaning agent containing a specific surfactant that does not have the problem of bubble generation while maintaining the cleaning and sterilizing power.

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 1.0 to 1.6% 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, And 0.001 to 10% by weight of at least one surfactant having a structure of formula (1), the remainder is a disinfecting detergent 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 surfactant used in the disinfectant cleaning agent of the present invention has a low surface tension and less bubbles generated when cleaning the medical device, thereby effectively solving the problems of the conventional medical device cleaning agent generated by using an antifoaming agent or the like. That is, the conventional disinfectant cleaners are used to cause the problem of damaging the endotoxin filter during the disinfection and cleaning of the hemodialysis apparatus by using an antifoaming agent to suppress bubbles, the disinfectant cleaner of the present invention does not cause such problems Do not.

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 1.0 to 1.6% by weight of peracetic acid, 0.1 to 20% by weight of acetic acid, and 1 to 6% by weight of hydrogen peroxide in the disinfecting detergent in equilibrium. Of course, these contents may deviate slightly from the above range for the purpose of sufficient detergency and sterilization power, but it should be interpreted as being included in the scope of the medical device disinfecting detergent 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 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%.

There is no particular limitation on a medical device capable of disinfection and cleaning using the medical device disinfecting cleaning agent of the present invention, but since it has an excellent effect on the removal of organic substances and scale generated during hemodialysis, it is used in a hemodialysis device or a peripheral device thereof. It is desirable.

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, 50 to 55% by weight and phosphoric acid and 1,1-diphosphonic acid, respectively 0.1 to 10% by weight, 0.1 to 1.0% by weight ;

Mixing 15-25% by weight acetic acid;

Mixing 15-20 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; 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 may be diluted with a diluent appropriately (for example, 1/10 to 1/50) as necessary to effectively disinfect and wash medical devices such as a hemodialysis device or a peripheral device thereof. 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

50 g of reverse osmosis water, 10 g and 1 g of phosphoric acid and 1,1-diphosphonic acid were mixed, followed by 20 g of acetic acid. 17 g of hydrogen peroxide was mixed thereto to form peracetic acid, and kept at 35 to 45 ° C. for 7 hours. Aged by stirring at room temperature, and then 2 g of polyoxyethylene and oxypropylene block copolymer of Koremul-PE62 (concentrated) were added to prepare a disinfectant cleaner for medical devices. The concentrations of peracetic acid and hydrogen peroxide in the obtained disinfecting detergents were 1.67% and 5.78%, respectively.

Example 2: 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 5 g of phosphoric acid was used, and the concentrations of peracetic acid and hydrogen peroxide in the disinfectant cleaners obtained were 1.08% and 5.96%, respectively.

Example 3: 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 5 g of phosphoric acid and 0.5 g of 1,1-diphosphonic acid were used, respectively, and the concentrations of peracetic acid and hydrogen peroxide in the disinfectant cleaners obtained were 1.30% and 5.86%.

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 15 g of acetic acid was used, and the concentrations of peracetic acid and hydrogen peroxide were 1.01% and 5.86%, respectively.

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

Except that 10g of acetic acid was used to prepare a medical device disinfecting detergent in the same manner as in Example 1, the concentration of peracetic acid and hydrogen peroxide in the obtained disinfecting detergent was 1.01% and 5.94%, respectively.

Example 6 Use of the Disinfecting Cleanser of the Present Invention

It was washed by the method described in Table 1 using the cleaning agent prepared in Example 1. That is, while using hemodialysis apparatus such as Gambrosa AK200Ultra for about 2 months, it was disinfected and washed under the following conditions.

brother Dilution ratio Cleaner dose (ml) Pre-rinse (ml) Infusion (minutes) Contact time (minutes) Post-rinse (minutes) manufacturer Model Number Gambro AK / 90/95 1/25-1/230 80 to 150 10 7 20 30 ~ Gambro AK100 1/35 60 10 3 ON 30 ~ Gambro AK200 Ultra 1/35 60 10 7 ON 30 ~ Gambro COBE C-3 1/9 250 - 9 to 45 - 18-30 Nikiso DBB22B / 26B - 60 to 80 30 - 30 30 Nipro NIPRO 1 / 43-1 / 45 100-110 10 10 to 15 90 30 Torrey TR-321 / 322 1/16 122-150 10 5 40-90 35 Baxter 450/550 / Median 1/35 255 2 516-50 30 6-25 Baxter 450/550 / Median 1 / 16.5 170 2 6-50 Set 23-30 Medi-Teck NHD-2000 1/35 250 10 20 20 60 Medi-Teck ALthin - 220 - 5 30 ~ 30 ~ Medi-Teck Touch-m 1/35 150 Set 7 8 7

* Set: arbitrarily adjusted

ON: over-night

As a result of using the disinfectant cleaner as described above, most of the hemodialysis apparatus currently in use was able to be effectively disinfected and washed without the generation of bubbles and shortening the life of the endotoxin filter.

According to the medical device disinfecting cleaning agent of the present invention, it is possible to disinfect and clean the hemodialysis device or its peripheral device without using an antifoaming agent. Can be prevented.

Claims (5)

1.0 to 1.6% 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, and at least having the structure of formula (1) A medical device disinfectant cleaner comprising 0.001 to 10% by weight of one surfactant, 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 disinfecting cleaner according to claim 1, wherein the medical device is a hemodialysis device or a peripheral device thereof. Mixing 50 to 55% by weight of purified water, reverse osmosis water, or deionized purified water with 0.1 to 10% by weight and 0.1 to 1.0% by weight of phosphoric acid and 1,1-diphosphonic acid, respectively; Mixing 15-25% by weight acetic acid; Mixing 15-20 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; 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 Wherein l, m and n are each an integer of 1 to 50, and the sum of l and n is 2 to 50.