Auxiliary agent for preparing a cleaning composition for medical equipment by blending with a chlorine-based oxidizing agent, and a cleaning composition for medical equipment using the same

Abstract

To provide an auxiliary capable of discharging to a sewage system as used after use, without necessitating use of a neutralizing treatment device or waste liquid recovery when discharging, capable of discharging as it is after use and for preparing a medical machine cleaning composition, and a medical machine cleaning composition using the same.SOLUTION: The present invention provides an auxiliary for formulating a cleaning composition for medical devices in combination with a chlorine-based oxidizing agent. The auxiliary of the invention contains a buffer solution and is adjusted to a pH of 5 to 7. The cleaning composition for medical devices obtained by the present invention is useful, for example, for cleaning and / or disinfecting liquid feed lines of dialysis devices. At the time of disposal, it can be directly discharged into the sewage system without the use of a neutralization device or the collection of the waste liquid at the time of discharging.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to an auxiliary agent for preparing a cleaning composition for medical instruments by blending with a chlorine-based oxidizing agent, and to a cleaning composition for medical instruments using the same. [Background technology]

[0002] Generally, strong alkaline sodium hypochlorite and cleaning or disinfecting agents containing sodium hypochlorite (hereinafter referred to as cleaning agents, etc.) are used to clean dialysis equipment.

[0003] However, the pH of solutions containing sodium hypochlorite for dialysis equipment cleaning agents and other products often does not meet sewerage discharge standards (generally pH 5.0 or higher and 9.0 or lower), and the resulting effluent cannot be directly disposed of in the sewer. Because the effluent has a strongly alkaline pH, its disposal requires the use of a designated neutralization treatment device or effluent collection by a specialized company. The installation of such neutralization treatment devices and the effluent collection work impose an excessive operational burden, particularly on small-scale dialysis treatment facilities and facilities that are tenants.

[0004] For example, the detergent for dialysis equipment described in Patent Document 1 contains sodium hypochlorite and is expected to have cleaning and sterilizing effects. However, the pH of the solution is relatively high, around 13, at the time of preparation. Therefore, it still does not comply with the effluent standards for sewerage systems, and disposal of the detergent requires the installation of a neutralization treatment device and wastewater recovery work as described above. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-249499 Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention addresses the above-mentioned problems, and its object is to provide an auxiliary agent for preparing a medical instrument cleaning composition by blending it with a chlorine-based oxidizing agent, which can be disposed of directly in the sewer after use without the need for a neutralization treatment device or wastewater recovery, and a medical instrument cleaning composition using the auxiliary agent. [Means for solving the problem]

[0007] The present invention is an auxiliary agent for preparing a medical device cleaning composition by blending with a chlorine-based oxidizing agent, the auxiliary agent containing a buffer and having a pH of 5 to 7.

[0008] In one embodiment, the buffer solution is at least one selected from the group consisting of phosphate buffer, acetate buffer, sodium citrate buffer, citrate phosphate buffer, sodium borate buffer, tartrate buffer, Tris buffer, phosphate buffered saline, and McIlvaine buffer.

[0009] In one embodiment, the coagent of the present invention further contains at least one second component selected from the group consisting of nitrogen compounds and acids.

[0010] In a further embodiment, the nitrogen compound is at least one compound selected from the group consisting of ammonia, melamine, urea, acetamide, sulfamic acid, sulfamide, cyclolamic acid, sulfamic acid, toluenesulfonamide, succinimide, phthalimide, isocyanuric acid, chloramine, N-chlorotoluenesulfonamide, uric acid, and saccharin, and salts thereof.

[0011] In a further embodiment, the acids are at least one acid selected from the group consisting of citric acid, malic acid, succinic acid, butyric acid, propionic acid, acetic acid, lactic acid, tartaric acid, fumaric acid, formic acid, hydrochloric acid, and nitric acid.

[0012] The present invention also provides a medical instrument cleaning composition containing the above auxiliary and a chlorine-based oxidizing agent, and having a pH of 4.75 to 9.24.

[0013] The present invention also provides a method for cleaning a medical device, which comprises the step of supplying the above-described medical device cleaning composition into the medical device. [Effects of the Invention]

[0014] According to the present invention, medical equipment such as dialysis machines and their accessories can be effectively cleaned and disinfected. The wastewater from cleaning and other processes can be directly discharged into the public sewer system after use, without the need for a special neutralization treatment device or collection by a specialized company. This allows the cleaning composition of the present invention to be widely used regardless of the size of facilities providing dialysis therapy and other treatments. These advantages can help establish small-scale facilities and contribute to the spread of dialysis therapy to a wider range of areas, including building tenant medical facilities, depopulated areas, and remote areas. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a graph showing the change in pH of the effluent obtained by cleaning a dialysis machine with the diluted detergent solution prepared in Example 10. [Figure 2] These photographs show the results of an evaluation of the cleaning ability of the cleaning diluents (E2) and (E3) prepared in Examples 2 and 3, three days after their preparation, to remove purified beef protein residues from a stainless steel plate. (a) is a photograph showing the purified beef protein residues on the stainless steel plate before the cleaning, and (b) is a photograph showing the absence of residues on the stainless steel plate after the cleaning. DETAILED DESCRIPTION OF THE INVENTION

[0016] The present invention will be described in detail below.

[0017] (auxiliary agent) The auxiliary of the present invention is used to prepare a cleaning composition for medical instruments by mixing with a chlorine-based oxidizing agent.

[0018] Examples of medical devices to be cleaned include dialysis machines used in hemodialysis, medical ultrasonic cleaners, washer-disinfectors, and endoscope cleaners. The term "dialysis machine" as used herein encompasses artificial dialysis machines and their peripheral devices used in dialysis therapy (e.g., fluid delivery lines (dialysis tubing), fluid delivery pumps, RO water production systems, multi-person supply systems, and dialysate A and B dissolving systems). Such dialysis machines are necessary for producing and supplying purified dialysate. Unpurified dialysate not only causes harm to patients but also poses a risk of causing malfunctions of the dialysis machine. Furthermore, waste products that should be removed from the patient's blood may remain or deposit on the dialysis machine, creating a high need for cleaning these products. In the present invention, the medical device is preferably a dialysis machine because it allows for more effective cleaning.

[0019] The auxiliary of the present invention contains a buffer solution. Examples of such buffer solutions include phosphate buffer solutions (e.g., an aqueous solution containing sodium dihydrogen phosphate and disodium hydrogen phosphate); acetate buffer solutions (e.g., an aqueous solution containing acetic acid and sodium acetate); sodium citrate buffer solutions (e.g., an aqueous solution containing citric acid and trisodium citrate); citrate phosphate buffer solutions (e.g., an aqueous solution containing citric acid and disodium hydrogen phosphate); sodium borate buffer solutions (e.g., an aqueous solution containing sodium borate and sodium hydroxide); tartrate buffer solutions (e.g., an aqueous solution containing tartaric acid and sodium tartrate); Tris buffer solutions (e.g., an aqueous solution containing Tris base); phosphate buffered saline solutions (e.g., an aqueous solution containing sodium chloride, potassium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate), McIlvaine buffer solutions, and combinations thereof. Phosphate buffer solutions are particularly preferred because they are versatile and can appropriately control the pH of the cleaning composition when used in combination with a chlorine-based oxidizing agent, as described below.

[0020] The auxiliary agent of the present invention may contain a second component other than the buffer solution. This second component can prolong the cleaning and / or disinfecting effect on medical devices and, together with the buffer solution, can control the pH of the cleaning composition described below to an appropriate level. Examples of the second component include nitrogen compounds and / or acids.

[0021] Examples of nitrogen compounds include ammonia, melamine, urea, acetamide, sulfamic acid, sulfamide, cycloamic acid, sulfamic acid (amidosulfuric acid), toluenesulfonamide, succinimide, phthalimide, isocyanuric acid, chloramine, N-chlorotoluenesulfonamide, uric acid, saccharin, and salts thereof, and combinations thereof. Sulfamic acid is preferred because it can stably maintain the pH of the resulting cleaning composition, is versatile, and / or has little odor.

[0022] Examples of acids include citric acid, malic acid, succinic acid, butyric acid, propionic acid, acetic acid, lactic acid, tartaric acid, fumaric acid, formic acid, hydrochloric acid, and nitric acid, and combinations thereof. Citric acid and acetic acid, and combinations thereof, are preferred because they can stably maintain the pH of the resulting cleaning composition.

[0023] In the present invention, the second component is contained in an amount such that, when mixed with the buffer solution, the pH satisfies the range corresponding to the acceptable limit of pH desired as a sewerage effluent standard (for example, 5 to 9, preferably 5 to 7). The specific contents of the second component and buffering agent are not particularly limited, as they vary depending on the types of compounds constituting the second component, the type and composition ratio of the buffering agent (a compound that exhibits a buffering effect in water) contained in the buffer solution, etc., and an appropriate combination of contents can be selected by a person skilled in the art.

[0024] The auxiliary of the present invention may also contain water separately to dilute the buffer solution or the second component. Since the water is intended for use in cleaning medical devices, it is preferably purified water obtained by subjecting tap water to one or more of ion exchange, distillation, reverse osmosis, and ultrafiltration. The water is contained in an amount sufficient to dilute the buffer solution, for example, at a dilution ratio of 100 times or less, preferably 50 times or less, based on the solution. By including water in the auxiliary of the present invention at such a ratio, the resulting auxiliary itself has an appropriate pH, as described below.

[0025] Furthermore, the auxiliary of the present invention may contain other components. Examples of other components include preservatives such as chlorine-based oxidizing agents (e.g., sodium hypochlorite). The content of other components that may be contained in the auxiliary of the present invention is not particularly limited, and an appropriate amount can be selected by a person skilled in the art.

[0026] The auxiliary of the present invention has an overall pH of 5 to 7, preferably 5.5 to 7.0. The pH range of such an auxiliary satisfies the allowable pH limit (5.0 or more and 9.0 or less) required for sewage effluent standards.

[0027] The auxiliary of the present invention is used as a component of the cleaning composition described below. This maintains or improves the cleaning ability of the resulting cleaning composition, and maintains a pH that allows for disposal into a sewer system as is, regardless of whether the composition is used or not. The term "cleaning ability" as used herein refers to a property required for cleaning medical devices, such as the ability to remove contaminants and impurities adhering to the medical device, and / or the ability to reduce or inhibit the progression of alteration, decomposition, or deterioration of the materials constituting the medical device when removing contaminants and impurities from the medical device. Thus, when formulated into a cleaning composition, the auxiliary of the present invention can maintain or improve the properties associated with such cleaning ability for a predetermined period of time.

[0028] (Cleaning composition for medical devices) The cleaning composition of the present invention is used for cleaning and / or disinfecting medical equipment, and contains the above-mentioned auxiliary agent and a chlorine-based oxidizing agent. The cleaning composition of the present invention has liquid properties.

[0029] The chlorine-based oxidizing agent is composed of a compound having excellent oxidizing power, and examples thereof include sodium hypochlorite, sodium dichloroisocyanurate, potassium dichloroisocyanurate, calcium hypochlorite, sodium chlorite, potassium chlorite, chlorine dioxide, and combinations thereof. The chlorine-based oxidizing agent is preferably sodium hypochlorite, because of its strong oxidizing power, its versatility, and its wide application in cleaning dialysis equipment.

[0030] The content of the chlorine-based oxidizing agent in the cleaning composition of the present invention is not particularly limited, but is preferably 200 ppm to 1000 ppm, more preferably 300 ppm to 500 ppm. If the content of the chlorine-based oxidizing agent in the cleaning composition is less than 200 ppm, the cleaning power of the composition as a whole may be insufficient, and a larger amount of the cleaning composition may be required to clean medical instruments. If the content of the chlorine-based oxidizing agent in the cleaning composition is more than 1000 ppm, the pH of the cleaning composition itself increases both before and after cleaning, and if left as is, it may be difficult to meet the allowable pH limit (5.0 to 9.0) required for sewage discharge standards, for example.

[0031] The cleaning composition of the present invention may also contain water. The water may be water that has been contained in the above-mentioned auxiliary agent, or water that has been newly added during the preparation of the cleaning composition. Since the water that can be added to the cleaning composition is intended for use in cleaning medical devices, it is preferably purified water obtained by subjecting ordinary water to one or more of ion exchange, distillation, reverse osmosis, and ultrafiltration.

[0032] The cleaning composition of the present invention has an overall pH of 4.75 to 9.24, preferably 5.00 to 9.00. When the pH of the cleaning composition is within this range, the pH of the effluent after cleaning a medical device satisfies, for example, the allowable pH limit (5.0 to 9.0) required for sewage discharge standards. As a result, the effluent after use can be directly disposed of in the sewer without the need for neutralization using a neutralization treatment device or effluent recovery by a specialized company.

[0033] Furthermore, after preparation, the cleaning composition of the present invention can maintain a substantially stable concentration of chlorine due to the chlorine-based oxidizing agent within the composition for a predetermined period of time, and the pH can be kept stable or only slightly changed within the period of time. As a result, the cleaning power of the prepared cleaning composition due to chlorine can be stably maintained for the predetermined period of time, and the composition can be disposed of as wastewater at any time.

[0034] (Method of cleaning medical equipment) Next, a method for cleaning a medical device using the cleaning composition of the present invention will be described.

[0035] In the present invention, the cleaning composition is supplied from a fluid supply line of a medical device (e.g., a dialysis device). The fluid supply conditions (e.g., flow rate) for supply are not particularly limited and can be appropriately selected by those skilled in the art depending on the type, scale, etc. of the medical device used.

[0036] Materials of construction within medical devices onto which the cleaning composition can be applied include, but are not necessarily limited to, Teflon (registered trademark), polyvinyl chloride, silicone, stainless steel, polyethylene, polypropylene, fluororubber, nitrile rubber, polyvinyl chloride, polystyrene, acrylonitrile butadiene styrene (ABS) resin, and polytetrafluoroethylene (PTFE).

[0037] In the present invention, after the above-mentioned cleaning composition is supplied to the medical device, water (e.g., purified water) or the like may be supplied as needed, and the cleaning composition remaining in the medical device may be discharged.

[0038] In this way, the interior of the medical device is cleaned, and waste products derived from the patient's blood that have accumulated inside the medical device are effectively removed. [Example]

[0039] The present invention will be described in detail below with reference to examples, but the present invention is not limited to these examples.

[0040] (Reference Example 1, Comparative Examples 1 and 2: Preparation of Standard Cleaning Agent Solutions and Diluted Cleaning Agent Solutions) A 12% by mass sodium hypochlorite aqueous solution (food additive grade) was diluted twice with RO water to prepare a standard detergent solution (R1) with a chlorine concentration (hypochlorite ion concentration) of 60,000 ppm. Furthermore, this standard detergent solution (R1) was diluted with RO water to prepare a diluted detergent solution (C) with a hypochlorite ion concentration of 300 ppm. 300 ) and a cleaning agent standard solution (C 500 ) were prepared, respectively.

[0041] These cleaning agent standard solutions (R1) and cleaning agent dilution solutions (C 300 ) and (C 500 The pH of each of the samples was measured immediately after preparation and from 1 day to 10 days after preparation (at room temperature) using a pH meter (pH-33B, manufactured by Horiba Advanced Techno Co., Ltd.). The results are shown in Table 1.

[0042] [Table 1]

[0043] As shown in Table 1, the cleaning agent standard solution (R1) prepared in Reference Example 1 exhibited a generally stable pH range of 12.1 to 13.1 from immediately after preparation until 10 days had elapsed, whereas the cleaning agent diluents (C 300 ) and (C 500The pH of each of the detergent diluents (C) decreased immediately after preparation, and after 10 days, the pH had dropped to nearly 10. 300 ) and (C 500 ) is prone to pH fluctuations during storage and is therefore unstable. Furthermore, even after 10 days, it did not meet the sewerage discharge standards (pH 5.0 or higher and 9.0 or lower), and could not be disposed of directly in the sewer as wastewater; it was necessary to neutralize or dilute it to further lower the pH before it could be disposed of in the sewer.

[0044] (Examples 1 to 3: Preparation of standard detergent solutions and diluted detergent solutions) A phosphate buffer solution (aqueous solution of sodium dihydrogen phosphate and disodium hydrogen phosphate; manufactured by Mitejima Chemical Co., Ltd.) and RO water were added to a 12% by mass aqueous sodium hypochlorite solution (food additive grade) so that the phosphate ion concentration after preparation was 43 g / L, and sulfamic acid was further added so that the sulfamic acid (amidosulfuric acid) concentration after preparation was 1 / 7 of the total mass of the phosphate buffer used, thereby preparing a detergent standard solution (E1) with a hypochlorite ion concentration of 60,000 ppm.Furthermore, this detergent standard solution (E1) was diluted with RO water to prepare a detergent diluted solution (E2) with a chlorine concentration (hypochlorite ion concentration) of 300 ppm and a detergent standard solution (E3) with the same concentration of 500 ppm.

[0045] The pH of these detergent standard solution (E1) and diluted detergent solutions (E2) and (E3) was measured immediately after preparation and from 1 to 7 days after preparation using a pH meter (pH-33B, manufactured by Horiba Advanced Techno Co., Ltd.). Furthermore, as an indicator of cleaning ability, the chlorine concentration in the standard solution (E1) and diluted solutions (E2) and (E3) was measured visually using an "Aqua Check HC" manufactured by Nissan Chemical Co., Ltd. and "Hypochlorous Acid Test Paper (High Concentration)" manufactured by Kyoritsu Chemical Research Institute, Inc. The results are shown in Table 2.

[0046] [Table 2]

[0047] As shown in Table 2, the pH of the detergent standard solution (E1) and detergent diluents (E2) and (E3) prepared in Examples 1 to 3 decreased slightly immediately after preparation, but remained within the pH range of 8 to 9 even after 7 days. Both solutions met the sewerage discharge standard (pH 5.0 or higher and 9.0 or lower), indicating that they could be directly disposed of as wastewater in the sewer system. Furthermore, the detergent diluents (E2) and (E3), which were intended for use as actual detergents, maintained their chlorine concentrations at least from immediately after preparation until 5 days later, demonstrating that the hypochlorite ion-based cleaning ability was adequately maintained throughout this period. In particular, the pH range of detergent diluents (E2) and (E3) met the sewerage discharge standard and maintained adequate cleaning ability even after 5 hours, which is the time when detergents are prepared and used in a medical setting.

[0048] (Examples 4 to 6: Preparation of standard detergent solutions and diluted detergent solutions) Except for not adding sulfamic acid, a standard cleaning agent solution (E4) with a hypochlorite ion concentration of 60,000 ppm was prepared in the same manner as in Example 1. Furthermore, this standard cleaning agent solution (E4) was diluted with RO water to prepare a diluted cleaning agent solution (E5) with a chlorine concentration (hypochlorite ion concentration) of 300 ppm and a standard cleaning agent solution (E6) with the same concentration of 500 ppm.

[0049] Except for using these detergent standard solution (E4) and detergent diluted solutions (E5) and (E6), the pH of each solution was measured immediately after preparation and from 1 to 3 days after preparation in the same manner as in Example 1. In addition, the chlorine concentration in each of the detergent standard solution (E4), diluted solutions (E5), and diluted solutions (E6) was measured as an index of cleaning ability. The results are shown in Table 3.

[0050] [Table 3]

[0051] As shown in Table 3, the pH of the standard detergent solution (E4) and detergent diluents (E5) and (E6) prepared in Examples 4 to 6 decreased slightly immediately after preparation, but remained within the pH range of 8 to 9 even after three days. All of these solutions met the sewerage wastewater standards (pH 5.0 or higher and 9.0 or lower), indicating that they could be directly disposed of in the sewer system. Furthermore, the chlorine concentration of detergent diluents (E5) and (E6), which were intended for use as actual detergents, was roughly maintained at least from immediately after preparation until two days later, demonstrating that the hypochlorite ion-based cleaning ability was adequately maintained over this period.

[0052] (Examples 7 to 9: Preparation of standard detergent solutions and diluted detergent solutions) Citric acid was used instead of sulfamic acid, and the citric acid after preparation A cleaning agent standard solution (E7) with a hypochlorite ion concentration of 60,000 ppm was prepared in the same manner as in Example 1, except that the content of was added so as to be 1 / 7 times the total mass of the buffer solution (phosphate buffer) used. Furthermore, this cleaning agent standard solution (E7) was diluted with RO water to prepare a cleaning agent diluted solution (E8) with a chlorine concentration (hypochlorite ion concentration) of 300 ppm and a cleaning agent standard solution (E9) with the same concentration of 500 ppm.

[0053] Except for using these detergent standard solution (E7) and detergent diluted solutions (E8) and (E9), the pH of each solution was measured immediately after preparation and from 1 to 3 days after preparation in the same manner as in Example 1. In addition, the chlorine concentration in each of the standard solution (E7) and diluted solutions (E8) and (E9) was measured as an index of cleaning ability. The results are shown in Table 4.

[0054] [Table 4]

[0055] As shown in Table 4, the pH of the standard detergent solution (E7) and detergent diluents (E8) and (E9) prepared in Examples 7 to 9 decreased slightly immediately after preparation, but remained within the pH range of 6.5 to 7.5 even after three days. All of these solutions met the sewerage wastewater standard (pH 5.0 or higher and 9.0 or lower), indicating that they could be directly disposed of in the sewer system. Furthermore, the chlorine concentration of detergent diluents (E8) and (E9), intended for use as actual detergents, was roughly maintained at least from immediately after preparation until one day later, demonstrating that the hypochlorite ion-based cleaning ability was adequately maintained over this period.

[0056] Example 10: Cleaning of dialysis equipment and change in pH just before sewer pipe The standard cleaning agent solution (E1) prepared in Example 1 was diluted with RO water to prepare a diluted cleaning agent solution (E10) with a chlorine concentration (hypochlorite ion concentration) of 400 ppm. The pH of the diluted cleaning agent solution (E10) immediately after preparation was 9.00.

[0057] This diluted detergent solution (E10) was used to clean a dialysis machine as follows.

[0058] For the dialysis machine (manufactured by Nipro Corporation; located on the third floor of the facility) used on the patient, water was pumped through the dialysis tubing at a flow rate of 500 mL / min for the first 10 minutes of measurement, and then the diluted detergent solution (E10) obtained above was continuously pumped at a flow rate of 500 mL / min from 10 to 30 minutes after the start of measurement. Next, pumping of water through the dialysis machine was stopped (flow rate of 0 mL / min) from 30 to 90 minutes after the start of measurement, allowing the diluted detergent solution (E10) to remain in the dialysis tubing. After that, RO water was pumped through the dialysis tubing at a flow rate of 500 mL / min from 90 to 120 minutes after the start of measurement to wash out any remaining diluted detergent solution (E10). During this series of operations, wastewater from the dialysis tubing of the dialysis machine was sampled at regular intervals using a pH meter (pH-230SDJ) manufactured by Sato Shoji Co., Ltd., attached to the facility's sewer conduit (a single pipe dedicated to the dialysis machine). The results are shown in Figure 1.

[0059] As shown in Figure 1, the pH of the diluted detergent solution (E10) discharged from the dialysis machine and discarded into the sewerage pipe was always within the range of 5.0 to 9.0 during the 20 minutes (10 to 30 minutes from the start) during which it was continuously pumped, and during the 30 minutes (90 to 120 minutes) during which the diluted detergent solution (E10) was washed with RO water. This indicates that the pH of the effluent met the sewerage standards and could be discarded as is, without any additional neutralization or dilution procedures.

[0060] Example 11: Evaluation of cleaning ability of diluted detergent solutions Forty milliliters of each of the diluted detergent solutions (E2) and (E3) prepared in Examples 2 and 3, which had been left for three days after preparation, were poured into flat-bottom containers. TOSI (a test soil (simulated contaminant) conforming to ISO 15883, prepared by applying purified beef protein to a stainless steel plate with the same composition as human plasma proteins (hemoglobin, albumin, thrombin, and fibrinogen); manufactured by Nichion Corporation) was completely immersed in the solution for 60 minutes for cleaning. The amount of purified beef protein remaining on the stainless steel plate at the start of immersion (0 minutes) was set as 100, and the amount of the purified beef protein remaining at 30 and 60 minutes after immersion was visually confirmed and quantified. Furthermore, the degree of color development of both TOSI samples after 60 minutes was visually assessed using the protein color indicator "Amido Black 10B Solution" (manufactured by Fujifilm Wako Pure Chemical Corporation) after the color reaction. Furthermore, the pH of each diluted solution (E2) and (E3) in the flat-bottom pad at the start (0 min) and after immersion was completed were measured using a pH meter (pH-33B, manufactured by Horiba Advanced Techno Co., Ltd.). The results are shown in Table 5. Figure 2 shows the state of the TOSI surface immediately before the start of immersion and after 60 min of immersion, following a color reaction using the protein color indicator "Amido Black 10B Solution" (manufactured by Fujifilm Wako Pure Chemical Corporation).

[0061] [Table 5]

[0062] As shown in Table 5, both diluted detergent solutions (E2) and (E3) obtained in Examples 2 and 3 were able to completely remove purified beef protein from TOSI over a 60-minute period. In particular, before the immersion, red purified beef protein was present on the stainless steel plate of the TOSI (Figure 2(a)). However, after immersion in diluted detergent solutions (E2) and (E3) for 60 minutes, the purified beef protein residue had completely disappeared from the stainless steel plate (Figure 2(b)), and no color was observed in the color indicator reaction. This demonstrates that both diluted detergent solutions (E2) and (E3) are useful as cleaners for medical equipment such as dialysis machines.

[0063] (Example 12: Component Deterioration Test) The materials shown in Table 6 (stainless steel (SUS16), fluororesin, silicone resin, nitrile rubber, rigid polyvinyl chloride (PVC), flexible PVC, polyethylene (PE), polypropylene (PP), polystyrene (PS), polycarbonate (PC), acrylonitrile-butadiene-styrene resin (ABS), and polytetrafluoroethylene (PTFE)) whose masses A (g) had been measured in advance were completely immersed in 500 mL of the diluted detergent solution (E3) obtained in Example 3 (chlorine concentration (hypochlorite ion concentration) 500 ppm). The immersion state was maintained while the diluted detergent solution (E3) was renewed every three days.

[0064] After two weeks, the components were removed from the diluted detergent solution (E3), dried, and their masses B (g) were measured. The rate of change (%) in deterioration of each component was calculated using the following formula:

[0065]

number

[0066] Regarding this change rate (%), if the mass B (g) after immersion decreased compared to the mass A (g) before immersion, it was calculated as a negative percentage. The results are shown in Table 6.

[0067] (Comparative Example 3: Component Deterioration Test) Instead of the diluted detergent solution (E3), the detergent standard solution (C 500 The same procedure as in Example 12 was repeated except that 500 mL of the standard solution (C ) (chlorine concentration (hypochlorous acid concentration) 500 ppm) was used. 500 The masses A and B (g) were measured before and after immersion in the solution, and the rate of change (%) was calculated. The results are shown in Table 6.

[0068] [Table 6]

[0069] As shown in Table 6, the diluted detergent solution (E3) prepared in Example 3 caused a slight decrease in mass (deterioration of components) after immersion in silicone resin and polyethylene (PE), but no deterioration was observed in other components. In contrast, the diluted detergent solution (C) prepared in Comparative Example 2 caused a slight decrease in mass (deterioration of components) after immersion in silicone resin and polyethylene (PE). 500 ) was observed to cause a significant decrease in mass (deterioration of components) after immersion in fluororesin, silicone resin, hard polyvinyl chloride (PVC), soft PVC, PE, and polycarbonate (PC), indicating that it has a strong tendency to accelerate component deterioration for a greater number of materials. [Industrial Applicability]

[0070] The present invention is useful for cleaning medical equipment such as artificial dialysis equipment.

Claims

1. An auxiliary agent for removing waste products from a patient's blood in a dialysis machine when combined with sodium hypochlorite, containing a buffer and having a pH of 5 to 7; The auxiliary agent, wherein the buffer solution is at least one selected from the group consisting of phosphate buffer, sodium citrate buffer, citrate phosphate buffer, sodium borate buffer, tartrate buffer, Tris buffer, phosphate buffered saline, and McIlvaine buffer.

2. The auxiliary according to claim 1, further comprising at least one second component selected from the group consisting of nitrogen compounds and acids.

3. 3. The auxiliary according to claim 2, wherein the nitrogen compound is at least one compound selected from the group consisting of ammonia, melamine, urea, acetamide, sulfamic acid, sulfamide, cyclolamic acid, sulfamic acid, toluenesulfonamide, succinimide, phthalimide, isocyanuric acid, chloramine, N-chlorotoluenesulfonamide, uric acid, and saccharin, and salts thereof.

4. 3. The auxiliary according to claim 2, wherein the acids are at least one acid selected from the group consisting of citric acid, malic acid, succinic acid, butyric acid, propionic acid, acetic acid, lactic acid, tartaric acid, fumaric acid, formic acid, hydrochloric acid, and nitric acid.

5. A composition for removing waste products from a patient's blood in a dialysis machine, comprising the auxiliary agent according to any one of claims 1 to 4 and sodium hypochlorite, and having a pH of 4.75 to 9.24.

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