WO2020261771A1 - Peracetic acid composition for cleaning medical devices, and method for producing same - Google Patents

Peracetic acid composition for cleaning medical devices, and method for producing same Download PDF

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Publication number
WO2020261771A1
WO2020261771A1 PCT/JP2020/018593 JP2020018593W WO2020261771A1 WO 2020261771 A1 WO2020261771 A1 WO 2020261771A1 JP 2020018593 W JP2020018593 W JP 2020018593W WO 2020261771 A1 WO2020261771 A1 WO 2020261771A1
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mass
acid
cleaning
salt
sterilizing
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PCT/JP2020/018593
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French (fr)
Japanese (ja)
Inventor
和志 杉本
君塚　健一
守悟 佐藤
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三菱瓦斯化学株式会社
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Priority to JP2021527438A priority Critical patent/JPWO2020261771A1/ja
Publication of WO2020261771A1 publication Critical patent/WO2020261771A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
    • A01N25/22—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests containing ingredients stabilising the active ingredients
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
    • A01N25/30—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests characterised by the surfactants
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
    • A01N37/02—Saturated carboxylic acids or thio analogues thereof; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
    • A01N37/16—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group; Thio analogues thereof
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00—Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22—Organic compounds
    • C11D7/26—Organic compounds containing oxygen
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00—Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22—Organic compounds
    • C11D7/32—Organic compounds containing nitrogen
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00—Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22—Organic compounds
    • C11D7/36—Organic compounds containing phosphorus

Definitions

  • the sterilizing and cleaning composition may contain a phosphorus-based stabilizer as an additive.
  • the carboxylic acid-based stabilizer may be ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
  • the carboxylic acid stabilizer may be diethylenetriamine pentaacetic acid (DTPA) or a salt thereof.
  • the carboxylic acid-based stabilizer may be ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
  • the sterilizing and cleaning composition contains 0.0001 to 0.30% by mass of the phosphorus-based stabilizer and 0.0001 to 0.30% by mass of the above-mentioned and the carboxylic acid-based stabilizer. % May be included.
  • TPO Total Peroxide Concentration
  • the total peroxide concentration of the sterilization and cleaning composition was determined by the iodine reduction titration method. Specifically, about 0.1 g of the sample is precisely weighed, placed in a 250 mL Erlenmeyer flask, 100 mL of pure water is added, 10 mL of 1.8 mol / L sulfuric acid is added, and then 10 mL of a 10 mass% potassium iodide solution, 1 mass%. A few drops of ammonium molybdate solution were added to prepare a test solution.
  • ⁇ pH measurement> The pH of the cleaning composition and the diluted solution of the cleaning composition was measured using a pH meter (LAQUA, D-71S, manufactured by HORIBA, Ltd.).
  • Bacillus cereus standard strain (manufactured by Microbiologicals, product name: Bacillus cereus ATCC10876) was applied to MYP agar (manufactured by AZONE Co., Ltd., product name: Sanispec raw medium) and cultured at 35 ° C. for 7 days. Distilled sterilized water was added to this agar medium, and the cells were scraped off with a spreader and collected, and washed with sterilized distilled water by centrifugation. In order to obtain only the spore type, the bacteria that survived by heating at 80 ° C. for 10 minutes were used as a spore suspension.
  • the cleaning composition was appropriately diluted with sterilized distilled water to prepare a sample solution.
  • 0.5 mL of 1 mass% albumin solution and 50 ⁇ L of spore suspension were added to 4.5 mL of each sample solution, and the mixture was allowed to act at 25 ° C. for 120 minutes.
  • dilute 10-fold with 0.1 mol / L sterilized sodium thiosulfate solution and use a medium for detecting Bacillus cereus (manufactured by Nissui Pharmaceutical Co., Ltd., product name: Compact Dry X-BC) at 35 ° C. 48.
  • the cells were cultured for hours and the viable cell count was measured. In addition, the viable cell count of the spore suspension was measured and used as the viable cell count at the start.
  • the cleaning composition was appropriately diluted with pure water to prepare 50 g of a sample solution.
  • a washing evaluation indicator (Nescos IC WI, manufactured by Sakura Color Products Corporation) was immersed in each sample solution for 60 minutes, washed with 10 mL of pure water, and dried at room temperature.
  • the color difference ( ⁇ Eab) from the clean white part of the cleaning evaluation indicator was measured using a handy type spectrocolor difference meter (NF555, manufactured by Nippon Denshoku Industries Co., Ltd.) set to a C light source and a 2 degree field of view.
  • the protein removal rate was calculated from the ratio of the color difference after washing, with the color difference of the unwashed washing evaluation indicator as 100.
  • ⁇ Calcium carbonate dissolution amount test> The cleaning composition was appropriately diluted with pure water to prepare 50 g of a sample solution. Ca carbonate (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) was added little by little to each sample solution, and the dissolved weight was defined as the amount of Ca carbonate dissolved.
  • Example 1 22.0 g of pure water and 60% by mass of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, manufactured by Italmatch Japan Co., Ltd., product name: Dayquest 2010) 0.17 g, ethylenediaminetetraacetic acid disodium di.
  • HEDP 1-hydroxyethylidene-1,1-diphosphonic acid
  • Examples 15 to 20> The sterilizing and cleaning compositions having the concentrations shown in Table 2 were obtained in the same manner as in Example 1 except that the formulations were as shown in Table 2 and aged at 50 ° C. for 1 day. The sterilization and cleaning compositions were aged at 50 ° C. for 1 day after preparation, and the total peroxide concentration (TPO) was measured after 20 days at 25 ° C. to calculate the stability. The results are shown in Table 2.
  • Examples 21 to 22, Comparative Examples 7 to 12> A sterilizing and cleaning composition having the concentration shown in Table 3 was obtained in the same manner as in Example 1 except that the formulation was as shown in Table 3 and the mixture was aged at 25 ° C. for 21 days.
  • TPO total peroxide concentration
  • the results are shown in Table 3. The following were used as 50% phytic acid and NaOH shown in the table. 50% by mass phytic acid solution (50% phytic acid, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) Sodium hydroxide (NaOH, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.)
  • Example 102 Comparative Example 101>
  • the sterilizing and cleaning compositions having the concentrations shown in Table 7 were obtained in the same manner as in Example 101 except that the formulations were as described in Table 7. With respect to the obtained cleaning composition, the total peroxide concentration was measured 14 days after the preparation, and the stability was calculated. A pH measurement, a sterilization test, a protein removal test, and a calcium carbonate dissolution amount test were carried out, and the number of bacteria, the protein removal rate, and the calcium carbonate dissolution amount after 120 minutes were calculated. The results are shown in Tables 7 and 8.
  • the stability shown in Table 7 was evaluated in the same manner as in Example 101.
  • the following pyrophosphoric acids were used as the pyrophosphoric acids shown in the table. Pyrophosphoric acid (manufactured by Junsei Chemical Co., Ltd., product name: diphosphoric acid)
  • the composition for sterilization and cleaning of medical devices in which the stability of the peroxide is high, the wastewater meets the sewage exclusion standard, and the protein removing ability is improved by adding the additive. It has been shown that goods can be provided.

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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pest Control & Pesticides (AREA)
  • Dentistry (AREA)
  • Plant Pathology (AREA)
  • Zoology (AREA)
  • Environmental Sciences (AREA)
  • Agronomy & Crop Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Toxicology (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Detergent Compositions (AREA)

Abstract

[Problem] To provide a medical device sterilizing and cleaning composition that has high peroxide stability, meets sewage disposal standards when discarded, and has improved protein-removing ability. [Solution] The present invention provides a sterilization and cleaning composition that: contains 0.001 to15% by mass peracetic acid, 0.01 to 70% by mass acetic acid and/or a salt thereof, 0.001 to 25% by mass hydrogen peroxide, and water; and contains an additive, the pH value of the composition being 4.0 to 10.0.

Description

医療機器洗浄用過酢酸組成物及びその製造方法Peracetic acid composition for cleaning medical equipment and its manufacturing method
　本発明は、医療機器の殺菌・洗浄に適する殺菌及び洗浄用過酢酸組成物並びにその製造方法に関する。 The present invention relates to a sterilizing and cleaning peracetic acid composition suitable for sterilizing and cleaning medical devices, and a method for producing the same.
　従来、医療機器の殺菌・洗浄には、酸性やアルカリ性の薬品が使用されており、過酸水溶液もその１つである。しかしながら、酸性やアルカリ性の薬品が使用されるために、その廃液が下水排除基準を満たさないまま排水されて、コンクリート製の下水道管が損傷している例が後を絶たない。下水道管の損傷は、下水への排水ができなくなると共に、道路陥没を引き起こす可能性もあり、早急な対応が必要である。このような背景のもと、東京都下水道局は、２０１９年１月に、透析排水と下水道管についての注意喚起を発表した。東京都下水道局では、排水についての下水排除基準を水素イオン濃度（ｐＨ）が５を超え９未満の範囲内に収めることを求めている。 Conventionally, acidic and alkaline chemicals have been used for sterilization and cleaning of medical devices, and peracid aqueous solutions are one of them. However, due to the use of acidic and alkaline chemicals, the waste liquid is drained without satisfying the sewage exclusion standard, and there are many cases where the concrete sewer pipe is damaged. Damage to sewer pipes can prevent drainage to sewage and can cause road collapse, so immediate action is required. Against this background, the Tokyo Metropolitan Government Bureau of Sewerage announced in January 2019 a warning regarding dialysis drainage and sewer pipes. The Tokyo Metropolitan Government Bureau of Sewerage requires that the sewage exclusion standard for wastewater be within the range where the hydrogen ion concentration (pH) exceeds 5 and is less than 9.
　医療機器の殺菌・洗浄に用いる殺菌及び洗浄用過酢酸組成物としては、酸性の過酢酸水溶液（特許文献１）、アルミニウム腐食抑制性の酸性酸化剤含有組成物（特許文献２）、アルカリ性の殺菌洗浄用製剤（特許文献３）などが知られている。しかしながら、これらの組成物は、必ずしも排水についての下水排除基準を満たすものとは言えない。よって、依然として、配水管を傷めない洗浄剤が求められている。 Examples of the peracetic acid composition for sterilization and cleaning used for sterilization and cleaning of medical equipment include an acidic peracetic acid aqueous solution (Patent Document 1), an aluminum corrosion-suppressing acidic oxidizing agent-containing composition (Patent Document 2), and alkaline sterilization. A cleaning preparation (Patent Document 3) and the like are known. However, these compositions do not always meet the sewage exclusion criteria for wastewater. Therefore, there is still a demand for a cleaning agent that does not damage the water pipe.
特開2010-184868号公報Japanese Unexamined Patent Publication No. 2010-184868 ＷＯ2010/095231号公報WO2010 / 095231 特表2016-532634号公報Special Table 2016-532634
　過酸化物の安定性が高く、かつ排水が下水排除基準を満たす、医療機器殺菌及び洗浄用組成物が求められている。 There is a demand for medical device sterilization and cleaning compositions that have high peroxide stability and drainage that meets sewage exclusion standards.
　本発明者らは、鋭意検討を重ねた結果、添加剤を添加することにより、過酸化物の安定性が高く、排水が下水排除基準を満たし、かつタンパク除去力が向上した、医療機器殺菌及び洗浄用組成物を提供することができることを見出した。 As a result of diligent studies, the present inventors have improved the stability of peroxides, drainage meets sewage exclusion criteria, and improved protein removal ability by adding additives. It has been found that a cleaning composition can be provided.
　すなわち、本発明は、下記の実施形態を含む。 That is, the present invention includes the following embodiments.
　＜１＞
　過酢酸を０．００１～１５質量％、酢酸及び／又はその塩を０．０１～７０質量％、過酸化水素を０．００１～２５質量％、及び水を含み、
　添加剤を含み、
　前記組成物のｐＨ値が、４．０～１０．０である、殺菌及び洗浄用組成物。
　＜２＞
　前記添加剤が、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、カルボン酸系安定剤、及びすず酸塩からなる群より選択される１種以上である、
　＜１＞に記載の殺菌及び洗浄用組成物。
　＜３＞
　前記添加剤がポリオキシエチレンラウリルエーテル酢酸及び／又はその塩である、＜１＞又は＜２＞に記載の殺菌及び洗浄用組成物。
　＜４＞
　前記添加剤がリン系安定剤である、＜１＞～＜３＞のいずれかに記載の殺菌及び洗浄用組成物。
　＜５＞
　前記添加剤がカルボン酸系安定剤である、＜１＞～＜４＞のいずれかに記載の殺菌及び洗浄用組成物。
　＜６＞
　前記添加剤が、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、及びカルボン酸系安定剤である、＜１＞又は＜２＞に記載の殺菌及び洗浄用組成物。
　＜７＞
　前記リン系安定剤が、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩、ジエチレントリアミンペンタメチレンホスホン酸（ＤＴＰＰ）又はその塩のいずれかを含む、＜６＞に記載の殺菌及び洗浄用組成物。
　＜８＞
　前記カルボン酸系安定剤が、エチレンジアミン四酢酸（ＥＤＴＡ）又はその塩、ジエチレントリアミン五酢酸（ＤＴＰＡ）又はその塩のいずれかを含む、＜６＞に記載の殺菌及び洗浄用組成物。
　＜９＞
　前記リン系安定剤が、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩であって、
　前記カルボン酸系安定剤が、エチレンジアミン四酢酸（ＥＤＴＡ）又はその塩である、＜６＞に記載の殺菌及び洗浄用組成物。
　＜１０＞
　前記ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩を０．００１～５質量％含む、＜６＞～＜９＞のいずれかに記載の殺菌及び洗浄用組成物。
　＜１１＞
　前記リン系安定剤を０．０００１質量％以上０．５質量％未満、及び前記カルボン酸系安定剤を０．０００１質量％以上０．５質量％未満含む、＜６＞～＜９＞のいずれかに記載の殺菌及び洗浄用組成物。
　＜１２＞
　前記組成物のｐＨ値が、５．０～９．０である＜１＞～＜１１＞のいずれかに記載の組成物。
　＜１３＞
　少なくとも下記成分を混合する混合工程を含む、＜１＞～＜１２＞のいずれかに記載の組成物の製造方法。
　（ｉ）添加剤
　（ｉｉ）過酸化水素水及び酢酸
　（ｉｉｉ）酢酸塩
　＜１４＞
　少なくとも下記成分を混合する混合工程を含む、＜１＞～＜１２＞のいずれかに記載の組成物の製造方法。
　（ｉ）添加剤
　（ｉｉ）過酸化水素水及び酢酸
　（ｉｉｉ）アルカリ
　＜１５＞
　前記添加剤、酢酸及びアルカリを混合した後、３０～５０℃で過酸化水素水を混合する、＜１４＞に記載の製造方法。
　＜１６＞
　＜１＞～＜１２＞のいずれかに記載の組成物と、
　追加の水
とを含む、殺菌及び洗浄用希釈組成物。
　＜１７＞
　過酢酸を０．００１～１．５質量％、酢酸及び／又はその塩を０．０１～７質量％、過酸化水素を０．００１～２．５質量％、及び水を含み、
　添加剤を含み、
　前記組成物のｐＨ値が、４．０～１０．０である、＜１６＞に記載の殺菌及び洗浄用希釈組成物。
　＜１８＞
　＜１＞～＜１２＞のいずれかに記載の組成物又は＜１６＞若しくは＜１７＞に記載の希釈組成物を用いる、医療用器具の殺菌及び洗浄方法。
　＜１９＞
　前記医療用器具の殺菌及び洗浄方法が、浸漬法、噴霧法、塗布法、通液法、循環法、封入法から選択される、＜２０＞に記載の殺菌及び洗浄方法。
　＜２０＞
　前記医療用器具が、透析用器具である、＜１８＞又は＜１９＞に記載の殺菌及び洗浄方法。 <1>
It contains 0.001 to 15% by mass of peracetic acid, 0.01 to 70% by mass of acetic acid and / or a salt thereof, 0.001 to 25% by mass of hydrogen peroxide, and water.
Contains additives,
A composition for sterilization and cleaning, wherein the pH value of the composition is 4.0 to 10.0.
<2>
The additive is one or more selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a tin acid salt.
The sterilizing and cleaning composition according to <1>.
<3>
The sterilizing and cleaning composition according to <1> or <2>, wherein the additive is polyoxyethylene lauryl ether acetic acid and / or a salt thereof.
<4>
The sterilizing and cleaning composition according to any one of <1> to <3>, wherein the additive is a phosphorus-based stabilizer.
<5>
The sterilizing and cleaning composition according to any one of <1> to <4>, wherein the additive is a carboxylic acid-based stabilizer.
<6>
The sterilizing and cleaning composition according to <1> or <2>, wherein the additive is polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, and a carboxylic acid-based stabilizer.
<7>
The sterilization and sterilization according to <6>, wherein the phosphorus-based stabilizer contains either 1-hydroxyetidronic acid-1,1-diphosphonic acid (HEDP) or a salt thereof, diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof. Cleaning composition.
<8>
The sterilizing and cleaning composition according to <6>, wherein the carboxylic acid-based stabilizer contains any one of ethylenediaminetetraacetic acid (EDTA) or a salt thereof, diethylenetriamine pentaacetic acid (DTPA) or a salt thereof.
<9>
The phosphorus-based stabilizer is 1-hydroxyetidronic acid-1,1-diphosphonic acid (HEDP) or a salt thereof.
The sterilizing and cleaning composition according to <6>, wherein the carboxylic acid-based stabilizer is ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
<10>
The sterilizing and cleaning composition according to any one of <6> to <9>, which contains 0.001 to 5% by mass of the polyoxyethylene lauryl ether acetic acid and / or a salt thereof.
<11>
Any of <6> to <9>, which comprises 0.0001% by mass or more and less than 0.5% by mass of the phosphorus-based stabilizer and 0.0001% by mass or more and less than 0.5% by mass of the carboxylic acid-based stabilizer. The sterilizing and cleaning composition according to the above.
<12>
The composition according to any one of <1> to <11>, wherein the pH value of the composition is 5.0 to 9.0.
<13>
The method for producing a composition according to any one of <1> to <12>, which comprises a mixing step of mixing at least the following components.
(I) Additives (ii) Hydrogen peroxide solution and acetic acid (iii) Acetate <14>
The method for producing a composition according to any one of <1> to <12>, which comprises a mixing step of mixing at least the following components.
(I) Additives (ii) Hydrogen peroxide solution and acetic acid (iii) Alkali <15>
The production method according to <14>, wherein the additive, acetic acid and alkali are mixed, and then a hydrogen peroxide solution is mixed at 30 to 50 ° C.
<16>
The composition according to any one of <1> to <12> and
Diluted composition for sterilization and cleaning, including with additional water.
<17>
It contains 0.001 to 1.5% by mass of peracetic acid, 0.01 to 7% by mass of acetic acid and / or a salt thereof, 0.001 to 2.5% by mass of hydrogen peroxide, and water.
Contains additives,
The diluted composition for sterilization and cleaning according to <16>, wherein the pH value of the composition is 4.0 to 10.0.
<18>
A method for sterilizing and cleaning medical instruments using the composition according to any one of <1> to <12> or the diluted composition according to <16> or <17>.
<19>
The sterilization and cleaning method according to <20>, wherein the sterilization and cleaning method for the medical instrument is selected from a dipping method, a spraying method, a coating method, a liquid passing method, a circulation method, and an encapsulation method.
<20>
The sterilization and cleaning method according to <18> or <19>, wherein the medical device is a dialysis device.
　本発明によれば、添加剤を添加することにより、過酸化物の安定性が高く、排水が下水排除基準を満たし、かつタンパク除去力が向上した、医療機器殺菌及び洗浄用組成物を提供することができる。本発明の組成物は、ｐＨ値が下水排除基準を満たすため、使用後の廃液を中和処理する必要なく排水することができる。 According to the present invention, there is provided a composition for sterilizing and cleaning medical devices, in which the stability of peroxide is high, the wastewater meets the sewage exclusion standard, and the protein removing ability is improved by adding an additive. be able to. Since the pH value of the composition of the present invention satisfies the sewage exclusion standard, the waste liquid after use can be drained without the need for neutralization treatment.
　１．殺菌及び洗浄用組成物
　本発明の一実施形態において、殺菌及び洗浄用組成物は、過酢酸、過酸化水素、酢酸及び／又はその塩、及び水、ならびに添加剤を含む。 1. 1. Sterilizing and Cleaning Compositions In one embodiment of the invention, the sterilizing and cleaning composition comprises peracetic acid, hydrogen peroxide, acetic acid and / or salts thereof, and water, and additives.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、そのｐＨ値が４．０～１０．０であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、例えば、４．０、４．５、５．０、５．１、５．２、５．３、５．４、５．５、５．６、５．７、５．８、５．９、６．０、６．５、７．０、７．５、８．０，８．５、９．０，９．５、１０．０などであってよいが、これらの値に限定されない。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、例えば、４．０～１０．０、４．０～９．５、４．０～９．０、４．０～８．５、４．０～８．０、４．０～７．５、４．０～７．０、４．０～６．５、４．０～６．０であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、４．５～１０．０、４．５～９．５、４．５～９．０、４．５～８．５、４．５～８．０、４．５～７．５、４．５～７．０、４．５～６．５、４．５～６．０であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５．０～１０．０、５．０～９．５、５．０～９．０、５．０～８．５、５．０～８．０、５．０～７．５、５．０～７．０、５．０～６．５、５．０～６．０であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５．１～１０．０、５．１～９．５、５．１～９．０、５．１～８．５、５．１～８．０、５．１～７．５、５．１～７．０、５．１～６．５、５．１～６．０であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５．２～１０．０、５．２～９．５、５．２～９．０、５．２～８．５、５．２～８．０、５．２～７．５、５．２～７．０、５．２～６．５、５．２～６．０であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５．３～１０．０、５．３～９．５、５．３～９．０、５．３～８．５、５．３～８．０、５．３～７．５、５．３～７．０、５．３～６．５、５．３～６．０であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５．４～１０．０、５．４～９．５、５．４～９．０、５．４～８．５、５．４～８．０、５．４～７．５、５．４～７．０、５．４～６．５、５．４～６．０であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５．５～１０．０、５．５～９．５、５．５～９．０、５．５～８．５、５．５～８．０、５．５～７．５、５．５～７．０、５．５～６．５、５．５～６．０であってよい。本発明の好ましい実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５．０～９．０である。本発明のより好ましい実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５．０超である。本発明のより好ましい実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５超１０以下である。本発明のより好ましい別の実施形態において、殺菌及び洗浄用組成物のｐＨ値は、５超９以下である。 In one embodiment of the present invention, the sterilizing and cleaning composition may have a pH value of 4.0 to 10.0. In one embodiment of the invention, the pH values of the sterilizing and cleaning compositions are, for example, 4.0, 4.5, 5.0, 5.1, 5.2, 5.3, 5.4, 5 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 It may be 10.0, etc., but is not limited to these values. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition is, for example, 4.0 to 10.0 to 4.0 to 9.5, 4.0 to 9.0, 4.0 to 8. It may be 5.5, 4.0 to 8.0, 4.0 to 7.5, 4.0 to 7.0, 4.0 to 6.5, 4.0 to 6.0. In one embodiment of the invention, the pH values of the sterilizing and cleaning compositions are 4.5-10.0, 4.5-9.5, 4.5-9.0, 4.5-8.5. , 4.5 to 8.0, 4.5 to 7.5, 4.5 to 7.0, 4.5 to 6.5, 4.5 to 6.0. In one embodiment of the invention, the pH values of the sterilizing and cleaning compositions are 5.0 to 10.0, 5.0 to 9.5, 5.0 to 9.0, 5.0 to 8.5. , 5.0 to 8.0, 5.0 to 7.5, 5.0 to 7.0, 5.0 to 6.5, 5.0 to 6.0. In one embodiment of the invention, the pH values of the sterilizing and cleaning compositions are 5.1 to 10.0, 5.1 to 9.5, 5.1 to 9.0, 5.1 to 8.5. It may be 5.1 to 8.0, 5.1 to 7.5, 5.1 to 7.0, 5.1 to 6.5, 5.1 to 6.0. In one embodiment of the invention, the pH value of the sterilizing and cleaning composition is 5.2 to 10.0, 5.2 to 9.5, 5.2 to 9.0, 5.2 to 8.5. It may be 5.2 to 8.0, 5.2 to 7.5, 5.2 to 7.0, 5.2 to 6.5, 5.2 to 6.0. In one embodiment of the invention, the pH value of the sterilizing and cleaning composition is 5.3 to 10.0, 5.3 to 9.5, 5.3 to 9.0, 5.3 to 8.5. It may be 5.3 to 8.0, 5.3 to 7.5, 5.3 to 7.0, 5.3 to 6.5, 5.3 to 6.0. In one embodiment of the invention, the pH value of the sterilizing and cleaning composition is 5.4 to 10.0, 5.4 to 9.5, 5.4 to 9.0, 5.4 to 8.5. It may be 5.4 to 8.0, 5.4 to 7.5, 5.4 to 7.0, 5.4 to 6.5, 5.4 to 6.0. In one embodiment of the invention, the pH value of the sterilizing and cleaning composition is 5.5 to 10.0, 5.5 to 9.5, 5.5 to 9.0, 5.5 to 8.5. It may be 5.5 to 8.0, 5.5 to 7.5, 5.5 to 7.0, 5.5 to 6.5, 5.5 to 6.0. In a preferred embodiment of the present invention, the sterilizing and cleaning composition has a pH value of 5.0 to 9.0. In a more preferred embodiment of the invention, the sterilizing and cleaning composition has a pH value greater than 5.0. In a more preferred embodiment of the present invention, the pH value of the sterilizing and cleaning composition is more than 5 and less than 10. In another more preferred embodiment of the present invention, the pH value of the sterilizing and cleaning composition is greater than 5 and 9 or less.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、過酢酸を０．００１～１５質量％、酢酸及び／又はその塩を０．０１～７０質量％、過酸化水素を０．００１～２５質量％、及び水を含み、
　添加剤を含み、
　前記組成物のｐＨ値が、４．０～１０．０であってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition contains 0.001 to 15% by mass of peracetic acid, 0.01 to 70% by mass of acetic acid and / or a salt thereof, and 0.001 to 0.001% by mass of hydrogen peroxide. Contains 25% by weight and water,
Contains additives,
The pH value of the composition may be 4.0 to 10.0.
　本発明の一実施形態において、殺菌及び洗浄用組成物に含まれる添加剤は、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、カルボン酸系安定剤、及びすず酸塩からなる群より選択される１種以上であることができる。 In one embodiment of the present invention, the additive contained in the sterilizing and cleaning composition comprises polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a tin acid salt. It can be one or more selected from the group.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩を含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof as an additive.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、リン系安定剤を含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain a phosphorus-based stabilizer as an additive.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、カルボン酸系安定剤を含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain a carboxylic acid-based stabilizer as an additive.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、すず酸塩を含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain tin salt as an additive.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、リン系安定剤及びカルボン酸系安定剤を含むものであってよい。この実施形態において、殺菌及び洗浄用組成物は、添加剤として、すず酸塩をさらに含み得る。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain a phosphorus-based stabilizer and a carboxylic acid-based stabilizer as additives. In this embodiment, the sterilizing and cleaning composition may further comprise tinate as an additive.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、及びカルボン酸系安定剤を含むものであってよい。この実施形態において、殺菌及び洗浄用組成物は、添加剤として、すず酸塩をさらに含み得る。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, and a carboxylic acid-based stabilizer as additives. .. In this embodiment, the sterilizing and cleaning composition may further comprise tinate as an additive.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、及びリン系安定剤を含むものであってよい。この実施形態において、殺菌及び洗浄用組成物は、添加剤として、すず酸塩をさらに含み得る。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof, and a phosphorus-based stabilizer as additives. In this embodiment, the sterilizing and cleaning composition may further comprise tinate as an additive.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、及びカルボン酸系安定剤を含むものであってよい。この実施形態において、殺菌及び洗浄用組成物は、添加剤として、すず酸塩をさらに含み得る。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof, and a carboxylic acid-based stabilizer as additives. In this embodiment, the sterilizing and cleaning composition may further comprise tinate as an additive.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、添加剤として、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、及びすず酸塩を含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof, and a tin salt salt as additives.
　本発明の一実施形態において、上記の殺菌及び洗浄用組成物は、すず酸塩を０．０００１～５質量％の濃度で含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition described above may contain tin salt at a concentration of 0.0001 to 5% by mass.
　本発明の別の実施形態において、殺菌及び洗浄用組成物は、過酢酸を０．００１～１５質量％、酢酸及び／又はその塩を０．０１～７０質量％、過酸化水素を０．００１～２５質量％、及び水を含み、
　添加剤としてすず酸塩を含み、
　前記組成物のｐＨ値が、４．０～１０．０であってよい。 In another embodiment of the invention, the sterilizing and cleaning composition comprises 0.001 to 15% by weight of peracetic acid, 0.01 to 70% by weight of acetic acid and / or a salt thereof, and 0.001 by weight of hydrogen peroxide. Contains up to 25% by weight and water,
Contains tin salt as an additive,
The pH value of the composition may be 4.0 to 10.0.
　本発明の一実施形態において、上記の殺菌及び洗浄用組成物は、リン系安定剤及びカルボン酸系安定剤をさらに含み得る。本発明の殺菌及び洗浄用組成物において、前記リン系安定剤の濃度は０．０００１質量％以上０．５質量％未満であってよく、前記カルボン酸系安定剤の濃度は０．０００１質量％以上０．５質量％未満であってよい。 In one embodiment of the present invention, the above sterilizing and cleaning composition may further contain a phosphorus-based stabilizer and a carboxylic acid-based stabilizer. In the sterilization and cleaning composition of the present invention, the concentration of the phosphorus-based stabilizer may be 0.0001% by mass or more and less than 0.5% by mass, and the concentration of the carboxylic acid-based stabilizer is 0.0001% by mass. It may be more than 0.5% by mass and less than 0.5% by mass.
　以下、各成分について説明する。 Each component will be described below.
　（１）添加剤
　本発明の殺菌及び洗浄用組成物は、過酢酸、過酸化水素、酢酸及び／又はその塩、及び水を含み、添加剤をさらに含み得る。これらの添加剤を添加することにより、過酸化水素の安定性が向上するとともに、殺菌及び洗浄用組成物のｐＨ値を４．０～１０．０に調整することができる。さらに、本発明の殺菌及び洗浄用組成物は、ｐＨ値を上記の範囲に調整することができることにより、優れたタンパク除去力も達成することができる。本発明の殺菌及び洗浄用組成物は、添加剤として、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、カルボン酸系安定剤、及びすず酸塩からなる群より選択される１種以上を含むものであってよい。 (1) Additives The sterilizing and cleaning composition of the present invention contains peracetic acid, hydrogen peroxide, acetic acid and / or salts thereof, and water, and may further contain additives. By adding these additives, the stability of hydrogen peroxide can be improved, and the pH value of the sterilizing and cleaning composition can be adjusted to 4.0 to 10.0. Furthermore, the sterilizing and cleaning composition of the present invention can also achieve excellent protein removing ability by adjusting the pH value within the above range. The sterilizing and cleaning composition of the present invention is selected as an additive from the group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a tin acid salt. It may contain more than a seed.
　＜ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩＞
　本発明の殺菌及び洗浄用組成物は、添加剤として、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩を含み得る。本発明の殺菌及び洗浄用組成物は、添加剤としてポリオキシエチレンラウリルエーテル酢酸及び／又はその塩を単独で含んでもよく、リン系安定剤、カルボン酸系安定剤、及びすず酸塩からなる群より選択される１種以上と組み合わせて含んでもよい。本発明の殺菌及び洗浄用組成物において用いられ得るポリオキシエチレンラウリルエーテル酢酸及び／は、下記の一般式で表される。ポリオキシエチレンラウリルエーテル酢酸の塩は、例えばナトリウム塩、カリウム塩などであってよいが、これらに限定されない。ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩は、好ましくはポリオキシエチレンラウリルエーテル酢酸である。
　　Ｒ１－（Ｏ－Ｒ２）ｎ－Ｏ－Ｒ３－ＣＯＯＨ
　（式中、Ｒ１はラウリル基であり、Ｒ２はエチレン基であり、Ｒ３はメチレン基であり、ｎは１～３０の数を表す。） <Polyoxyethylene lauryl ether acetic acid and / or its salt>
The sterilizing and cleaning composition of the present invention may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof as an additive. The sterilizing and cleaning composition of the present invention may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof alone as an additive, and is a group consisting of a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a tin salt salt. It may be included in combination with one or more selected more. The polyoxyethylene lauryl ether acetic acid and / that can be used in the sterilizing and cleaning composition of the present invention is represented by the following general formula. The salt of polyoxyethylene lauryl ether acetic acid may be, for example, a sodium salt, a potassium salt, or the like, but is not limited thereto. The polyoxyethylene lauryl ether acetic acid and / or a salt thereof is preferably polyoxyethylene lauryl ether acetic acid.
R 1- (OR 2 ) n-OR 3- COOH
(In the formula, R 1 is a lauryl group, R 2 is an ethylene group, R 3 is a methylene group, and n represents a number from 1 to 30.)
　好ましい実施形態において、ｎは、２～２０であってよい。好ましい実施形態において、ｎは例えば、４、４．５、５、５．５、６、６．５、７、７．５、８、８．５、９、９．５、１０、１１、１２、１３、１４、１５であってよいが、これらに限定されない。より好ましい実施形態において、ｎは４．５又は１０である。 In a preferred embodiment, n may be 2 to 20. In a preferred embodiment, n is, for example, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12 , 13, 14, and 15, but are not limited thereto. In a more preferred embodiment, n is 4.5 or 10.
　本発明の殺菌及び洗浄用組成物において用いられるポリオキシエチレンラウリルエーテル酢酸及び／又はその塩の分子量は、３００～１２００であってよい。好ましい実施形態において、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩の分子量は、４００～１０００である。 The molecular weight of the polyoxyethylene lauryl ether acetic acid and / or a salt thereof used in the sterilizing and cleaning composition of the present invention may be 300 to 1200. In a preferred embodiment, the molecular weight of polyoxyethylene lauryl ether acetic acid and / or a salt thereof is 400-1000.
　本発明の殺菌及び洗浄用組成物において、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩の濃度は、０．００１～５質量％であってよい。ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩の濃度は、好ましくは０．０１～２質量％であってよく、より好ましくは０．０１～１質量％であってよい。 In the sterilizing and cleaning composition of the present invention, the concentration of polyoxyethylene lauryl ether acetic acid and / or a salt thereof may be 0.001 to 5% by mass. The concentration of polyoxyethylene lauryl ether acetic acid and / or a salt thereof may be preferably 0.01 to 2% by mass, and more preferably 0.01 to 1% by mass.
　＜リン系安定剤＞
　本発明の殺菌及び洗浄用組成物は、添加剤としてリン系安定剤を含み得る。リン系安定剤としては、過酸化水素を安定化し、かつ殺菌及び洗浄用組成物のｐＨ値を上記の範囲に調整することができるものであればいずれも使用できる。本発明の殺菌及び洗浄用組成物は、添加剤としてリン系安定剤を単独で含んでもよく、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、カルボン酸系安定剤、及びすず酸塩からなる群より選択される１種以上と組み合わせて含んでもよい。本発明の殺菌及び洗浄用組成物において用いることができるリン系安定剤としては、例えばピロリン酸又はその塩、リン酸又はその塩、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩、ジエチレントリアミンペンタメチレンホスホン酸（ＤＴＰＰ）又はその塩、ニトリロトリスメチレンホスホン酸又はその塩、２－ホスホノブタン－１，２，４－トリカルボン酸又はその塩、及びエチレンジアミンテトラメチレンホスホン酸又はその塩が挙げられるが、これらに限定されない。本発明の一実施形態において、リン系安定剤は、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩であってよい。本発明の別の実施形態において、リン系安定剤は、ジエチレントリアミンペンタメチレンホスホン酸（ＤＴＰＰ）又はその塩であってよい。本発明のさらに別の実施形態において、リン系安定剤は、ピロリン酸又はその塩であってよい。本発明の好ましい実施形態において、リン系安定剤は、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩であってよい。 <Phosphorus stabilizer>
The sterilizing and cleaning composition of the present invention may contain a phosphorus-based stabilizer as an additive. As the phosphorus-based stabilizer, any one that can stabilize hydrogen peroxide and adjust the pH value of the sterilizing and cleaning composition within the above range can be used. The sterilizing and cleaning composition of the present invention may contain a phosphorus-based stabilizer alone as an additive, and is a group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a carboxylic acid-based stabilizer, and a tin salt salt. It may be included in combination with one or more selected more. Examples of the phosphorus-based stabilizer that can be used in the sterilizing and cleaning composition of the present invention include pyrophosphate or a salt thereof, phosphoric acid or a salt thereof, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof. Examples include salts, diethylenetriaminepentamethylenephosphonic acid (DTPP) or salts thereof, nitrilotrismethylenephosphonic acid or salts thereof, 2-phosphonobutane-1,2,4-tricarboxylic acid or salts thereof, and ethylenediaminetetramethylenephosphonic acid or salts thereof. However, it is not limited to these. In one embodiment of the present invention, the phosphorus stabilizer may be 1-hydroxyetidron-1,1-diphosphonic acid (HEDP) or a salt thereof. In another embodiment of the invention, the phosphorus stabilizer may be diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof. In yet another embodiment of the present invention, the phosphorus-based stabilizer may be pyrophosphoric acid or a salt thereof. In a preferred embodiment of the present invention, the phosphorus-based stabilizer may be 1-hydroxyetidron-1,1-diphosphonic acid (HEDP) or a salt thereof.
　本発明の殺菌及び洗浄用組成物において、リン系安定剤の濃度は、０．０００１質量％以上０．５質量％未満であってよく、好ましくは０．０００１～０．３０質量％であってよく、より好ましくは０．０００１～０．２０質量％であり、さらにより好ましくは０．０００１～０．１０質量％であってよい。 In the sterilizing and cleaning composition of the present invention, the concentration of the phosphorus-based stabilizer may be 0.0001% by mass or more and less than 0.5% by mass, preferably 0.0001 to 0.30% by mass. It is better, more preferably 0.0001 to 0.20% by mass, and even more preferably 0.0001 to 0.10% by mass.
　＜カルボン酸系安定剤＞
　本発明の殺菌及び洗浄用組成物は、添加剤としてカルボン酸系安定剤を含み得る。カルボン酸系安定剤としては、過酸化水素を安定化し、かつ殺菌及び洗浄用組成物のｐＨ値を上記の範囲に調整することができるものであればいずれも使用できる。本発明の殺菌及び洗浄用組成物は、添加剤としてカルボン酸系安定剤を単独で含んでもよく、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、及びすず酸塩からなる群より選択される１種以上と組み合わせて含んでもよい。本発明の殺菌及び洗浄用組成物において用いることができるカルボン酸系安定剤としては、例えばエチレンジアミン四酢酸（ＥＤＴＡ）又はその塩、ジエチレントリアミン五酢酸（ＤＴＰＡ）又はその塩、ピコリン酸又はその塩、ジピコリン酸又はその塩、ニトリロ三酢酸又はその塩、Ｎ－（２-ヒドロキシエチル）エチレンジアミン－Ｎ，Ｎ’，Ｎ”－三酢酸又はその塩、トリエチレンテトラミン－Ｎ，Ｎ，Ｎ’，Ｎ”，Ｎ”’，Ｎ”’－六酢酸又はその塩、１，３-プロパンジアミン－Ｎ，Ｎ，Ｎ’，Ｎ’－四酢酸、１，３－ジアミノ－２－プロパノール－Ｎ，Ｎ，Ｎ’，Ｎ’－四酢酸、Ｎ－（２－ヒドロキシエチル）イミノ二酢酸又はその塩、Ｎ，Ｎ－ジ（２－ヒドロキシエチル）グリシン又はその塩、グリコールエーテルジアミン四酢酸、及び（Ｓ，Ｓ）－エチレンジアミン－Ｎ，Ｎ’－二コハク酸又はその塩が挙げられるが、これらに限定されない。本発明の一実施形態において、カルボン酸系安定剤は、エチレンジアミン四酢酸（ＥＤＴＡ）又はその塩であってよい。本発明の別の実施形態において、カルボン酸系安定剤は、ジエチレントリアミン五酢酸（ＤＴＰＡ）又はその塩であってよい。本発明の好ましい実施形態において、カルボン酸系安定剤は、エチレンジアミン四酢酸（ＥＤＴＡ）又はその塩であってよい。 <Carboxylic acid stabilizer>
The sterilizing and cleaning composition of the present invention may contain a carboxylic acid-based stabilizer as an additive. As the carboxylic acid-based stabilizer, any agent that can stabilize hydrogen peroxide and adjust the pH value of the sterilizing and cleaning composition within the above range can be used. The sterilizing and cleaning composition of the present invention may contain a carboxylic acid-based stabilizer alone as an additive, and is a group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, and a tin acid salt. It may be included in combination with one or more selected more. Examples of the carboxylic acid-based stabilizer that can be used in the sterilizing and cleaning composition of the present invention include ethylenediaminetetraacetic acid (EDTA) or a salt thereof, diethylenetriaminetetraacetic acid (DTPA) or a salt thereof, picolinic acid or a salt thereof, and dipicolin. Acid or its salt, nitrilotriacetic acid or its salt, N- (2-hydroxyethyl) ethylenediamine-N, N', N "-triacetic acid or its salt, triethylenetetramine-N, N, N', N', N "', N"'-hexacetic acid or a salt thereof, 1,3-propanediamine-N, N, N', N'-tetraacetic acid, 1,3-diamino-2-propanol-N, N, N' , N'-tetraacetic acid, N- (2-hydroxyethyl) iminodiacetic acid or a salt thereof, N, N-di (2-hydroxyethyl) glycine or a salt thereof, glycol etherdiaminetetraacetic acid, and (S, S). -Ethylenediamine-N, N'-disuccinic acid or a salt thereof can be mentioned, but is not limited thereto. In one embodiment of the present invention, the carboxylic acid-based stabilizer may be ethylenediaminetetraacetic acid (EDTA) or a salt thereof. In another embodiment of the invention, the carboxylic acid stabilizer may be diethylenetriamine pentaacetic acid (DTPA) or a salt thereof. In a preferred embodiment of the present invention, the carboxylic acid-based stabilizer may be ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
　本発明の殺菌及び洗浄用組成物において、カルボン酸系安定剤の濃度は、０．０００１質量％以上０．５質量％未満であってよく、好ましくは０．０００１～０．３０質量％であってよく、より好ましくは０．０００１～０．２０質量％であり、さらにより好ましくは０．０００１～０．１０質量％であってよい。 In the sterilizing and cleaning composition of the present invention, the concentration of the carboxylic acid-based stabilizer may be 0.0001% by mass or more and less than 0.5% by mass, preferably 0.0001 to 0.30% by mass. It may be more preferably 0.0001 to 0.20% by mass, and even more preferably 0.0001 to 0.10% by mass.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、
　前記リン系安定剤として、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩、ジエチレントリアミンペンタメチレンホスホン酸（ＤＴＰＰ）又はその塩のいずれかを含み、
　前記カルボン酸系安定剤として、エチレンジアミン四酢酸（ＥＤＴＡ）又はその塩、ジエチレントリアミン五酢酸（ＤＴＰＡ）又はその塩のいずれかを含み得る。 In one embodiment of the invention, the sterilizing and cleaning composition is
The phosphorus-based stabilizer contains either 1-hydroxyetidron-1,1-diphosphonic acid (HEDP) or a salt thereof, diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof, and comprises.
The carboxylic acid-based stabilizer may include either ethylenediaminetetraacetic acid (EDTA) or a salt thereof, diethylenetriamine pentaacetic acid (DTPA) or a salt thereof.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、
　前記リン系安定剤として、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩を含み、
　前記カルボン酸系安定剤として、エチレンジアミン四酢酸（ＥＤＴＡ）又はその塩を含み得る。 In one embodiment of the invention, the sterilizing and cleaning composition is
The phosphorus-based stabilizer contains 1-hydroxyetidronic acid-1,1-diphosphonic acid (HEDP) or a salt thereof.
The carboxylic acid-based stabilizer may include ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、前記リン系安定剤を０．０００１質量％以上０．５質量％未満、及び前記カルボン酸系安定剤を０．０００１質量％以上０．５質量％未満含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition contains 0.0001% by mass or more and less than 0.5% by mass of the phosphorus-based stabilizer and 0.0001% by mass or more of the carboxylic acid-based stabilizer. It may contain less than 5.5% by mass.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、前記リン系安定剤を０．０００１～０．３０質量％、及び前記及び前記カルボン酸系安定剤を０．０００１～０．３０質量％含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition contains 0.0001 to 0.30% by mass of the phosphorus-based stabilizer and 0.0001 to 0.30% by mass of the above-mentioned and the carboxylic acid-based stabilizer. % May be included.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、前記リン系安定剤を０．０００１～０．２０質量％、及び前記及び前記カルボン酸系安定剤を０．０００１～０．２０質量％含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition contains 0.0001 to 0.20% by mass of the phosphorus-based stabilizer and 0.0001 to 0.20% by mass of the above-mentioned and the carboxylic acid-based stabilizer. % May be included.
　本発明の一実施形態において、殺菌及び洗浄用組成物は、前記リン系安定剤を０．０００１～０．１０質量％、及び前記及び前記カルボン酸系安定剤を０．０００１～０．１０質量％含むものであってよい。 In one embodiment of the present invention, the sterilizing and cleaning composition contains 0.0001 to 0.10% by mass of the phosphorus-based stabilizer and 0.0001 to 0.10% by mass of the above-mentioned and the carboxylic acid-based stabilizer. % May be included.
　＜すず酸塩＞
　本発明の殺菌及び洗浄用組成物は、過酢酸、過酸化水素、酢酸及び／又はその塩、及び水を含み、添加剤としてすず酸塩を含み得る。すず酸塩を添加することにより、過酸化水素の安定性が向上するとともに、殺菌及び洗浄用組成物のｐＨ値を４．０～１０．０に調整することができる。本発明の殺菌及び洗浄用組成物は、添加剤としてすず酸塩を単独で含んでもよく、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、及びカルボン酸系安定剤からなる群より選択される１種以上の添加剤と組み合わせて含んでもよい。本発明において、すず酸塩は、例えば、すず酸ナトリウム、すず酸カリウム、すず酸ストロンチウムなどであってよいが、これらに限定されない。本発明の好ましい実施形態において、すず酸塩はすず酸ナトリウムであってよい。 <Stin salt>
The sterilizing and cleaning composition of the present invention contains peracetic acid, hydrogen peroxide, acetic acid and / or salts thereof, and water, and may contain tin acid salt as an additive. By adding the tin salt salt, the stability of hydrogen peroxide can be improved, and the pH value of the sterilizing and cleaning composition can be adjusted to 4.0 to 10.0. The sterilizing and cleaning composition of the present invention may contain tin acid salt alone as an additive, and comprises a group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, and a carboxylic acid-based stabilizer. It may be included in combination with one or more of the more selected additives. In the present invention, the tin salt salt may be, for example, sodium tin acid, potassium tin acid, strontium tin acid, and the like, but is not limited thereto. In a preferred embodiment of the present invention, the tin salt may be sodium tin.
　本発明の殺菌及び洗浄用組成物において、前記すず酸塩の濃度は、０．０００１～５質量％であってよく、好ましくは０．０００１～１質量％、より好ましくは０．０００１～０．５質量％、さらにより好ましくは０．０００１～０．２質量％であってよい。 In the sterilizing and cleaning composition of the present invention, the concentration of the tin salt salt may be 0.0001 to 5% by mass, preferably 0.0001 to 1% by mass, and more preferably 0.0001 to 0%. It may be 5% by mass, and even more preferably 0.0001 to 0.2% by mass.
　（２）その他の成分
　＜過酸化水素＞
　本発明の殺菌及び洗浄用組成物中には、過酸化水素が含まれる。本発明の殺菌及び洗浄用組成物中には、過酸化水素は、それ自体、殺菌・洗浄能力を有するため、組成物全体の殺菌・洗浄効果を高めるのに寄与するだけでなく、酢酸との平衡反応により十分な量の過酢酸の生成及び維持（水溶液中における安定性）に寄与している。よって、酢酸と過酸化水素との組み合わせにより、さらに本発明の組成物の殺菌・洗浄効果を高めることができる。 (2) Other components <Hydrogen peroxide>
Hydrogen peroxide is contained in the sterilizing and cleaning composition of the present invention. In the sterilizing and cleaning composition of the present invention, hydrogen peroxide itself has a sterilizing and cleaning ability, so that it not only contributes to enhancing the sterilizing and cleaning effect of the entire composition, but also with acetic acid. The equilibrium reaction contributes to the production and maintenance (stability in aqueous solution) of a sufficient amount of peracetic acid. Therefore, the combination of acetic acid and hydrogen peroxide can further enhance the bactericidal / cleaning effect of the composition of the present invention.
　本発明の殺菌及び洗浄用組成物中における過酸化水素の濃度は、０．００１～２５質量％であってよく、好ましくは０．００５～２０質量％、より好ましくは０．０１～１５質量％、さらにより好ましくは０．０２～１０質量％であってよい。過酸化水素の濃度が低すぎると酢酸との平衡反応により生成する過酢酸の量が十分でなく、本発明の殺菌・洗浄効果が十分に発揮されない場合がある。一方、過酸化水素の濃度が高すぎても前記効果は高まらず、かえって安全性に問題が生じる場合がある。 The concentration of hydrogen peroxide in the sterilizing and cleaning composition of the present invention may be 0.001 to 25% by mass, preferably 0.005 to 20% by mass, and more preferably 0.01 to 15% by mass. , Even more preferably 0.02 to 10% by mass. If the concentration of hydrogen peroxide is too low, the amount of peracetic acid produced by the equilibrium reaction with acetic acid may not be sufficient, and the bactericidal / cleaning effect of the present invention may not be sufficiently exhibited. On the other hand, if the concentration of hydrogen peroxide is too high, the effect will not be enhanced, and there may be a problem in safety.
　＜酢酸及び／又はその塩＞
　本発明の殺菌及び洗浄用組成物において用いられる酢酸としては、当技術分野で通常用いられるものを用いることができる。酢酸の塩としては、水溶液とした際にアルカリ性である酢酸塩であれば特に限定されず、例えば、酢酸ナトリウム、酢酸カリウム、酢酸リチウム、酢酸ベリリウム、酢酸マグネシウム、酢酸アルミニウム、酢酸カルシウム、酢酸ルビジウム、酢酸ストロンチウム、酢酸セシウム、酢酸バリウム、酢酸アンモニウムなどが挙げられる。 <Acetic acid and / or its salt>
As the acetic acid used in the sterilizing and cleaning composition of the present invention, acetic acid usually used in the art can be used. The salt of acetic acid is not particularly limited as long as it is an acetic acid salt that is alkaline when made into an aqueous solution. For example, sodium acetate, potassium acetate, lithium acetate, beryllium acetate, magnesium acetate, aluminum acetate, calcium acetate, rubidium acetate, etc. Examples thereof include strontium acetate, cesium acetate, barium acetate and ammonium acetate.
　本発明の殺菌及び洗浄用組成物中における酢酸及び／又はその塩の濃度は、０．０１～７０質量％であってよく、好ましくは０．０５～６０質量％であってよく、より好ましくは０．１～５５質量％であり、さらにより好ましくは０．２～５０質量％であってよい。 The concentration of acetic acid and / or a salt thereof in the sterilizing and cleaning composition of the present invention may be 0.01 to 70% by mass, preferably 0.05 to 60% by mass, and more preferably. It may be 0.1 to 55% by mass, and even more preferably 0.2 to 50% by mass.
　本発明の殺菌及び洗浄用組成物において、酢酸及び／又はその塩の濃度は、過酢酸の濃度の３．５～２５０倍であってよい。本発明の一実施形態において、酢酸及び／又はその塩の濃度は、過酢酸の濃度の３．５～２５０倍、３．５～１５０倍、３．５～１００倍、５～２５０倍、５～１５０倍、５～１００倍、１０～２５０倍、１０～１５０倍、１０～１００倍、などであってよい。本発明の好ましい実施形態において、酢酸及び／又はその塩の濃度は、過酢酸の濃度の１０～２５０倍、１０～１５０倍、１０～１００倍であってよい。酢酸及び／又はその塩の濃度が上記の濃度であれば、殺菌及び洗浄対象物に付着した炭酸カルシウム等のカルシウムスケールを十分に除去することができる。 In the sterilizing and cleaning composition of the present invention, the concentration of acetic acid and / or a salt thereof may be 3.5 to 250 times the concentration of peracetic acid. In one embodiment of the present invention, the concentration of acetic acid and / or a salt thereof is 3.5 to 250 times, 3.5 to 150 times, 3.5 to 100 times, 5 to 250 times, 5 times the concentration of peracetic acid. It may be up to 150 times, 5 to 100 times, 10 to 250 times, 10 to 150 times, 10 to 100 times, and the like. In a preferred embodiment of the present invention, the concentration of acetic acid and / or a salt thereof may be 10 to 250 times, 10 to 150 times, 10 to 100 times the concentration of peracetic acid. When the concentration of acetic acid and / or a salt thereof is the above concentration, calcium scale such as calcium carbonate adhering to the object to be sterilized and washed can be sufficiently removed.
　＜過酢酸＞
　本発明の殺菌及び洗浄用組成物において用いられる過酢酸としては、当技術分野で通常用いられるものを用いることができる。 <Peracetic acid>
As the peracetic acid used in the sterilization and cleaning composition of the present invention, those usually used in the art can be used.
　本発明の殺菌及び洗浄用組成物中における過酢酸の濃度は、０．００１～１５質量％であってよい。本発明の一実施形態において、殺菌及び洗浄用組成物中における過酢酸の濃度は、例えば、０．００１質量％、０．００５質量％、０．０１質量％、０．１質量％、０．３質量％、０．４質量％、０．５質量％、０．６質量％、１．０質量％、３．０質量％、４．０質量％、５．０質量％、１０質量％、１５質量％であってよいが、これらに限定されない。本発明の一実施形態において、殺菌及び洗浄用組成物中における過酢酸の濃度は、例えば、０．００１～１５質量％、０．００１～１０質量％、０．００１～５質量％、０．００１～３質量％、０．００５～１５質量％、０．００５～１０質量％、０．００５～５質量％、０．００５～３質量％、０．０１～１５質量％、０．０１～１０質量％、０．０１～５質量％、０．０１～３質量％、０．１～１５質量％、０．１～１０質量％、０．１～５質量％、０．１～３質量％、０．３～１５質量％、０．３～１０質量％、０．３～５質量％、０．３～３質量％、０．４～１５質量％、０．４～１０質量％、０．４～５質量％、０．４～３質量％、０．５～１５質量％、０．５～１０質量％、０．５～５質量％、０．５～３質量％、０．６～１５質量％、０．６～１０質量％、０．６～５質量％、０．６～３質量％、１．０～１５質量％、１．０～１０質量％、１．０～５質量％、１．０～３質量％、などであってよい。本発明の一実施形態において、殺菌及び洗浄用組成物中における過酢酸の濃度は、好ましくは０．００１～１０質量％であってよく、より好ましくは０．００５～５質量％であり、さらにより好ましくは０．０１～３質量％であってよい。 The concentration of peracetic acid in the sterilizing and cleaning composition of the present invention may be 0.001 to 15% by mass. In one embodiment of the present invention, the concentration of peracetic acid in the sterilizing and cleaning composition is, for example, 0.001% by mass, 0.005% by mass, 0.01% by mass, 0.1% by mass, 0. 3% by mass, 0.4% by mass, 0.5% by mass, 0.6% by mass, 1.0% by mass, 3.0% by mass, 4.0% by mass, 5.0% by mass, 10% by mass, It may be 15% by mass, but is not limited to these. In one embodiment of the present invention, the concentration of peracetic acid in the sterilizing and cleaning composition is, for example, 0.001 to 15% by mass, 0.001 to 10% by mass, 0.001 to 5% by mass, 0. 001 to 3% by mass, 0.005 to 15% by mass, 0.005 to 10% by mass, 0.005 to 5% by mass, 0.005 to 3% by mass, 0.01 to 15% by mass, 0.01 to 10% by mass, 0.01-5% by mass, 0.01-3% by mass, 0.1-15% by mass, 0.1-10% by mass, 0.1-5% by mass, 0.1-3% by mass %, 0.3 to 15% by mass, 0.3 to 10% by mass, 0.3 to 5% by mass, 0.3 to 3% by mass, 0.4 to 15% by mass, 0.4 to 10% by mass, 0.4 to 5% by mass, 0.4 to 3% by mass, 0.5 to 15% by mass, 0.5 to 10% by mass, 0.5 to 5% by mass, 0.5 to 3% by mass, 0. 6 to 15% by mass, 0.6 to 10% by mass, 0.6 to 5% by mass, 0.6 to 3% by mass, 1.0 to 15% by mass, 1.0 to 10% by mass, 1.0 to It may be 5% by mass, 1.0 to 3% by mass, and the like. In one embodiment of the present invention, the concentration of peracetic acid in the sterilizing and cleaning composition may be preferably 0.001 to 10% by mass, more preferably 0.005 to 5% by mass, and further. More preferably, it may be 0.01 to 3% by mass.
　＜その他の成分＞
　本発明の殺菌及び洗浄用組成物には、さらに必要に応じて、一般的な殺菌及び洗浄用薬剤等に使用される添加剤など、例えば界面活性剤、増粘剤、香料、着色剤、加水分解酵素等が適宜配合されていてもよい。本発明の殺菌及び洗浄用組成物中、過酸化水素、酢酸及び／又はその塩、過酢酸、及び必要に応じて添加する安定剤その他の添加剤以外の残分は、主として水である。 <Other ingredients>
The sterilizing and cleaning composition of the present invention further includes, as necessary, additives used in general sterilizing and cleaning agents and the like, for example, surfactants, thickeners, fragrances, colorants, and water additions. Degrading enzymes and the like may be appropriately blended. In the sterilizing and cleaning composition of the present invention, the residue other than hydrogen peroxide, acetic acid and / or salts thereof, peracetic acid, and stabilizers and other additives added as needed is mainly water.
　本発明の殺菌及び洗浄用組成物は、希釈することなくそのまま用いるか、あるいは任意の濃度に希釈して殺菌及び洗浄用希釈組成物とすることができる。希釈剤としては通常、水が用いられる。希釈剤として用いられる水は、例えば純水、超純水、蒸留水、精製水、注射用水、水道水などが用いられ得る。希釈倍率は、殺菌及び洗浄用希釈組成物として殺菌及び洗浄効果を発揮する濃度にすることができる希釈倍率であればよく、特に限定されないが、好ましくは１～１００００倍、より好ましくは１～１０００倍である。 The sterilizing and cleaning composition of the present invention can be used as it is without being diluted, or can be diluted to an arbitrary concentration to obtain a sterilizing and cleaning diluted composition. Water is usually used as the diluent. As the water used as the diluent, for example, pure water, ultrapure water, distilled water, purified water, injection water, tap water and the like can be used. The dilution ratio may be any dilution ratio as long as it can be used as a dilution composition for sterilization and cleaning to exhibit a sterilization and cleaning effect, and is not particularly limited, but is preferably 1 to 10000 times, more preferably 1 to 1000 times. It is double.
　３．殺菌及び洗浄用希釈組成物
　本発明の殺菌及び洗浄用希釈組成物は、過酢酸、酢酸及び／又はその塩、過酸化水素、及び水、並びに添加剤を含み、さらに希釈剤として追加の水を含む。各成分については、上述した通りである。 3. 3. Diluted composition for sterilization and cleaning The diluted composition for sterilization and cleaning of the present invention contains peracetic acid, acetic acid and / or salts thereof, hydrogen peroxide, and water, and additives, and further water is added as a diluent. Including. Each component is as described above.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物は、上記の殺菌及び洗浄用組成物と、追加の水とを含む。 In one embodiment of the present invention, the sterilizing and cleaning diluted composition comprises the above sterilizing and cleaning composition and additional water.
　本発明の殺菌及び洗浄用希釈組成物は、上記の殺菌及び洗浄用組成物を水で希釈することにより作製され得る。上述のように、希釈倍率は、殺菌及び洗浄用希釈組成物として殺菌及び洗浄効果を発揮する濃度にすることができる希釈倍率であればよく、特に限定されないが、好ましくは１～１００００倍、より好ましくは１～１０００倍である。 The sterilization and cleaning dilution composition of the present invention can be prepared by diluting the above sterilization and cleaning composition with water. As described above, the dilution ratio may be any dilution ratio that can be used as a dilution composition for sterilization and cleaning to exhibit a sterilization and cleaning effect, and is not particularly limited, but is preferably 1 to 10000 times. It is preferably 1 to 1000 times.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物は、過酢酸の濃度が、０．００１～１．５質量％であってよく、好ましくは０．００１～１．０質量％、より好ましくは０．００５～０．５質量％、さらにより好ましくは０．００５～０．３質量％であってよい。 In one embodiment of the present invention, the diluted composition for sterilization and cleaning may have a peracetic acid concentration of 0.001 to 1.5% by mass, preferably 0.001 to 1.0% by mass. It may be preferably 0.005 to 0.5% by mass, and even more preferably 0.005 to 0.3% by mass.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物は、酢酸及び／又はその塩の濃度が、０．０１～７質量％であってよく、好ましくは０．０５～６質量％、より好ましくは０．１～５．５質量％、さらにより好ましくは０．２～５質量％であってよい。 In one embodiment of the present invention, the diluted composition for sterilization and cleaning may have a concentration of acetic acid and / or a salt thereof of 0.01 to 7% by mass, preferably 0.05 to 6% by mass, and more. It may be preferably 0.1 to 5.5% by mass, and even more preferably 0.2 to 5% by mass.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物は、過酸化水素の濃度が、０．００１～２．５質量％であってよく、好ましくは０．００５～２質量％、より好ましくは０．０１～１．５質量％、さらにより好ましくは０．０２～１．０質量％であってよい。 In one embodiment of the present invention, the diluted composition for sterilization and cleaning may have a hydrogen peroxide concentration of 0.001 to 2.5% by mass, preferably 0.005 to 2% by mass, more preferably. May be 0.01 to 1.5% by mass, and even more preferably 0.02 to 1.0% by mass.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物は、過酢酸を０．００１～１．５質量％、酢酸及び／又はその塩を０．０１～７質量％、過酸化水素を０．００１～２．５質量％、及び水を含み、
　添加剤を含み、
　前記組成物のｐＨ値が、４．０～１０．０であるものであってよい。 In one embodiment of the invention, the sterilizing and cleaning dilution composition contains 0.001 to 1.5% by weight of peracetic acid, 0.01 to 7% by weight of acetic acid and / or a salt thereof, and 0 to hydrogen peroxide. Includes 0.01-2.5% by weight and water
Contains additives,
The pH value of the composition may be 4.0 to 10.0.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物は、添加剤として、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、カルボン酸系安定剤、及びすず酸塩からなる群より選択される１種以上を含み得る。 In one embodiment of the invention, the diluting composition for sterilization and cleaning comprises, as additives, polyoxyethylene lauryl ether acetic acid and / or salts thereof, phosphorus stabilizers, carboxylic acid stabilizers, and tin salts. It may include one or more selected from the group.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物に含まれ得るポリオキシエチレンラウリルエーテル酢酸及び／又はその塩の濃度は、０．００００１～０．１質量％であってよく、好ましくは０．００００５～０．０５質量％であってよく、より好ましくは０．０００１～０．０３質量％であってよく、さらにより好ましくは０．０００１～０．０１質量％であってよい。 In one embodiment of the present invention, the concentration of polyoxyethylene lauryl ether acetic acid and / or a salt thereof that can be contained in the diluting composition for sterilization and cleaning may be 0.00001 to 0.1% by mass, preferably 0.00001 to 0.1% by mass. It may be 0.00005 to 0.05% by mass, more preferably 0.0001 to 0.03% by mass, and even more preferably 0.0001 to 0.01% by mass.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物に含まれ得るリン系安定剤の濃度は、０．０００１～０．０５質量％であってよく、好ましくは０．０００１～０．０３質量％、より好ましくは０．０００１～０．０２質量％、さらにより好ましくは０．０００１～０．０１質量％であってよい。 In one embodiment of the present invention, the concentration of the phosphorus-based stabilizer that can be contained in the diluted composition for sterilization and cleaning may be 0.0001 to 0.05% by mass, preferably 0.0001 to 0.03. It may be% by mass, more preferably 0.0001 to 0.02% by mass, and even more preferably 0.0001 to 0.01% by mass.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物に含まれ得るカルボン酸系安定剤の濃度は、０．０００１～０．０５質量％であってよく、好ましくは０．０００１～０．０３質量％、より好ましくは０．０００１～０．０２質量％、さらにより好ましくは０．０００１～０．０１質量％であってよい。 In one embodiment of the present invention, the concentration of the carboxylic acid-based stabilizer that can be contained in the diluted composition for sterilization and cleaning may be 0.0001 to 0.05% by mass, preferably 0.0001 to 0. It may be 03% by mass, more preferably 0.0001 to 0.02% by mass, and even more preferably 0.0001 to 0.01% by mass.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物に含まれ得るすず酸塩の濃度は、０．０００１～０．５質量％であってよく、好ましくは０．０００１～０．１質量％、より好ましくは０．０００１～０．０５質量％、さらにより好ましくは０．０００１～０．０２質量％であってよい。 In one embodiment of the present invention, the concentration of tin salt that can be contained in the diluting composition for sterilization and cleaning may be 0.0001 to 0.5% by mass, preferably 0.0001 to 0.1% by mass. %, More preferably 0.0001 to 0.05% by mass, and even more preferably 0.0001 to 0.02% by mass.
　４．殺菌及び洗浄用組成物及び殺菌及び洗浄用希釈組成物の製造方法
　本発明の一実施形態において、殺菌及び洗浄用組成物の製造方法は、少なくとも下記成分：
　（ｉ）添加剤
　（ｉｉ）過酸化水素水及び酢酸
　（ｉｉｉ）酢酸塩
を混合する混合工程を含むものであってよい。この製造方法では、中和熱が発生せず、作業性が良い。水溶液が平衡状態に達することにより、水溶液中には過酢酸も存在することになるが、混合工程において、過酢酸が加えられていてもよい。各成分については上述した通りである。各成分を混合する順序は任意であってよく、本発明の殺菌及び洗浄用組成物では、混合した各成分が平衡状態となっている。 4. Method for Producing Composition for Sterilization and Cleaning and Diluted Composition for Sterilization and Cleaning In one embodiment of the present invention, the method for producing the composition for sterilization and cleaning includes at least the following components:
(I) Additive (ii) Hydrogen peroxide solution and acetic acid (iii) Acetate may be mixed. In this manufacturing method, heat of neutralization is not generated and workability is good. When the aqueous solution reaches an equilibrium state, peracetic acid is also present in the aqueous solution, but peracetic acid may be added in the mixing step. Each component is as described above. The order in which the components are mixed may be arbitrary, and in the sterilizing and cleaning composition of the present invention, the mixed components are in an equilibrium state.
　上記酢酸塩としては、水溶液とした際にアルカリ性である酢酸塩であればよく、例えば酢酸ナトリウム、酢酸カリウム、酢酸リチウム、酢酸ベリリウム、酢酸マグネシウム、酢酸アルミニウム、酢酸カルシウム、酢酸ルビジウム、酢酸ストロンチウム、酢酸セシウム、酢酸バリウム、酢酸アンモニウムを用いることができるがこれらに限定されない。本発明の一実施形態において、酢酸塩は、酢酸ナトリウムであってよい。本発明の別の実施形態において、酢酸塩は、酢酸カリウムであってよい。 The acetate may be an acetate that is alkaline when made into an aqueous solution, for example, sodium acetate, potassium acetate, lithium acetate, beryllium acetate, magnesium acetate, aluminum acetate, calcium acetate, rubidium acetate, strontium acetate, acetic acid. Cesium, barium acetate, and ammonium acetate can be used, but are not limited thereto. In one embodiment of the invention, the acetate salt may be sodium acetate. In another embodiment of the invention, the acetate salt may be potassium acetate.
　本発明の一実施形態において、殺菌及び洗浄用組成物の製造方法は、少なくとも下記成分：
　（ｉ）添加剤
　（ｉｉ）過酸化水素水及び酢酸
　（ｉｉｉ）アルカリ
を混合する混合工程を含むものであってよい。この製造方法では、中和熱が発生し平行移動速度が増加して反応が加速され得る。水溶液が平衡状態に達することにより、水溶液中には過酢酸も存在することになるが、混合工程において、過酢酸が加えられていてもよい。各成分については上述した通りである。各成分を混合する順序は任意であってよく、本発明の殺菌及び洗浄用組成物では、混合した各成分が平衡状態となっている。 In one embodiment of the present invention, the method for producing a sterilizing and cleaning composition comprises at least the following components:
(I) Additive (ii) A mixing step of mixing hydrogen peroxide solution and acetic acid (iii) alkali may be included. In this production method, heat of neutralization can be generated and the translation rate can be increased to accelerate the reaction. When the aqueous solution reaches an equilibrium state, peracetic acid is also present in the aqueous solution, but peracetic acid may be added in the mixing step. Each component is as described above. The order in which the components are mixed may be arbitrary, and in the sterilizing and cleaning composition of the present invention, the mixed components are in an equilibrium state.
　上記アルカリとしては、例えば水酸化ナトリウム、水酸化カリウム、水酸化リチウム、水酸化ベリリウム、水酸化マグネシウム、水酸化アルミニウム、水酸化カルシウム、水酸化ルビジウム、水酸化ストロンチウム、水酸化セシウム、水酸化バリウム、アンモニアなどを用いることができるがこれらに限定されない。本発明の一実施形態において、アルカリは、水酸化ナトリウムであってよい。本発明の別の実施形態において、アルカリは、水酸化カリウムであってよい。 Examples of the alkali include sodium hydroxide, potassium hydroxide, lithium hydroxide, beryllium hydroxide, magnesium hydroxide, aluminum hydroxide, calcium hydroxide, rubidium hydroxide, strontium hydroxide, cesium hydroxide, barium hydroxide, and the like. Ammonia and the like can be used, but the present invention is not limited to these. In one embodiment of the invention, the alkali may be sodium hydroxide. In another embodiment of the invention, the alkali may be potassium hydroxide.
　アルカリを使用する上記の製造方法は、添加剤、酢酸及びアルカリを混合した後、３０～５０℃で過酸化水素水を混合する工程を含み得る。この製造方法では、中和熱が発生するため、添加剤、酢酸及びアルカリを混合することにより発生する中和熱を利用して、３０～５０℃で過酸化水素水を混合することができ、これにより平行移動速度が増加して反応を加速させることができる。 The above production method using an alkali may include a step of mixing an additive, acetic acid and an alkali, and then mixing a hydrogen peroxide solution at 30 to 50 ° C. Since heat of neutralization is generated in this production method, hydrogen peroxide solution can be mixed at 30 to 50 ° C. by utilizing the heat of neutralization generated by mixing additives, acetic acid and alkali. As a result, the translation speed can be increased to accelerate the reaction.
　本発明の一実施形態において、殺菌及び洗浄用組成物の製造方法は、下記工程（Ａ）及び（Ｂ）：
　工程（Ａ）　少なくとも、（ｉ）添加剤、（ｉｉ）過酸化水素水及び酢酸、および（ｉｉｉ）酢酸塩またはアルカリ
を混合する工程と；
　工程（Ｂ）　工程（Ａ）で得られた水溶液（ａ）を１日以上静置する工程
　とを含むものであってよい。工程（Ａ）で得られた水溶液（ａ）を工程（Ｂ）において静置することにより、水溶液が平衡状態に達する。酢酸塩を用いる実施形態において、工程（Ｂ）において静置する温度は、好ましくは２０～６０℃であるが、より好ましくは２０～５０℃である。また、工程（Ｂ）において静置する時間は、好ましくは１日以上であり、例えば２日以上、３日以上、５日以上、１０日以上、３０日以上などであってよい。アルカリを用いる実施形態においては、上述のように、中和熱の発生により、反応を加速することができる。 In one embodiment of the present invention, the method for producing the sterilizing and cleaning composition is described in the following steps (A) and (B):
Step (A) At least (i) with the step of mixing the additive, (ii) hydrogen peroxide solution and acetic acid, and (iii) acetate or alkali;
Step (B) It may include a step of allowing the aqueous solution (a) obtained in the step (A) to stand for one day or more. By allowing the aqueous solution (a) obtained in the step (A) to stand in the step (B), the aqueous solution reaches an equilibrium state. In the embodiment using the acetate salt, the temperature at which the mixture is allowed to stand in the step (B) is preferably 20 to 60 ° C, more preferably 20 to 50 ° C. In addition, the standing time in the step (B) is preferably 1 day or more, and may be, for example, 2 days or more, 3 days or more, 5 days or more, 10 days or more, 30 days or more. In the embodiment using alkali, as described above, the reaction can be accelerated by the generation of heat of neutralization.
　本発明のさらに別の実施形態において、殺菌及び洗浄用組成物の製造方法は、下記工程（Ｃ）～（Ｅ）：
　工程（Ｃ）　少なくとも、（ｉｉ）過酸化水素水及び酢酸、および（ｉ）添加剤を混合する工程と；
　工程（Ｄ）　工程（Ｃ）で得られた水溶液（ｃ）を１日以上静置する工程と；
　工程（Ｅ）　工程（Ｄ）で得られた水溶液（ｄ）、（ｉｉｉ）酢酸塩またはアルカリ、及び水を混合する工程
　とを含むものであってよい。工程（Ｃ）で得られた水溶液（ｃ）を静置することにより、水溶液が平衡状態に達する。工程（Ｄ）において静置する温度は、好ましくは２０～６０℃であるが、より好ましくは２０～５０℃である。また、工程（Ｄ）において静置する時間は、好ましくは１日以上であり、例えば２日以上、３日以上、５日以上、１０日以上、３０日以上などであってよい。その後、平衡状態に達した水溶液（ｄ）に酢酸塩またはアルカリ、及び水を混合する。 In yet another embodiment of the present invention, the method for producing the sterilizing and cleaning composition is described in the following steps (C) to (E):
Step (C) At least (ii) a step of mixing hydrogen peroxide solution and acetic acid, and (i) an additive;
Step (D) A step of allowing the aqueous solution (c) obtained in the step (C) to stand for one day or more;
Step (E) It may include a step of mixing the aqueous solution (d) obtained in the step (D), (iii) acetate or alkali, and water. By allowing the aqueous solution (c) obtained in the step (C) to stand, the aqueous solution reaches an equilibrium state. The temperature at which it is allowed to stand in the step (D) is preferably 20 to 60 ° C, but more preferably 20 to 50 ° C. In addition, the standing time in the step (D) is preferably 1 day or more, and may be, for example, 2 days or more, 3 days or more, 5 days or more, 10 days or more, 30 days or more. Then, acetate or alkali and water are mixed with the aqueous solution (d) that has reached an equilibrium state.
　本発明の一実施形態において、殺菌及び洗浄用希釈組成物の製造方法は、少なくとも下記成分：
　（ｉ）添加剤
　（ｉｉ）過酸化水素水及び酢酸
　（ｉｉｉ）酢酸塩又はアルカリ
を混合する混合工程と、
　得られた混合液を希釈する希釈工程
　とを含むものであってよい。水溶液が平衡状態に達することにより、水溶液中には過酢酸も存在することになるが、混合工程において、過酢酸が加えられていてもよい。各成分については上述した通りである。本発明の殺菌及び洗浄用希釈組成物の製造方法において、前記希釈工程は、前記混合工程で得られた混合物と水とを混合することを含み得る。希釈剤として用いられる水は、例えば純水、超純水、蒸留水、精製水、注射用水、水道水などが用いられ得る。 In one embodiment of the present invention, the method for producing a diluted composition for sterilization and cleaning comprises at least the following components:
(I) Additives (ii) Hydrogen peroxide solution and acetic acid (iii) Acetate or alkali mixing step and
It may include a dilution step of diluting the obtained mixed solution. When the aqueous solution reaches an equilibrium state, peracetic acid is also present in the aqueous solution, but peracetic acid may be added in the mixing step. Each component is as described above. In the method for producing a dilution composition for sterilization and washing of the present invention, the dilution step may include mixing the mixture obtained in the mixing step with water. As the water used as the diluent, for example, pure water, ultrapure water, distilled water, purified water, injection water, tap water and the like can be used.
　５．殺菌及び洗浄用組成物を用いた殺菌及び洗浄方法
　本発明の上記殺菌及び洗浄用組成物又は上記殺菌及び洗浄用希釈組成物は、希釈することなくそのまま用いるか、あるいは任意の濃度に希釈して、例えば、医療用器具、飲料食品容器、工業排水、空調設備の冷却水、衣類、調理器具、食器、浴室、台所、洗濯槽、風呂釜、家具、ペットの殺菌、洗浄等に用いることができる。 5. Sterilization and cleaning method using sterilization and cleaning composition The sterilization and cleaning composition of the present invention or the sterilization and cleaning dilution composition can be used as it is without dilution, or diluted to an arbitrary concentration. For example, it can be used for medical appliances, beverage food containers, industrial wastewater, cooling water for air conditioning equipment, clothing, cooking utensils, tableware, bathrooms, kitchens, washing tubs, bath kettles, furniture, sterilization of pets, washing, etc. ..
　本発明の一実施形態において、上記殺菌及び洗浄用組成物又は上記殺菌及び洗浄用希釈組成物を用いる、医療用器具の殺菌及び洗浄方法が提供される。本発明の殺菌及び洗浄方法において、前記医療用器具の殺菌及び洗浄方法が、浸漬法、噴霧法、塗布法、通液法、循環法、封入法から選択されてよい。本発明の医療用器具の殺菌及び洗浄方法において、用いる殺菌及び洗浄用組成物又は殺菌及び洗浄用希釈組成物の量や、殺菌及び洗浄する時間は、微生物の種類や量、洗浄用組成物又は殺菌及び洗浄用希釈組成物の濃度などに従って、適宜選択することができる。 In one embodiment of the present invention, there is provided a method for sterilizing and cleaning medical instruments using the above sterilization and cleaning composition or the above sterilization and cleaning dilution composition. In the sterilization and cleaning method of the present invention, the sterilization and cleaning method for the medical device may be selected from a dipping method, a spraying method, a coating method, a liquid passing method, a circulation method, and an encapsulation method. In the method for sterilizing and cleaning medical instruments of the present invention, the amount of the sterilizing and cleaning composition or the sterilizing and cleaning diluted composition used, the sterilizing and cleaning time, the type and amount of microorganisms, the cleaning composition or It can be appropriately selected according to the concentration of the diluted composition for sterilization and cleaning.
　本発明の殺菌及び洗浄方法において、前記医療用器具としては、透析用器具、内視鏡用器具、外科手術器具、産科・泌尿器科用器具、麻酔装置類、人工呼吸装置類、歯科用器具、注射針などが挙げられるが、これらに限定されない。本発明の殺菌及び洗浄方法において、前記医療用器具は、好ましくは透析用器具である。 In the sterilization and cleaning method of the present invention, the medical instruments include dialysis instruments, endoscopic instruments, surgical instruments, obstetrics / urology instruments, anesthesia devices, artificial respiration devices, dental instruments, etc. Examples include, but are not limited to, injection needles. In the sterilization and cleaning method of the present invention, the medical device is preferably a dialysis device.
　以下に、本発明の実施例を示す。しかしながら、これらの実施例は、本発明の実施形態を例示するものであって、本発明の範囲を限定することを意図するものではない。 Examples of the present invention are shown below. However, these examples illustrate embodiments of the invention and are not intended to limit the scope of the invention.
　＜殺菌及び洗浄用組成物中の過酸化水素濃度の測定方法＞
　本発明において、殺菌及び洗浄用組成物（過酢酸組成物）の過酸化水素濃度は酸化還元滴定により行った。具体的には試料約０．１ｇを精密に量り、２５０ｍＬの三角フラスコに入れ、純水１００ｍＬ、１．８ｍｏｌ／Ｌ硫酸を１０ｍＬ加えて検液とした。この検液にフェロイン試液を数滴加えて、０．１ｍｏｌ／Ｌ硫酸セリウム（ＩＶ）溶液で滴定し、過酸化水素濃度を算出した。 <Method of measuring hydrogen peroxide concentration in sterilization and cleaning composition>
In the present invention, the hydrogen peroxide concentration of the sterilization and cleaning composition (peracetic acid composition) was determined by redox titration. Specifically, about 0.1 g of the sample was precisely weighed, placed in a 250 mL Erlenmeyer flask, and 100 mL of pure water and 10 mL of 1.8 mol / L sulfuric acid were added to prepare a test solution. Several drops of ferroin test solution were added to this test solution, and the mixture was titrated with a 0.1 mol / L cerium (IV) sulfate solution to calculate the hydrogen peroxide concentration.
　＜殺菌及び洗浄用組成物中の酢酸及び過酢酸濃度の測定方法＞
　本発明において、殺菌及び洗浄用組成物（過酢酸組成物）の酢酸濃度及び過酢酸濃度は中和滴定により行った。具体的には殺菌及び洗浄用組成物の試料約０．１ｇを精密に量り、１００ｍＬビーカーに入れ、純水約５０ｍＬを加えて検液とした。この検液を０．１ｍｏｌ／Ｌ水酸化ナトリウム溶液で滴定し、第一変曲点での添加量から酢酸濃度を算出し、第一変曲点から第二変曲点までの添加量から過酢酸濃度を算出した。 <Method for measuring acetic acid and peracetic acid concentrations in sterilization and cleaning compositions>
In the present invention, the acetic acid concentration and the peracetic acid concentration of the sterilization and cleaning composition (peracetic acid composition) were subjected to neutralization titration. Specifically, about 0.1 g of a sample of the sterilization and cleaning composition was precisely weighed, placed in a 100 mL beaker, and about 50 mL of pure water was added to prepare a test solution. This test solution is titrated with a 0.1 mol / L sodium hydroxide solution, the acetic acid concentration is calculated from the amount added at the first inflection point, and the amount added from the first inflection point to the second inflection point is excessive. The acetic acid concentration was calculated.
　＜殺菌及び洗浄用組成物の全過酸化物濃度（ＴＰＯ）＞
　本発明において、殺菌及び洗浄用組成物（過酢酸組成物）の全過酸化物濃度は、ヨウ素還元滴定法により行った。具体的には試料約０．１ｇを精密に量り、２５０ｍＬの三角フラスコに入れ、純水１００ｍＬ、１．８ｍｏｌ／Ｌ硫酸１０ｍＬを加えた後、１０質量％のヨウ化カリウム溶液１０ｍＬ、１質量％モリブデン酸アンモニウム溶液を数滴加えて検液とした。この検液に０．１ｍｏｌ／Ｌチオ硫酸ナトリウム溶液を滴下し、指示薬にでんぷんを使用して液の青紫色が消失し無色となったところを終点として、遊離したヨウ素を定量した。そのヨウ素量から、過酸化水素換算で全過酸化物濃度を算出した。 <Total Peroxide Concentration (TPO) of Sterilization and Cleaning Compositions>
In the present invention, the total peroxide concentration of the sterilization and cleaning composition (peracetic acid composition) was determined by the iodine reduction titration method. Specifically, about 0.1 g of the sample is precisely weighed, placed in a 250 mL Erlenmeyer flask, 100 mL of pure water is added, 10 mL of 1.8 mol / L sulfuric acid is added, and then 10 mL of a 10 mass% potassium iodide solution, 1 mass%. A few drops of ammonium molybdate solution were added to prepare a test solution. A 0.1 mol / L sodium thiosulfate solution was added dropwise to this test solution, and starch was used as an indicator to quantify free iodine, starting from the point where the bluish purple color of the solution disappeared and became colorless. From the amount of iodine, the total peroxide concentration was calculated in terms of hydrogen peroxide.
　＜殺菌及び洗浄用組成物の安定度＞
　本発明の殺菌及び洗浄用組成物（過酢酸組成物）の安定度は仕込み時の全過酸化物濃度（ＴＰＯ）を１００とし、測定時の全過酸化物濃度の比率により算出した。 <Stability of sterilization and cleaning composition>
The stability of the sterilization and cleaning composition (peracetic acid composition) of the present invention was calculated by setting the total peroxide concentration (TPO) at the time of preparation to 100 and the ratio of the total peroxide concentration at the time of measurement.
　＜ｐＨ測定＞
　洗浄用組成物及び洗浄用組成物の希釈液のｐＨは、ｐＨメーター（ＬＡＱＵＡ、Ｄ－７１Ｓ、株式会社堀場製作所製）を用いて測定した。 <pH measurement>
The pH of the cleaning composition and the diluted solution of the cleaning composition was measured using a pH meter (LAQUA, D-71S, manufactured by HORIBA, Ltd.).
　＜芽胞懸濁液の調整＞
　セレウス菌標準菌株（Ｍｉｃｒｏｂｉｏｌｏｇｉｃｓ社製、製品名：Ｂａｃｉｌｌｕｓ ｃｅｒｅｕｓ ＡＴＣＣ１０８７６）をＭＹＰ寒天（ＡＺＯＮＥ株式会社製、製品名：サニスペック生培地）に塗布し、３５℃で７日間培養した。この寒天培地に減菌蒸留水を加え、菌体をコンラージ棒で掻き取り採取し、遠心分離により減菌蒸留水で洗浄した。芽胞型のみを得るため８０℃で１０分間加熱し生残した菌を芽胞懸濁液とした。 <Preparation of spore suspension>
Bacillus cereus standard strain (manufactured by Microbiologicals, product name: Bacillus cereus ATCC10876) was applied to MYP agar (manufactured by AZONE Co., Ltd., product name: Sanispec raw medium) and cultured at 35 ° C. for 7 days. Distilled sterilized water was added to this agar medium, and the cells were scraped off with a spreader and collected, and washed with sterilized distilled water by centrifugation. In order to obtain only the spore type, the bacteria that survived by heating at 80 ° C. for 10 minutes were used as a spore suspension.
＜殺菌試験＞
　洗浄用組成物を減菌蒸留水で適宜希釈し、試料液を調製した。各試料液４．５ｍＬに１質量％アルブミン溶液を０．５ｍＬ，芽胞懸濁液５０μＬを加え、２５℃で１２０分間作用させた。作用後、０．１ｍｏｌ／Ｌ減菌チオ硫酸ナトリウム溶液で１０倍に希釈し、セレウス菌検出用培地（日水製薬株式会社製、製品名：コンパクトドライＸ－ＢＣ）を用いて３５℃で４８時間培養し生菌数を測定した。また、芽胞懸濁液の生菌数を測定し、開始時の生菌数とした。 <Sterilization test>
The cleaning composition was appropriately diluted with sterilized distilled water to prepare a sample solution. 0.5 mL of 1 mass% albumin solution and 50 μL of spore suspension were added to 4.5 mL of each sample solution, and the mixture was allowed to act at 25 ° C. for 120 minutes. After action, dilute 10-fold with 0.1 mol / L sterilized sodium thiosulfate solution, and use a medium for detecting Bacillus cereus (manufactured by Nissui Pharmaceutical Co., Ltd., product name: Compact Dry X-BC) at 35 ° C. 48. The cells were cultured for hours and the viable cell count was measured. In addition, the viable cell count of the spore suspension was measured and used as the viable cell count at the start.
＜タンパク除去試験＞
　洗浄用組成物を純水で適宜希釈し、試料液５０ｇを調製した。各試料液に洗浄評価インジケータ（ネスコスＩＣ　Ｗ・Ｉ、株式会社サクラクレパス製）を６０分間浸漬した後、純水１０ｍＬで洗浄し、常温で乾燥した。Ｃ光源、２度視野に設定したハンディ型分光色差計（ＮＦ５５５、日本電色工業株式会社製）を用いて洗浄評価インジケータの汚れの付着していない白色部からの色差（ΔＥａｂ）を測定した。タンパク除去率は未洗浄の洗浄評価インジケータの色差を１００とし、洗浄後の色差の比率により算出した。 <Protein removal test>
The cleaning composition was appropriately diluted with pure water to prepare 50 g of a sample solution. A washing evaluation indicator (Nescos IC WI, manufactured by Sakura Color Products Corporation) was immersed in each sample solution for 60 minutes, washed with 10 mL of pure water, and dried at room temperature. The color difference (ΔEab) from the clean white part of the cleaning evaluation indicator was measured using a handy type spectrocolor difference meter (NF555, manufactured by Nippon Denshoku Industries Co., Ltd.) set to a C light source and a 2 degree field of view. The protein removal rate was calculated from the ratio of the color difference after washing, with the color difference of the unwashed washing evaluation indicator as 100.
＜炭酸Ｃａ溶解量試験＞
　洗浄用組成物を純水で適宜希釈し、試料液５０ｇを調製した。各試料液に炭酸Ｃａ（富士フイルム和光純薬株式会社製）を少量ずつ添加し、溶解した重量を炭酸Ｃａ溶解量とした。 <Calcium carbonate dissolution amount test>
The cleaning composition was appropriately diluted with pure water to prepare 50 g of a sample solution. Ca carbonate (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) was added little by little to each sample solution, and the dissolved weight was defined as the amount of Ca carbonate dissolved.
　＜実施例１＞
　純水２２．０ｇと６０質量％の１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ、イタルマッチジャパン株式会社製、製品名：デイクエスト２０１０）を０．１７ｇ、エチレンジアミン四酢酸二ナトリウム・二水和物（ＥＤＴＡ・２Ｎａ・２Ｈ２Ｏ、ＭＰ Ｂｉｏｍｅｄｉｃａｌｓ，Ｉｎｃ．製）を０．１１ｇ、氷酢酸（昭和電工株式会社製、製品名：９９％純良酢酸）を１８．０ｇ、酢酸ナトリウム三水和物（富士フイルム和光純薬株式会社製）を４５．６ｇ、４５質量％の過酸化水素水（三菱ガス化学株式会社製、製品名：ＳＥＲ４５）を１４．２ｇ、ＰＥ容器内で調合した。調合時の全過酸化物濃度は６．１％であった。調合後、２５℃で７日間熟成し、過酸化水素５．６質量％、酢酸１７．１質量％、過酢酸１．１質量％、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）０．１質量％、エチレンジアミン四酢酸二ナトリウム（ＥＤＴＡ・２Ｎａ）０．１質量％、ｐＨ　５．１の透析装置洗浄用として使用される過酢酸組成物を得た。得られた過酢酸組成物については、調合してから２５℃で１４日後に全過酸化物濃度（ＴＰＯ）を測定し、安定度を算出した。その結果は表１に示した。 <Example 1>
22.0 g of pure water and 60% by mass of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, manufactured by Italmatch Japan Co., Ltd., product name: Dayquest 2010) 0.17 g, ethylenediaminetetraacetic acid disodium di. hydrate (EDTA · 2Na · 2H 2 O , MP Biomedicals, Inc manufactured.) the 0.11 g, glacial acetic acid (manufactured by Showa Denko KK, product name: 99% Junryo acetate) to 18.0 g, sodium acetate Sanshui 45.6 g of Japanese product (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) and 14.2 g of 45 mass% hydrogen peroxide solution (manufactured by Mitsubishi Gas Chemicals Co., Ltd., product name: SER45) were prepared in a PE container. The total peroxide concentration at the time of preparation was 6.1%. After preparation, it is aged at 25 ° C. for 7 days, hydrogen peroxide 5.6% by mass, acetic acid 17.1% by mass, peracetic acid 1.1% by mass, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) 0. A peracetic acid composition of 1% by mass, 0.1% by mass of disodium ethylenediaminetetraacetate (EDTA.2Na), and pH 5.1 was obtained for use in cleaning dialysis equipment. For the obtained peracetic acid composition, the total peroxide concentration (TPO) was measured 14 days after preparation at 25 ° C., and the stability was calculated. The results are shown in Table 1.
　＜実施例２～１４、比較例１～６＞
　添加剤として表１に記載されたものを用いた以外は、実施例１と同様にして、表１に示す濃度の殺菌及び洗浄用組成物を得た。殺菌及び洗浄用組成物について、全過酸化物濃度（ＴＰＯ）を測定し、安定度を算出した。その結果は表１に示した。表中に示されている、ＤＴＰＰ、すず酸Ｎａ・３Ｈ２Ｏ、及びＤＴＰＡとしては、下記のものを用いた。
　ジエチレントリアミンペンタメチレンホスホン酸（ＤＴＰＰ、三菱ガス化学株式会社製、精製品）
　すず酸ナトリウム三水和物（すず酸Ｎａ・３Ｈ２Ｏ、富士フイルム和光純薬株式会社製）
　ジエチレントリアミン五酢酸（ＤＴＰＡ、株式会社同仁化学研究所製） <Examples 2 to 14, Comparative Examples 1 to 6>
The sterilizing and cleaning compositions having the concentrations shown in Table 1 were obtained in the same manner as in Example 1 except that the additives shown in Table 1 were used. For the sterilization and cleaning compositions, the total peroxide concentration (TPO) was measured and the stability was calculated. The results are shown in Table 1. Are shown in Table, DTPP, stannate Na · 3H 2 O, and as DTPA was used as follows.
Diethylenetriamine pentamethylene phosphonic acid (DTPP, manufactured by Mitsubishi Gas Chemical Company, Ltd., refined product)
Sodium tin trihydrate (Na 3H 2 O tin, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.)
Diethylenetriamine pentaacetic acid (DTPA, manufactured by Dojin Chemical Laboratory Co., Ltd.)
　＜実施例１５～２０＞
　表２に記載されたとおりの配合とし、５０℃で１日間熟成した以外は、実施例１と同様にして、表２に示す濃度の殺菌及び洗浄用組成物を得た。殺菌及び洗浄用組成物について、調合してから上記５０℃で１日間の熟成、並びに２５℃で２０日間経過後に全過酸化物濃度（ＴＰＯ）を測定し、安定度を算出した。その結果は表２に示した。 <Examples 15 to 20>
The sterilizing and cleaning compositions having the concentrations shown in Table 2 were obtained in the same manner as in Example 1 except that the formulations were as shown in Table 2 and aged at 50 ° C. for 1 day. The sterilization and cleaning compositions were aged at 50 ° C. for 1 day after preparation, and the total peroxide concentration (TPO) was measured after 20 days at 25 ° C. to calculate the stability. The results are shown in Table 2.
　＜実施例２１～２２、比較例７～１２＞
　表３に記載されたとおりの配合とし、２５℃で２１日間熟成した以外は、実施例１と同様にして、表３に示す濃度の殺菌及び洗浄用組成物を得た。殺菌及び洗浄用組成物について、調合してから２５℃で２１日間経過後に全過酸化物濃度（ＴＰＯ）を測定し、安定度を算出した。その結果は表３に示した。表中に示されている、５０％フィチン酸、及びＮａＯＨとしては、下記のものを用いた。
　５０質量％フィチン酸溶液（５０％フィチン酸、富士フイルム和光純薬株式会社製）
　水酸化ナトリウム（ＮａＯＨ、富士フイルム和光純薬株式会社製） <Examples 21 to 22, Comparative Examples 7 to 12>
A sterilizing and cleaning composition having the concentration shown in Table 3 was obtained in the same manner as in Example 1 except that the formulation was as shown in Table 3 and the mixture was aged at 25 ° C. for 21 days. For the sterilizing and cleaning compositions, the total peroxide concentration (TPO) was measured 21 days after the preparation at 25 ° C., and the stability was calculated. The results are shown in Table 3. The following were used as 50% phytic acid and NaOH shown in the table.
50% by mass phytic acid solution (50% phytic acid, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.)
Sodium hydroxide (NaOH, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.)
　＜実施例２３～２５、比較例１３～１４＞
　表４に記載されたとおりの配合とした以外は、実施例２１と同様にして、表４に示す濃度の殺菌及び洗浄用組成物を得た。殺菌及び洗浄用組成物について、調合してから２５℃で２１日間経過後に全過酸化物濃度（ＴＰＯ）を測定し、安定度を算出した。その結果は表４に示した。表中に示されている、ピロリン酸としては、下記のものを用いた。
　ピロリン酸（純正化学株式記会社製、製品名：二りん酸） <Examples 23 to 25, Comparative Examples 13 to 14>
The sterilizing and cleaning compositions having the concentrations shown in Table 4 were obtained in the same manner as in Example 21 except that the formulations were as shown in Table 4. For the sterilizing and cleaning compositions, the total peroxide concentration (TPO) was measured 21 days after the preparation at 25 ° C., and the stability was calculated. The results are shown in Table 4. The following pyrophosphoric acids were used as shown in the table.
Pyrophosphoric acid (manufactured by Junsei Chemical Co., Ltd., product name: diphosphoric acid)
　＜比較例１５～２１＞
　表５に記載されたとおりの配合とし、２５℃で１１日間熟成した以外は、実施例２１と同様にして、表５に示す濃度の殺菌及び洗浄用組成物を得た。殺菌及び洗浄用組成物について、調合してから２５℃で２１日間経過後に全過酸化物濃度（ＴＰＯ）を測定し、安定度を算出した。その結果は表５に示した。表中に示されている、ジピコリン酸、及びＥＤＴＭＰとしては、下記のものを用いた。
　ジピコリン酸（富士フイルム和光純薬株式会社製）
　エチレンジアミンテトラメチレンホスホン酸（ＥＤＴＭＰ、東京化成工業株式会社製） <Comparative Examples 15 to 21>
A sterilizing and cleaning composition having the concentration shown in Table 5 was obtained in the same manner as in Example 21 except that the formulation was as shown in Table 5 and the mixture was aged at 25 ° C. for 11 days. For the sterilizing and cleaning compositions, the total peroxide concentration (TPO) was measured 21 days after the preparation at 25 ° C., and the stability was calculated. The results are shown in Table 5. The following dipicolinic acid and EDTMP shown in the table were used.
Dipicolinic acid (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.)
EDTMP, manufactured by Tokyo Chemical Industry Co., Ltd.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000005
Figure JPOXMLDOC01-appb-T000005
Figure JPOXMLDOC01-appb-T000006
Figure JPOXMLDOC01-appb-T000006
Figure JPOXMLDOC01-appb-T000007
Figure JPOXMLDOC01-appb-T000007
　＜実施例２６～２９＞
　下記に、本発明の殺菌及び洗浄用組成物の製造方法について検討した結果を例として示す。アルカリを用いた実施例２６及び２８では、酢酸塩を用いた実施例２７及び２９と比較して、中和熱による反応速度の増加が認められた。 <Examples 26 to 29>
The results of examining the method for producing the sterilizing and cleaning composition of the present invention are shown below as an example. In Examples 26 and 28 using alkali, an increase in the reaction rate due to heat of neutralization was observed as compared with Examples 27 and 29 using acetate.
Figure JPOXMLDOC01-appb-T000008
Figure JPOXMLDOC01-appb-T000008
　＜実施例１０１＞
　純水２８．２ｇと６０質量％の１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ、イタルマッチジャパン株式会社製、製品名：デイクエスト２０１０）を０．０２ｇ、エチレンジアミン四酢酸二ナトリウム・二水和物（ＥＤＴＡ・２Ｎａ・２Ｈ２Ｏ、ＭＰ　Ｂｉｏｍｅｄｉｃａｌｓ，Ｉｎｃ．製）を０．０１ｇ、ポリオキシエチレン（４．５）ラウリルエーテル酢酸（花王株式会社製、製品名：カオーアキポＲＬＭ－４５）を０．０１ｇ、９９質量％酢酸（昭和電工株式会社製、製品名：９９％純良酢酸）を８．０ｇ、４５質量％の過酸化水素（三菱ガス化学株式会社製、製品名：ＳＥＲ４５）を１４．２ｇ、酢酸ナトリウム三水和物（富士フイルム和光純薬株式会社製）を４９．６ｇ、ＰＥ容器内で混合した。混合後、２５℃で７日間熟成することで過酸化水素５．８質量％、酢酸７．６質量％、過酢酸０．４質量％、酢酸ナトリウム２９．９質量％、１－ヒドロキシエチリデン－１，１－ジホスホン酸０．０１質量％、エチレンジアミン四酢酸二ナトリウム０．０１質量％、ポリオキシエチレン（４．５）ラウリルエーテル酢酸０．０１質量％の洗浄用組成物を得た。得られた洗浄用組成物については、調合してから１４日後に全過酸化物濃度を測定し、安定度を算出した。ｐＨ測定、殺菌試験、タンパク除去試験、炭酸Ｃａ溶解量試験を実施し、１２０分後の菌数、タンパク除去率、炭酸Ｃａ溶解量を算出した。その結果は表７及び表８に示した。表７に示す安定度については、下記のように評価した。
　Ａ：９５％以上
　Ｂ：８０％以上
　Ｃ：８０％未満 <Example 101>
28.2 g of pure water and 60% by mass of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, manufactured by Italmatch Japan Co., Ltd., product name: Dayquest 2010) 0.02 g, ethylenediaminetetraacetic acid disodium di 0.01 g of hydrate (EDTA · 2Na · 2H 2 O, MP Biomedicals, Inc.), polyoxyethylene (4.5) lauryl ether acetic acid (manufactured by Kao Co., Ltd., product name: Kao Akipo RLM-45) 0.01 g, 99 mass% acetic acid (manufactured by Showa Denko Co., Ltd., product name: 99% pure good acetic acid) 8.0 g, 45 mass% hydrogen peroxide (manufactured by Mitsubishi Gas Chemicals Co., Ltd., product name: SER45) 14 .2 g and sodium acetate trihydrate (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) were mixed in a PE container at 49.6 g. After mixing, it is aged at 25 ° C. for 7 days to obtain 5.8% by mass of hydrogen peroxide, 7.6% by mass of acetic acid, 0.4% by mass of peracetic acid, 29.9% by mass of sodium acetate, and 1-hydroxyethylidene-1. , 1-diphosphonic acid 0.01% by mass, ethylenediamine disoacetate disodium 0.01% by mass, polyoxyethylene (4.5) lauryl ether acetic acid 0.01% by mass was obtained. With respect to the obtained cleaning composition, the total peroxide concentration was measured 14 days after the preparation, and the stability was calculated. A pH measurement, a sterilization test, a protein removal test, and a calcium carbonate dissolution amount test were carried out, and the number of bacteria, the protein removal rate, and the calcium carbonate dissolution amount after 120 minutes were calculated. The results are shown in Tables 7 and 8. The stability shown in Table 7 was evaluated as follows.
A: 95% or more B: 80% or more C: less than 80%
　＜実施例１０２、比較例１０１＞
　表７に記載されたとおりの配合とした以外は、実施例１０１と同様にして、表７に示す濃度の殺菌及び洗浄用組成物を得た。得られた洗浄用組成物については、調合してから１４日後に全過酸化物濃度を測定し、安定度を算出した。ｐＨ測定、殺菌試験、タンパク除去試験、炭酸Ｃａ溶解量試験を実施し、１２０分後の菌数、タンパク除去率、炭酸Ｃａ溶解量を算出した。その結果は表７及び表８に示した。表７に示す安定度については、実施例１０１と同様に評価した。表中に示されているピロリン酸としては、下記のものを用いた。
　ピロリン酸（純正化学株式会社製、製品名：二りん酸） <Example 102, Comparative Example 101>
The sterilizing and cleaning compositions having the concentrations shown in Table 7 were obtained in the same manner as in Example 101 except that the formulations were as described in Table 7. With respect to the obtained cleaning composition, the total peroxide concentration was measured 14 days after the preparation, and the stability was calculated. A pH measurement, a sterilization test, a protein removal test, and a calcium carbonate dissolution amount test were carried out, and the number of bacteria, the protein removal rate, and the calcium carbonate dissolution amount after 120 minutes were calculated. The results are shown in Tables 7 and 8. The stability shown in Table 7 was evaluated in the same manner as in Example 101. The following pyrophosphoric acids were used as the pyrophosphoric acids shown in the table.
Pyrophosphoric acid (manufactured by Junsei Chemical Co., Ltd., product name: diphosphoric acid)
Figure JPOXMLDOC01-appb-T000009
Figure JPOXMLDOC01-appb-T000009
Figure JPOXMLDOC01-appb-T000010
Figure JPOXMLDOC01-appb-T000010
　上記の通り、本発明によれば、添加剤を添加することにより、過酸化物の安定性が高く、排水が下水排除基準を満たし、かつタンパク除去力が向上した、医療機器殺菌及び洗浄用組成物を提供することができることが示された。 As described above, according to the present invention, the composition for sterilization and cleaning of medical devices, in which the stability of the peroxide is high, the wastewater meets the sewage exclusion standard, and the protein removing ability is improved by adding the additive. It has been shown that goods can be provided.

Claims (20)

  1. 　過酢酸を０．００１～１５質量％、酢酸及び／又はその塩を０．０１～７０質量％、過酸化水素を０．００１～２５質量％、及び水を含み、
    　添加剤を含み、
    　前記組成物のｐＨ値が、４．０～１０．０である、殺菌及び洗浄用組成物。     It contains 0.001 to 15% by mass of peracetic acid, 0.01 to 70% by mass of acetic acid and / or a salt thereof, 0.001 to 25% by mass of hydrogen peroxide, and water.
    Contains additives,
    A composition for sterilization and cleaning, wherein the pH value of the composition is 4.0 to 10.0.
  2. 　前記添加剤が、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、カルボン酸系安定剤、及びすず酸塩からなる群より選択される１種以上である、
    　請求項１に記載の殺菌及び洗浄用組成物。     The additive is one or more selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a tin acid salt.
    The sterilizing and cleaning composition according to claim 1.
  3. 　前記添加剤がポリオキシエチレンラウリルエーテル酢酸及び／又はその塩である、請求項１又は２に記載の殺菌及び洗浄用組成物。 The sterilizing and cleaning composition according to claim 1 or 2, wherein the additive is polyoxyethylene lauryl ether acetic acid and / or a salt thereof.
  4. 　前記添加剤がリン系安定剤である、請求項１～３のいずれか一項に記載の殺菌及び洗浄用組成物。 The sterilizing and cleaning composition according to any one of claims 1 to 3, wherein the additive is a phosphorus-based stabilizer.
  5. 　前記添加剤がカルボン酸系安定剤である、請求項１～４のいずれか一項に記載の殺菌及び洗浄用組成物。 The sterilizing and cleaning composition according to any one of claims 1 to 4, wherein the additive is a carboxylic acid-based stabilizer.
  6. 　前記添加剤が、ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩、リン系安定剤、及びカルボン酸系安定剤である、請求項１又は２に記載の殺菌及び洗浄用組成物。 The sterilizing and cleaning composition according to claim 1 or 2, wherein the additive is polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, and a carboxylic acid-based stabilizer.
  7. 　前記リン系安定剤が、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩、ジエチレントリアミンペンタメチレンホスホン酸（ＤＴＰＰ）又はその塩のいずれかを含む、請求項６に記載の殺菌及び洗浄用組成物。 The sterilization and sterilization according to claim 6, wherein the phosphorus-based stabilizer contains either 1-hydroxyetidronic acid-1,1-diphosphonic acid (HEDP) or a salt thereof, diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof. Cleaning composition.
  8. 　前記カルボン酸系安定剤が、エチレンジアミン四酢酸（ＥＤＴＡ）又はその塩、ジエチレントリアミン五酢酸（ＤＴＰＡ）又はその塩のいずれかを含む、請求項６に記載の殺菌及び洗浄用組成物。 The sterilizing and cleaning composition according to claim 6, wherein the carboxylic acid-based stabilizer comprises either ethylenediaminetetraacetic acid (EDTA) or a salt thereof, diethylenetriamine pentaacetic acid (DTPA) or a salt thereof.
  9. 　前記リン系安定剤が、１－ヒドロキシエチリデン－１，１－ジホスホン酸（ＨＥＤＰ）又はその塩であって、
    　前記カルボン酸系安定剤が、エチレンジアミン四酢酸（ＥＤＴＡ）又はその塩である、請求項６に記載の殺菌及び洗浄用組成物。     The phosphorus-based stabilizer is 1-hydroxyetidronic acid-1,1-diphosphonic acid (HEDP) or a salt thereof.
    The sterilizing and cleaning composition according to claim 6, wherein the carboxylic acid-based stabilizer is ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
  10. 　前記ポリオキシエチレンラウリルエーテル酢酸及び／又はその塩を０．００１～５質量％含む、請求項６～９のいずれか一項に記載の殺菌及び洗浄用組成物。 The sterilizing and cleaning composition according to any one of claims 6 to 9, which contains 0.001 to 5% by mass of the polyoxyethylene lauryl ether acetic acid and / or a salt thereof.
  11. 　前記リン系安定剤を０．０００１質量％以上０．５質量％未満、及び前記カルボン酸系安定剤を０．０００１質量％以上０．５質量％未満含む、請求項６～９のいずれか一項に記載の殺菌及び洗浄用組成物。 Any one of claims 6 to 9, wherein the phosphorus-based stabilizer is contained in an amount of 0.0001% by mass or more and less than 0.5% by mass, and the carboxylic acid-based stabilizer is contained in an amount of 0.0001% by mass or more and less than 0.5% by mass. The sterilizing and cleaning composition according to the section.
  12. 　前記組成物のｐＨ値が、５．０～９．０である請求項１～１１のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 11, wherein the pH value of the composition is 5.0 to 9.0.
  13. 　少なくとも下記成分を混合する混合工程を含む、請求項１～１２のいずれか一項に記載の組成物の製造方法。
    　（ｉ）添加剤
    　（ｉｉ）過酸化水素水及び酢酸
    　（ｉｉｉ）酢酸塩     The method for producing a composition according to any one of claims 1 to 12, which comprises a mixing step of mixing at least the following components.
    (I) Additives (ii) Hydrogen peroxide solution and acetic acid (iii) Acetate
  14. 　少なくとも下記成分を混合する混合工程を含む、請求項１～１２のいずれか一項に記載の組成物の製造方法。
    　（ｉ）添加剤
    　（ｉｉ）過酸化水素水及び酢酸
    　（ｉｉｉ）アルカリ     The method for producing a composition according to any one of claims 1 to 12, which comprises a mixing step of mixing at least the following components.
    (I) Additives (ii) Hydrogen peroxide solution and acetic acid (iii) Alkaline
  15. 　前記添加剤、酢酸及びアルカリを混合した後、３０～５０℃で過酸化水素水を混合する、請求項１４に記載の製造方法。 The production method according to claim 14, wherein the additive, acetic acid and alkali are mixed, and then a hydrogen peroxide solution is mixed at 30 to 50 ° C.
  16. 　請求項１～１２のいずれか１項に記載の組成物と、
    　追加の水
    とを含む、殺菌及び洗浄用希釈組成物。     The composition according to any one of claims 1 to 12, and
    Diluted composition for sterilization and cleaning, including with additional water.
  17. 　過酢酸を０．００１～１．５質量％、酢酸及び／又はその塩を０．０１～７質量％、過酸化水素を０．００１～２．５質量％、及び水を含み、
    　添加剤を含み、
    　前記組成物のｐＨ値が、４．０～１０．０である、請求項１６に記載の殺菌及び洗浄用希釈組成物。     It contains 0.001 to 1.5% by mass of peracetic acid, 0.01 to 7% by mass of acetic acid and / or a salt thereof, 0.001 to 2.5% by mass of hydrogen peroxide, and water.
    Contains additives,
    The diluted composition for sterilization and cleaning according to claim 16, wherein the pH value of the composition is 4.0 to 10.0.
  18. 　請求項１～１２のいずれか一項に記載の組成物又は請求項１６若しくは１７に記載の希釈組成物を用いる、医療用器具の殺菌及び洗浄方法。 A method for sterilizing and cleaning medical instruments using the composition according to any one of claims 1 to 12 or the diluted composition according to claim 16 or 17.
  19. 　前記医療用器具の殺菌及び洗浄方法が、浸漬法、噴霧法、塗布法、通液法、循環法、封入法から選択される、請求項１８に記載の殺菌及び洗浄方法。 The sterilization and cleaning method according to claim 18, wherein the sterilization and cleaning method for the medical device is selected from a dipping method, a spraying method, a coating method, a liquid passing method, a circulation method, and an encapsulation method.
  20. 　前記医療用器具が、透析用器具である、請求項１８又は１９に記載の殺菌及び洗浄方法。 The sterilization and cleaning method according to claim 18 or 19, wherein the medical device is a dialysis device.
PCT/JP2020/018593 2019-06-26 2020-05-08 Peracetic acid composition for cleaning medical devices, and method for producing same WO2020261771A1 (en)

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JPH08311495A (en) * 1995-05-22 1996-11-26 Ecolab Inc Method of disinfecting and bleaching article and compositionused therefor
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* Cited by examiner, † Cited by third party
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JPS63286158A (en) * 1987-05-19 1988-11-22 Menikon:Kk Disinfection of contact lens
JPH08311495A (en) * 1995-05-22 1996-11-26 Ecolab Inc Method of disinfecting and bleaching article and compositionused therefor
WO2000022931A1 (en) * 1998-10-19 2000-04-27 Saraya Co., Ltd. Bactericidal/disinfectant peracetic acid composition
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