JP2012140487A - Enzyme-containing cleanser composition for endoscope-cleansing machine - Google Patents
Enzyme-containing cleanser composition for endoscope-cleansing machine Download PDFInfo
- Publication number
- JP2012140487A JP2012140487A JP2010292240A JP2010292240A JP2012140487A JP 2012140487 A JP2012140487 A JP 2012140487A JP 2010292240 A JP2010292240 A JP 2010292240A JP 2010292240 A JP2010292240 A JP 2010292240A JP 2012140487 A JP2012140487 A JP 2012140487A
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- Prior art keywords
- cleaning
- endoscope
- enzyme
- mass
- acid
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- DEFVIWRASFVYLL-UHFFFAOYSA-N ethylene glycol bis(2-aminoethyl)tetraacetic acid Chemical compound OC(=O)CN(CC(O)=O)CCOCCOCCN(CC(O)=O)CC(O)=O DEFVIWRASFVYLL-UHFFFAOYSA-N 0.000 description 1
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- XYXCXCJKZRDVPU-UHFFFAOYSA-N hexane-1,2,3-triol Chemical compound CCCC(O)C(O)CO XYXCXCJKZRDVPU-UHFFFAOYSA-N 0.000 description 1
- FHKSXSQHXQEMOK-UHFFFAOYSA-N hexane-1,2-diol Chemical compound CCCCC(O)CO FHKSXSQHXQEMOK-UHFFFAOYSA-N 0.000 description 1
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- NBZBKCUXIYYUSX-UHFFFAOYSA-N iminodiacetic acid Chemical compound OC(=O)CNCC(O)=O NBZBKCUXIYYUSX-UHFFFAOYSA-N 0.000 description 1
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- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 description 1
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- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 description 1
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- MGFYIUFZLHCRTH-UHFFFAOYSA-N nitrilotriacetic acid Chemical compound OC(=O)CN(CC(O)=O)CC(O)=O MGFYIUFZLHCRTH-UHFFFAOYSA-N 0.000 description 1
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- GTCCGKPBSJZVRZ-UHFFFAOYSA-N pentane-2,4-diol Chemical compound CC(O)CC(C)O GTCCGKPBSJZVRZ-UHFFFAOYSA-N 0.000 description 1
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- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
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- 229920000642 polymer Polymers 0.000 description 1
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- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- AVTYONGGKAJVTE-OLXYHTOASA-L potassium L-tartrate Chemical compound [K+].[K+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O AVTYONGGKAJVTE-OLXYHTOASA-L 0.000 description 1
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- 238000012545 processing Methods 0.000 description 1
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- 125000001453 quaternary ammonium group Chemical group 0.000 description 1
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- OARRHUQTFTUEOS-UHFFFAOYSA-N safranin Chemical compound [Cl-].C=12C=C(N)C(C)=CC2=NC2=CC(C)=C(N)C=C2[N+]=1C1=CC=CC=C1 OARRHUQTFTUEOS-UHFFFAOYSA-N 0.000 description 1
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
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- 239000011734 sodium Substances 0.000 description 1
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- HELHAJAZNSDZJO-OLXYHTOASA-L sodium L-tartrate Chemical compound [Na+].[Na+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O HELHAJAZNSDZJO-OLXYHTOASA-L 0.000 description 1
- 229940079827 sodium hydrogen sulfite Drugs 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
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- 235000011006 sodium potassium tartrate Nutrition 0.000 description 1
- NTHWMYGWWRZVTN-UHFFFAOYSA-N sodium silicate Chemical compound [Na+].[Na+].[O-][Si]([O-])=O NTHWMYGWWRZVTN-UHFFFAOYSA-N 0.000 description 1
- 229910052911 sodium silicate Inorganic materials 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
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- 239000004328 sodium tetraborate Substances 0.000 description 1
- 235000010339 sodium tetraborate Nutrition 0.000 description 1
- RWVGQQGBQSJDQV-UHFFFAOYSA-M sodium;3-[[4-[(e)-[4-(4-ethoxyanilino)phenyl]-[4-[ethyl-[(3-sulfonatophenyl)methyl]azaniumylidene]-2-methylcyclohexa-2,5-dien-1-ylidene]methyl]-n-ethyl-3-methylanilino]methyl]benzenesulfonate Chemical compound [Na+].C1=CC(OCC)=CC=C1NC1=CC=C(C(=C2C(=CC(C=C2)=[N+](CC)CC=2C=C(C=CC=2)S([O-])(=O)=O)C)C=2C(=CC(=CC=2)N(CC)CC=2C=C(C=CC=2)S([O-])(=O)=O)C)C=C1 RWVGQQGBQSJDQV-UHFFFAOYSA-M 0.000 description 1
- KVCGISUBCHHTDD-UHFFFAOYSA-M sodium;4-methylbenzenesulfonate Chemical compound [Na+].CC1=CC=C(S([O-])(=O)=O)C=C1 KVCGISUBCHHTDD-UHFFFAOYSA-M 0.000 description 1
- 230000003381 solubilizing effect Effects 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 239000012089 stop solution Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 1
- 235000019408 sucralose Nutrition 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- POWFTOSLLWLEBN-UHFFFAOYSA-N tetrasodium;silicate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-][Si]([O-])([O-])[O-] POWFTOSLLWLEBN-UHFFFAOYSA-N 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 description 1
- 229940074410 trehalose Drugs 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 230000005514 two-phase flow Effects 0.000 description 1
- 239000004034 viscosity adjusting agent Substances 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
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Landscapes
- Endoscopes (AREA)
- Detergent Compositions (AREA)
Abstract
Description
本発明は、内視鏡洗浄機用酵素含有洗浄剤組成物及び内視鏡の洗浄方法に関する。 The present invention relates to an enzyme-containing cleaning composition for an endoscope cleaner and a method for cleaning an endoscope.
従来より、内視鏡は、使用した後の再処理方法として、十分に洗浄し、消毒を行った後、次の処置に用いられていた。内視鏡の洗浄用として、内視鏡自動洗浄機が存在しているが、洗浄力が不十分なために、内視鏡洗浄機を用いる前には、必ず手洗いにより洗浄を行うことが必要であった。この原因の一つは、洗浄時に泡立ちが生じ、超音波や水流による物理力を内視鏡に働かせることができないためであると考えられる。また、凝固血液のような表面に固着した汚れは、表面の目に見える汚れはある程度洗浄することができても、フィブリンのような残留タンパクは通常の洗浄剤では落とすことができない。この残留タンパクの影響により、洗浄後の消毒工程において、消毒不良の原因になることがあることも、他の原因として挙げられる。 Conventionally, as a reprocessing method after use, an endoscope has been used for the next treatment after being thoroughly cleaned and disinfected. Although there is an automatic endoscope cleaning machine for cleaning endoscopes, it is necessary to wash by hand before using the endoscope cleaning machine due to insufficient cleaning power. Met. One reason for this is thought to be that foaming occurs during cleaning, and physical force due to ultrasonic waves or water flow cannot be applied to the endoscope. In addition, dirt that adheres to the surface, such as coagulated blood, can be washed to some extent with visible dirt on the surface, but residual proteins such as fibrin cannot be removed with ordinary detergents. Another cause is that this residual protein may cause disinfection failure in the disinfection process after cleaning.
特許文献1には、ポリオキシエチレン−ポリオキシプロピレン系ノニオン界面活性剤を含有する洗浄液を用いた特定の内視鏡洗浄方法が開示されている。特許文献1には、内視鏡を浸漬させた洗浄液を、洗浄液の液面下に存在する循環液排出手段により循環させることが記載されている。また、特許文献2には、気液2相流により内視鏡管を洗浄する方法が開示されている。また、特許文献3には、特定のポリオキシエチレン−ポリオキシプロピレンブロックポリマー、特定のポリオキシアルキレンアルキルエーテル、アルカノールアミン類、特定の無機アルカリ剤を特定条件で含有する医療器具用洗浄剤組成物が開示されている。また、特許文献4には、液媒体、酵素組成物、特定の分散性安定成分、及び特定の界面活性剤を含有し、アルカリ金属水酸化物または活性塩素源を実質的に含まない、液体安定化酵素含有洗剤組成物が開示されている。 Patent Document 1 discloses a specific endoscope cleaning method using a cleaning liquid containing a polyoxyethylene-polyoxypropylene nonionic surfactant. Patent Document 1 describes that a cleaning liquid in which an endoscope is immersed is circulated by a circulating liquid discharging means existing below the surface of the cleaning liquid. Patent Document 2 discloses a method of cleaning an endoscope tube by a gas-liquid two-phase flow. Patent Document 3 discloses a cleaning composition for medical devices containing a specific polyoxyethylene-polyoxypropylene block polymer, a specific polyoxyalkylene alkyl ether, an alkanolamine, and a specific inorganic alkaline agent under specific conditions. Is disclosed. Patent Document 4 includes a liquid medium, an enzyme composition, a specific dispersible stabilizing component, and a specific surfactant, and is substantially free of alkali metal hydroxide or an active chlorine source. A chemical enzyme-containing detergent composition is disclosed.
内視鏡自動洗浄機による洗浄では、水道水を加温することなくそのままの温度で用いることが一般的であるが、特許文献1の一般式(I)の界面活性剤では、水温が低いときに、著しい泡立ちが生じ洗浄性が低下する。また、引用文献1では、循環のための排出ノズルを水中、すなわち洗浄液の液面下に設けることが記載されているが、液面下にノズルを設置すると、水流の状態が目視では確認することができないため、ノズルの目詰まりによって、洗浄性が低下しても気がつくことができず、洗浄不良の原因となり、内視鏡のカバー等にも水流が届かないため汚れが洗浄機に蓄積しやすい。また、特許文献2の方法は、内視鏡の管路内を洗浄するものであり、外側表面に適用することができない。また、特許文献3の洗浄剤組成物は、内視鏡洗浄剤に固着した凝固血液を目に見えない残留タンパクの部分まで洗浄することができない。また、特許文献4のような食器加工分野での洗浄では、一般に温水が用いられるのに対し、内視鏡洗浄機による洗浄では、水道水等を加温することなく用いられることが多く、低温で泡立ちの問題が発生する。このように、従来、低温でも泡立ちが少なく、且つ洗浄力に優れた内視鏡自動洗浄機用の洗浄剤は見出されていなかった。 In washing with an endoscope automatic washer, it is common to use tap water at the same temperature without heating, but the surfactant of general formula (I) in Patent Document 1 has a low water temperature. In addition, significant foaming occurs and the cleaning properties are reduced. Also, in the cited document 1, it is described that the discharge nozzle for circulation is provided in water, that is, below the surface of the cleaning liquid. However, when the nozzle is installed below the liquid surface, the state of the water flow should be confirmed visually. Therefore, it is difficult to notice even if the cleaning performance deteriorates due to clogging of the nozzles, which causes poor cleaning, and the water flow does not reach the endoscope cover, etc., and dirt easily accumulates in the cleaning machine. . Moreover, the method of patent document 2 wash | cleans the inside of the pipe line of an endoscope, and cannot be applied to an outer surface. Moreover, the detergent composition of Patent Document 3 cannot wash the coagulated blood adhering to the endoscope detergent to the invisible residual protein portion. Moreover, in the washing | cleaning in the tableware processing field like patent document 4, although warm water is generally used, in the washing | cleaning by an endoscope washing machine, it is often used without heating tap water etc., and low temperature This causes foaming problems. As described above, a cleaning agent for an automatic endoscope cleaning machine that has low foaming even at low temperatures and has excellent cleaning power has not been found.
本発明の課題は、低温でも泡立ちが少なく、且つ洗浄力に優れた内視鏡洗浄機用酵素含有洗浄剤組成物及び内視鏡の洗浄方法を提供することである。 An object of the present invention is to provide an enzyme-containing cleaning composition for an endoscope cleaning machine and a method for cleaning an endoscope that have less foaming even at a low temperature and have excellent cleaning power.
本発明は、内視鏡洗浄機用酵素含有洗浄剤組成物であって、(A)界面活性剤〔以下、(A)成分という〕を1〜50質量%及び(B)プロテアーゼ〔以下、(B)成分という〕を含有し、含有する界面活性剤の中で下記一般式(I)で表される非イオン界面活性剤〔以下、(A1)成分という〕の割合が90質量%以上である、内視鏡洗浄機用酵素含有洗浄剤組成物に関する。
R−O−[(EO)m/(PO)n]−H (I)
〔式中、Rは炭素数7〜9の分岐鎖アルキル基、EOはエタンジイルオキシ基、POはプロパンジイルオキシ基、m及びnは平均付加モル数であり、mは1〜30の数、nは2〜50の数である。“/”はEOとPOがランダムでもブロックでもよいことを示す記号である。また、EOとPOの付加順序は問わない。〕
The present invention is an enzyme-containing cleaning composition for an endoscope cleaning machine, which comprises (A) a surfactant (hereinafter referred to as (A) component) in an amount of 1 to 50% by mass and (B) a protease (hereinafter referred to as ( B) component] and the proportion of the nonionic surfactant represented by the following general formula (I) [hereinafter referred to as component (A1)] is 90% by mass or more. The present invention relates to an enzyme-containing cleaning composition for an endoscope cleaning machine.
R—O — [(EO) m / (PO) n ] —H (I)
[Wherein, R is a branched alkyl group having 7 to 9 carbon atoms, EO is an ethanediyloxy group, PO is a propanediyloxy group, m and n are average added mole numbers, m is a number of 1 to 30, n is a number from 2 to 50. “/” Is a symbol indicating that EO and PO may be random or block. The order of adding EO and PO is not limited. ]
本発明において、内視鏡洗浄機用酵素含有洗浄剤組成物とは、内視鏡洗浄機で用いる洗浄剤組成物であって酵素を含有するものという意味であり、内視鏡洗浄機により内視鏡を洗浄するための酵素含有洗浄剤組成物である。 In the present invention, the enzyme-containing cleaning composition for an endoscope cleaning machine means a cleaning composition that is used in an endoscope cleaning machine and contains an enzyme. An enzyme-containing cleaning composition for cleaning an endoscope.
また、本発明は、上記本発明の内視鏡洗浄機用酵素含有洗浄剤組成物を水で50〜1000倍に希釈した希釈洗浄液を用いた内視鏡洗浄機による内視鏡の洗浄方法であって、前記希釈洗浄液の水流により内視鏡を洗浄する洗浄方法に関する。 The present invention also relates to a method for cleaning an endoscope with an endoscope cleaning machine using a diluted cleaning solution obtained by diluting the enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention with water 50 to 1000 times. Further, the present invention relates to a cleaning method for cleaning an endoscope with a water flow of the diluted cleaning liquid.
本発明によれば、低温でも泡立ちが少なく、且つ洗浄力に優れた内視鏡洗浄機用酵素含有洗浄剤組成物及び内視鏡の洗浄方法が提供される。 According to the present invention, there are provided an enzyme-containing cleaning composition for an endoscope cleaner and a method for cleaning an endoscope, which are less foamed even at a low temperature and have excellent cleaning power.
<(A)成分>
(A)成分は、界面活性剤である。(A)成分としては、非イオン界面活性剤、陰イオン界面活性剤、陽イオン界面活性剤、両性イオン界面活性剤のいずれも使用可能であるが、しかしながら、内視鏡洗浄機に関しては、洗浄時の水温に温度管理がされていないものが多く、常温や温水で洗浄した場合には、特に泡が問題にならない場合でも、水温が低くなると、泡が消えにくくなる。
<(A) component>
The component (A) is a surfactant. As the component (A), any of a nonionic surfactant, an anionic surfactant, a cationic surfactant, and a zwitterionic surfactant can be used. In many cases, the temperature of the water is not controlled, and when it is washed with room temperature or warm water, the bubbles are difficult to disappear when the water temperature is low, even if the bubbles are not a problem.
一方、洗浄力を高めるために、内視鏡洗浄機の中では常に高圧で噴出された水が循環しており、非常に泡立ちやすくなっている。泡がたつと、泡により超音波や水流の物理力が緩和され、内視鏡表面に伝わりにくくなり洗浄力が低下する。それだけではなく、内視鏡洗浄機に備えられている洗浄水の供給や排出を感知するための水位センサーの誤感知を起こし、洗浄が停止してしまう。また、RO水や、イオン交換水など極端に硬度が低い水を使用したときにも同様の問題が見られる。そのため5℃の低硬度の水を使用した場合でも泡立ちが抑制されていることが必要である。このような条件では、ほとんどすべての界面活性剤が高い起泡性を有し洗浄に適さない。一方起泡性の非常に低い界面活性剤を用いると、洗浄力弱すぎて使用に適さない。 On the other hand, in order to increase the cleaning power, the water jetted at a high pressure is constantly circulating in the endoscope cleaning machine, which makes it very easy to foam. When the bubbles build up, the physical force of the ultrasonic waves and water flow is relaxed by the bubbles, and it becomes difficult to be transmitted to the endoscope surface and the cleaning power is reduced. Not only that, the water level sensor for detecting the supply and discharge of the cleaning water provided in the endoscope cleaning machine causes a false detection and the cleaning stops. The same problem is also observed when extremely low hardness water such as RO water or ion exchange water is used. Therefore, it is necessary that foaming is suppressed even when water having a low hardness of 5 ° C. is used. Under such conditions, almost all surfactants have high foaming properties and are not suitable for cleaning. On the other hand, if a surfactant having a very low foaming property is used, the cleaning power is too weak to be suitable for use.
本発明のように、(A)成分として(A1)成分を一定量以上用いた場合にのみ、低温で泡立ちを少なくすることと洗浄力を両立させることができる。しかも、少量でも他の種類の界面活性剤が混ざると、泡立ちが増加したり、洗浄力が低下してしまうために、洗浄剤組成物中の大部分の界面活性剤が、(A1)成分の特定の界面活性剤のみで構成されていなくてはならない。具体的には、一般式(I)で表される非イオン界面活性剤の割合が、(A)成分中、90質量%以上でなくてはならない。また、95質量%以上であることが好ましく、99質量%以上であることがより好ましい。
R−O−[(EO)m/(PO)n]−H (I)
〔式中、Rは炭素数7〜9の分岐鎖アルキル基、EOはエタンジイルオキシ基、POはプロパンジイルオキシ基、m及びnは平均付加モル数であり、mは1〜30の数、nは2〜50の数である。“/”はEOとPOがランダムでもブロックでもよいことを示す記号である。また、EOとPOの付加順序は問わない。〕
Only when a certain amount or more of the component (A1) is used as the component (A) as in the present invention, it is possible to reduce both foaming and cleaning power at a low temperature. Moreover, when other types of surfactants are mixed even in a small amount, foaming increases or the cleaning power decreases, so that most of the surfactants in the cleaning composition are composed of the component (A1). It must consist only of specific surfactants. Specifically, the proportion of the nonionic surfactant represented by the general formula (I) must be 90% by mass or more in the component (A). Moreover, it is preferable that it is 95 mass% or more, and it is more preferable that it is 99 mass% or more.
R—O — [(EO) m / (PO) n ] —H (I)
[Wherein, R is a branched alkyl group having 7 to 9 carbon atoms, EO is an ethanediyloxy group, PO is a propanediyloxy group, m and n are average added mole numbers, m is a number of 1 to 30, n is a number from 2 to 50. “/” Is a symbol indicating that EO and PO may be random or block. The order of adding EO and PO is not limited. ]
洗浄力の点からRの炭素数は8〜9が好ましい。また低温での泡立ちを抑制する点において、mは1〜20であることが好ましく、2〜15であることがより好ましく、3〜10であることが特に好ましい。また、nは3〜20であることが好ましく、4〜10であることが特に好ましい。また、EOとPOはランダム付加体であることが好ましい。 From the viewpoint of detergency, the carbon number of R is preferably 8-9. Moreover, in the point which suppresses foaming at low temperature, m is preferably 1-20, more preferably 2-15, and particularly preferably 3-10. N is preferably from 3 to 20, particularly preferably from 4 to 10. EO and PO are preferably random adducts.
一般式(I)の界面活性剤は曇点が低いことから、高温にすると分離しやすいため、他の種類の界面活性剤を併用することができるが、泡立ちを抑制するために、他の種類の界面活性剤は全界面活性剤中の10質量%以下でなくてはならない。 Since the surfactant of the general formula (I) has a low cloud point, it can be easily separated at a high temperature. Therefore, other types of surfactants can be used in combination, but other types can be used to suppress foaming. The surfactant should be 10% by mass or less based on the total surfactant.
<(B)成分>
(B)成分はプロテアーゼである。プロテアーゼは、好ましくは中性からアルカリ側に至適pHが存在するものであれば如何なる酵素でもよく、またこの条件を満たす複数のプロテアーゼを組合せて使用することが可能である。本発明の(D)成分はBacillus SPに由来するズブチリシンプロテアーゼが好ましく、中でも、Bacillus Halodurans、Bacillus clausiiに由来するズブチリシンプロテアーゼが好ましい。市販されているアルカリプロテアーゼとしては、ノボザイムズジャパン社から入手できるアルカラーゼ、サビナーゼ、エバラーゼ、エスペラーゼ、カンナーゼ、オボザイム、ジェネンコア・インターナショナル社から入手できるプラフェクト、プロペラーゼなどがある。また特開2007−61101号公報に記載されたプロテアーゼも好適に使用できる。
<(B) component>
Component (B) is a protease. The protease may be any enzyme as long as it has an optimum pH from neutral to alkaline, and a plurality of proteases satisfying this condition can be used in combination. The component (D) of the present invention is preferably a subtilisin protease derived from Bacillus SP, and among them, a subtilisin protease derived from Bacillus Halodurans or Bacillus clausii is preferred. Examples of commercially available alkaline proteases include Alcalase, Sabinase, Evalase, Esperase, Cannase, Ovozyme, and Perfect, Properase available from Genencor International, available from Novozymes Japan. In addition, proteases described in JP-A-2007-61101 can also be suitably used.
また、本発明の内視鏡洗浄機用酵素含有洗浄剤組成物を水で50〜1000倍に希釈した希釈洗浄液中、(B)成分の含有量(タンパク質分解活性)は、固着タンパク質除去効果及びコストの観点から、洗浄剤1gあたり、0.01〜200PUが好ましく、0.05〜100PUがより好ましく、0.1〜50PUがさらに好ましく、0.5〜20PUが特に好ましい。本発明の内視鏡洗浄機用酵素含有洗浄剤組成物中の(B)成分の含有量は、このような希釈洗浄液中の含有量を考慮して適宜決定できる。 In addition, in the diluted cleaning solution obtained by diluting the enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention 50 to 1000 times with water, the content (proteolytic activity) of the component (B) is the fixed protein removal effect and From a viewpoint of cost, 0.01-200 PU is preferable per 1 g of cleaning agents, 0.05-100 PU is more preferable, 0.1-50 PU is further more preferable, 0.5-20 PU is especially preferable. The content of the component (B) in the enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention can be appropriately determined in consideration of the content in such a diluted cleaning solution.
なお、タンパク質分解活性(PU/g)は次の方法により測定される。
1w/v%の濃度でカゼイン(ハマーステイン:メルク社)を含む50mmol/Lホウ酸緩衝液(pH10.5)1mLを30℃で5分間保温した後、0.1gの酵素溶液と混合し、30℃で15分間反応を行う。反応停止液(0.11mol/Lトリクロロ酢酸−0.22mol/L酢酸ナトリウム−0.33mol/L酢酸)2mLを加え、室温で10分間放置する。次に酸変性タンパク質をろ過(No.2ろ紙;ワットマン社製)し、ろ液0.5mLにアルカリ性銅溶液[1w/v%酒石酸カリウム・ナトリウム水溶液:1w/v%硫酸銅水溶液:炭酸ナトリウムの0.1mol/L水酸化ナトリウム水溶液溶解物(炭酸ナトリウム濃度2w/v%)=1:1:100(V/V)]2.5mLを添加し30℃、10分間保温する。さらに、希釈フェノール試薬[フェノール試薬(関東化学社製)をイオン交換水で2倍に希釈したもの]0.25mLを加え、30℃で30分間保温後、このサンプルの660nmにおける吸光度を測定する。また、上記の酵素反応系に反応停止液を混合した後、酵素溶液を加えたものをブランクとして同様に吸光度を測定する。次にサンプルとブランクとの吸光度差により、遊離してきた酸可溶性のタンパク質分解物量(チロシン換算された量)が得られ、これを反応時間(本条件の場合:15分)及び酵素溶液量(本条件の場合:0.1g)で除して、タンパク質分解活性値を求めることができる。なお、1PUは、上記の反応条件において1分間に1mmolのチロシンに相当する酸可溶性タンパク質分解物を遊離する酵素量とする。
The proteolytic activity (PU / g) is measured by the following method.
1 mL of 50 mmol / L borate buffer solution (pH 10.5) containing casein (Hammerstein: Merck) at a concentration of 1 w / v% was kept at 30 ° C. for 5 minutes, and then mixed with 0.1 g of enzyme solution. The reaction is performed at 30 ° C. for 15 minutes. Add 2 mL of the reaction stop solution (0.11 mol / L trichloroacetic acid-0.22 mol / L sodium acetate-0.33 mol / L acetic acid) and let stand at room temperature for 10 minutes. Next, the acid-denatured protein was filtered (No. 2 filter paper; manufactured by Whatman), and an alkaline copper solution [1 w / v% potassium tartrate / sodium tartrate aqueous solution: 1 w / v% copper sulfate aqueous solution: sodium carbonate was added to 0.5 mL of the filtrate. 0.1 mol / L aqueous sodium hydroxide solution (sodium carbonate concentration 2 w / v%) = 1: 1: 100 (V / V)] 2.5 mL is added, and the mixture is kept at 30 ° C. for 10 minutes. Further, 0.25 mL of a diluted phenol reagent [phenol reagent (manufactured by Kanto Chemical Co., Ltd.) diluted twice with ion-exchanged water] is added, and the mixture is incubated at 30 ° C. for 30 minutes, and then the absorbance at 660 nm of this sample is measured. Moreover, after mixing a reaction stop liquid with said enzyme reaction system, what added an enzyme solution is measured similarly as a blank. Next, the amount of acid-soluble proteolysate that has been liberated (the amount converted to tyrosine) is obtained from the difference in absorbance between the sample and the blank, and this is the reaction time (in this case: 15 minutes) and the amount of enzyme solution (this In the case of conditions: Dividing by 0.1 g), the proteolytic activity value can be determined. Note that 1 PU is the amount of enzyme that liberates an acid-soluble proteolysate corresponding to 1 mmol of tyrosine per minute under the above reaction conditions.
<(C)成分>
本発明の内視鏡洗浄機用酵素含有洗浄剤組成物は、多価アルコール〔(C)成分〕を含有することが好ましい。
<(C) component>
The enzyme-containing cleaning composition for an endoscope cleaner according to the present invention preferably contains a polyhydric alcohol [component (C)].
(A1)成分は、低泡性ではあるが曇点が低く高温で分離しやすい界面活性剤である。(A1)成分を高温で可溶化するために、他の界面活性剤を加えると、低温における泡立ちの問題が生じ、パラトルエンスルホン酸ナトリウムのような一般的なヒドロトロープ剤を配合すると、プロテアーゼの安定性が低下する。しかしながら、多価アルコールを配合することにより、泡立ちや酵素の安定性に影響を与えることなく、高温での配合安定性を高めることができる。 The component (A1) is a surfactant that has a low foaming property but has a low cloud point and is easily separated at a high temperature. When other surfactants are added to solubilize the component (A1) at a high temperature, foaming problems at low temperatures occur, and when a general hydrotrope such as sodium paratoluenesulfonate is added, Stability is reduced. However, blending polyhydric alcohol can improve blending stability at high temperatures without affecting foaming or enzyme stability.
(C)成分の多価アルコールとは、ヒドロキシ基を分子中に2個以上有し、窒素原子を含まない化合物である。具体的には、炭素数2〜10の直鎖、分岐鎖、又は環状の炭化水素を基本骨格とするもの、又は、糖骨格を基本骨格とするものが挙げられ、少なくとも水素原子の2つ以上が水酸基で置換されたもの、または、それらの、1〜4分子がエーテル結合により縮合したものである。本発明の多価アルコールとしてはケトン基やアルデヒド基等の他の官能基も有することができるが、水酸基やエーテル基以外の他の官能基は無い方が好ましい。多価アルコールとしては、炭素数3〜6の直鎖の炭化水素を基本骨格とするものが好ましい。具体的な多価アルコールとしては、エチレングリコール、プロピレングリコール、ジプロピレングリコール、1,3−ブタンジオール、1,2−ブタンジオール、ジブチレングリコール、2,4−ペンタンジオール、1.2−ペンタンジオール、1,5−ペンタンジオール、3−メチル2,4−ペンタンジオール、1,6−ヘキサンジオール、1,2−ヘキサンジオール、グリセリンモノアルキルエーテル、グリセリン、1,2,3−ヘキサントリオール、ソルビトール、キシリトール、グルコース、エリスリトール、ペンタエリスリトール、トレハロース、マルチトール、スクラロース、イノシトール、ジグリセリン、トリグリセリン、テトラグリセリン、シクロヘキサンテトラオール等が挙げられる。より好ましくは、炭素数が3〜6で水酸基を2つ有するものである。特に好ましくは、プロピレングリコール、1,3ブタンジオール、ジプロピレングリコールである。多価アルコールの配合量としては、(A1)成分の可溶化の点で、本発明の内視鏡洗浄機用酵素含有洗浄剤組成物中、5〜80質量%が好ましく、10〜80質量%がより好ましく、20〜70質量%が更に好ましく、30〜60質量%がより更に好ましい。また(A)成分/(C)成分の質量比、好ましくは(A1)成分/(C)成分の質量比は、好ましくは1/1以上、より好ましくは1/1〜1/20、更に好ましくは1/2〜1/20、より更に好ましくは1/3〜1/10である。 The polyhydric alcohol of component (C) is a compound that has two or more hydroxy groups in the molecule and does not contain a nitrogen atom. Specific examples include those having a basic skeleton of a straight chain, branched chain or cyclic hydrocarbon having 2 to 10 carbon atoms, or those having a sugar skeleton as a basic skeleton, and at least two hydrogen atoms or more. Is substituted with a hydroxyl group, or 1 to 4 molecules thereof are condensed by an ether bond. The polyhydric alcohol of the present invention can have other functional groups such as a ketone group and an aldehyde group, but preferably has no other functional group other than a hydroxyl group and an ether group. As a polyhydric alcohol, what has a C3-C6 linear hydrocarbon as a basic skeleton is preferable. Specific polyhydric alcohols include ethylene glycol, propylene glycol, dipropylene glycol, 1,3-butanediol, 1,2-butanediol, dibutylene glycol, 2,4-pentanediol, and 1.2-pentanediol. 1,5-pentanediol, 3-methyl 2,4-pentanediol, 1,6-hexanediol, 1,2-hexanediol, glycerol monoalkyl ether, glycerol, 1,2,3-hexanetriol, sorbitol, Examples include xylitol, glucose, erythritol, pentaerythritol, trehalose, maltitol, sucralose, inositol, diglycerin, triglycerin, tetraglycerin, and cyclohexanetetraol. More preferably, it has 3 to 6 carbon atoms and two hydroxyl groups. Particularly preferred are propylene glycol, 1,3 butanediol, and dipropylene glycol. The blending amount of the polyhydric alcohol is preferably 5 to 80% by mass, and preferably 10 to 80% by mass in the enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention in terms of solubilizing the component (A1). Is more preferable, 20-70 mass% is still more preferable, and 30-60 mass% is still more preferable. The mass ratio of component (A) / component (C), preferably the mass ratio of component (A1) / component (C) is preferably 1/1 or more, more preferably 1/1 to 1/20, still more preferably. Is 1/2 to 1/20, more preferably 1/3 to 1/10.
<(D)成分>
本発明の内視鏡洗浄機用酵素含有洗浄剤組成物は、アルカリ剤〔(D)成分〕を含有することが好ましい。
<(D) component>
The enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention preferably contains an alkaline agent (component (D)).
本発明の洗浄剤組成物にアルカリ剤を添加することにより、より洗浄力を向上することができる。アルカリ剤としては、アルカノールアミン、アルキルアミン、4級アンモニウムなどの有機アルカリ化合物、アルカリ金属の水酸化物、炭酸塩、リン酸塩、珪酸塩から選ばれる一種以上を配合することが可能である。アルカリ金属の水酸化物、炭酸塩、リン酸塩、珪酸塩としては、水酸化カリウム、水酸化ナトリウム、炭酸カリウム、炭酸ナトリウム、リン酸カリウム、リン酸ナトリウム、1号珪酸カリウム、1号珪酸ナトリウム、2号珪酸カリウム、2号珪酸ナトリウム、オルト珪酸カリウム、オルト珪酸カリウムなどを挙げる事ができるが、好ましくはアルカノールアミンである。アルカノールアミンとしては、一般式 N(R1)(R2)(R3) で表されるものが挙げられる。R1はOH基を1〜3含む炭素数1〜8の炭化水素基であり、R2、R3は、それぞれ、独立に、水素原子、炭素数1〜4のアルキル基又は炭素数1〜4のアルカノール基である。R1は、炭素数2〜4のアルカノール基が好ましく、R2、R3としては、水素原子が好ましい。前記一般式のアルカノールアミンとしてはモノエタノールアミン、モノプロパノールアミン、モノイソプロパノールアミン、ジエタノールアミン、トリエタノールアミン、N−メチルプロパノールアミン、N−ジメチルエタノールアミン、2−アミノ−2−メチル−1−プロパノール、トリスヒドロキシアミノメタン等が挙げられ中でも、洗浄力の点からモノエタノールアミン、モノプロパノールアミン、モノイソプロパノールアミン、トリスヒドロキシアミノメタンが好ましく、モノエタノールアミンが最も好ましい。アルカリ剤の配合量としては、本発明の内視鏡洗浄機用酵素含有洗浄剤組成物中、1〜30質量%が好ましく、2〜20質量%がより好ましく、5〜15質量%が特に好ましい。 Detergency can be further improved by adding an alkaline agent to the cleaning composition of the present invention. As an alkaline agent, it is possible to mix | blend 1 or more types chosen from organic alkali compounds, such as an alkanolamine, an alkylamine, and quaternary ammonium, an alkali metal hydroxide, carbonate, phosphate, and silicate. Alkali metal hydroxides, carbonates, phosphates and silicates include potassium hydroxide, sodium hydroxide, potassium carbonate, sodium carbonate, potassium phosphate, sodium phosphate, No. 1 potassium silicate, No. 1 sodium silicate Examples include No. 2 potassium silicate, No. 2 sodium silicate, ortho orthosilicate, and ortho orthosilicate, and alkanolamine is preferable. Examples of the alkanolamine include those represented by the general formula N (R 1 ) (R 2 ) (R 3 ). R 1 is a hydrocarbon group having 1 to 8 carbon atoms containing 1 to 3 OH groups, and R 2 and R 3 are each independently a hydrogen atom, an alkyl group having 1 to 4 carbon atoms or 1 to 1 carbon atoms. 4 alkanol groups. R 1 is preferably a C 2-4 alkanol group, and R 2 and R 3 are preferably hydrogen atoms. Examples of the alkanolamine of the general formula include monoethanolamine, monopropanolamine, monoisopropanolamine, diethanolamine, triethanolamine, N-methylpropanolamine, N-dimethylethanolamine, 2-amino-2-methyl-1-propanol, Among these, monoethanolamine, monopropanolamine, monoisopropanolamine, and trishydroxyaminomethane are preferable from the viewpoint of detergency, and monoethanolamine is most preferable. As a compounding quantity of an alkaline agent, 1-30 mass% is preferable in the enzyme-containing cleaning composition for endoscope washing machines of this invention, 2-20 mass% is more preferable, 5-15 mass% is especially preferable. .
<その他の成分>
本発明の内視鏡洗浄機用酵素含有洗浄剤組成物(高濃度品)には、本発明の目的を損なわない範囲で、金属封鎖剤、溶剤、ハイドロトロープ剤、分散剤、pH調整剤、増粘剤、粘度調整剤、香料、着色剤、酸化防止剤、防腐剤、抑泡剤、漂白剤、漂白活性化剤などを配合することができる。これらの成分は、該洗浄剤組成物を希釈して調製する洗浄液に配合してもよい。
<Other ingredients>
The enzyme-containing cleaning composition for endoscope cleaning machine (high concentration product) of the present invention is a metal sequestering agent, solvent, hydrotrope agent, dispersant, pH adjuster, as long as the object of the present invention is not impaired. Thickeners, viscosity modifiers, fragrances, colorants, antioxidants, preservatives, foam inhibitors, bleaches, bleach activators, and the like can be blended. You may mix | blend these components with the washing | cleaning liquid prepared by diluting this cleaning composition.
本発明の内視鏡洗浄機用酵素含有洗浄剤組成物は、金属封鎖剤を含有することができる。金属封鎖剤を含有することにより、アルカリ土類金属イオンや、アルカリ土類金属塩により結合して固着したタンパク質汚れをより効率的に洗浄することができる。 The enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention can contain a metal sequestering agent. By containing a metal sequestering agent, protein soil bound and fixed by alkaline earth metal ions or alkaline earth metal salts can be more efficiently washed.
金属封鎖剤としては、アミノカルボン酸系、有機酸系、ホスホン酸系、リン酸系、ポリカルボン酸系、のいずれも用いることができる。例えば、ニトリロ三酢酸、イミノ二酢酸、エチレンジアミン四酢酸、ジエチレントリアミン五酢酸、グリコールエーテルジアミン四酢酸、ヒドロキシエチルイミノ二酢酸、トリエチレンテトラアミン六酢酸、ジエンコル酸、等のアミノポリ酢酸又はこれらの塩、ジグリコール酸、オキシジコハク酸、カルボキシメチルオキシコハク酸、クエン酸、乳酸、酒石酸、シュウ酸、リンゴ酸、グルコン酸、カルボキシメチルコハク酸、カルボキシメチル酒石酸、グルタミン酸二酢酸、等の有機酸またはこれらの塩、アミノトリ(メチレンホスホン酸)、1−ヒドロキシエチリデン−1,1−ジホスホン酸、エチレンジアミンテトラ(メチレンホスホン酸)、ジエチレントリアミンペンタ(メチレンホスホン酸)などのホスホン酸またはその塩、トリポリリン酸などのリン酸またはその塩、ポリアクリル酸、ポリアクリル酸、等のポリカルボン酸またはその塩などが挙げられる。 As the metal sequestering agent, any of aminocarboxylic acid type, organic acid type, phosphonic acid type, phosphoric acid type and polycarboxylic acid type can be used. For example, aminopolyacetic acid such as nitrilotriacetic acid, iminodiacetic acid, ethylenediaminetetraacetic acid, diethylenetriaminepentaacetic acid, glycol etherdiaminetetraacetic acid, hydroxyethyliminodiacetic acid, triethylenetetraaminehexaacetic acid, diencoric acid, etc. Glycolic acid, oxydisuccinic acid, carboxymethyloxysuccinic acid, citric acid, lactic acid, tartaric acid, oxalic acid, malic acid, gluconic acid, carboxymethyl succinic acid, carboxymethyl tartaric acid, glutamic acid diacetic acid, etc., or salts thereof, Phosphonic acids or salts thereof such as aminotri (methylenephosphonic acid), 1-hydroxyethylidene-1,1-diphosphonic acid, ethylenediaminetetra (methylenephosphonic acid), diethylenetriaminepenta (methylenephosphonic acid), Phosphoric acid or a salt thereof, such as phosphoric acid, polyacrylic acid, polyacrylic acid, polycarboxylic acid or a salt thereof and the like.
これらの塩の対イオンとしては、アルカリ金属、4級アミン、アルカノールアミン等が挙げられるが、医療器具に対する防食性の点から、アルカノールアミン塩が好ましい。さらに、モノエタノールアミン塩が好ましい。金属封鎖剤としてアルカノールアミン塩型の化合物を用いる場合には、アルカノールアミンのみの量を(D)成分の一部として取り扱うものとする。 The counter ions of these salts include alkali metals, quaternary amines, alkanolamines, etc., but alkanolamine salts are preferred from the viewpoint of anticorrosive properties for medical devices. Furthermore, monoethanolamine salts are preferred. When an alkanolamine salt type compound is used as the metal sequestering agent, the amount of alkanolamine alone is handled as part of the component (D).
金属封鎖剤は、タンパク質汚れの除去効果及びコストの観点から、本発明の本発明の内視鏡洗浄機用酵素含有洗浄剤組成物から調製した洗浄液中、好ましくは0.002〜0.5質量%、より好ましくは0.005〜0.3質量%、更に好ましくは0.01〜0.2質量%、より更に好ましくは0.02〜0.1%質量%となるように配合することが好ましい。 The metal sequestering agent is preferably 0.002 to 0.5 mass in the cleaning liquid prepared from the enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention of the present invention from the viewpoint of the effect of removing protein stains and cost. %, More preferably 0.005 to 0.3% by mass, still more preferably 0.01 to 0.2% by mass, and still more preferably 0.02 to 0.1% by mass. preferable.
また、本発明の内視鏡洗浄機用酵素含有洗浄剤組成物には、酵素安定剤として水溶性カルシウム塩、ホウ酸またはその塩、ホウ砂等のホウ素化合物、ギ酸またはその塩を含有することができる。 Moreover, the enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention contains a water-soluble calcium salt, boric acid or a salt thereof, a boron compound such as borax, formic acid or a salt thereof as an enzyme stabilizer. Can do.
溶剤としては、エタノール、プロパノール等の1価のアルコール類、エチレングリコールエチルエーテル、プロピレングリコールエチルエーテル、エチレングリコールブチルエーテル、ジエチレングリコールブチルエーテル等のグリコールエーテル類、ハイドロトロープ剤としてはパラトルエンスルホン酸、安息香酸、キシレンスルホン酸又はその塩、尿素等、分散剤としては、ポリビニルピロリドン、酸化防止剤としては、ブチルヒドロキシトルエン、亜硫酸ナトリウム、亜流酸水素ナトリウム、抑泡剤として、平均分子量500〜10000のポリプロピレングリコール、炭素数8〜18、平均ポリプロピレングリコール付加モル数1〜10のポリプロピレングリコールアルキルエーテル、シリコーン、シリカ等が挙げられる。pH調整剤としては、グルコン酸、リンゴ酸、コハク酸、酢酸等が挙げられる。なお、溶剤として(C)成分に該当する化合物を用いることもできるが、その場合、当該化合物の量は(C)成分の量に算入する。 Solvents include monohydric alcohols such as ethanol and propanol, glycol ethers such as ethylene glycol ethyl ether, propylene glycol ethyl ether, ethylene glycol butyl ether, and diethylene glycol butyl ether. Hydrotropes include para-toluenesulfonic acid, benzoic acid, Xylenesulfonic acid or a salt thereof, urea, etc., as a dispersant, polyvinylpyrrolidone, as an antioxidant, butylhydroxytoluene, sodium sulfite, sodium hydrogen sulfite, as a foam inhibitor, polypropylene glycol having an average molecular weight of 500 to 10,000, Examples thereof include polypropylene glycol alkyl ethers having 8 to 18 carbon atoms and an average number of moles of added polypropylene glycol of 1 to 10, silicone, silica and the like. Examples of the pH adjuster include gluconic acid, malic acid, succinic acid, acetic acid and the like. In addition, although the compound applicable to (C) component can also be used as a solvent, the amount of the said compound is counted in the quantity of (C) component in that case.
本発明の内視鏡洗浄機用酵素含有洗浄剤組成物は、25℃のpHが好ましくは10.5以上、更に好ましくは10.5〜13、より好ましく10.5〜12.5、より更に好ましくは11〜12である。本発明の内視鏡洗浄機用洗浄剤組成物は、そのまま使用してもよいが、通常、該洗浄剤組成物を水で希釈して調製した洗浄液を洗浄に用いる。希釈倍率は限定されないが、通常50倍〜1000倍程度に希釈することが好ましい。洗浄力には、洗浄時のpHも重要であり、本発明の内視鏡洗浄機用洗浄剤組成物は、水による200倍希釈物のpHが25℃で9.5以上、更に10以上、より更に10.5以上であることが望ましい。また、200倍希釈物のpHの上限値は基材損傷性の観点から12以下が好ましい。 In the enzyme-containing cleaning composition for an endoscope cleaning machine of the present invention, the pH at 25 ° C. is preferably 10.5 or more, more preferably 10.5 to 13, more preferably 10.5 to 12.5, and still more. Preferably it is 11-12. Although the cleaning composition for an endoscope cleaning machine of the present invention may be used as it is, a cleaning solution prepared by diluting the cleaning composition with water is usually used for cleaning. Although a dilution rate is not limited, it is preferable to dilute normally about 50 to 1000 times. The pH at the time of washing is also important for the detergency, and the cleaning composition for an endoscope washing machine of the present invention has a pH of 9.5 or more at 25 ° C., more than 10 at a 200-fold dilution with water, Furthermore, it is desirable that it is 10.5 or more. The upper limit of the pH of the 200-fold diluted product is preferably 12 or less from the viewpoint of substrate damage.
<内視鏡の洗浄方法>
本発明の内視鏡の洗浄方法は、上記本発明の内視鏡洗浄機用酵素含有洗浄剤組成物を水で50〜1000倍に希釈した希釈洗浄液を用いた内視鏡洗浄機による内視鏡の洗浄方法であって、前記希釈洗浄液の水流により内視鏡を洗浄する。本発明の洗浄方法では、内視鏡洗浄機内部に内視鏡を浸漬する液体部を設け、該液体部の水面より上から、前記希釈洗浄液の水流を供給することが好ましい。前記液体部を設ける場合、該液体部の液体を前記希釈洗浄液として循環使用することが好ましい。また、本発明の洗浄方法では、前記希釈洗浄液のpHは9.5以上、更に10以上、より更に10.5以上が好ましく、基材損傷性の観点から12以下が好ましい。
<Cleaning method of endoscope>
The endoscope cleaning method according to the present invention includes an endoscope cleaning machine using a diluted cleaning solution obtained by diluting the enzyme-containing cleaning composition for an endoscope cleaning machine according to the present invention 50 to 1000 times with water. A method for cleaning a mirror, wherein an endoscope is cleaned with a water flow of the diluted cleaning solution. In the cleaning method of the present invention, it is preferable that a liquid part for immersing the endoscope is provided in the endoscope cleaning machine, and the water flow of the diluted cleaning liquid is supplied from above the water surface of the liquid part. When the liquid part is provided, it is preferable to circulate and use the liquid in the liquid part as the diluted cleaning liquid. In the cleaning method of the present invention, the pH of the diluted cleaning solution is preferably 9.5 or higher, more preferably 10 or higher, and still more preferably 10.5 or higher, and is preferably 12 or lower from the viewpoint of substrate damage.
内視鏡洗浄機による内視鏡の洗浄方法としては、特開昭60−220032号公報に示されたような水の噴射による方法や、特開平11−151198号公報に記載された超音波による洗浄方法がある。このような流水や超音波を用いた洗浄方法が、オリンパス社製内視鏡洗浄消毒機OER−2、OER−3等に使用されている。このような洗浄機では、内視鏡浸漬することができる洗浄槽に貯留した洗浄液を、水面上に設置したノズルから高圧で内視鏡表面や洗浄漕カバーに対して噴出させて洗浄を行っている。さらに、引き続き、洗浄液を排出し、すすぎを行い、さらに引き続きに消毒液に浸漬することで内視鏡を再使用可能な状態にしている。ここで洗浄液を噴出するノズルを水面上に設置することは、洗浄液の噴出状態を目視で確認できる、カバーを洗浄することができるというメリットがある一方、洗浄槽内は泡が非常に立ちやすいという問題がある。万が一、洗浄液の循環ラインやノズルに目詰まりがあると洗浄力が低下してしまう。洗浄が十分でないとその後、消毒を行ったとしても、十分な効果を得ることができず、菌が生存してしまし院内感染の原因となる恐れがあるため、ノズルからの水の噴出状態を目視で確認できることは非常に重要である。一方、洗浄槽内で泡が立つと、洗浄槽内に設置された水位センサーが誤動作して洗浄作業が停止したり、洗浄槽から泡があふれたり、洗浄力が低下したりという様々な問題が生じることが知られている。 As an endoscope cleaning method using an endoscope cleaning machine, a method using water injection as disclosed in JP-A-60-220032, or an ultrasonic wave described in JP-A-11-151198 is used. There is a cleaning method. Such a cleaning method using flowing water or ultrasonic waves is used in an endoscope cleaning / disinfecting machine OER-2, OER-3, etc. manufactured by Olympus. In such a cleaning machine, cleaning is performed by ejecting cleaning liquid stored in a cleaning tank that can be immersed in the endoscope from a nozzle installed on the water surface to the endoscope surface or the cleaning tub cover at high pressure. Yes. Furthermore, the endoscope is reusable by continuously discharging the cleaning liquid, rinsing, and subsequently immersing in the disinfecting liquid. Here, installing the nozzle for ejecting the cleaning liquid on the water surface has the advantage that the spraying state of the cleaning liquid can be visually confirmed and the cover can be cleaned, while bubbles are very easily formed in the cleaning tank. There's a problem. If the cleaning liquid circulation line or nozzle is clogged, the cleaning power will decrease. If the cleaning is not enough afterwards, even if disinfection is performed, sufficient effects cannot be obtained, and the bacteria may survive and may cause nosocomial infection. It is very important that it can be confirmed visually. On the other hand, if bubbles are generated in the cleaning tank, the water level sensor installed in the cleaning tank malfunctions and the cleaning operation stops, bubbles overflow from the cleaning tank, and the cleaning power decreases. It is known to occur.
本発明の洗浄剤組成物は上記のような洗浄方法に使用できるが、内視鏡洗浄機に供給した場合に泡立ちの問題が発生することなく洗浄を行うことができる。本発明の洗浄剤組成物の希釈倍率としては、洗浄力やコストの観点から50〜1000倍であることが好ましく、100〜500倍であることがより好ましく、200〜400倍であることが特に好ましい。また、洗浄剤組成物は、洗浄機にセットすることにより、洗浄機に自動的供給されることが洗浄剤組成物の投入忘れを防ぐことができることから好ましい。また、本発明の洗浄剤組成物から調製した希釈洗浄液の粘度は10000mPa・s以下であることが好ましく、1000mPa・sであることがより好ましく300ppm以下であることが特に好ましい。このときの洗浄温度(希釈洗浄液の温度)は洗浄力の点で5〜50℃、更に10〜40℃が好ましい。また、洗浄時間は30秒〜30分、更に1分〜15分が好ましい。 The cleaning composition of the present invention can be used in the above-described cleaning method, but can be cleaned without causing a problem of foaming when supplied to an endoscope cleaning machine. The dilution ratio of the cleaning composition of the present invention is preferably 50 to 1000 times, more preferably 100 to 500 times, and particularly preferably 200 to 400 times from the viewpoint of detergency and cost. preferable. In addition, it is preferable that the cleaning composition is automatically supplied to the cleaning machine by setting the cleaning composition in the cleaning machine because it is possible to prevent forgetting to put in the cleaning composition. The viscosity of the diluted cleaning liquid prepared from the cleaning composition of the present invention is preferably 10,000 mPa · s or less, more preferably 1000 mPa · s, and particularly preferably 300 ppm or less. The washing temperature (temperature of the diluted washing solution) at this time is preferably 5 to 50 ° C., more preferably 10 to 40 ° C. in terms of washing power. The washing time is preferably 30 seconds to 30 minutes, more preferably 1 minute to 15 minutes.
表1の内視鏡洗浄機用酵素含有洗浄剤組成物を調製し、以下の方法で抑泡性と洗浄性を評価した。結果を表1に示す。なお、pHは、堀場製作所製 pHメータ F−21を用いて測定した。 The enzyme-containing detergent composition for an endoscope washer shown in Table 1 was prepared, and the antifoaming property and the detergency were evaluated by the following methods. The results are shown in Table 1. In addition, pH was measured using HORIBA, Ltd. pH meter F-21.
<抑泡性>
オリンパスメディカルシステムズ社製の内視鏡洗浄消毒装置OER−2を用いて評価を行った。5℃に冷却した水道水を供給した。内視鏡洗浄機用酵素含有洗浄剤組成物は、水道水と同時に洗浄槽に投入した。洗浄時間を10分に設定し、洗浄時の泡状態を以下の基準で評価した。
4 泡立ちが少なく動作に問題がない。
3 泡立ちが多く、泡により多少液面の上昇が見られる。洗浄には特に問題ない
2 泡立ちが激しく、液面が上昇し、長時間洗浄した場合、泡があふれる出てくることもある。泡立ちによる洗浄性の低下がみられる
1 著しい泡立ちのためが装置から液が多量に漏れるため、使用不可能。
評価点が3点以上であれば、内視鏡洗浄機用酵素含有洗浄剤組成物として使用可能である。
<Foam suppression>
Evaluation was performed using an endoscope cleaning / disinfecting apparatus OER-2 manufactured by Olympus Medical Systems. Tap water cooled to 5 ° C. was supplied. The enzyme-containing cleaning composition for an endoscope cleaning machine was put into a cleaning tank simultaneously with tap water. The washing time was set to 10 minutes, and the foam state during washing was evaluated according to the following criteria.
4 There are few bubbles and there is no problem in operation.
3 There is much foaming, and the liquid level is slightly increased by the foam. There is no particular problem with cleaning. 2 Foaming is intense, the liquid level rises, and if washed for a long time, bubbles may overflow. Deterioration of cleaning performance due to foaming is observed. 1 Unusable due to significant foaming because liquid leaks from the device.
If the evaluation score is 3 or more, it can be used as an enzyme-containing cleaning composition for an endoscope cleaning machine.
<洗浄性>
テフロン製のテストピースに、グリセリン、血清、ムチン、小麦粉、サフラニンからなるEN/ISO15883-5 Annex Rに記載のモデル汚れを10mg/cm2の割合で塗布し、室温で1時間乾燥させたものを実験に用いた。洗浄は、オリンパスメディカルシステムズ(株)製内視鏡洗浄消毒器OER-2内に固定し、洗浄時間を10分に設定し洗浄を行った。洗浄終了後、テストピースを取り出し、別に用意した水槽中のイオン交換水を用いて穏やかにすすいだ。乾燥後、目視で汚れの残留があるかを判定した後、目視で残留が認められないものに関しては、Coomassie Protein Assay Reagent(タンパク質定量キット添付の試薬、Thermo Scientific社製)に3分間浸漬後(CBB染色)、イオン交換水で充分濯いだ後の染色状態で下記の判定基準に従い判定した。尚、試験にあたっては5枚のテストピースを用い、結果はその平均値とした。
判定基準
5:目視でも、CBB染色後でも汚れの残留がほとんどみられない。
4:目視では残留が認められないが、CBB染色では、一部にタンパク質の残留が認められる。
3:目視では残留が認められないが、CBB染色では、全面にタンパク質の残留が認められる
2:目視でも僅かに残留が見られる
1:目視で多くの血液の残留が認められる
評価点3.6以上であれば、再使用にあたっては問題ないレベルであり、良好に洗浄できたものと判断する。
<Detergency>
A model soil described in EN / ISO15883-5 Annex R consisting of glycerin, serum, mucin, flour and safranin was applied to a Teflon test piece at a rate of 10 mg / cm 2 and dried at room temperature for 1 hour. Used for experiments. The cleaning was carried out by fixing in an endoscope cleaning / disinfecting device OER-2 manufactured by Olympus Medical Systems Co., Ltd., and setting the cleaning time to 10 minutes. After washing, the test piece was taken out and rinsed gently with ion-exchanged water in a separately prepared water tank. After drying, determine whether there is any residual dirt visually, and if there is no visible residue, immerse in Coomassie Protein Assay Reagent (reagent supplied with the protein quantification kit, manufactured by Thermo Scientific) for 3 minutes ( CBB staining), and after rinsing with ion-exchanged water, the dyeing state was determined according to the following criteria. In the test, five test pieces were used, and the result was an average value.
Judgment criteria 5: Residual dirt is hardly observed even visually or after CBB staining.
4: No residue is visually observed, but protein residue is partially observed in CBB staining.
3: Although no residue is visually observed, protein residue is observed on the entire surface by CBB staining. 2: A slight residue is visually observed 1: A large amount of blood is visually observed Evaluation point 3.6 If it is above, it is a level which does not have a problem in reuse, and it is judged that it was able to wash | clean well.
・分岐型非イオン界面活性剤(1):一般式(I)中のRが炭素数9の分岐鎖アルキル基、mが9、nが5.2、EOとPOがランダム付加体である非イオン界面活性剤(Plurafac LF901(BASFジャパン製))
・分岐型非イオン界面活性剤(2):一般式(I)中のRが炭素数9の分岐鎖アルキル基、mが5.8、nが4.8、EOとPOがランダム付加体である非イオン界面活性剤(Plurafac LF900(BASFジャパン製))
・分岐型非イオン界面活性剤(3):便宜上一般式(I)の構造で表すと、一般式(I)中のRが炭素数12〜14の分岐鎖アルキル基、mが7.0、nが7.5、EOとPOがEO、POの順のブロック付加体である非イオン界面活性剤(ソフタノール7085(日本触媒(株)製))
・分岐型非イオン界面活性剤(4):便宜上一般式(I)の構造で表すと、一般式(I)中のRが炭素数8の分岐鎖アルキル基、mが3、nが0である非イオン界面活性剤
Branched nonionic surfactant (1): R in the general formula (I) is a branched alkyl group having 9 carbon atoms, m is 9, n is 5.2, and EO and PO are random adducts. Ionic surfactant (Plurafac LF901 (manufactured by BASF Japan))
Branched nonionic surfactant (2): R in the general formula (I) is a branched alkyl group having 9 carbon atoms, m is 5.8, n is 4.8, and EO and PO are random adducts. Certain nonionic surfactant (Plurafac LF900 (manufactured by BASF Japan))
Branched nonionic surfactant (3): When represented by the structure of the general formula (I) for convenience, R in the general formula (I) is a branched alkyl group having 12 to 14 carbon atoms, m is 7.0, Nonionic surfactant (Softanol 7085 (manufactured by Nippon Shokubai Co., Ltd.)), which is a block adduct in the order of n = 7.5, EO and PO = EO, PO
Branched nonionic surfactant (4): When represented by the structure of general formula (I) for convenience, R in general formula (I) is a branched alkyl group having 8 carbon atoms, m is 3, and n is 0. A nonionic surfactant
・直鎖型非イオン界面活性剤(1):便宜上一般式(I)の構造で表すと、一般式(I)中のRが炭素数12の直鎖アルキル基、mが5.7、nが3.6、EOとPOがEO、POの順のブロック付加体である非イオン界面活性剤
・直鎖型非イオン界面活性剤(2):便宜上一般式(I)の構造で表すと、一般式(I)中のRが炭素数8の直鎖アルキル基、mが0、nが3.0である非イオン界面活性剤
・直鎖型非イオン界面活性剤(3):便宜上一般式(I)の構造で表すと、一般式(I)中のRが炭素数8の直鎖アルキル基、mが3.0、nが2.5、EOとPOがEO、POの順のブロック付加体である非イオン界面活性剤
・直鎖型非イオン界面活性剤(4):便宜上一般式(I)の構造で表すと、一般式(I)中のRが炭素数8の直鎖アルキル基、mが7.0、nが10.0、EOとPOがEO、POの順のブロック付加体である非イオン界面活性剤
・直鎖型非イオン界面活性剤(5):R’−O−(EO)m1−(PO)n1−(EO)m2−Hで表される非イオン界面活性剤であって、該式中、R’が炭素数8の直鎖アルキル基、m1が3.5、n1が2.5、m2が3.5、EO、PO、EOがこの順のブロック付加体である非イオン界面活性剤
-Linear nonionic surfactant (1): For convenience, when represented by the structure of the general formula (I), R in the general formula (I) is a linear alkyl group having 12 carbon atoms, m is 5.7, n 3.6, EO and PO are block adducts in the order of EO and PO. Nonionic surfactant / linear nonionic surfactant (2): For convenience, the structure of the general formula (I) R in general formula (I) is a linear alkyl group having 8 carbon atoms, m is 0, and n is 3.0. Nonionic surfactant / linear nonionic surfactant (3): General formula for convenience In the structure of (I), R in the general formula (I) is a linear alkyl group having 8 carbon atoms, m is 3.0, n is 2.5, EO and PO are EO, and PO in this order. Nonionic surfactant / linear nonionic surfactant as an adduct (4): When represented by the structure of general formula (I) for the sake of convenience, R in general formula (I) is a straight chain having 8 carbon atoms. Nonionic surfactant / linear nonionic surfactant (5): R ′ which is an alkyl group, m is 7.0, n is 10.0, EO and PO are block adducts in the order of EO and PO A nonionic surfactant represented by —O— (EO) m1 — (PO) n1 — (EO) m2 —H, wherein R ′ is a linear alkyl group having 8 carbon atoms, and m1 is 3.5, n1 is 2.5, m2 is 3.5, EO, PO, and EO are non-ionic surfactants in this order.
・サビナーゼ:ノボザイム社製、プロテアーゼ、酵素活性 12PU/g Sabinase: Novozyme, protease, enzyme activity 12 PU / g
Claims (8)
R−O−[(EO)m/(PO)n]−H (I)
〔式中、Rは炭素数7〜9の分岐鎖アルキル基、EOはエタンジイルオキシ基、POはプロパンジイルオキシ基、m及びnは平均付加モル数であり、mは1〜30の数、nは2〜50の数である。“/”はEOとPOがランダムでもブロックでもよいことを示す記号である。また、EOとPOの付加順序は問わない。〕 An enzyme-containing cleaning composition for an endoscope cleaning machine, which contains (A) a surfactant in an amount of 1 to 50% by mass and (B) a protease, and contains the following general formula (I The enzyme-containing cleaning composition for an endoscope cleaning machine, wherein the ratio of the nonionic surfactant represented by) is 90% by mass or more.
R—O — [(EO) m / (PO) n ] —H (I)
[Wherein, R is a branched alkyl group having 7 to 9 carbon atoms, EO is an ethanediyloxy group, PO is a propanediyloxy group, m and n are average added mole numbers, m is a number of 1 to 30, n is a number from 2 to 50. “/” Is a symbol indicating that EO and PO may be random or block. The order of adding EO and PO is not limited. ]
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