JP6732454B2 - Cleaning disinfectant composition - Google Patents
Cleaning disinfectant composition Download PDFInfo
- Publication number
- JP6732454B2 JP6732454B2 JP2016002322A JP2016002322A JP6732454B2 JP 6732454 B2 JP6732454 B2 JP 6732454B2 JP 2016002322 A JP2016002322 A JP 2016002322A JP 2016002322 A JP2016002322 A JP 2016002322A JP 6732454 B2 JP6732454 B2 JP 6732454B2
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- Prior art keywords
- cleaning
- weight
- composition
- liquid
- disinfectant
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- 239000000203 mixture Substances 0.000 title claims description 108
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- FZQSLXQPHPOTHG-UHFFFAOYSA-N [K+].[K+].O1B([O-])OB2OB([O-])OB1O2 Chemical compound [K+].[K+].O1B([O-])OB2OB([O-])OB1O2 FZQSLXQPHPOTHG-UHFFFAOYSA-N 0.000 description 1
- 229940050528 albumin Drugs 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 229910052783 alkali metal Inorganic materials 0.000 description 1
- 150000001340 alkali metals Chemical class 0.000 description 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 description 1
- 150000001342 alkaline earth metals Chemical class 0.000 description 1
- 125000000217 alkyl group Chemical group 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 229940025131 amylases Drugs 0.000 description 1
- 239000003443 antiviral agent Substances 0.000 description 1
- 125000002648 azanetriyl group Chemical group *N(*)* 0.000 description 1
- 229960000686 benzalkonium chloride Drugs 0.000 description 1
- QRUDEWIWKLJBPS-UHFFFAOYSA-N benzotriazole Chemical compound C1=CC=C2N[N][N]C2=C1 QRUDEWIWKLJBPS-UHFFFAOYSA-N 0.000 description 1
- 239000012964 benzotriazole Substances 0.000 description 1
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 1
- 239000003876 biosurfactant Substances 0.000 description 1
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 1
- 239000004327 boric acid Substances 0.000 description 1
- 230000001680 brushing effect Effects 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229960005069 calcium Drugs 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 description 1
- 239000001527 calcium lactate Substances 0.000 description 1
- 229960002401 calcium lactate Drugs 0.000 description 1
- 235000011086 calcium lactate Nutrition 0.000 description 1
- 159000000007 calcium salts Chemical class 0.000 description 1
- 229940095731 candida albicans Drugs 0.000 description 1
- 150000004649 carbonic acid derivatives Chemical class 0.000 description 1
- 239000005018 casein Substances 0.000 description 1
- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 description 1
- 235000021240 caseins Nutrition 0.000 description 1
- 229940106157 cellulase Drugs 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 238000010411 cooking Methods 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 239000000539 dimer Substances 0.000 description 1
- JOLYVEWZEPKDIJ-UTLKBRERSA-L dipotassium;(2s)-2-(dodecanoylamino)pentanedioate Chemical compound [K+].[K+].CCCCCCCCCCCC(=O)N[C@H](C([O-])=O)CCC([O-])=O JOLYVEWZEPKDIJ-UTLKBRERSA-L 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- UQGFMSUEHSUPRD-UHFFFAOYSA-N disodium;3,7-dioxido-2,4,6,8,9-pentaoxa-1,3,5,7-tetraborabicyclo[3.3.1]nonane Chemical compound [Na+].[Na+].O1B([O-])OB2OB([O-])OB1O2 UQGFMSUEHSUPRD-UHFFFAOYSA-N 0.000 description 1
- DWHHIPIOLSXJLV-UHFFFAOYSA-N dodecyl 2-aminopropanoate Chemical compound CCCCCCCCCCCCOC(=O)C(C)N DWHHIPIOLSXJLV-UHFFFAOYSA-N 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 229950003499 fibrin Drugs 0.000 description 1
- 235000019253 formic acid Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 235000013922 glutamic acid Nutrition 0.000 description 1
- 239000004220 glutamic acid Substances 0.000 description 1
- 229960002449 glycine Drugs 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000000415 inactivating effect Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000006101 laboratory sample Substances 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 125000005647 linker group Chemical group 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229940035034 maltodextrin Drugs 0.000 description 1
- 108010003855 mesentericopeptidase Proteins 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 229910017604 nitric acid Inorganic materials 0.000 description 1
- 229960001774 octenidine Drugs 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- WXZMFSXDPGVJKK-UHFFFAOYSA-N pentaerythritol Chemical compound OCC(CO)(CO)CO WXZMFSXDPGVJKK-UHFFFAOYSA-N 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000656 polylysine Polymers 0.000 description 1
- 229920001451 polypropylene glycol Polymers 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229940099874 potassium lauroyl glutamate Drugs 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000002797 proteolythic effect Effects 0.000 description 1
- 150000003242 quaternary ammonium salts Chemical class 0.000 description 1
- 238000012958 reprocessing Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229940045944 sodium lauroyl glutamate Drugs 0.000 description 1
- 239000004328 sodium tetraborate Substances 0.000 description 1
- IWIUXJGIDSGWDN-UQKRIMTDSA-M sodium;(2s)-2-(dodecanoylamino)pentanedioate;hydron Chemical compound [Na+].CCCCCCCCCCCC(=O)N[C@H](C([O-])=O)CCC(O)=O IWIUXJGIDSGWDN-UQKRIMTDSA-M 0.000 description 1
- 125000006850 spacer group Chemical group 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 229960004072 thrombin Drugs 0.000 description 1
- ILJSQTXMGCGYMG-UHFFFAOYSA-N triacetic acid Chemical class CC(=O)CC(=O)CC(O)=O ILJSQTXMGCGYMG-UHFFFAOYSA-N 0.000 description 1
- WUUHFRRPHJEEKV-UHFFFAOYSA-N tripotassium borate Chemical compound [K+].[K+].[K+].[O-]B([O-])[O-] WUUHFRRPHJEEKV-UHFFFAOYSA-N 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- 239000012224 working solution Substances 0.000 description 1
Landscapes
- Detergent Compositions (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Cleaning In General (AREA)
- Cleaning By Liquid Or Steam (AREA)
Description
本発明は、液体の洗浄殺菌剤組成物、好ましくは医療器具用の洗浄殺菌剤組成物に関するものである。より詳しくは、医療器具に付着した汚れ、特に血液などのタンパク質汚れの固化を抑制しながら、高い洗浄効果と殺菌効果を同時に発揮できる医療器具用洗浄殺菌剤組成物に関する。 The present invention relates to a liquid cleaning and disinfecting composition, preferably a cleaning and disinfecting composition for medical devices. More specifically, the present invention relates to a cleaning and disinfecting composition for medical devices, which can simultaneously exhibit high cleaning effect and sterilizing effect while suppressing solidification of stains attached to medical devices, particularly protein stains such as blood.
医療器具の再生処理は、まず洗浄剤で血液などの汚れを除去した後、消毒や滅菌工程に進む。洗浄の目的は、無機物や有機物、特に微生物などの汚染物を医療器具から除去することであり、これらを可能な限り除去することでその後の消毒や滅菌の確実性を高めることができる。洗浄剤としては、主に汚れの除去効果を最大限に発揮するアルカリ洗浄剤や酵素洗浄剤が用いられている。一方で、洗浄と消毒を同時に実施可能となれば、再生処理の第一段階で、医療器具に付着している細菌やウイルスの数の減少（バイオバーデンを減少させる）、作業者の感染リスクの低減、医療器具間の交差汚染の予防、及び自然環境への汚染水の排出防止という利点を享受することができ、このため、近年、洗浄のみならず殺菌効果も謳った酵素洗浄剤が一部販売されている。 To regenerate medical equipment, first remove stains such as blood with a cleaning agent, and then proceed to a disinfection and sterilization process. The purpose of cleaning is to remove contaminants such as inorganic substances and organic substances, particularly microorganisms, from the medical device, and by removing these substances as much as possible, the certainty of the subsequent disinfection and sterilization can be increased. As the cleaning agent, an alkaline cleaning agent or an enzyme cleaning agent that maximizes the effect of removing dirt is mainly used. On the other hand, if cleaning and disinfection can be performed at the same time, the number of bacteria and viruses adhering to medical devices (reducing bioburden) and the risk of infection of workers will be reduced in the first stage of the reprocessing process. It is possible to enjoy the advantages of reduction, prevention of cross-contamination between medical devices, and prevention of discharge of contaminated water to the natural environment. For this reason, in recent years, some enzyme cleaning agents are not only effective for cleaning but also have a bactericidal effect. It is sold.
しかしながら、洗浄効果と殺菌効果の両方を持つとされる酵素洗浄剤を評価すると、有機物存在下で高い殺菌効果を有していても、血液などのタンパク質汚れに対して変性及び固着を引き起こすことが確認された。非特許文献１でも、塩化ベンザルコニウムやグルコン酸クロルヘキシジンなどの殺菌効果を有する成分（消毒薬）は、血液などのタンパク質汚れを固着させてしまい、その後の洗浄剤を用いた浸漬洗浄でも汚れが落ちず、洗浄効果が発揮されないことが示されている。 However, when an enzyme detergent that is said to have both a cleaning effect and a bactericidal effect is evaluated, even if it has a high bactericidal effect in the presence of organic matter, it may cause denaturation and sticking to protein stains such as blood. confirmed. In Non-Patent Document 1 as well, components having a bactericidal effect (disinfectant) such as benzalkonium chloride and chlorhexidine gluconate fix protein stains such as blood, and stains are caused even after immersion cleaning using a cleaning agent. It does not fall off, and it is shown that the cleaning effect is not exhibited.
なお、医療分野以外では殺菌効果と洗浄効果が同時に期待されるものとして、環境用や衣類用に用いられる「酸素系漂白剤」及び「塩素系漂白剤」が挙げられる。 In addition to the medical field, the bactericidal effect and the cleaning effect are expected at the same time to include "oxygen-based bleaching agents" and "chlorine-based bleaching agents" used for environment and clothes.
また、その他の先行技術として、特許文献１には、（ａ）酸性物質、（ｂ）塩基性物質、（ｃ）タンパク質分解酵素、並びに（ｄ）ポリリジン、クロロヘキシジン及び第４級アンモニウム塩型殺菌剤から選ばれる１種類以上を、（ａ）＋（ｂ）が０．５モル／ｋｇ以上になるように配合してなる医療用殺菌洗浄剤組成物が記載されている。 In addition, as other prior art, in Patent Document 1, (a) an acidic substance, (b) a basic substance, (c) a proteolytic enzyme, and (d) polylysine, chlorohexidine and a quaternary ammonium salt type bactericide A bactericidal/cleansing composition for medical use is described in which one or more kinds selected from (a)+(b) are blended so as to be 0.5 mol/kg or more.
さらに、特許文献２には、（Ａ）１，４−ビス（３，３’−（１−デシルピリジニウム）メチルオキシ）ブタンジブロマイドを０．０１質量％以上、（Ｂ）エチレンジアミン四酢酸塩を０．０００６２５質量％以上含有する殺カリシウイルス剤組成物が記載されている。 Furthermore, in Patent Document 2, (A) 1,4-bis(3,3′-(1-decylpyridinium)methyloxy)butanedibromide is added in an amount of 0.01% by mass or more, and (B) ethylenediaminetetraacetic acid salt. A calicivirus agent composition containing 0.000625 mass% or more is described.
本発明者らが、酸素系漂白剤、塩素系漂白剤及び特許文献１記載の殺菌洗浄剤組成物について、医療器具用洗浄剤の洗浄力評価で頻用される洗浄インジケーター（血液汚れ用）に対する洗浄効果及びヨーロッパ標準法ＥＮ１３７２７とＥＮ１３６２４にて血液汚れ存在下での殺菌効果を評価したところ、酸素系漂白剤（実用液濃度１重量％）では洗浄効果がなかったものの、塩素系漂白剤（有効塩素濃度２００ｐｐｍ）及び特許文献１記載の殺菌洗浄剤組成物では洗浄効果が確認された。しかし、酸素系漂白剤（実用液濃度１重量％）、塩素系漂白剤（有効塩素濃度２００ｐｐｍ）及び特許文献１記載の殺菌洗浄剤組成物はいずれも血液存在下での殺菌効果がないことが明らかとなった。さらに、塩素系漂白剤の有効塩素濃度を２００ｐｐｍ以上として殺菌効果を高めた場合、金属を主な素材とする医療器具についてはさびや腐食が生じる恐れがある。 The present inventors used the oxygen-based bleaching agent, the chlorine-based bleaching agent, and the sterilizing detergent composition described in Patent Document 1 to wash the indicator (for blood stains) frequently used in the washing power evaluation of the detergent for medical instruments. When the effect and the sterilizing effect in the presence of blood stains were evaluated by the European standard methods EN 13727 and EN 13624, the oxygen-based bleaching agent (concentration of practical solution: 1% by weight) had no cleaning effect, but the chlorine-based bleaching agent (effective chlorine A cleaning effect was confirmed with the sterilizing detergent composition described in Patent Document 1 (concentration: 200 ppm). However, the oxygen-based bleaching agent (concentration of practical solution: 1% by weight), the chlorine-based bleaching agent (effective chlorine concentration: 200 ppm), and the germicidal detergent composition described in Patent Document 1 all have no germicidal effect in the presence of blood. It became clear. Furthermore, when the effective chlorine concentration of the chlorine-based bleaching agent is set to 200 ppm or more to enhance the bactericidal effect, rust and corrosion may occur with respect to medical devices mainly made of metal.
一方、特許文献２において、ヨーロッパ標準法ＥＮ１０４０で９９．９９９％以上と高い殺菌効果が得られる殺カリシウイルス剤組成物について洗浄効果を評価したところ、血液汚れに対する洗浄効果は全く見られなかった。そのため、血液などのタンパク質汚れが医療器具に残っている場合、当該特許文献２記載の殺カリシウイルス剤組成物によれば、それが医療器具に固着・変性してしまい、不十分な洗浄、消毒及び滅菌に起因して分医療器具由来の感染が生じる恐れがある。 On the other hand, in Patent Document 2, when the cleaning effect was evaluated for the calicivirus agent composition capable of obtaining a high bactericidal effect of 99.999% or more by the European Standard Method EN1040, the cleaning effect on blood stains was not found at all. Therefore, when protein stains such as blood remain on the medical device, the calicivirus agent composition described in Patent Document 2 adheres to and denatures the medical device, resulting in insufficient cleaning and disinfection. In addition, due to sterilization, there is a possibility that an infection derived from a medical instrument may occur.
本発明の課題は、被験対象物に付着した汚れ、特に医療器具に付着した血液などのタンパク質汚れの固化を抑制しながら、高い洗浄効果と殺菌効果を同時に発揮できる洗浄殺菌剤組成物を提供することである。さらに本発明の課題は、１種類以上の酵素を含有する洗浄殺菌剤組成物であって、酵素安定性に優れた洗浄殺菌剤組成物を提供することである。 An object of the present invention is to provide a cleaning and disinfecting composition capable of exhibiting a high cleaning effect and a bactericidal effect at the same time while suppressing solidification of stains adhered to a test object, particularly protein stains such as blood adhered to medical equipment. That is. A further object of the present invention is to provide a cleaning and disinfecting composition containing one or more kinds of enzymes, which is excellent in enzyme stability.
本発明者らは、上記課題を解決すべく鋭意検討を重ねていたところ、下記の組成を有する液体組成物が被験対象物に付着したタンパク質汚れの固化及び変性を有意に抑制しながら、洗浄効果と殺菌効果を同時に発揮できることを見出した：
（ａ）タンパク質分解酵素：０．０１重量％以上
（ｂ）両性界面活性剤またはノニオン界面活性剤：０．１重量％以上
（ｃ）ジェミニ型殺菌剤またはビグアニジン系殺菌剤：０．０１重量％以上
（ｄ）必要に応じて金属イオン封鎖剤：０．０５重量％以上。
なお、上記濃度は実際に使用する実用液中の濃度である。
The inventors of the present invention have made extensive studies to solve the above-mentioned problems, and a liquid composition having the following composition significantly suppresses the solidification and denaturation of protein stains attached to a test object, while having a cleaning effect. It has been found that the bactericidal effect can be exhibited simultaneously with
(A) Proteolytic enzyme: 0.01 wt% or more (b) Amphoteric surfactant or nonionic surfactant: 0.1 wt% or more (c) Gemini type fungicide or biguanidine fungicide: 0.01 wt% Above (d) If necessary, sequestering agent: 0.05% by weight or more.
The above concentration is the concentration in the practical liquid actually used.
本発明はかかる知見に基づいて完成したものであり、下記の実施形態を有するものである。
（Ｉ）液体洗浄殺菌剤組成物（実用液）
（Ｉ−１）実用液において、
（ａ）タンパク質分解酵素を０．０１重量％以上、
（ｂ）両性界面活性剤及びノニオン界面活性剤からなる群から選択される少なくとも１種の界面活性剤を０．１重量％以上
（ｃ）ジェミニ型殺菌剤及びビグアニジン系殺菌剤からなる群から選択される少なくとも１種の殺菌剤を０．０１重量％以上
を含有することを特徴とする液体形態を有する洗浄殺菌剤組成物。
（Ｉ−２）上記（ｂ）界面活性剤が両性界面活性剤０．１重量％以上、
（ｃ）殺菌剤がジェミニ型殺菌剤０．０１重量％以上
である（Ｉ−１）に記載する洗浄殺菌剤組成物。
（Ｉ−３）上記（ｂ）界面活性剤がノニオン界面活性剤０．３重量％以上、
（ｃ）殺菌剤がビグアニジン系殺菌剤０．０２重量％以上
である（Ｉ−１）に記載する洗浄殺菌剤組成物。
（Ｉ−４）さらに（ｄ）金属イオン封鎖剤を０．０５重量％以上含有する（Ｉ−１）または（Ｉ−２）に記載する洗浄殺菌剤組成物。
（Ｉ−５）上記金属イオン封鎖剤がニトリロ三酢酸である（Ｉ−４）に記載する洗浄殺菌剤組成物。
（Ｉ−６）ｐＨが７〜１０である（Ｉ−１）〜（Ｉ−５）のいずれかに記載する洗浄殺菌剤組成物。
（Ｉ−７）さらに（ｅ）酵素安定剤及び（ｆ）アルカリ剤を含有する（Ｉ−１）〜（Ｉ−６）のいずれかに記載する洗浄殺菌剤組成物。
（Ｉ−８）さらにタンパク質分解酵素以外の酵素、ｐＨ調整剤、防錆剤、消泡剤、着色剤、及び香料よりなる群から選択される少なくとも１種を含有する（Ｉ−１）〜（Ｉ−７）
のいずれかに記載する洗浄殺菌剤組成物。
（Ｉ−９）タンパク質に起因する汚れが付着した被験対象物を洗浄殺菌するための液体組成物である（Ｉ−１）〜（Ｉ−８）のいずれかに記載する洗浄殺菌剤組成物。
（Ｉ−１０）上記被験対象物が医療器具または臨床検査器具である（Ｉ−９）に記載する洗浄殺菌剤組成物。
The present invention has been completed based on such findings, and has the following embodiments.
(I) Liquid cleaning bactericidal composition (practical liquid)
(I-1) In a practical liquid,
(A) 0.01% by weight or more of proteolytic enzyme,
(B) 0.1 wt% or more of at least one surfactant selected from the group consisting of amphoteric surfactants and nonionic surfactants (c) selected from the group consisting of gemini type fungicides and biguanidine fungicides. A cleaning disinfectant composition having a liquid form, characterized in that it contains at least 0.01% by weight of at least one disinfectant.
(I-2) The above-mentioned (b) surfactant is amphoteric surfactant 0.1% by weight or more,
(C) The cleaning and disinfectant composition described in (I-1), wherein the disinfectant is 0.01% by weight or more of Gemini type disinfectant.
(I-3) The above (b) surfactant is 0.3% by weight or more of a nonionic surfactant,
(C) The cleaning disinfectant composition according to (I-1), wherein the disinfectant is 0.02% by weight or more of a biguanidine disinfectant.
(I-4) The cleaning and disinfectant composition according to (I-1) or (I-2), which further contains (d) a sequestering agent in an amount of 0.05% by weight or more.
(I-5) The cleaning/bactericidal composition according to (I-4), wherein the sequestering agent is nitrilotriacetic acid.
(I-6) The cleaning and disinfecting composition according to any one of (I-1) to (I-5), which has a pH of 7 to 10.
(I-7) The cleaning and disinfectant composition according to any one of (I-1) to (I-6), which further comprises (e) an enzyme stabilizer and (f) an alkaline agent.
(I-8) Further, at least one selected from the group consisting of enzymes other than proteolytic enzymes, pH adjusters, rust preventives, defoamers, colorants, and fragrances is included (I-1) to ( I-7)
The cleaning and disinfecting composition according to any one of 1.
(I-9) The cleaning and disinfecting agent composition according to any one of (I-1) to (I-8), which is a liquid composition for cleaning and sterilizing a test object having stains caused by proteins attached.
(I-10) The cleaning and disinfectant composition according to (I-9), wherein the test object is a medical device or a clinical test device.
（II）液体洗浄殺菌剤組成物（濃縮タイプ）
（II−１）使用時に水で５０〜２００倍に希釈することで（Ｉ−１）〜（Ｉ−１０）のいずれかに記載する液体洗浄殺菌剤組成物になるように調製して使用される濃縮タイプの液体洗浄殺菌剤組成物。
(II) Liquid cleaning disinfectant composition (concentrated type)
(II-1) Prepared and used so as to be the liquid cleaning and disinfectant composition described in any of (I-1) to (I-10) by diluting with water 50 to 200 times at the time of use. A concentrated type liquid cleaning and disinfectant composition.
（III）液体洗浄殺菌剤組成物による洗浄殺菌方法
（III−１）下記の工程を有する被験対象物の洗浄殺菌方法：
（１）被験対象物を（Ｉ−１）〜（Ｉ−１０）のいずれかに記載する液体洗浄殺菌剤組成物または（II−１）に記載する濃縮タイプの液体洗浄殺菌剤組成物の５０〜２００倍希釈液に浸漬する工程、
（２）被験対象物を液体洗浄殺菌剤組成物から取り出し、水で洗浄する工程。
（III−２）（１）浸漬工程を超音波照射のもとで行う（III−１）に記載する洗浄殺菌方法。
（III−３）さらに被験対象物をブラッシングする工程を有する（III−１）または（III−２）に記載する洗浄殺菌方法。
（III−４）（１）浸漬工程の浸漬温度条件が２０〜７０℃である（III−１）〜（III−３）のいずれかに記載する洗浄殺菌方法。
（III−５）被験対象物がタンパク質に起因する汚れが付着した被験対象物である（III−１）〜（III−４）のいずれかに記載する洗浄殺菌方法。
（III−６）上記被験対象物が医療器具または臨床検査器具である（III−５に記載する洗浄殺菌方法。
(III) Method for cleaning and sterilizing with liquid cleaning and sterilizing agent composition (III-1) Method for cleaning and sterilizing test object having the following steps:
(1) subject was (I-1) ~ a (I-10) Liquid cleaning disinfectant composition according to any one or (II-1) liquid body cleaning disinfectant composition concentrate the type described in A step of immersing in a 50 to 200-fold diluted solution,
(2) A step of taking out the test object from the liquid cleaning germicide composition and washing with water.
(III-2) (1) The cleaning and sterilizing method according to (III-1), wherein the dipping step is performed under ultrasonic irradiation.
(III-3) The cleaning and sterilizing method according to (III-1) or (III-2), which further includes a step of brushing the test object.
(III-4) (1) The cleaning and sterilizing method as described in any of (III-1) to (III-3), wherein the immersion temperature condition in the immersion step is 20 to 70°C.
(III-5) The cleaning and sterilizing method according to any one of (III-1) to (III-4), in which the test object is a test object having stains caused by proteins attached.
(III-6) The test object is a medical device or a clinical test device (the cleaning/sterilizing method described in III-5).
本発明の洗浄殺菌剤組成物によれば、微生物が生残している恐れがある例えば実験器具、並びに食品工業備品及び器具（例えば食品工場、厨房または食堂等で使用される調理器具、作業台、食器、コンベアベルト、床、及び壁など）、または微生物のほか、血液などのタンパク質汚れが付着している例えば医療器具や臨床検査器具などの被験対象物を浸漬または超音波洗浄機で洗浄する操作によって、被験対象物に対する汚れの固着を有意に抑制しながら除去洗浄することが可能となる。また、本発明の洗浄殺菌剤組成物によれば、血液存在下での殺菌力評価（ヨーロッパ標準法の不潔条件下）において短時間で殺菌効果を発揮することが可能となる。このため、本発明の洗浄殺菌剤組成物によれば、初期工程の洗浄作業で滅菌前菌数（バイオバーデン）を減らして次の工程である消毒や滅菌の確実性を高めることが出来ると同時に、作業者の感染リスクの低減、医療器具や臨床検査器具間の交差汚染の予防、または／及び自然環境への汚染水の排出を防止することが出来る。 According to the cleaning and disinfectant composition of the present invention, for example, laboratory equipment in which microorganisms may remain, and food industry equipment and equipment (for example, cooking equipment used in food factories, kitchens or cafeterias, workbench, Tableware, conveyor belts, floors, walls, etc.), or microorganisms and protein stains such as blood adhere to test objects such as medical instruments and clinical laboratory instruments that are immersed or washed with an ultrasonic cleaner. Thereby, it becomes possible to remove and wash while significantly suppressing the adhesion of dirt to the test object. Further, according to the cleaning and sterilizing agent composition of the present invention, it becomes possible to exert a bactericidal effect in a short time in the bactericidal activity evaluation in the presence of blood (under the unclean condition of the European Standard Method). Therefore, according to the cleaning and disinfectant composition of the present invention, it is possible to reduce the number of pre-sterilization bacteria (bioburden) in the cleaning operation in the initial step and increase the certainty of the next step of disinfection and sterilization. It is possible to reduce the risk of infection of workers, prevent cross-contamination between medical instruments and clinical laboratory instruments, and/or prevent discharge of contaminated water to the natural environment.
（Ｉ）液体洗浄殺菌剤組成物（実用液）
本発明で使用される用語「実用液」は、被験対象物、好ましくは医療器具や臨床検査器具等の洗浄殺菌に実際に使用される濃度を有する溶液を示す。本発明の濃縮タイプの液体洗浄殺菌剤組成物の場合、これを水で５０〜２００倍に希釈して実際に使用する濃度に希釈した液を「実用液」という。
以下、当該実用液を構成する各成分について説明する。
(I) Liquid cleaning bactericidal composition (practical liquid)
The term "practical liquid" used in the present invention refers to a solution having a concentration actually used for cleaning and sterilizing a test subject, preferably a medical instrument, a clinical laboratory instrument, or the like. In the case of the concentrated type liquid cleaning and disinfectant composition of the present invention, a liquid obtained by diluting this with water 50 to 200 times to a concentration to be actually used is referred to as "practical liquid".
Hereinafter, each component constituting the practical liquid will be described.
＜（ａ）タンパク質分解酵素＞（以下「（ａ）成分」とも称する）
（ａ）成分は、洗浄用に使用される酵素であれば限定されず、中性からアルカリ側ｐＨ、具体的にはｐＨ６〜１２の範囲にタンパク質分解活性の至適を持つものであれば良い。タンパク質分解酵素は一種単独で用いても良いし、また２種以上を任意に組み合わせて用いても良い。制限されないものの、より具体的には、例えば、ノボザイムズ（Ｎｏｖｏｚｙｍｅｓ）社製のプロテアーゼであるアルカラーゼ（Ａｌｃａｌａｓｅ）、エスペラーゼ（Ｅｓｐｅｒａｓｅ）、サビナーゼ（Ｓａｖｉｂｎａｓｅ）、サビナーゼ エビティ（Ｓａｖｉｂｎａｓｅ Ｅｖｉｔｙ）、エバラーゼ（Ｅｖｅｒｌａｓｅ）、リカナーゼ（Ｌｉｑｕａｎａｓｅ）、リカナーゼ エビティ（Ｌｉｑｕａｎａｓｅ Ｅｖｉｔｙ）、及びブレーズ エビティ（Ｂｌａｚｅ Ｅｖｉｔｙ）など；ジェネンコア（Ｇｅｎｅｎｃｏｒ）社製のピュラフェクト、ピュラフェクトＯＸ、プロペラーゼ、及びプロテックスシリーズ（プロテックス７Ｌ、プロテックス１４Ｌ、プロテックス６Ｌ、プロテックス８９Ｌ、プロテックスＯＸＧ、プロテックス４０Ｌ）、アルカリプロテアーゼＧＬ、及びプロモッド２２３ＬＰなどが例示される。
<(a) Proteolytic enzyme> (hereinafter also referred to as “(a) component”)
The component (a) is not limited as long as it is an enzyme used for washing, and may be any one having an optimum proteolytic activity in a neutral to alkaline pH range, specifically, a pH range of 6 to 12. .. The proteolytic enzymes may be used alone or in any combination of two or more. Although not limited, more specifically, for example, a protease manufactured by Novozymes, such as Alcalase, Esperase, Savinase, Savinase Evity, Everase, Everase. (Liquanase), Licanase Evity (Liquanase Evity), and Blaze Evity (Blaze Evity), etc. Examples include Protex OXG, Protex 40L), alkaline protease GL, and Promod 223LP.
上記（ａ）成分の配合量は、実用液中で０．０１重量％以上、好ましくは０．０１〜０．２重量％、より好ましくは０．０２〜０．２重量％である。酵素としての洗浄力を得るためには、０．０１重量％以上の割合で配合することが好ましく、上限は特に制限されるものではない。但し、酵素を実用液中で０．２重量％よりも多く配合しても配合量の増加に応じた洗浄効果の向上が少ない。このため、経済的観点から０．２重量％程度を上限とすることができる。 The blending amount of the component (a) in the practical liquid is 0.01% by weight or more, preferably 0.01 to 0.2% by weight, more preferably 0.02 to 0.2% by weight. In order to obtain the detergency as an enzyme, it is preferable to mix it in a proportion of 0.01% by weight or more, and the upper limit is not particularly limited. However, even if the enzyme is blended in the practical liquid in an amount of more than 0.2% by weight, the cleaning effect is not improved in accordance with the increase in the blending amount. Therefore, from the economical viewpoint, the upper limit can be about 0.2% by weight.
＜（ｂ）界面活性剤＞（以下「（ｂ）成分」とも称する）
（ｂ）成分としては、両性界面活性剤及びノニオン界面活性剤を挙げることができる。両性界面活性剤及びノニオン界面活性剤はそれぞれを単独で使用してもよいし、また両者を組み合わせて使用することもできる。また両性界面活性剤同士を２種以上任意に組み合わせて使用することも、またノニオン界面活性剤同士を２種以上任意に組み合わせて使用することもできる。好ましくは両性界面活性剤またはノニオン界面活性剤のいずれか一方の使用であり、より好ましくは血液汚れ存在下での真菌に対する殺菌効果に優れていることから両性界面活性剤の使用である。
<(b) Surfactant> (hereinafter, also referred to as “(b) component”)
Examples of the component (b) include amphoteric surfactants and nonionic surfactants. The amphoteric surfactant and the nonionic surfactant may be used alone or in combination of both. Further, the amphoteric surfactants may be used in any combination of two or more, and the nonionic surfactants may be used in any combination of two or more. The use of either an amphoteric surfactant or a nonionic surfactant is preferable, and the use of an amphoteric surfactant is more preferable because it has an excellent bactericidal effect against fungi in the presence of blood stains.
両性界面活性剤としては、アミノ酸型両性界面活性剤、ベタイン型両性界面活性剤、及びアミンオキシド型両性界面活性剤を挙げることができる。アミノ酸型両性界面活性剤としては、例えばラウロイルグルタミン酸ナトリウム、ラウロイルグルタミン酸カリウム、及びラウロイルメチル-β-アラニン、ラウリルアミノプロピオン酸塩、及びラウリルアミノジ酢酸塩等；ベタイン型両性界面活性剤としては、例えばラウリルジメチルアミノ酢酸ベタイン、ステアリルジメチルアミノ酢酸ベタイン、ドデシルアミノメチルジメチルスルホプロピルベタイン、オクタデシルアミノメチルジメチルスルホプロピルベタイン、ヤシ油脂肪酸アミドプロピルベタイン、及びラウリン酸アミドプロピルベタイン等；アミンオキシド型両性界面活性剤としては、例えばラウリルジメチルアミンN‐オキシド、デシルジメチルアミンオキシド、及びオレイルジメチルアミンN‐オキシド等を例示することができる。好ましくはラウリルアミノプロピオン酸塩、ラウリルアミノジ酢酸塩、ラウリルジメチルアミノ酢酸ベタイン、ヤシ油脂肪酸アミドプロピルベタイン、ラウリン酸アミドプロピルベタイン、ラウリルジメチルアミンオキシド及びデシルジメチルアミンオキシドなどから選ばれる少なくとも１種が挙げられる。 Examples of the amphoteric surfactant include amino acid type amphoteric surfactants, betaine type amphoteric surfactants, and amine oxide type amphoteric surfactants. Examples of the amino acid-type amphoteric surfactant include sodium lauroyl glutamate, potassium lauroyl glutamate, and lauroyl methyl-β-alanine, lauryl aminopropionate, and lauryl amino diacetate; and the betaine-type amphoteric surfactant includes, for example, Lauryl dimethylamino acetic acid betaine, stearyl dimethyl amino acetic acid betaine, dodecylaminomethyl dimethyl sulfopropyl betaine, octadecyl aminomethyl dimethyl sulfopropyl betaine, coconut oil fatty acid amide propyl betaine, lauric acid amide propyl betaine, etc.; amine oxide amphoteric surfactant Examples thereof include lauryldimethylamine N-oxide, decyldimethylamine oxide, and oleyldimethylamine N-oxide. Preferably, at least one selected from laurylaminopropionate, laurylaminodiacetic acid salt, lauryldimethylaminoacetic acid betaine, coconut oil fatty acid amide propyl betaine, lauric acid amide propyl betaine, lauryl dimethylamine oxide and decyldimethylamine oxide. Can be mentioned.
（ｂ）成分として両性界面活性剤を用いる場合の当該配合量としては、実用液中で０．１重量％以上、好ましくは０．１〜０．４重量％、より好ましくは０．２〜０．４重量％である。後述する（ｃ）殺菌剤による汚れの固着を防いで洗浄力を得るためには０．１重量％以上の割合で配合することが好ましく、上限は特に制限されない。但し、０．４重量％を超えて過剰に配合しても配合量に応じた洗浄効果の向上は少ないため、経済的観点から、好ましくは０．４重量％程度を上限とすることができる。 When an amphoteric surfactant is used as the component (b), the compounding amount is 0.1% by weight or more, preferably 0.1 to 0.4% by weight, and more preferably 0.2 to 0% in a practical liquid. It is 0.4% by weight. In order to prevent the stains from being fixed by the (c) bactericide described later and to obtain the detergency, it is preferable to mix the sterilizing agent in an amount of 0.1% by weight or more, and the upper limit is not particularly limited. However, even if it is excessively blended in excess of 0.4% by weight, the improvement of the cleaning effect depending on the blending amount is small, so from the economical viewpoint, the upper limit can be preferably about 0.4% by weight.
ノニオン界面活性剤としては、制限はされないものの、例えば高級アルコールエチレンオキサイド系、アルキルフェノールエチレンオキサイド系、脂肪酸エチレンオキサイド系、多価アルコール脂肪酸エステルエチレンオキサイド系、高級アルキルアミンエチレンオキサイド系、脂肪酸アミドエチレンオキサイド系、ポリプロピレングリコールエチレンオキサイド系などのポリエチレングリコール型非イオン界面活性剤；グリセリン及びペンタエリスリトールの脂肪酸エステル、ソルビトール及びソルビタンの脂肪酸エステル、ショ糖の脂肪酸エステルなどの多価アルコール型非イオン界面活性剤；アルキルポリグルコシド、バイオサーファクタントのソホロリピッド、ラムノリピッド、サーファクチン、マンノシルエリスリトールリピッド、アルスロファクチン、及び脂肪酸アルカノールアミドが挙げられる。 Although the nonionic surfactant is not limited, for example, higher alcohol ethylene oxide-based, alkylphenol ethylene oxide-based, fatty acid ethylene oxide-based, polyhydric alcohol fatty acid ester ethylene oxide-based, higher alkylamine ethylene oxide-based, fatty acid amide ethylene oxide-based Polyethylene glycol type nonionic surfactant such as polypropylene glycol ethylene oxide type; polyhydric alcohol type nonionic surfactant such as fatty acid ester of glycerin and pentaerythritol, fatty acid ester of sorbitol and sorbitan, fatty acid ester of sucrose; alkyl Mention may be made of polyglucosides, biosurfactants sophorolipids, rhamnolipids, surfactins, mannosylerythritol lipids, arthrofactins, and fatty acid alkanolamides.
（ｂ）成分としてノニオン界面活性剤を用いる場合の配合量としては、実用液中で０．３重量％以上、好ましくは０．３〜０．６重量％、より好ましくは０．４〜０．６重量％である。後述する（ｃ）殺菌剤による汚れの固着を防いで洗浄力を得るためには０．３重量％以上の割合で配合することが好ましく、上限は特に制限されない。但し、０．６重量％を超えて過剰に配合しても配合量に応じた洗浄効果の向上は少ないため、経済的観点から、好ましくは０．６重量％程度を上限とすることができる。 When a nonionic surfactant is used as the component (b), the compounding amount is 0.3% by weight or more, preferably 0.3 to 0.6% by weight, more preferably 0.4 to 0. 6% by weight. In order to prevent the stains from being fixed by the (c) bactericide described later and to obtain a detergency, it is preferable to add it in a proportion of 0.3% by weight or more, and the upper limit is not particularly limited. However, even if it is excessively blended in excess of 0.6% by weight, the improvement of the cleaning effect depending on the blending amount is small, so from the economical point of view, the upper limit is preferably about 0.6% by weight.
＜（ｃ）殺菌剤＞（以下「（ｃ）成分」とも称する）
（ｃ）成分としては、ジェミニ型殺菌剤及びビグアニジン系殺菌剤を挙げることができる。ジェミニ型殺菌剤及びビグアニジン系殺菌剤はそれぞれを単独で使用してもよいし、また両者を組み合わせて使用することもできる。またジェミニ型殺菌剤同士を２種以上任意に組み合わせて使用することも、またビグアニジン系殺菌剤同士を２種以上任意に組み合わせて使用することもできる。好ましくはジェミニ型殺菌剤またはビグアニジン系殺菌剤のいずれか一方の使用であり、より好ましくは血液汚れ存在下での真菌に対する殺菌効果に優れていることからジェミニ型殺菌剤の使用である。
<(c) Fungicide> (hereinafter also referred to as “(c) component”)
Examples of the component (c) include gemini type bactericides and biguanidine type bactericides. The gemini type bactericide and the biguanidine type bactericide may be used alone or in combination of both. Further, two or more kinds of Gemini type bactericides may be used in an arbitrary combination, and two or more biguanidine fungicides may be used in an arbitrary combination. The use of either a Gemini-type disinfectant or a biguanidine-type disinfectant is preferable, and the use of a Gemini-type disinfectant is more preferable because it has an excellent bactericidal effect against fungi in the presence of blood stains.
ジェミニ型殺菌剤は、対応する１鎖１親水基型（モノメリック型）界面活性剤をスペーサーと呼ばれる連結基でつないだ２量体構造を有し、且つ殺菌活性を有する化合物である。この限りにおいて、ヘテロジェミニ型殺菌剤であってもよい。ジェミニ型殺菌剤としては、制限されないものの、例えば１，１’−（１，１０−デカンジイル）ビス（４−オクチルイミノ−１，４−ジヒドロピリジン）（慣用名：オクテニジン）、及びその二塩酸塩、並びに１，４−ビス（３，３’−（１−デシルピリジニウム）メチルオキシ）ブタンジブロマイド（製品名：ハイジェニア）（タマ化学工業（株）製））（特許文献３参照）などが挙げられる。好ましくはハイジェニアである。ハイジェニアは、各種ウイルスの不活性化や防除に有効な抗ウイルス剤であるが、本発明においては他成分の洗浄効果を邪魔することなく殺菌効果を発揮することができる。なお、制限はされないものの、（ｃ）成分としてジェミニ型殺菌剤を用いる場合、前述する（ｂ）成分として両性界面活性剤を使用することが好ましく、そうすることで血液汚れ存在下で真菌を含むあらゆる細菌に対して優れた殺菌効果を発揮することができる。 The Gemini type bactericide is a compound having a dimer structure in which corresponding 1-chain 1-hydrophilic group type (monomeric type) surfactants are connected by a linking group called a spacer, and having bactericidal activity. As long as this is the case, it may be a heterogemini type bactericide. The Gemini-type bactericide is not limited, but includes, for example, 1,1′-(1,10-decanediyl)bis(4-octylimino-1,4-dihydropyridine) (conventional name: octenidine), and its dihydrochloride. And 1,4-bis(3,3′-(1-decylpyridinium)methyloxy)butanedibromide (product name: Hygenia) (manufactured by Tama Chemical Industry Co., Ltd.)) (see Patent Document 3) and the like. .. It is preferably Hygenia. Hygenia is an antiviral agent effective for inactivating and controlling various viruses, but in the present invention, it can exert a bactericidal effect without disturbing the cleaning effect of other components. Although not limited, when using a Gemini-type bactericide as the component (c), it is preferable to use an amphoteric surfactant as the above-mentioned component (b), so that a fungus is contained in the presence of blood stains. It can exert an excellent bactericidal effect against all kinds of bacteria.
（ｃ）成分としてジェミニ型殺菌剤を用いる場合、その配合量は、実用液中で０．０１重量％以上、好ましくは０．０１〜０．１重量％、より好ましくは０．０２〜０．０５重量％である。その配合量が０．０１重量％を大きく下回ると９９．９９９％以上の殺菌効果が得られなくなる傾向がある。また、殺菌効果の点からは、上限は特に制限されないものの、ジェミニ型殺菌剤を過剰に配合しすぎると汚れが固着する恐れがある。このため、上記するように、好ましくは０．１重量％以下、より好ましくは０．０５重量％以下である。 When a Gemini type bactericide is used as the component (c), its content is 0.01% by weight or more, preferably 0.01 to 0.1% by weight, more preferably 0.02 to 0. It is 05% by weight. If the blending amount is much less than 0.01% by weight, the bactericidal effect of 99.999% or more tends not to be obtained. Further, from the viewpoint of bactericidal effect, the upper limit is not particularly limited, but if the Gemini type bactericide is excessively blended, dirt may be fixed. Therefore, as described above, it is preferably 0.1% by weight or less, more preferably 0.05% by weight or less.
ビグアニジン系殺菌剤としては、例えばポリヘキサメチレンビグアナイド（ＰＨＭＢ）及びその塩（例えばポリヘキサメチレンビグアニジン塩酸塩）、クロルヘキシジン及びその塩（例えば、グルコン酸クロルヘキシジン等）などが挙げられる。好ましくはポリヘキサメチレンビグアナイド（ＰＨＭＢ）である。 Examples of the biguanidine fungicides include polyhexamethylene biguanide (PHMB) and salts thereof (eg polyhexamethylene biguanidine hydrochloride), chlorhexidine and salts thereof (eg chlorhexidine gluconate) and the like. Preferred is polyhexamethylene biguanide (PHMB).
（ｃ）成分としてビグアニジン系殺菌剤を用いる場合、その配合量は、実用液中で０．０２重量％以上、好ましくは０．０２〜０．１重量％、より好ましくは０．０２重量％以上０．０５重量％未満である。０．０２重量％を大きく下回ると９９．９９９％以上の殺菌効果が得られなくなる傾向がある。また、殺菌効果の点からは、上限は特に制限されないものの、ビグアニジン系殺菌剤を過剰に配合しすぎると汚れが固着する恐れがある。このため、上記するように、上限として好ましくは０．０５重量％未満を挙げることができる。本範囲内であれば、他成分による洗浄効果を邪魔することなく殺菌効果を発揮することができる。 When a biguanidine fungicide is used as the component (c), its content is 0.02% by weight or more, preferably 0.02 to 0.1% by weight, more preferably 0.02% by weight or more in a practical liquid. It is less than 0.05% by weight. If it is much less than 0.02% by weight, 99.999% or more of the bactericidal effect tends not to be obtained. Further, from the viewpoint of the bactericidal effect, the upper limit is not particularly limited, but if the biguanidine-based bactericide is excessively blended, stains may be fixed. Therefore, as described above, the upper limit is preferably less than 0.05% by weight. Within this range, the bactericidal effect can be exhibited without disturbing the cleaning effect of other components.
＜（ｄ）金属イオン封鎖剤＞（以下「（ｄ）成分」とも称する）
（ｄ）成分は、任意成分であるが、上記（ｂ）成分として両性界面活性剤を用い、上記（ｃ）成分としてジェミニ型殺菌剤を用いるときは、アルカリ性条件下での緩衝作用及び殺菌効果の補助の目的で、同時に（ｄ）成分を配合することが好ましい。
<(d) Sequestering agent> (hereinafter also referred to as “(d) component”)
The component (d) is an optional component, but when an amphoteric surfactant is used as the component (b) and a Gemini type germicide is used as the component (c), a buffering action and a germicidal effect under alkaline conditions. For the purpose of assisting the above, it is preferable to mix the component (d) at the same time.
金属イオン封鎖剤としては、ニトリロ三酢酸（ＮＴＡ）、ヒドロキシエチレンジアミン三酢酸（ＨＥＤＴＡ）、ジエチレントリアミノ五酢酸（ＤＴＰＡ）、トリエチレンテトラアミン六酢酸（ＴＴＨＡ）、ヒドロキシエチルイミノ二酢酸（ＨＩＭＤＡ）、１，３‐プロパンジアミン四酢酸（１，３‐ＰＤＴＡ）、ジヒドロキシエチルグリシン（ＤＨＥＧ）、メチルグリシン二酢酸（ＭＧＤＡ）、グルタミン酸二酢酸（ＧＬＤＡ）、アスパラギン酸二酢酸（ＡＳＤＡ）、β‐アラニン二酢酸（ＡＤＡ）、セリン二酢酸（ＳＤＡ）、ヒドロキシエタンジホスホン酸（ＨＥＤＰ）、エチレンジアミンテトラメチレンホスホン酸（ＥＤＴＭＰ）及びそれらの金属塩を挙げることができる。これらはいずれも液体洗浄殺菌剤組成物（実用液）の良好な洗浄力及び殺菌剤に貢献するものの、保存安定性（酵素安定性を含む）の観点から、好ましくはニトリロ三酢酸及びその金属塩であり、より好ましくはニトリロ三酢酸である。
なお、金属塩としては、制限されないものの、ナトリウムやカリウム等のアルカリ金属との塩；カルシウム等のアルカリ土類金属との塩；マグネシウムとの塩；アンモニウムとの塩を例示することができる。
As sequestering agents, nitrilotriacetic acid (NTA), hydroxyethylenediaminetriacetic acid (HEDTA), diethylenetriaminopentaacetic acid (DTPA), triethylenetetraaminehexaacetic acid (TTHA), hydroxyethyliminodiacetic acid (HIMDA), 1 ,3-Propanediaminetetraacetic acid (1,3-PDTA), Dihydroxyethylglycine (DHEG), Methylglycine diacetic acid (MGDA), Glutamic acid diacetic acid (GLDA), Aspartic acid diacetic acid (ASDA), β-alanine diacetic acid (ADA), serine diacetic acid (SDA), hydroxyethanediphosphonic acid (HEDP), ethylenediaminetetramethylenephosphonic acid (EDTMP) and their metal salts may be mentioned. Although these contributes to good detergency and disinfecting agents either liquid body cleaning disinfectant composition (practically fluid), from the viewpoint of storage stability (including enzyme stability), preferably nitrilotriacetic acid and their metal It is a salt, more preferably nitrilotriacetic acid.
Examples of the metal salt include, but are not limited to, salts with alkali metals such as sodium and potassium; salts with alkaline earth metals such as calcium; salts with magnesium; salts with ammonium.
この場合、（ｄ）成分の配合量としては、実用液中で０．０５重量％以上を挙げることができる。上記目的からは配合量の上限は特に制限されないものの、実用液の５０〜２００倍の濃さを有する濃縮タイプの液体洗浄殺菌剤組成物における（ａ）成分の安定性を考慮すると、その上限は好ましくは０．４重量％、より好ましくは０．２重量％を挙げることができる。この観点から（ｄ）成分の配合量として、好ましくは０．０５〜０．４重量％、より好ましくは０．０５〜０．２重量％である。 In this case, the blending amount of the component (d) may be 0.05% by weight or more in a practical liquid. Although the upper limit of the compounding amount is not particularly limited for the above purpose, the upper limit thereof is taken into consideration in consideration of the stability of the component (a) in the concentrated type liquid cleaning and disinfectant composition having a concentration of 50 to 200 times that of the practical liquid. It is preferably 0.4% by weight, more preferably 0.2% by weight. From this viewpoint, the blending amount of the component (d) is preferably 0.05 to 0.4% by weight, more preferably 0.05 to 0.2% by weight.
＜（ｅ）酵素安定化剤＞（以下「（ｅ）成分」とも称する）
本発明の洗浄殺菌剤組成物は、上記（ａ）成分、（ｂ）成分、及び（ｃ）成分（または上記（ａ）成分、（ｂ）成分、（ｃ）成分、及び（ｄ）成分）に加えて、酵素安定性の観点から（ｅ）酵素安定化剤を含有することが望ましい。（ｅ）成分の例としては、炭素数１〜４のアルコール、炭素数２〜６の多価アルコール、炭素数３〜８のグリコールエーテル、塩化カルシウムや乳酸カルシウムなどの水溶性カルシウム塩、ホウ酸、ホウ酸ナトリウム、ホウ酸カリウム、４ホウ酸ナトリウム、４ホウ酸カリウム、アセトアミド、グリシン、及びマルトデキストリンなどが挙げられる。これらの中でも酵素安定性の観点からエチルアルコール、エチレングリコール、プロピレングリコール、エチレングリコールモノエチルエーテル、ジエチレングリコール、モノエチルエーテル、ジプロピレングリコールメチルエーテル、グリセリン、及びソルビトールが好ましい。これらは単独で用いても良いし、２種以上を任意に組み合わせて用いても良い。
<(e) Enzyme stabilizer> (hereinafter also referred to as “(e) component”)
The cleaning and disinfectant composition of the present invention comprises the above component (a), component (b), and component (c) (or component (a), component (b), component (c), and component (d)). In addition to the above, it is desirable to contain (e) an enzyme stabilizer from the viewpoint of enzyme stability. Examples of the component (e) include alcohols having 1 to 4 carbon atoms, polyhydric alcohols having 2 to 6 carbon atoms, glycol ethers having 3 to 8 carbon atoms, water-soluble calcium salts such as calcium chloride and calcium lactate, and boric acid. , Sodium borate, potassium borate, sodium tetraborate, potassium tetraborate, acetamide, glycine, and maltodextrin. Among these, ethyl alcohol, ethylene glycol, propylene glycol, ethylene glycol monoethyl ether, diethylene glycol, monoethyl ether, dipropylene glycol methyl ether, glycerin, and sorbitol are preferable from the viewpoint of enzyme stability. These may be used alone or in any combination of two or more.
本発明の組成物が（ｅ）成分を含有する場合、当該（ｅ）成分の配合量は、実用液中で０．０１〜０．３重量％であることが好ましい。より好ましくは０．０３〜０．３重量％であり、さらに好ましくは０．０５〜０．２重量％である。配合安定性及び酵素安定性の観点から（ｅ）成分の配合割合の上限は制限されないものの、０．３重量％を超えて配合しても配合量に応じた配合安定性の向上、及び組成物中の酵素安定性の向上は少ない。このため、経済性の観点から０．３重量％程度を上限とすることが好ましい。なお、配合安定性とは、組成物の安定性を維持する効果を意味し、例えば組成物中の成分の分離や沈殿物（析出物）の発生の有無からその効果を判断することができる。 When the composition of the present invention contains the component (e), the compounding amount of the component (e) is preferably 0.01 to 0.3% by weight in the practical liquid. It is more preferably 0.03 to 0.3% by weight, and further preferably 0.05 to 0.2% by weight. Although the upper limit of the blending ratio of the component (e) is not limited from the viewpoint of blending stability and enzyme stability, the blending stability is improved according to the blending amount even if blending exceeds 0.3% by weight, and the composition There is little improvement in enzyme stability inside. Therefore, from the viewpoint of economy, it is preferable to set the upper limit to about 0.3% by weight. The compounding stability means the effect of maintaining the stability of the composition, and the effect can be judged from, for example, the separation of components in the composition and the presence or absence of a precipitate.
＜（ｆ）アルカリ剤＞（以下、「（ｆ）成分」とも称する）
本発明の洗浄殺菌剤組成物は、上記（ｅ）成分を含有する場合、同時に（ｆ）アルカリ剤を含有することが望ましい。（ｆ）成分として、炭酸塩及び重炭酸塩等の無機塩、モノエタノールアミン（ＭＥＡ）、ジエタノールアミン（ＤＥＡ）、トリエタノールアミン（ＴＥＡ）、トリス（ヒドロキシメチル）アミノメタン、モノイソプロパノールアミン（ＭＩＰＡ）、及びトリイソプロパノールアミン（ＴＩＰＡ）等のアルカノールアミンが挙げられる。これらは単独で用いても良いし、２種以上を任意に組み合わせて用いても良い。
<(f) Alkaline agent> (hereinafter, also referred to as “(f) component”)
When the cleaning and disinfectant composition of the present invention contains the above-mentioned component (e), it is desirable to simultaneously contain (f) an alkaline agent. As the component (f), inorganic salts such as carbonates and bicarbonates, monoethanolamine (MEA), diethanolamine (DEA), triethanolamine (TEA), tris(hydroxymethyl)aminomethane, monoisopropanolamine (MIPA) , And alkanolamines such as triisopropanolamine (TIPA). These may be used alone or in any combination of two or more.
本発明の組成物が（ｆ）成分を含有する場合、当該（ｆ）成分の配合量は、実用液中で０．０２重量％以上、好ましくは０．０２〜０．２重量％、より好ましくは０．０２〜０．１５重量％である。（ｆ）成分を０．０２重量％以上の割合で配合すると、洗浄力に必要なアルカリ度を得ることができる。特にプロテアーゼとしてアルカリプロテアーゼを用いる場合は、その洗浄力を発揮するために必要なアルカリ性を保つことができる。なお、アルカリ剤としてアルカノールアミンを用いる場合、その配合量が０．２重量％を超えると不快臭が強くなる。そのため、アルカリ剤としてアルカノールアミンを用いる場合、実用液中の配合量は０．２重量％以下であることが好ましい。 When the composition of the present invention contains the component (f), the content of the component (f) in the practical liquid is 0.02% by weight or more, preferably 0.02 to 0.2% by weight, more preferably Is 0.02 to 0.15% by weight. When the component (f) is blended in a proportion of 0.02% by weight or more, the alkalinity required for detergency can be obtained. In particular, when an alkaline protease is used as the protease, it is possible to maintain the alkalinity necessary to exert its detergency. When an alkanolamine is used as the alkaline agent, the unpleasant odor becomes strong when the blending amount exceeds 0.2% by weight. Therefore, when alkanolamine is used as the alkaline agent, the blending amount in the practical liquid is preferably 0.2% by weight or less.
＜（ｇ）ｐＨ調整剤＞（以下「（ｇ）成分」と称する）
本発明の洗浄殺菌剤組成物は、（ｇ）成分を用いて、実用液のｐＨが７〜１０となるように調整することが好ましい。好ましくはｐＨ８〜１０である。
<(g) pH adjuster> (hereinafter referred to as “(g) component”)
The cleaning and disinfectant composition of the present invention is preferably adjusted by using the component (g) so that the pH of the practical solution is 7 to 10. The pH is preferably 8 to 10.
（ｇ）成分としては、酸性のｐＨ調整剤を挙げることができる。具体的には、塩酸、硫酸及び硝酸などの無機酸；またはクエン酸、乳酸及びギ酸などの有機酸を例示することができる。 Examples of the component (g) include acidic pH adjusters. Specific examples include inorganic acids such as hydrochloric acid, sulfuric acid and nitric acid; and organic acids such as citric acid, lactic acid and formic acid.
＜その他の配合可能な成分＞
さらに本発明には、本発明の効果を損なわない範囲で、任意にタンパク質分解酵素以外の酵素、色素（着色剤）、防錆剤、消泡剤、及び／または香料などを配合することが出来る。これらは当業界において洗浄剤や殺菌剤に配合して使用されるものであればよく、慣用に従って選択使用することができる。
なお、タンパク質分解酵素以外の酵素としては、脂質分解酵素（リパーゼ）、澱粉分解酵素（アミラーゼ）、及びセルロース分解酵素（セルラーゼ）を挙げることができ、これらのうち１種または２種以上を任意に選択して、（ａ）成分であるタンパク質分解酵素と組み合わせて使用することができる。制限されないものの、好適には、脂質分解酵素、澱粉分解酵素、及びセルロース分解酵素の３種の酵素を、（ａ）成分であるタンパク質分解酵素と組み合わせて使用する。
また、防錆剤としてはベンゾトリアゾールやケイ酸塩などが挙げられる。
<Other compoundable ingredients>
Further, in the present invention, an enzyme other than a proteolytic enzyme, a dye (colorant), a rust preventive, an antifoaming agent, and/or a fragrance, etc. can be optionally mixed in the range not impairing the effects of the present invention. .. These may be those used by being blended with detergents and bactericides in the art, and can be selected and used according to common practice.
Examples of enzymes other than proteolytic enzymes include lipid degrading enzymes (lipases), starch degrading enzymes (amylases), and cellulolytic enzymes (cellulases), and one or more of these can be arbitrarily selected. It can be selected and used in combination with the protease of the component (a). Although not limited, it is preferable to use three kinds of enzymes, a lipolytic enzyme, a starch degrading enzyme, and a cellulolytic enzyme, in combination with the proteolytic enzyme as the component (a).
Further, examples of the rust preventive agent include benzotriazole and silicate.
本発明の洗浄殺菌剤組成物は、上記各成分を混合配合して、上記に示した配合量（濃度）よりも５０〜２００倍高い濃度になるように予め調製しておいたもの（濃縮タイプ）を、使用時に水で５０〜２００倍に希釈してｐＨ７〜１０の洗浄液（実用液）として使用することが好ましい。 The cleaning and disinfectant composition of the present invention is prepared by mixing and blending the above components so that the concentration is 50 to 200 times higher than the blending amount (concentration) shown above (concentrated type. It is preferable to dilute 50) to 50-200 times with water before use as a cleaning solution (practical solution) having a pH of 7-10.
その使用方法、つまり本発明の洗浄殺菌剤組成物を用いた被験対象物の洗浄殺菌方法としては、まず本発明の液体洗浄殺菌剤組成物（実用液）を浸漬液として、これに被験対象物を浸漬し（浸漬工程）、次いで所定時間後に当該浸漬液から被験対象物を取り出し、水で洗浄する（水洗工程）方法を挙げることができる。
浸漬液の温度は、通常２０℃〜７０℃の範囲に調整することができる。但し、（ａ）タンパク質分解酵素による洗浄効果を効果的に得るためには好ましくは３０〜６０℃、より好ましくは３５〜５５℃に調整することが望ましい。浸漬時間は、制限されないものの、通常１０〜６０分間を例示することができる。なお、浸漬中に超音波照射をしてもよい。また、必要に応じて、浸漬中または水洗中に被験対象物をブラッシングしてもよい。
Its use, i.e. as a washing and disinfecting process of the test object with a cleaning disinfectant composition of the present invention, the liquid body cleaning disinfectant composition of the present invention (practical solution) as an immersion fluid First, subject to this Examples include a method of immersing an object (immersion step), and after a predetermined time, removing the test object from the immersion liquid and washing with water (water washing step).
The temperature of the immersion liquid can usually be adjusted within the range of 20°C to 70°C. However, in order to effectively obtain the cleaning effect of the (a) proteolytic enzyme, it is desirable to adjust the temperature to preferably 30 to 60°C, more preferably 35 to 55°C. Although the immersion time is not limited, it can be typically 10 to 60 minutes. In addition, you may irradiate an ultrasonic wave during immersion. In addition, the test object may be brushed during immersion or washing with water, if necessary.
本発明の洗浄殺菌剤組成物を用いて洗浄殺菌する被験対象物としては、制限されないものの、微生物によって汚染された実験器具や食品工業備品・器具、または微生物による汚染に加えて生体試料や血液などのタンパク質汚れが付着した医療器具や臨床検査器具を例示することができる。好ましくは血液などのタンパク質汚れが付着した医療器具である。上記する本発明の洗浄殺菌剤組成物を用いて上記工程に従って被験対象物を処理することで洗浄と殺菌とを同時に実施することができる。特に生体試料や血液などのタンパク質汚れが付着した医療器具については、本発明の洗浄殺菌剤組成物を用いた上記洗浄殺菌方法により適切に医療器具を再生することができる。このため、洗浄殺菌剤組成物は医療器具用洗浄殺菌剤組成物、特に生体試料や血液などのタンパク質汚れが付着した医療器具用の洗浄殺菌剤組成物として好適に使用することができる。 The test object to be washed and sterilized using the cleaning and sterilizing agent composition of the present invention is not limited, but it is a laboratory sample or food industry equipment or instrument contaminated with microorganisms, or biological sample or blood in addition to contamination with microorganisms. Examples of the medical device and the clinical test device to which the protein stain of (3) is attached can be exemplified. A medical device to which protein stains such as blood are attached is preferable. Cleaning and sterilization can be performed at the same time by treating the test subject with the above-described cleaning and disinfecting composition of the present invention according to the above steps. In particular, with respect to a medical device to which a biological sample or protein stain such as blood adheres, the medical device can be properly regenerated by the above-mentioned cleaning and sterilizing method using the cleaning and sterilizing agent composition of the present invention. Therefore, the cleaning and disinfecting composition can be preferably used as a cleaning and disinfecting composition for medical devices, particularly as a cleaning and disinfecting composition for medical devices to which protein stains such as biological samples and blood adhere.
なお、本発明の洗浄殺菌剤組成物（実用液）の洗浄効果は、後述する実験例に記載するように、ステンレス板にモデル血液汚れ（ヒト血漿タンパク［ヘモグロビン、アルブミン、トロンビン、フィビリン］と同組成になるように調整した精製牛タンパク［ＩＳＯ１５８８３のスウェーデン法］）を付着して乾燥させた「洗浄評価インジケーターＴＯＳＩ（登録商標）」（ＰＥＲＥＧ製）を用いて、評価することができる。具体的には本発明の洗浄殺菌剤組成物（実用液）（４０℃）に上記洗浄評価インジケーターを所定時間浸漬し、次いでこれを水で洗浄してから「パワークイック残留タンパク検出液」（サラヤ株式会社）で染色し、洗浄後のインジケーターに残留した汚れ（血液タンパク質）の除去性を目視により評価することで実施することができる。当該インジケーターのモデル血液汚れが３０分の浸漬で完全に除去された場合を「洗浄力良好」と、また１０分間の浸漬で完全に除去された場合を「洗浄力が非常に良好」と評価することができる。 The cleaning effect of the cleaning/bactericidal composition (practical solution) of the present invention is the same as that of model blood stains (human plasma protein [hemoglobin, albumin, thrombin, fibrin]) on a stainless plate, as described in Experimental Examples described later. The evaluation can be performed using "washing evaluation indicator TOSI (registered trademark)" (manufactured by PEREG) to which purified bovine protein adjusted to have a composition [Swedish method of ISO15883] is attached and dried. Specifically, the above-mentioned cleaning evaluation indicator is immersed in the cleaning/bactericidal composition (practical solution) of the present invention (40° C.) for a predetermined time, then this is washed with water, and then “Power Quick Residual Protein Detection Liquid” (Sarayya) It can be carried out by visually observing the removability of stains (blood proteins) remaining on the indicator after washing with a dye. Models blood contamination of the indicator to evaluate the the case where it is completely removed by immersion in 30 minutes "detergency good" and the case where it is completely removed by a 10 minute immersion the "detergency very good" be able to.
また、本発明の洗浄殺菌剤組成物（実用液）の殺菌効果は、後述する実験例に記載するように、欧州標準化委員会（ＣＥＮ）が定める欧州規格に基づいたｉｎ ｖｉｔｒｏ試験（ヨーロッパ標準法）により細菌または／及び真菌に対する殺菌作用を測定することで評価することができる。例えば、細菌（例えば緑膿菌（グラム陰性菌）、黄色ブドウ球菌（グラム陽性菌））に対する殺菌作用はヨーロッパ標準法のＥＮ１３７２７の不潔条件と同じ方法で評価することができ、試験前後の菌数の対数減少値が５Ｌｏｇ１０以上であれば細菌に対して殺菌活性を有すると判定することができる。また真菌（例えば酵母）に対する殺菌作用はヨーロッパ標準法のＥＮ１３６２４の不潔条件と同じ方法で評価することができ、試験前後の菌数の対数減少値が４Ｌｏｇ１０以上であれば真菌に対して殺菌活性を有すると判定することができる。本発明の洗浄殺菌剤組成物において、試験を行った細菌または／及び真菌のすべてに対する殺菌効果が、ヨーロッパ標準法に記載される判定基準において○または△の評価である場合（○及び△の評価基準は実験例参照）を、当該洗浄殺菌剤組成物（実用液）について「殺菌効果あり」とするが、より好ましい洗浄殺菌剤組成物（実用液）は、試験を行ったすべての細菌または／及び真菌に対して良好な殺菌活性（ヨーロッパ標準法に記載される判定基準において○の評価）を発揮する液体組成物であり、当該洗浄殺菌剤組成物（実用液）（またはその濃縮タイプ）をより好ましい洗浄殺菌剤組成物と位置づけることができる。 The bactericidal effect of the cleaning/bactericidal composition (practical liquid) of the present invention is, as described in Experimental Examples to be described later, an in vitro test (European standard method) based on European standards established by the European Commission for Standardization (CEN). It can be evaluated by measuring the bactericidal action against bacteria or/and fungi according to (4). For example, the bactericidal action against bacteria (for example, Pseudomonas aeruginosa (Gram-negative bacterium), Staphylococcus aureus (Gram-positive bacterium)) can be evaluated by the same method as the European standard method EN13727 dirty condition, and the number of bacteria before and after the test can be evaluated. If the logarithmic reduction value of 5 is 10 or more, it can be determined that the bacteria have bactericidal activity. The bactericidal activity against fungi (for example, yeast) can be evaluated by the same method as the European standard method EN13624 filthy condition, and if the log reduction value of the number of bacteria before and after the test is 4 Log 10 or more, the bactericidal activity against fungi is obtained. Can be determined to have. In the cleaning and disinfectant composition of the present invention, the bactericidal effect on all the tested bacteria and/or fungi is evaluated as ○ or △ in the criteria described in the European Standard Method (evaluation of ○ and △). For the criteria, refer to Experimental Example), "there is a bactericidal effect" for the cleaning and sterilizing agent composition (practical liquid), but a more preferable cleaning and sterilizing agent composition (practical liquid) is all bacteria or/ And a liquid composition exhibiting a good bactericidal activity against fungi (evaluation of ○ in the criteria described in the European Standard Method), and the cleaning bactericidal composition (practical liquid) (or its concentrated type) It can be regarded as a more preferable cleaning and disinfectant composition.
（II）液体洗浄殺菌剤組成物（濃縮タイプ）
本発明は、上記実用液である医療器具用洗浄殺菌剤組成物よりも５０〜２００倍濃い濃度を有する濃縮タイプの液体洗浄殺菌剤組成物であってもよい。当該濃縮タイプの液体洗浄殺菌剤組成物は、上記（ａ）成分、（ｂ）成分、及び（ｃ）成分（または（ａ）成分、（ｂ）成分、（ｃ）成分、及び（ｄ）成分）を下記の割合で含有することができる。
（ａ）タンパク質分解酵素
０．５重量％以上、好ましくは０．５〜２０重量％、より好ましくは１〜２０重量％
（ｂ）界面活性剤
（ｂ−１）両性界面活性剤の場合
１０重量％以上、好ましくは１０〜４０重量％、より好ましくは１５〜４０重量％
（ｂ−２）ノニオン界面活性剤の場合
３０重量％以上、好ましくは３０〜６０重量％、より好ましくは４０〜６０重量％
（ｃ）殺菌剤
（ｃ−１）ジェミニ型殺菌剤
１重量％以上、好ましくは１〜１０重量％、より好ましくは２〜１０重量％
（ｃ−２）ビグアニジン系殺菌剤
２重量％以上、好ましくは２〜１０重量％、より好ましくは２〜５重量％。
(II) Liquid cleaning disinfectant composition (concentrated type)
The present invention may be a concentrated type liquid cleaning and disinfecting composition having a concentration of 50 to 200 times higher than that of the above-mentioned practical liquid, which is a cleaning and disinfecting composition for medical devices. The concentrated type liquid cleaning bactericidal composition is the above-mentioned component (a), component (b), and component (c) (or component (a), component (b), component (c), and component (d)). ) Can be contained in the following proportions.
(A) Proteolytic enzyme 0.5% by weight or more, preferably 0.5 to 20% by weight, more preferably 1 to 20% by weight
(B) Surfactant (b-1) Amphoteric surfactant: 10% by weight or more, preferably 10 to 40% by weight, more preferably 15 to 40% by weight
(B-2) Nonionic surfactant: 30% by weight or more, preferably 30 to 60% by weight, more preferably 40 to 60% by weight.
(C) Microbicide (c-1) Gemini type microbicide 1% by weight or more, preferably 1 to 10% by weight, more preferably 2 to 10% by weight.
(C-2) Biguanidine fungicide 2% by weight or more, preferably 2 to 10% by weight, more preferably 2 to 5% by weight.
（ｂ）成分として両性界面活性剤、及び（ｃ）殺菌剤としてジェミニ型殺菌剤を配合する場合、さらに（ｄ）成分として下記（ｄ）金属イオン封鎖剤、好ましくは保存安定性の観点からニトリロ三酢酸またはその金属塩、より好ましくはニトリロ三酢酸を配合することが好ましい。 When an amphoteric surfactant is added as the component (b) and a gemini type fungicide as the fungicide (c), the following (d) sequestering agent as the component (d), preferably nitrilo from the viewpoint of storage stability. It is preferable to add triacetic acid or a metal salt thereof, more preferably nitrilotriacetic acid.
（ｄ）金属イオン封鎖剤、好ましくはニトリロ三酢酸
１重量％以上、好ましくは１〜２０重量％、より好ましくは２．５〜２０重量％。
(D) Sequestering agent, preferably 1% by weight or more of nitrilotriacetic acid , preferably 1 to 20% by weight, more preferably 2.5 to 20% by weight.
また当該濃縮タイプの洗浄殺菌剤組成物は、上記（ａ）成分、（ｂ）成分、及び（ｃ）成分（または（ａ）成分、（ｂ）成分、（ｃ）成分、及び（ｄ）成分）に加えて、（ｅ）成分及び（ｆ）成分を下記の割合で含有することができる。
（ｅ）酵素安定化剤
１重量％以上、好ましくは３〜３０重量％、より好ましくは５〜２０重量％
（ｆ）アルカリ剤
２重量％以上、好ましくは２〜２０重量％、より好ましくは２〜１５重量％。
Further, the concentrated type cleaning and disinfectant composition is the above-mentioned component (a), component (b), and component (c) (or component (a), component (b), component (c), and component (d)). In addition to ), the component (e) and the component (f) can be contained in the following proportions.
(E) Enzyme stabilizer 1% by weight or more, preferably 3 to 30% by weight, more preferably 5 to 20% by weight.
(F) Alkali agent 2% by weight or more, preferably 2 to 20% by weight, more preferably 2 to 15% by weight.
さらに濃縮タイプの液体洗浄殺菌剤組成物も、前述する実用液と同様に（ｇ）ｐＨ調整剤を用いてｐＨが７〜１０、好ましくはｐＨ８〜９．５となるように調整されていることが好ましい。また濃縮タイプの液体洗浄殺菌剤組成物は、前述する実用液と同様に、本発明の効果を損なわない範囲で、任意にタンパク質分解酵素以外の酵素（脂質分解酵素（リパーゼ）、澱粉分解酵素（アミラーゼ）、または／及びセルロース分解酵素（セルラーゼ））、色素（着色剤）、防錆剤、消泡剤、及び／または香料などを配合することが出来る。 Further, the concentrated type liquid cleaning and disinfectant composition is also adjusted to have a pH of 7 to 10, preferably 8 to 9.5 by using the (g) pH adjuster as in the practical liquid described above. Is preferred. Further, the concentrated type liquid cleaning bactericidal composition, like the practical liquid described above, may optionally contain an enzyme other than a proteolytic enzyme (lipolytic enzyme (lipase), starch degrading enzyme ( (Amylase) and/or cellulolytic enzyme (cellulase)), pigment (colorant), rust preventive, antifoaming agent, and/or fragrance can be added.
本発明の濃縮タイプの液体洗浄殺菌剤組成物は、上記各成分を混合配合して調製しておいたものを、使用時（被験対象物の洗浄殺菌時）に水で５０〜２００倍に希釈してｐＨ７〜１０の洗浄液（実用液）として使用される。被験対象物は前述した通りであり、好ましくは医療器具及び臨床検査器具であり、特に生体試料や血液などのタンパク質汚れが付着した医療器具である。 The concentrated type liquid cleaning and disinfecting composition of the present invention is prepared by mixing and blending the above components, and is diluted 50 to 200 times with water at the time of use (during cleaning and sterilization of a test object). And used as a cleaning liquid (practical liquid) having a pH of 7 to 10. The test subject is as described above, preferably a medical device and a clinical test device, and particularly a medical device to which a biological sample or protein stain such as blood is attached.
以下、実施例によって本発明を具体的に説明する。但し、組成物においては、本発明の範囲から逸脱することなく種々の変更を加えることが可能であるため、本発明はこれら具体例によって限定されるものではない。 Hereinafter, the present invention will be specifically described with reference to examples. However, the present invention is not limited to these specific examples because various modifications can be made to the composition without departing from the scope of the present invention.
実験例１
ｐＨは、ｐＨメーターを用いて測定した。各種液体洗浄殺菌剤組成物を実用液濃度に調製したものについてそれぞれ測定した。
Experimental example 1
The pH was measured using a pH meter. Each of the various liquid cleaning and sterilizing composition prepared to practical liquid concentrations was measured.
（１）洗浄力評価
本発明の液体洗浄殺菌剤組成物の洗浄力評価に、医療器具用洗浄剤の洗浄力評価で頻用されている、ステンレス板にモデル血液汚れを付着して乾燥させた「洗浄インジケーターＴＯＳＩ（登録商標）」（ＰＥＲＥＧ製）を用いた。インジケーターに付属しているプラスチックカバーを外して、４０℃の液体洗浄殺菌剤組成物に１０分間浸漬し、次いで水で洗浄してから「パワークイック残留タンパク検出液」（サラヤ株式会社製）で染色し、洗浄後のインジケーターに残留した汚れ（血液タンパク質）の除去性を下記の基準に基づいて目視観察することで評価した。
(1) Detergency Evaluation A model blood stain is adhered to a stainless plate and dried, which is frequently used in the detergency evaluation of the liquid cleaning disinfectant composition of the present invention in the detergency evaluation of a cleaning agent for medical devices. A cleaning indicator TOSI (registered trademark)" (manufactured by PEREG) was used. Remove the plastic cover attached to the indicator, immerse in a liquid cleaning bactericidal composition at 40°C for 10 minutes, then wash with water and stain with "Power Quick Residual Protein Detecting Solution" (Salaya Co., Ltd.) Then, the removability of stains (blood proteins) remaining on the indicator after washing was evaluated by visual observation based on the following criteria.
＜洗浄力評価基準＞
○：完全に除去
△：除去なし（初期（浸漬洗浄未処理）のインジケーターに付着した汚れの量から変わらない）
×：固着（汚れの広がり）
<Cleaning power evaluation criteria>
◯: Completely removed Δ: No removal (no change from the amount of dirt attached to the indicator in the initial stage (untreated by immersion cleaning))
×: Sticking (spreading of dirt)
（２）殺菌力評価
ヨーロッパ標準法のＥＮ１３７２７の不潔条件と同じ方法で実施し、以下の評価基準で判定した。
＜試験条件＞
（有機物）作用時濃度０．３重量％ヒツジ赤血球＋０．３重量％ＢＳＡ
（温度／接触時間）４０℃／１０分間
（使用希釈水と作用時試作品濃度）ＣａＣＯ３換算で作用時に３００ｐｐｍとなる人工硬水を用いて、作用時に表１記載の濃度となるように実用液を調製した。
（作用菌株）
Ｐｓｅｕｄｏｍｏｎａｓ ａｅｒｕｇｉｎｏｓａ（緑膿菌）ＡＴＣＣ１５４４２
Ｓｔａｐｈｙｌｏｃｏｃｃｕｓ ａｕｒｅｕｓ（黄色ブドウ球菌）ＡＴＣＣ６５３８
(2) Evaluation of bactericidal activity It was carried out by the same method as the dirty condition of EN 13727 of European Standard Method, and judged by the following evaluation criteria.
<Test conditions>
(Organic matter) Concentration during action 0.3% by weight sheep red blood cells + 0.3% by weight BSA
(Temperature/contact time) 40° C./10 minutes (diluting water used and concentration of prototype during action) Using artificial hard water, the concentration of which is 300 ppm in terms of CaCO 3 when acting, and a working solution having a concentration shown in Table 1 during action is used. Was prepared.
(Acting strain)
Pseudomonas aeruginosa ATCC 15442
Staphylococcus aureus ATCC6538
＜殺菌力評価基準＞
初期菌数及び生存菌数から対数減少値を算出した。判定基準はヨーロッパ標準法に記載される基準から下記の通り判断した。
○：５ＬｏｇＲｅｄｕｃｔｉｏｎ以上（９９．９９９％以上）
△：３ＬｏｇＲｅｄｕｃｔｉｏｎ以上、５ＬｏｇＲｅｄｕｃｔｉｏｎ未満
×：３ＬｏｇＲｅｄｕｃｔｉｏｎ未満（９９．９％未満）
<Sterility evaluation standard>
A logarithmic reduction value was calculated from the initial bacterial count and the viable bacterial count. The judgment criteria were as follows based on the criteria described in the European Standard Law.
○: 5 Log Reduction or more (99.999% or more)
Δ: 3 Log Reduction or more and less than 5 Log Reduction ×: less than 3 Log Reduction (less than 99.9%)
表１に示す実施例１〜３の結果から分かるように、本発明の洗浄殺菌剤組成物は血液汚れに対して優れた洗浄力効果と殺菌効果を併せ持つ洗浄殺菌剤組成物である。そのため、血液などのタンパク質汚れが付着した医療器具や臨床検査器具であっても、本発明の洗浄殺菌剤組成物を用いて当該医療器具や臨床検査器具を洗浄殺菌処理することで、初期の洗浄作業で医療器具等に付着している細菌やウイルスの数を減らすことが出来ると同時に、作業者の感染リスクの低減、医療器具等の間における交差汚染の予防、自然環境への汚染水の排出防止が実現可能となる。 As can be seen from the results of Examples 1 to 3 shown in Table 1, the cleaning and disinfecting composition of the present invention is a cleaning and disinfecting composition having both excellent detergency and disinfection effects on blood stains. Therefore, even in the case of a medical device or a clinical test device to which protein stains such as blood are attached, by performing a sterilization treatment on the medical device or the clinical test device using the cleaning/sterilizing agent composition of the present invention, the initial cleaning is performed. The number of bacteria and viruses adhering to medical equipment can be reduced during work, while at the same time reducing the risk of worker infection, preventing cross-contamination between medical equipment, and discharging contaminated water to the natural environment. Prevention becomes feasible.
実験例２
ｐＨはｐＨメーターを用いて測定した。表３及び表５については濃縮タイプの洗浄殺菌剤組成物のｐＨを原液ｐＨ、これを水で１００倍希釈した実用液のｐＨを希釈ｐＨとしてそれぞれ測定した。
Experimental example 2
The pH was measured using a pH meter. In Tables 3 and 5, the pH of the concentrated-type cleaning and sterilizing agent composition was measured as a stock solution pH, and the pH of a practical solution prepared by diluting this 100 times with water was taken as a diluted pH.
（１）洗浄力評価
実験例１と同様に、ステンレス板にモデル血液汚れを付着して乾燥させた「洗浄インジケーターＴＯＳＩ（登録商標）」（ＰＥＲＥＧ製）を用いた。インジケーターに付属しているプラスチックカバーを外して、表２〜５に記載する処方に従って調製し、温度を４０℃に調整した液体洗浄殺菌剤組成物（実施例４〜２６、比較例５〜１０）に、１０分間及び３０分間浸漬し、次いで水で洗浄してから「パワークイック残留タンパク検出液」（サラヤ株式会社製）で染色し、洗浄後のインジケーターに残留した汚れ（血液タンパク質）の除去性を下記の基準に基づいて目視観察することで評価した。なお、表２〜５のうち、表３及び表５に示す処方は、１００倍濃縮タイプの液体洗浄殺菌剤組成物の処方である。従って、表３及び表５に記載する液体洗浄殺菌剤組成物は、試験に際して水で１００倍に希釈して使用した。
(1) Detergency Evaluation As in Experimental Example 1, a “cleaning indicator TOSI (registered trademark)” (manufactured by PEREG) in which model blood stains were attached to a stainless plate and dried was used. Liquid cleaning disinfectant compositions prepared according to the formulations shown in Tables 2 to 5 by removing the plastic cover attached to the indicator and adjusting the temperature to 40°C (Examples 4 to 26, Comparative Examples 5 to 10) Soak for 10 minutes and 30 minutes in water, then wash with water and stain with "PowerQuick residual protein detection solution" (made by Saraya Co., Ltd.) to remove stains (blood proteins) remaining on the indicator after washing. Was evaluated by visual observation based on the following criteria. In addition, among Tables 2-5, the prescriptions shown in Tables 3 and 5 are prescriptions for a 100-fold concentrated type liquid cleaning and disinfectant composition. Therefore, the liquid cleaning germicide compositions shown in Tables 3 and 5 were diluted 100 times with water before use.
＜洗浄力評価基準＞
〔表２〕
ＡとＡ´、ａとａ´、ＢとＢ´、ｂとｂ´でそれぞれ比較し、後者に比べて１０分間浸漬による洗浄効果が向上していれば＋、１０分間及び３０分間浸漬共に洗浄効果が後者よりも向上していれば＋＋とした。
〔表３〜５〕
○：完全に除去
△：除去なし（初期（浸漬洗浄未処理）のインジケーターに付着した汚れの量から変わらない）
×：固着（汚れの広がり）
<Cleaning power evaluation criteria>
[Table 2]
A and A', a and a', B and B', respectively compared with b and b ', if the improved cleaning effect by immersion for 10 minutes in comparison with the latter +, washed 10 minutes and 30 minutes immersion co If the effect is better than the latter, it is set to ++.
[Tables 3-5]
○: Completely removed △: No removal (no change from the amount of dirt attached to the indicator in the initial stage (not processed by immersion cleaning))
×: Sticking (spreading of dirt)
（２）殺菌力評価
ヨーロッパ標準法のＥＮ１３７２７及びＥＮ１３６２４の不潔条件と同じ方法で実施し、以下の評価基準で判定した。
＜試験条件＞
（有機物）作用時濃度０．３重量％ヒツジ赤血球＋０．３重量％ＢＳＡ
（温度／接触時間）４０℃／１０分間
（使用希釈水と作用時試作品濃度）ＣａＣＯ３換算で作用時に３００ｐｐｍとなる人工硬水を用いて、作用時に１％となるように各種液体洗浄殺菌剤組成物を希釈した。
（作用菌株）
Ｐｓｅｕｄｏｍｏｎａｓ ａｅｒｕｇｉｎｏｓａ（緑膿菌）ＡＴＣＣ１５４４２
Ｓｔａｐｈｙｌｏｃｏｃｃｕｓ ａｕｒｅｕｓ（黄色ブドウ球菌）ＡＴＣＣ６５３８
Ｃａｎｄｉｄａ ａｌｂｉｃａｎｓ（酵母）ＡＴＣＣ１０２３１
(2) Evaluation of bactericidal power It was carried out by the same method as the unclean condition of EN 13727 and EN 13624 of European standard method, and judged by the following evaluation criteria.
<Test conditions>
(Organic matter) Concentration during action 0.3% by weight sheep red blood cells + 0.3% by weight BSA
(Temperature/contact time) 40° C./10 minutes (diluted water used and concentration of prototype during action) Various kinds of liquid cleaning and sterilizing agents using artificial hard water, which has a CaCO 3 conversion of 300 ppm at the time of action, to be 1% at the time of action The composition was diluted.
(Acting strain)
Pseudomonas aeruginosa ATCC 15442
Staphylococcus aureus ATCC6538
Candida albicans (yeast) ATCC10231
＜殺菌力評価基準＞
初期菌数及び生存菌数から対数減少値を算出した。判定基準はヨーロッパ標準法に記載される基準から下記の通り判断した。
（細菌）○：５ＬｏｇＲｅｄｕｃｔｉｏｎ以上（９９．９９９％以上）
△：３ＬｏｇＲｅｄｕｃｔｉｏｎ以上、５ＬｏｇＲｅｄｕｃｔｉｏｎ未満
×：３ＬｏｇＲｅｄｕｃｔｉｏｎ未満（９９．９％未満）
（真菌）○：４ＬｏｇＲｅｄｕｃｔｉｏｎ以上（９９．９９％以上）
△：２ＬｏｇＲｅｄｕｃｔｉｏｎ以上、４ＬｏｇＲｅｄｕｃｔｉｏｎ未満
×：２ＬｏｇＲｅｄｕｃｔｉｏｎ未満（９９％未満）
<Sterility evaluation standard>
A logarithmic reduction value was calculated from the initial bacterial count and the viable bacterial count. The judgment criteria were as follows based on the criteria described in the European Standard Law.
(Bacteria) ○: 5 Log Reduction or more (99.999% or more)
Δ: 3 Log Reduction or more and less than 5 Log Reduction ×: less than 3 Log Reduction (less than 99.9%)
(Fungus) ○: 4 Log Reduction or more (99.99% or more)
Δ: 2 Log Reduction or more and less than 4 Log Reduction ×: less than 2 Log Reduction (less than 99%)
（３）酵素安定性
４０℃で１４日間保存後、カゼインを基質に用いたＦｏｌｉｎ−Ｌｏｗｒｙ法にて測定して酵素活性を算出し、保存前の酵素活性に対する相対値を残存活性とした。残存活性が８０％以上を○、８０％未満を×とした。
(3) Enzyme stability After storage at 40° C. for 14 days, the enzyme activity was calculated by the Folin-Lowry method using casein as a substrate, and the relative value to the enzyme activity before storage was taken as the residual activity. When the residual activity was 80% or more, it was evaluated as ◯, and when less than 80%, it was evaluated as x.
結果を表２〜５に合わせて示す。 The results are shown in Tables 2-5.
表２に示すように、界面活性剤としてノニオン界面活性剤より両性界面活性剤を用いるほうが血液汚れに対する洗浄効果が高いことがわかる。この実施例の結果から、殺菌剤の中でも比較的洗浄効果に対する妨害が少なかった殺菌剤１（ハイジェニア）を用いた場合の実験結果を表３〜５に示す。 As shown in Table 2, it is found that the amphoteric surfactant is more effective in cleaning blood stains than the nonionic surfactant as the surfactant. From the results of this example, Tables 3 to 5 show the experimental results in the case of using the bactericide 1 (Higenia), which has relatively less interference with the cleaning effect among the bactericides.
表３〜５に記載する結果から分かるように、本発明の液体洗浄殺菌剤組成物は、血液汚れに対して優れた洗浄力効果と殺菌効果を併せ持ち、かつ酵素安定性も有する洗浄殺菌剤組成物である。そのため、血液などのタンパク質汚れが付着した医療器具であっても、本発明の洗浄殺菌剤組成物を用いて当該医療器具を洗浄殺菌処理することで、初期の洗浄作業で医療器具に付着している細菌やウイルスの数を減らすことが出来ると同時に、作業者の感染リスクの低減、医療器具間の交差汚染の予防、自然環境への汚染水の排出防止が実現可能となる。 As can be seen from the results shown in Tables 3 to 5, the liquid cleaning and disinfecting composition of the present invention has both excellent detergency and bactericidal effects against blood stains, and also has enzyme stability. It is a thing. Therefore, even in the case of a medical device to which protein stains such as blood are attached, the medical device is washed and sterilized by using the cleaning and sterilizing agent composition of the present invention to be attached to the medical device in the initial cleaning operation. It is possible to reduce the number of bacteria and viruses present, reduce the risk of infection of workers, prevent cross-contamination between medical devices, and prevent discharge of contaminated water to the natural environment.
タンパク質分解酵素、界面活性剤、及び殺菌剤を配合することで、使用後の血液などのタンパク質汚れが付着した医療器具の洗浄作業をより安全に行なうことができる。 By mixing a protein degrading enzyme, a surfactant, and a bactericide, it is possible to more safely carry out the cleaning operation of a medical instrument having protein stains such as blood after use attached thereto.
Claims (9)
（ａ）タンパク質分解酵素を０．０１重量％以上、
（ｂ）両性界面活性剤及びノニオン界面活性剤からなる群から選択される少なくとも１種の界面活性剤を０．１重量％以上
（ｃ）ジェミニ型殺菌剤及びビグアニジン系殺菌剤からなる群から選択される少なくとも１種の殺菌剤を、ジェミニ型殺菌剤については０．０１〜０．１重量％、ビグアニジン系殺菌剤については０．０２〜０．１重量％の割合で
含有することを特徴とする、
液体形態を有するｐＨ８〜１０の洗浄殺菌剤組成物
（但し、ＨＬＢ値が１２〜１７のポリグリセリン脂肪酸エステルを含む洗浄殺菌剤組成物、ジ-C7-C10-n-アルキルジメチルアンモニウム化合物、モノ-n-C8-C14-アルキル-ジメチルベンジルアンモニウム化合物、グアニジンまたはそれらの混合物を含む洗浄消毒用組成物、並びにピロリドン化合物を含む抗菌組成物を除く）。 In a practical liquid,
(A) 0.01% by weight or more of proteolytic enzyme,
(B) 0.1 wt% or more of at least one surfactant selected from the group consisting of amphoteric surfactants and nonionic surfactants (c) selected from the group consisting of gemini type fungicides and biguanidine fungicides. The gemini type bactericide in an amount of 0.01 to 0.1% by weight and the biguanidine fungicide in an amount of 0.02 to 0.1% by weight. Characterized by that
A cleaning and disinfecting composition having a liquid form and having a pH of 8 to 10 (however, a cleaning and disinfecting composition containing a polyglycerin fatty acid ester having an HLB value of 12 to 17 , di-C7-C10-n-alkyldimethylammonium compound, mono- Excluding cleaning and disinfecting compositions containing n-C8-C14-alkyl-dimethylbenzylammonium compounds, guanidine or mixtures thereof, and antibacterial compositions containing pyrrolidone compounds ).
（ｃ）殺菌剤がジェミニ型殺菌剤０．０１〜０．１重量％
である、請求項１に記載する洗浄殺菌剤組成物。 The (b) surfactant is 0.1% by weight or more of an amphoteric surfactant,
(C) 0.01 to 0.1% by weight of Gemini type bactericide
The cleaning and disinfectant composition according to claim 1, which is
（ｃ）殺菌剤がビグアニジン系殺菌剤０．０２〜０．１重量％
である、請求項１に記載する洗浄殺菌剤組成物。 The (b) surfactant is 0.3% by weight or more of a nonionic surfactant,
(C) The bactericide is 0.02-0.1% by weight of a biguanidine bactericide
The cleaning and disinfectant composition according to claim 1, which is
（１）被験対象物を請求項１〜７のいずれか一項に記載する液体洗浄殺菌剤組成物または請求項８に記載する濃縮タイプの液体洗浄殺菌剤組成物の５０〜２００倍希釈液に浸漬する工程、（２）被験対象物を液体洗浄殺菌剤組成物から取り出し、水で洗浄する工程。 Method of cleaning and sterilizing test object having the following steps:
(1) the test object 50 to 200-fold dilutions of claims 1-7 or a liquid cleaning disinfectant compositions according to one item or a liquid cleaning fungicide composition concentrate the type described in claim 8 of The step of immersing, (2) the step of taking out the test object from the liquid cleaning germicide composition and cleaning it with water.
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