JP3370571B2 - Disinfectant cleaning agents for medical equipment and disinfecting cleaning methods - Google Patents
Disinfectant cleaning agents for medical equipment and disinfecting cleaning methodsInfo
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- JP3370571B2 JP3370571B2 JP23872397A JP23872397A JP3370571B2 JP 3370571 B2 JP3370571 B2 JP 3370571B2 JP 23872397 A JP23872397 A JP 23872397A JP 23872397 A JP23872397 A JP 23872397A JP 3370571 B2 JP3370571 B2 JP 3370571B2
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- Prior art keywords
- disinfecting
- acid
- cleaning
- hydrogen peroxide
- organic
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- Detergent Compositions (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- External Artificial Organs (AREA)
Description
【0001】[0001]
【発明の属する技術分野】本発明は、人工透析装置及び
その周辺機器、内視鏡等を始めとする各種医療機器の洗
浄消毒に使用される医療機器用殺菌洗浄剤と、これを用
いた消毒洗浄方法に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sterilizing detergent for medical equipment used for washing and disinfecting various medical equipment such as artificial dialysis equipment and its peripheral equipment, endoscopes, and disinfection using the same. Regarding the cleaning method.
【0002】[0002]
【従来の技術】人工透析装置は、使用中に血液等の体液
やその成分が付着して汚染されるが、この汚染を放置す
れば細菌やウィルスによる感染、異種蛋白質によるアナ
フラキシー等の原因となるため、使用後に付着汚染物を
洗浄除去すると共に殺菌して危険性を除く必要がある。
また、透析液の供給装置や供給ラインの汚れは細菌増殖
の要因となり、細菌感染やエンドトキシンによる患者の
発熱等を招く可能性があるが、特に近年ではPH調整の
ために重炭酸ナトリウムを配合した透析液が汎用されて
いることから、配管等の接液部に炭酸カルシウム等のカ
ルシウム塩が析出して付着し易くなっており、患者監視
装置の作動不良等のトラブルの要因にもなるため、殺菌
と共にこの汚れの除去も必要とされる。特に、このカル
シウム塩については、原因不明であるが、時折、炭酸カ
ルシウムと考えられる大きい析出物が多量に付着するこ
とがある。更に、透析液の供給ラインにおいては、透析
液に夾雑する細菌汚染を回避せねばならない。2. Description of the Related Art Artificial dialysis machines are contaminated with body fluids such as blood and its components during use. If left uncontaminated, infection with bacteria and viruses, anaphylaxis due to foreign proteins, etc. will occur. Therefore, it is necessary to remove the attached contaminants by washing and sterilize them after use to eliminate the danger.
Also, contamination of the dialysate supply device and supply line can cause bacterial growth, which can lead to fever in patients due to bacterial infection and endotoxin. In recent years, sodium bicarbonate has been added for pH adjustment. Since dialysate is commonly used, calcium salts such as calcium carbonate are likely to deposit and adhere to the liquid contact parts such as pipes, which may cause trouble such as malfunction of the patient monitoring device. Removal of this dirt is required along with sterilization. In particular, for this calcium salt, although the cause is unknown, sometimes large deposits, which are considered to be calcium carbonate, may adhere in large amounts. Further, in the dialysate supply line, bacterial contamination contaminating the dialysate must be avoided.
【0003】そこで、従来では、上述のような透析装置
及びその周辺機器における付着・汚染物の除去及び殺菌
のために、一般的に次亜塩素酸ナトリウム水溶液と酢酸
水溶液による二段階の洗浄が行われている。また、上記
の酢酸水溶液に代えて過酢酸水溶液を用いる二段階洗浄
法(特開平8−224299号)も提案されている。更
に、同様目的で一段階洗浄を行える消毒洗浄剤として、
次亜塩素酸ナトリウムと金属封鎖剤及び陰イオン界面活
性剤を含む水溶液からなるもの(特開平4−13555
9号、同7−233396号等)や、6〜8%の過酸化
水素と2〜10%の酢酸及び0.3〜1%の過酢酸を含
むと共に過酸化水素に対する酢酸及び過酢酸の合量の重
量比が1より小さい水溶液からなるもの(特許第259
9204号)等が提案されている。Therefore, conventionally, two-step cleaning with an aqueous solution of sodium hypochlorite and an aqueous solution of acetic acid is generally performed in order to remove and sterilize the adhered substances / contaminants in the above-mentioned dialysis apparatus and its peripheral equipment. It is being appreciated. Further, a two-step cleaning method (Japanese Patent Laid-Open No. 8-224299) using an aqueous solution of peracetic acid in place of the aqueous solution of acetic acid has also been proposed. Furthermore, as a disinfectant cleaner that can perform one-step cleaning for the same purpose,
An aqueous solution containing sodium hypochlorite, a sequestering agent, and an anionic surfactant (Japanese Patent Laid-Open No. 4-135555)
No. 9, 7-233396, etc.) and 6 to 8% hydrogen peroxide, 2 to 10% acetic acid and 0.3 to 1% peracetic acid, and a mixture of acetic acid and peracetic acid with respect to hydrogen peroxide. Consisting of an aqueous solution in which the weight ratio of the amounts is less than 1 (Patent No. 259
No. 9204) has been proposed.
【0004】一方、内視鏡においても、患者の体内に入
るものであるため、細菌やウィルスなどによる感染の危
険性を防ぐ高レベルの消毒が必要とされており、例えば
日本消化器内視鏡技師会消毒委員会による『内視鏡の洗
浄・消毒に関するガイドライン』では、「患者すべてを
感染者とみなし、1例ごとに2%グルタールアルデヒド
に10分間の浸漬をしなければならない」としている。
そして、実際の洗浄消毒では、使用後にまず外部の汚れ
を流水や拭き取りによって除き、次いで全管注入具を取
り付け、内部に洗浄剤を入れてブラッシングを行い、水
洗して送気によって脱水したのち、内部に2%以上のグ
ルタールアルデヒド水溶液を注入し、更に全体を2%以
上のグルタールアルデヒド水溶液に10分間浸漬し、最
後に水洗して送気による脱水を行うという手法が採用さ
れている。On the other hand, also in the endoscope, since it enters the patient's body, a high level of disinfection is required to prevent the risk of infection by bacteria or viruses. According to the "Guidelines for cleaning and disinfection of endoscopes" by the Society of Engineers' Disinfection Committee, "all patients must be considered infected and each must be immersed in 2% glutaraldehyde for 10 minutes". .
Then, in the actual cleaning and disinfecting, after use, first remove external dirt by running water or wiping, then attach all tube injection tool, put cleaning agent inside and brush, wash with water and dehydrate by air supply, A method of injecting 2% or more glutaraldehyde aqueous solution into the inside, further immersing the whole in 2% or more glutaraldehyde aqueous solution for 10 minutes, and finally washing with water to perform dehydration by air supply is adopted.
【0005】[0005]
【発明が解決しようとする課題】しかしながら、前記従
来の次亜塩素酸ナトリウム水溶液と酢酸水溶液又は過酢
酸水溶液による二段階洗浄では、殺菌消毒性に優れる反
面で洗浄性に劣り、油脂等の付着成分に対する除去能力
に乏しいことから、洗浄効果は充分とは言えない上、二
回に分けて洗浄を行うために操作的に煩雑で多大な労力
及び時間を費やすという問題があり、実際の医療現場に
おいては二段洗浄を行う時間的余裕がない場合も多々あ
る。また次亜塩素酸ナトリウムと金属封鎖剤及び陰イオ
ン界面活性剤を含む消毒洗浄剤では、消毒効果や体液成
分の除去効果は優れるが、前記の時折生じるカルシウム
塩の大きく多量な析出付着物に対する除去能力が不充分
であると共に、次亜塩素酸ナトリウムによる金属封鎖剤
の分解が経時的に進行して抗力低下をきたすため、調製
した洗浄液を長期保存できないという難点があった。However, the conventional two-step cleaning with the sodium hypochlorite aqueous solution and the acetic acid aqueous solution or the peracetic acid aqueous solution is excellent in sterilizing and disinfecting properties but is poor in the cleaning property, and the adhering components such as fats and oils are deteriorated. The cleaning effect is not sufficient due to its poor removal ability, and there is a problem in that it requires a lot of labor and time because it is operationally complicated to perform the cleaning in two steps. In many cases, there is not enough time to perform the two-step cleaning. In addition, a disinfecting detergent containing sodium hypochlorite, a sequestering agent and an anionic surfactant is excellent in disinfecting effect and removing effect of bodily fluid components, but removal of large and large amount of deposits of calcium salt that occasionally occurs as described above. In addition to insufficient capacity, the decomposition of the sequestering agent with sodium hypochlorite progresses over time, resulting in a decrease in drag. Therefore, the prepared cleaning liquid cannot be stored for a long time.
【0006】更に、前記提案の過酸化水素と酢酸及び過
酢酸を含有する水溶液では、過酸化水素を6%以上含む
ために医薬用外劇物に相当し、その流通において制約を
受けるばかりか、過酸化水素の量が多いために皮膚に接
触すると強い炎症を生じるため、取扱い上の安全性に問
題があり、しかも後述する比較例2の試験結果にて示す
ようにカルシウム塩除去性、殺菌性、蛋白質除去性のい
ずれについても充分に満足できる結果は得られなかっ
た。Further, the above-mentioned proposed aqueous solution containing hydrogen peroxide, acetic acid and peracetic acid, which contains 6% or more of hydrogen peroxide, corresponds to a non-medical deleterious substance and is not only restricted in its distribution. Since the amount of hydrogen peroxide is large, strong irritation occurs when it comes into contact with the skin, and thus there is a problem in safety in handling, and as shown in the test results of Comparative Example 2 described later, calcium salt removing property and bactericidal property are exhibited. However, no satisfactory results were obtained with respect to both protein removability.
【0007】一方、前記の内視鏡の消毒に使用されるグ
ルタールアルデヒドは、副作用及び毒性が強いため、残
留による危険性に加え、作業従事者の健康面の危惧も大
きく、しかも蛋白質と反応して強固な凝固物を形成する
性質があることから、前段階の洗浄で蛋白質を完全に除
去できなかった場合の残留が懸念されるという問題があ
った。On the other hand, the glutaraldehyde used for disinfection of the endoscope has strong side effects and toxicity, so that in addition to the risk of residue, there is a great concern for the health of workers, and it reacts with proteins. Since it has the property of forming a strong coagulation product, there is a problem that if the protein cannot be completely removed by the washing in the previous step, there is a concern that it may remain.
【0008】本発明は、上述の状況に鑑み、人工透析装
置及びその周辺機器、内視鏡等を始めとする種々の医療
機器の消毒洗浄において、一段階洗浄によって強力な除
菌洗浄効果が得られ、カルシウム塩の大きく多量な析出
物をも容易に除去可能であり、且つ洗浄剤の保存安定性
にも優れ、取扱いにおける安全性が高く、環境汚染の問
題のない消毒洗浄手段を提供することを目的としてい
る。In view of the above situation, the present invention provides a powerful disinfecting cleaning effect by one-step cleaning in disinfecting and cleaning various medical devices such as artificial dialysis machines and peripheral devices thereof, endoscopes and the like. To provide a disinfecting and cleaning means that can easily remove large and large amounts of calcium salts, has excellent storage stability of cleaning agents, has high safety in handling, and has no problem of environmental pollution. It is an object.
【0009】[0009]
【課題を解決するための手段】上記目的を達成するため
に、請求項1の発明に係る医療機器用消毒洗浄剤は、過
酸化水素3.5〜6%、有機酸5〜30%、有機過酸
0.4〜3.4%、及び安定化剤としての2−アミノエ
タンスルホン酸又はその塩0.002〜1%を含み、
(有機酸+有機過酸)/過酸化水素の重量比が1以上で
ある水溶液からなるものである。In order to achieve the above object, the disinfecting and cleaning agent for medical equipment according to the invention of claim 1 is hydrogen peroxide 3.5 to 6%, organic acid 5 to 30%, organic Peracid 0.4-3.4%, and 2-aminoethanesulfonic acid or its salt 0.002-1% as a stabilizer,
It is composed of an aqueous solution having a weight ratio of (organic acid + organic peracid) / hydrogen peroxide of 1 or more.
【0010】しかして、上記請求項1の医療機器用消毒
洗浄剤において、請求項2の発明では有機酸が酢酸であ
る構成を、請求項3の発明では有機酸が主成分の酢酸と
水溶液中のコハク酸含有量が0.1〜6%のコハク酸と
の2成分からなる構成を、それぞれ採用している。In the disinfecting and cleaning agent for medical equipment according to claim 1, the organic acid is acetic acid in the invention of claim 2, and in the acetic acid containing the organic acid as a main component and the aqueous solution in the invention of claim 3. 2) and succinic acid having a succinic acid content of 0.1 to 6%.
【0011】請求項4の発明は、上記請求項1〜3のい
ずれかの医療機器用消毒洗浄剤において、(有機酸+有
機過酸)/過酸化水素の重量比が2以上である構成とし
ている。According to a fourth aspect of the present invention, in the disinfectant cleaner for medical devices according to any of the first to third aspects, the weight ratio of (organic acid + organic peracid) / hydrogen peroxide is 2 or more. There is.
【0012】一方、請求項5の発明に係る医療機器の消
毒洗浄方法は、上記前記請求項1〜4のいずれかに記載
の医療機器用消毒洗浄剤を水で20〜100倍に希釈
し、この希釈液を用いて医療機器の消毒洗浄を行うこと
を特徴としている。On the other hand, the method for disinfecting and cleaning medical equipment according to a fifth aspect of the present invention is to dilute the disinfectant cleaning agent for medical equipment according to any one of the first to fourth aspects with water 20 to 100 times, It is characterized in that medical equipment is disinfected and washed using this diluted solution.
【0013】また、上記請求項5の消毒洗浄方法にて消
毒洗浄する医療機器を、請求項6の発明では人工透析装
置の透析ラインとし、請求項7の発明では内視鏡として
いる。The medical device to be disinfected and cleaned by the disinfecting and cleaning method of the fifth aspect is a dialysis line of an artificial dialysis device in the invention of the sixth aspect and an endoscope in the invention of the seventh aspect.
【0014】[0014]
【発明の実施の形態】本発明の医療機器用消毒洗浄剤
は、既述のように、過酸化水素、有機酸、有機過酸、及
び2−アミノエタンスルホン酸又はその塩を含有するも
のである。これら含有成分の内、過酸化水素と有機過酸
は、酸化剤として働き、微生物の細胞蛋白質を変性させ
たり破壊して殺菌効果をもたらすと共に、微生物が生成
した毒素を酸化分解して無害化する特性がある。また有
機酸は人工透析装置の透析ライン等に析出するカルシウ
ム塩を溶解除去する機能を果たす。そして、2−アミノ
エタンスルホン酸又はその塩は、消毒洗浄剤の保存安定
性を向上させる。BEST MODE FOR CARRYING OUT THE INVENTION As described above, the disinfectant cleaner for medical equipment of the present invention contains hydrogen peroxide, an organic acid, an organic peracid, and 2-aminoethanesulfonic acid or a salt thereof. is there. Among these ingredients, hydrogen peroxide and organic peracids act as oxidizing agents to denature or destroy the cellular proteins of microorganisms to bring about a bactericidal effect and to oxidize and decompose the toxins produced by microorganisms to render them harmless. There is a characteristic. The organic acid also has the function of dissolving and removing the calcium salt that precipitates in the dialysis line of the artificial dialysis device. And 2-aminoethane sulfonic acid or its salt improves the storage stability of a disinfecting detergent.
【0015】本発明においては、上記消毒洗浄剤におけ
る過酸化水素濃度を3.5〜6%とする。すなわち、過
酸化水素がこの濃度範囲にあれば、医薬用外劇物に相当
しないために流通における制約を受けない上、皮膚に接
触しても強い炎症を生じる恐れがないから、取扱い上の
安全性に問題はなく、且つ過酸化水素による既述特性を
充分に発揮させることができる。In the present invention, the hydrogen peroxide concentration in the disinfecting detergent is 3.5 to 6%. That is, if the concentration of hydrogen peroxide is within this range, it is not equivalent to a non-medical deleterious substance, so it is not restricted in distribution and there is no possibility of causing strong inflammation even if it comes into contact with the skin. There is no problem in the property, and the above-mentioned characteristics due to hydrogen peroxide can be sufficiently exhibited.
【0016】有機過酸は前記のように酸化剤として作用
するが、この有機過酸と過酸化水素とが共存することに
よって過酸化水素の単独存在下よりも高い殺菌効果が得
られる。しかして、このような有機過酸は、上記の過酸
化水素と有機酸を鉱酸等の触媒の存在下又は非存在下で
接触させることによって容易に生成する。例えば、常温
において触媒の非存在下で有機酸と過酸化水素を接触さ
せると、約3〜4週間の経過によって有機過酸含有量が
一定値に達し、過酸化水素と有機酸及び有機過酸を含有
する水溶液が得られる。この過酸化水素−有機酸−有機
過酸水溶液における有機過酸の濃度は、充分な殺菌効果
を得る上で0.4以上とし、また生成限界より上限を
3.4%とする。The organic peracid acts as an oxidizing agent as described above, but the coexistence of this organic peracid and hydrogen peroxide provides a higher bactericidal effect than in the presence of hydrogen peroxide alone. Thus, such an organic peracid is easily produced by contacting the above hydrogen peroxide with the organic acid in the presence or absence of a catalyst such as a mineral acid. For example, when the organic acid and hydrogen peroxide are brought into contact with each other in the absence of a catalyst at room temperature, the content of the organic peracid reaches a certain value after about 3 to 4 weeks, and the hydrogen peroxide, the organic acid and the organic peracid are brought into contact with each other. An aqueous solution containing is obtained. The concentration of the organic peracid in this hydrogen peroxide-organic acid-organic peracid aqueous solution is 0.4 or more in order to obtain a sufficient bactericidal effect, and the upper limit is 3.4% from the production limit.
【0017】上記の有機過酸の生成量は、過酸化水素と
有機酸の合量が同じであるとき、例えば前者/後者の重
量比で0.5程度とした場合と2程度とした場合とで、
さほど違いはない。この点と、有機酸によるカルシウム
溶解性の点を考慮すれば、同量程度の有機過酸を生成さ
せるためには、有機酸の使用量を過酸化水素よりも多く
することが有利である。しかるに、過酸化水素−有機酸
−有機過酸水溶液の保存安定性は有機酸濃度が高いほど
低下するという傾向があり、当該水溶液を36℃にて8
週間保存後の活性酸素残存率をも90%近くに維持する
上で、有機酸濃度は上限を30%に設定する必要があ
る。また該有機酸濃度の下限はカルシウム溶解性の面か
ら5%とする。しかして、有機酸と前記有機過酸の量
は、両者の合量を過酸化水素に対して重量比で1以上と
すべきであり、この重量比が1未満ではカルシウム塩溶
解性及び殺菌性の両面で満足な結果が得られない。The amount of the organic peracid produced is the same when the total amount of hydrogen peroxide and the organic acid is the same, for example, the former / latter weight ratio is about 0.5 and about 2 so,
It's not so different. Considering this point and the point of solubility of calcium by the organic acid, it is advantageous to use the organic acid in an amount larger than that of hydrogen peroxide in order to generate the same amount of the organic peracid. However, the storage stability of the hydrogen peroxide-organic acid-organic peracid aqueous solution tends to decrease as the concentration of the organic acid increases.
The upper limit of the organic acid concentration must be set to 30% in order to maintain the residual ratio of active oxygen after storage for a week near 90%. The lower limit of the organic acid concentration is 5% from the viewpoint of calcium solubility. Therefore, the total amount of the organic acid and the organic peracid should be 1 or more by weight ratio with respect to hydrogen peroxide, and if the weight ratio is less than 1, calcium salt solubility and bactericidal property are obtained. Satisfactory results cannot be obtained on both sides.
【0018】上記の有機酸としては、カルシウム塩、と
りわけ炭酸カルシウムに対する溶解力の大きさから、酢
酸、コハク酸、マレイン酸、クエン酸、リンゴ酸、グリ
コール酸等が好適である。これら有機酸は、危険性がな
く臭気もさほど問題にならないため、取扱い性がよいと
いう利点もある。次の表1は、0.2%濃度の有機酸1
リットルに対する炭酸カルシウム(CaCO3 )の溶解
量を示す。As the above-mentioned organic acid, acetic acid, succinic acid, maleic acid, citric acid, malic acid, glycolic acid and the like are preferable because of their high solubility in calcium salts, especially calcium carbonate. These organic acids also have an advantage that they are easy to handle because they are not dangerous and odors do not matter so much. The following table 1 shows that 0.2% concentration of organic acid 1
The amount of dissolved calcium carbonate (CaCO 3 ) per liter is shown.
【0019】[0019]
【表1】 [Table 1]
【0020】一方、過酸化水素−有機酸−有機過酸水溶
液の保存安定性は、有機酸成分として上記6種(表1中
のシュウ酸を除く6種)の比較では、酢酸を用いた場合
に最も優れ、次いでコハク酸が良好であるが、マレイン
酸、クエン酸、リンゴ酸、グリコール酸等ではよくな
い。また、過酸化水素と有機酸との接触による有機過酸
生成率は、有機酸成分が酢酸である場合に最も高く、次
いでコハク酸が高い。しかしてコハク酸は臭気がないと
いう利点もある。従って、有機酸としては、保存安定性
と有機過酸生成率の面より酢酸又はコハク酸がよいが、
コハク酸は溶解度が低いので多く配合できないという難
点があるため、酢酸を単独で用いるか、もしくは酢酸と
コハク酸とを前者を主成分として併用することが推奨さ
れる。しかして、この併用系では、前記の水溶液中の有
機酸濃度5〜30%中、特にコハク酸濃度を0.1〜6
%の範囲とするのがよい。On the other hand, the storage stability of the hydrogen peroxide-organic acid-organic peracid aqueous solution shows that when acetic acid is used, the comparison of the above 6 kinds (6 kinds excluding oxalic acid in Table 1) as the organic acid component is shown. Is the best, followed by succinic acid, but not maleic acid, citric acid, malic acid, glycolic acid, etc. In addition, the organic peracid production rate due to contact between hydrogen peroxide and organic acid is highest when the organic acid component is acetic acid, followed by succinic acid. However, succinic acid also has the advantage that it has no odor. Therefore, as the organic acid, acetic acid or succinic acid is preferable in terms of storage stability and organic peracid generation rate,
Since succinic acid has a low solubility and cannot be mixed in a large amount, it is recommended to use acetic acid alone or to use acetic acid and succinic acid as the main components in combination. In this combined system, however, the organic acid concentration in the aqueous solution is 5 to 30%, especially the succinic acid concentration is 0.1 to 6%.
It is good to set it in the range of%.
【0021】すなわち、本発明に係る医療機器用消毒洗
浄剤は、過酸化水素3.5〜6%、有機酸5〜30%、
及び有機過酸0.4〜3.4%を含むものであり、(有
機酸+有機過酸)/過酸化水素の重量比が1以上である
ことを特徴としている。しかして、特に殺菌力とカルシ
ウム塩溶解性を高める上では(有機酸+有機過酸)/過
酸化水素の重量比を2以上とすることが推奨される。ま
た、上記の有機酸は、既述のように、酢酸単独か、酢酸
と水溶液中濃度を0.1〜6%としたコハク酸との併用
とするのがよい。That is, the disinfecting and cleaning agent for medical equipment according to the present invention comprises hydrogen peroxide of 3.5 to 6%, organic acid of 5 to 30%,
And 0.4 to 3.4% of organic peracid, and is characterized in that the weight ratio of (organic acid + organic peracid) / hydrogen peroxide is 1 or more. Therefore, it is recommended to set the weight ratio of (organic acid + organic peracid) / hydrogen peroxide to 2 or more, particularly in order to improve the bactericidal activity and the solubility of calcium salt. As described above, the organic acid is preferably acetic acid alone or a combination of acetic acid and succinic acid having an aqueous solution concentration of 0.1 to 6%.
【0022】このような過酸化水素−有機酸−有機過酸
水溶液よりなる消毒洗浄剤においては、保存安定性の向
上が流通面より重要であるため、安定化剤を配合するこ
とが特に推奨される。しかして、このような安定化剤と
しては、1−ヒドロキシエチリデン−1,1−ジホスホ
ン酸(HEDP)、アミノトリメチレンホスホン酸(A
TMP)、ジピコリン酸、りん酸、これらの塩等の従来
より知られる安定化剤成分と共に、本発明者らが安定化
剤成分としての有用性を見い出した2−アミノエタンス
ルホン酸(タウリン)及びその塩が挙げられるが、これ
らの中でも特にタウリン及びHEDPとこれらのナトリ
ウム塩の如き塩が微量の添加で高い安定性向上作用を発
揮することが判明している。In such a disinfecting and cleaning agent composed of hydrogen peroxide-organic acid-organic peracid aqueous solution, it is particularly recommended to add a stabilizer because improvement in storage stability is more important than distribution. It As such stabilizers, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), aminotrimethylenephosphonic acid (A
TMP), dipicolinic acid, phosphoric acid, salts of these, and the like, together with conventionally known stabilizer components, 2-aminoethanesulfonic acid (taurine) and the like have been found by the present inventors to be useful as stabilizer components. Examples thereof include salts thereof, and among them, it has been found that particularly taurine and HEDP and salts such as sodium salts thereof exhibit a high stability improving action even when added in a trace amount.
【0023】しかるに、市販のHEDPは、それ自体の
特性によるのか含有不純物によるのかは定かではない
が、酸性下でカルシウムと不溶性塩を形成して濁りを生
じる現象が認められる。これに対し、タウリンは、カル
シウムと不溶性塩を形成せず、しかも金属腐食の抑制作
用を有するという特性がある。従って、本発明の消毒洗
浄剤においては、安定化剤としてタウリン又はそのナト
リウム塩の如き塩を含有する構成とする。しかして、こ
のタウリン又はその塩の添加量は0.002〜1%の範
囲、特に好ましくは0.01〜0.2%の範囲がよく、
少な過ぎては添加効果が充分に発揮されず、多過ぎては
不経済となる。However, it is not clear whether the commercially available HEDP is due to its own characteristics or impurities contained therein, but it is observed that an insoluble salt is formed with calcium under acidic conditions to cause turbidity. On the other hand, taurine has a characteristic that it does not form an insoluble salt with calcium and has an action of suppressing metal corrosion. Therefore, the disinfecting and cleaning agent of the present invention is configured to contain taurine or a salt thereof such as sodium salt as a stabilizer. Therefore, the addition amount of this taurine or its salt is preferably in the range of 0.002 to 1%, particularly preferably in the range of 0.01 to 0.2%,
If it is too small, the effect of addition will not be sufficiently exerted, and if it is too large, it will be uneconomical.
【0024】このような消毒洗浄剤は、医療機器の消毒
洗浄に際して水にて20〜100倍程度に希釈して使用
することにより、優れた殺菌消毒作用、炭酸カルシウム
等の析出付着物の除去作用、蛋白質や油脂等の汚れ成分
の洗浄作用を発揮する。洗浄対象とする医療機器には特
に制約はないが、とりわけ人工透析装置の透析ラインな
らびに内視鏡の消毒洗浄に高い適性を示す。When such a disinfecting detergent is used by diluting it with water about 20 to 100 times for disinfecting and cleaning medical equipment, it has an excellent sterilizing and disinfecting effect and an effect of removing deposits such as calcium carbonate. It exerts a cleaning action on dirt components such as proteins and oils and fats. There are no particular restrictions on the medical equipment to be cleaned, but it is highly suitable for disinfection and cleaning of dialysis lines of artificial dialysis machines and endoscopes.
【0025】すなわち、人工透析装置の透析ラインにお
いては、既述のように透析液中のカルシウム塩と重炭酸
ナトリウムから由来する炭酸カルシウムの析出・付着、
ならびに透析の際にラインへ移行する蛋白質を含む老廃
物の汚れを生じ易い上、希釈水その他による細菌汚染の
機会に晒されており、特に炭酸カルシウムの付着部は汚
れの蓄積と細菌増殖の場になるだけでなく透析装置の誤
作動の要因ともなる。そして、透析ラインの不潔は透析
を通しての感染に繋がって重大な医療事故を生む危険性
がある上、細菌の破片であるエンドトキシンが透析を通
して体内に入ればアレルギーや発熱の要因となる。従っ
て、透析ラインの清浄化は人工透析の安全な実施と管理
に重要であるが、本発明の消毒洗浄剤は既述の優れた消
毒洗浄機能を有することから、これによる消毒洗浄は上
記清浄化とその維持に非常に有効である。That is, in the dialysis line of the artificial dialysis device, as described above, precipitation / adhesion of calcium carbonate derived from calcium salt and sodium bicarbonate in the dialysate,
In addition, waste products containing proteins that migrate to the line during dialysis are prone to stains, and are exposed to the opportunity for bacterial contamination by dilution water and other factors. Not only will it cause malfunction of the dialysis machine. In addition, a dirty dialysis line may lead to infection through dialysis and cause a serious medical accident, and if endotoxin, which is a fragment of bacteria, enters the body through dialysis, it causes allergies and fever. Therefore, the cleaning of the dialysis line is important for the safe implementation and management of artificial dialysis. However, since the disinfecting and cleaning agent of the present invention has the excellent disinfecting and cleaning function described above, the disinfecting and cleaning by the disinfecting cleaning is performed as described above. And very effective in its maintenance.
【0026】また、内視鏡においては、管状形態である
ことによる消毒洗浄の困難性に加え、既述のように従来
の消毒に使用されていたグルタールアルデヒドが毒性を
有する上に付着した血液等の体液中の蛋白質を凝固させ
て除去困難にするという問題があった。しかるに、本発
明の消毒洗浄剤によれば、良好な消毒殺菌効果が得られ
る上、含有成分は最終的に二酸化炭素と水に分解するの
で毒性の問題がなく、しかも蛋白質を凝固させることな
く他の汚れ成分と共に洗浄除去する作用を発揮する。従
って、本発明の消毒洗浄剤は、前記のグルタールアルデ
ヒドに代わる内視鏡用消毒洗浄剤として極めて有効であ
る。In addition, in the endoscope, in addition to the difficulty of disinfection and cleaning due to the tubular form, the glutaraldehyde used in the conventional disinfection is toxic and blood adheres to it as described above. There has been a problem that proteins in body fluids such as the above are coagulated to make it difficult to remove. However, according to the disinfecting detergent of the present invention, a good disinfecting and sterilizing effect can be obtained, and since the contained component finally decomposes into carbon dioxide and water, there is no toxicity problem, and moreover, without coagulating the protein, other Exhibits the effect of washing and removing together with the dirt component of. Therefore, the disinfecting detergent of the present invention is extremely effective as an endoscope disinfecting detergent in place of the glutaraldehyde.
【0027】以下に、消毒洗浄剤の組成の差異と各種特
性及び性能との関係について、種々の試験を行った結果
を示す。The results of various tests conducted on the relationship between the composition difference of the disinfecting detergent and various characteristics and performances are shown below.
【0028】〔試験1〕
後記表2記載の濃度の過酸化水素と有機酸とを常温下で
接触させ、常温暗所で4週間保存後の有機過酸の生成量
(濃度%)を調べる一方、上記接触後の得られた過酸化
水素−有機酸−有機過酸水溶液を36℃の暗所で4週間
保存後と8週間保存後の活性酸素残留率(%)を測定し
た。その結果を表2に示す。なお、有機過酸の生成量は
過酢酸に換算した値で示した。また、活性酸素の残留率
は、過酸化水素と有機酸の混合接触時の当初の過酸化水
素由来の活性酸素を100%とし、これに対する保存後
の過酸化水素と有機過酸の両者に由来する活性酸素量を
残存率とした。表中の( )は測定の省略を意味する。[Test 1] Hydrogen peroxide having a concentration shown in Table 2 below and an organic acid were brought into contact with each other at room temperature, and the amount of produced organic peracid (concentration%) after storage for 4 weeks in a dark place at room temperature was examined. The hydrogen peroxide-organic acid-organic peracid aqueous solution obtained after the above contact was stored in a dark place at 36 ° C. for 4 weeks and after 8 weeks, and the residual ratio of active oxygen (%) was measured. The results are shown in Table 2. The amount of organic peracid produced was shown as a value converted to peracetic acid. In addition, the residual ratio of active oxygen is based on 100% of active oxygen derived from the initial hydrogen peroxide at the time of mixed contact of hydrogen peroxide and organic acid, and is derived from both hydrogen peroxide and organic peracid after storage. The amount of active oxygen used was defined as the residual rate. () In the table means omission of measurement.
【0029】[0029]
【表2】 [Table 2]
【0030】表2の結果から、過酸化水素と有機酸との
接触による有機過酸生成量は、有機酸成分が酢酸である
場合に最も高く、次いでコハク酸が高い。また酸濃度が
高くなるほど有機過酸生成量も多くなる傾向があるが、
酢酸とコハク酸を除いては0.4%以上の有機過酸濃度
が得られないことが判る。しかして、過酸化水素6%と
酢酸12%とを接触させた場合(b)と、逆に過酸化水
素12%と酢酸6%とを接触させた場合(q)とでは、
有機過酸生成量に殆ど差異がない。一方、過酸化水素−
有機酸−有機過酸水溶液の保存安定性は、有機酸成分と
して酢酸を用いた場合に最も優れ、次いでコハク酸が良
好であり、酢酸−コハク酸の併用系でも酢酸単独と遜色
はないが、マレイン酸、クエン酸、リンゴ酸、グリコー
ル酸等ではよくないことが明らかである。From the results shown in Table 2, the amount of organic peracid produced by contact between hydrogen peroxide and organic acid is highest when the organic acid component is acetic acid, followed by succinic acid. Also, as the acid concentration increases, the amount of organic peracid produced tends to increase,
It can be seen that an organic peracid concentration of 0.4% or more cannot be obtained except for acetic acid and succinic acid. Then, when the hydrogen peroxide 6% and acetic acid 12% are brought into contact with each other (b) and when the hydrogen peroxide 12% and acetic acid 6% are brought into contact with each other (q),
There is almost no difference in the amount of organic peracid produced. On the other hand, hydrogen peroxide
Storage stability of the organic acid-organic peracid aqueous solution is the best when acetic acid is used as the organic acid component, then succinic acid is good, acetic acid-similar to acetic acid alone in the combined system, It is clear that maleic acid, citric acid, malic acid, glycolic acid, etc. are not good.
【0031】〔試験2〕
前記試験1の水溶液(a),(c),(e)と、同水溶
液(c),(e),(o)に後記表3に記載の安定化剤
(タウリン=2−アミノエタンスルホン酸、HEDP=
1−ヒドロキシエチリデン−1,1−ジホスホン酸)を
添加した水溶液について、36℃の暗所で4週間保存後
と12週間保存後の活性酸素残留率(%)を測定した。
その結果を表3に示す。[Test 2] The aqueous solutions (a), (c) and (e) of Test 1 and the stabilizers (taurine) shown in Table 3 below were added to the aqueous solutions (c), (e) and (o). = 2-aminoethanesulfonic acid, HEDP =
With respect to the aqueous solution to which 1-hydroxyethylidene-1,1-diphosphonic acid) was added, the residual ratio (%) of active oxygen after storage for 4 weeks and after storage for 12 weeks in the dark at 36 ° C was measured.
The results are shown in Table 3.
【0032】[0032]
【表3】 [Table 3]
【0033】表3の結果から、安定化剤として微量のタ
ウリン又はHEDPを加えることによって消毒洗浄剤の
保存安定性が顕著に向上するが、タウリンとHEDPと
の比較ではタウリンの方がより高い安定化作用を示すこ
とが判る。From the results shown in Table 3, the storage stability of the disinfecting detergent is remarkably improved by adding a trace amount of taurine or HEDP as a stabilizer, but taurine is more stable than taurine in comparison with HEDP. It is understood that it shows a chemical action.
【0034】〔試験3〕
過酸化水素5.2%、酢酸16.9%、過酢酸1.26
%を含有する水溶液にタウリンを種々の割合で添加し、
これら水溶液を水で50倍に希釈した希釈液中に鉄板を
浸漬し、錆の発生状態を調べた。その結果、タウリン無
添加の水溶液では直ちに錆が発生したが、0.05%の
添加である程度の錆抑制作用が認められ、0.1%以上
の添加では1時間以上の経過後も錆を生じず、更に0.
5%の添加では24時間経過後も錆は認められず、タウ
リンによって腐食防止効果が得られることが判明した。[Test 3] Hydrogen peroxide 5.2%, acetic acid 16.9%, peracetic acid 1.26
% Taurine in various proportions to an aqueous solution containing
The iron plate was dipped in a diluting solution prepared by diluting these aqueous solutions 50 times with water, and the generation state of rust was examined. As a result, rust was immediately generated in the aqueous solution containing no taurine, but addition of 0.05% showed some rust-inhibiting effect, and addition of 0.1% or more caused rust even after 1 hour or more. No more.
When 5% was added, no rust was observed even after 24 hours, and it was proved that taurine provided a corrosion preventing effect.
【0035】[0035]
【実施例】次に、本発明の実施例を比較例及び参考例と
対比して具体的に説明する。後記表4〜7における
「比」は比較例、「参」は参考例、「実」は実施例を意
味する。EXAMPLES Next, examples of the present invention will be specifically described in comparison with comparative examples and reference examples. In Tables 4 to 7 below, “ratio” means a comparative example, “reference” means a reference example, and “actual” means an example.
【0036】
実施例1,2、比較例2、参考例1〜6
所定濃度の過酸化水素水溶液と酢酸水溶液とを混合し、
この混合液を常温で4週間保存して、表4に記載の各成
分を含む過酸化水素−酢酸−過酢酸水溶液からなる消毒
洗浄剤を調製した。なお、実施例1,2の消毒洗浄剤に
は表記の安定化剤を添加した。Examples 1 and 2, Comparative Example 2, Reference Examples 1 to 6 An aqueous solution of hydrogen peroxide having a predetermined concentration and an aqueous solution of acetic acid are mixed,
This mixed solution was stored at room temperature for 4 weeks to prepare a disinfecting and cleaning agent comprising a hydrogen peroxide-acetic acid-peracetic acid aqueous solution containing each component shown in Table 4. In addition, the stabilizer described above was added to the disinfecting detergents of Examples 1 and 2.
【0037】参考例7
過酸化水素水溶液と酢酸水溶液及びコハク酸水溶液を混
合し、参考例1〜6と同様にして表4に記載の各成分を
含む過酸化水素−有機酸−有機過酸水溶液からなる消毒
洗浄剤を調製した。なお、各成分の配合割合は、過酸化
水素6%に対し、酢酸15%とコハク酸3%とした。Reference Example 7 Hydrogen peroxide aqueous solution, acetic acid aqueous solution and succinic acid aqueous solution were mixed, and hydrogen peroxide-organic acid-organic peracid aqueous solution containing each component shown in Table 4 was prepared in the same manner as in Reference Examples 1-6. Was prepared. The mixing ratio of each component was as follows: hydrogen peroxide 6%, acetic acid 15% and succinic acid 3%.
【0038】[0038]
【表4】 [Table 4]
【0039】上記実施例1,2、比較例2及び参考例1
〜7の消毒洗浄剤と、比較例1としての7%過酸化水素
水溶液からなる消毒洗浄剤とを、それぞれ水で50倍に
希釈し、これら希釈水溶液を用いて炭酸カルシウム溶解
性と蛋白質除去性(比較例1及び実施例1,2について
は省略)を試験した。その結果を表5に示す。なお、各
試験方法は次のとおりである。Examples 1 and 2 above, Comparative Example 2 and Reference Example 1
7 to the disinfecting detergent and the 7% hydrogen peroxide aqueous solution as Comparative Example 1 were diluted 50 times with water, and the diluted aqueous solution was used to dissolve calcium carbonate and remove proteins. (Comparative Example 1 and Examples 1 and 2 are omitted) were tested. The results are shown in Table 5. The test methods are as follows.
【0040】〔炭酸カルシウム溶解性〕
消毒洗浄剤の1/50水溶液1リットル中に炭酸カルシ
ウムを0.1gずつ投入してマグネチックスターラーで
攪拌し、5分攪拌によって濁りが消失しなくなった手前
の投入量を溶解量とした。[Calcium Carbonate Solubility] 0.1 g of calcium carbonate was added to 1 liter of a 1/50 aqueous solution of a disinfecting detergent, and the mixture was stirred with a magnetic stirrer. The input amount was defined as the dissolution amount.
【0041】〔蛋白質除去性〕
人血清10μlをスライドガラスに滴下し、2日間常温
で放置乾燥させたものを蛋白質付着試料として、これを
消毒洗浄剤の1/50水溶液中に常温で浸漬し、蛋白質
が除去されるまでの浸漬時間を測定した。なお、蛋白質
の除去は、アミドブラック10B液を試料に塗布し、そ
の呈色の消失によって判定した。[Removal of Protein] 10 μl of human serum was dropped on a slide glass and left to dry at room temperature for 2 days as a protein-adhered sample, which was immersed in a 1/50 aqueous solution of a disinfecting detergent at room temperature, The immersion time until the protein was removed was measured. The removal of protein was judged by applying Amido Black 10B solution to the sample and losing the color.
【0042】[0042]
【表5】 [Table 5]
【0043】表5の結果から、炭酸カルシウム溶解性に
ついては、過酸化水素単独のもの(比較例1)では溶解
性を示さず、(有機酸+有機過酸)/過酸化水素の比が
1より少ないもの(比較例2)でも溶解性は不充分であ
るのに対し、同比が1以上である実施例の消毒洗浄剤で
は良好な溶解性を示し,特に同比が2以上のものは高い
溶解性を示すことが判る。また、蛋白質除去性について
も、(有機酸+有機過酸)/過酸化水素の比が1より少
ないもの(比較例2)より、同比が1である参考例の消
毒洗浄剤の方が高い除去性を示し、特に同比が2以上の
ものは高い除去性を示すことが判る。なお、ほぼ同様の
酸濃度である参考例3,6と実施例1の対比より、安定
化剤としてHEDPを使用した場合(参考例6)は炭酸
カルシウムの溶解性が低下するが、同じくタウリンを使
用した場合(実施例1)では該溶解量の低下をきたさな
いことが判る。From the results shown in Table 5, the solubility of calcium carbonate in the case of hydrogen peroxide alone (Comparative Example 1) did not show, and the ratio of (organic acid + organic peracid) / hydrogen peroxide was 1 The smaller amount (Comparative Example 2) has insufficient solubility, whereas the disinfecting and cleaning agents of the Examples having the same ratio of 1 or more show good solubility, and particularly the one having the same ratio of 2 or more has high solubility. It turns out that it shows sex. Also in terms of protein removability, the disinfecting detergent of the reference example having a ratio of (organic acid + organic peracid) / hydrogen peroxide of less than 1 (Comparative Example 2) has a higher removal rate than that of Comparative Example 2. It is understood that, when the ratio is 2 or more, the removability is high. From the comparison between Reference Examples 3 and 6 and Example 1 which have almost the same acid concentration, when HEDP is used as a stabilizer (Reference Example 6), the solubility of calcium carbonate decreases, but taurine is also used. It can be seen that when it is used (Example 1), the dissolution amount does not decrease.
【0044】〔殺菌試験〕
次に、実施例1、参考例1〜5,7及び比較例1,2の
消毒洗浄剤について、各々水で50倍及び35倍に希釈
した水溶液を調製し、これら希釈水溶液を用いて殺菌試
験を行った結果を表6及び表7に示す。この試験は、供
試菌として、Pseudom-onas aeruginosa 、Escherichis
o157、Staphylococcus aureus(MRSA)31、Bac-illus sub
tilisの4種を使用し、1mlの菌液(平均菌数108
個/ml)を10mlの上記希釈水溶液に30秒、5
分、10分、30分、60分間それぞれ接触させたの
ち、各50μlをSCPDL寒天平板培地に採り、コン
ラージ棒で広げ、これを24時間培養し、コロニー数を
計測した。[Sterilization test] Next, with respect to the disinfecting detergents of Example 1, Reference Examples 1 to 5, 7 and Comparative Examples 1 and 2, aqueous solutions diluted 50 times and 35 times with water were prepared, respectively. The results of the sterilization test using the diluted aqueous solution are shown in Tables 6 and 7. This test was conducted using Pseudom-onas aeruginosa and Escherichis as test bacteria.
o157, Staphylococcus aureus (MRSA) 31, Bac-illus sub
Using 4 kinds of tilis, 1 ml of bacterial solution (average number of bacteria 108
(/ Piece / ml) in 10 ml of the above diluted aqueous solution for 30 seconds, 5
After contacting each for 10 minutes, 30 minutes, and 60 minutes, 50 μl of each was put on a SCPDL agar plate medium, spread with a conradi stick, and this was cultured for 24 hours, and the number of colonies was counted.
【0045】[0045]
【表6】 [Table 6]
【0046】[0046]
【表7】 [Table 7]
【0047】表6及び表7の結果から、過酸化水素のみ
を含む比較例1の消毒洗浄剤では、1/35液及び1/
50液共に、4種の菌に対して殆ど殺菌性が認められな
いことが判る。しかして、Pseudomonas aeruginosa、Es
cherichia coli. o-157 、S-taphylococcus aureus(MRS
A)31の3種の菌に対しては、実施例1と各参考例及び比
較例2の消毒洗浄剤はいずれも、1/35液及び1/5
0液共に30秒の接触によってコロニーが発生せず、い
ずれも良好な殺菌性を示すことが明らかである。From the results shown in Tables 6 and 7, the disinfecting and cleaning agent of Comparative Example 1 containing only hydrogen peroxide had 1/35 solution and 1/35 solution.
It can be seen that almost no bactericidal activity was observed against 4 kinds of bacteria in both 50 solutions. Then Pseudomonas aeruginosa, Es
cherichia coli.o-157, S-taphylococcus aureus (MRS
With respect to the three kinds of bacteria A) 31, the disinfecting and cleaning agents of Example 1, each of the reference examples and the comparative example 2 were 1/35 liquid and 1/5.
It is clear that no colony was generated by contacting with the 0 liquid for 30 seconds, and all of them showed good bactericidal properties.
【0048】Bacillus su-btilisに対しては、実施例
1、参考例2〜5,7の消毒洗浄剤はいずれも、1/3
5液及び1/50液共に30秒の接触によってコロニー
が発生せず、優れた殺菌性を示す。これに対し、比較例
2の消毒洗浄剤では1/50液による10分の接触でコ
ロニーが認められる。また、実施例1の消毒洗浄剤で
は、1/35液及び1/50液共に、5分の接触ではコ
ロニーが認められるが、10分の接触によれば完全に除
菌できるため、比較例2のものよりも消毒洗浄剤として
優れる。これらの点より、消毒洗浄剤における(有機酸
+有機過酸)/過酸化水素の比を1以上とすべきこと、
更に同比を2以上に設定することが好ましいと言える。
なお、人工透析装置の透析ラインの消毒において、10
分以内に殺菌消毒を完了できることは、多忙で時間的余
裕の少ない実際の医療現場では非常に大きな利点とな
る。For Bacillus su-btilis, the disinfecting and cleaning agents of Example 1 and Reference Examples 2 to 5 and 7 were all 1/3.
Both 5 and 1/50 liquids show excellent bactericidal properties because no colonies are generated by contact for 30 seconds. On the other hand, in the disinfecting and cleaning agent of Comparative Example 2, colonies are observed after contact with the 1/50 liquid for 10 minutes. In addition, in the disinfecting and cleaning agent of Example 1, both the 1/35 solution and the 1/50 solution show colonies when contacted for 5 minutes, but the bacteria can be completely sterilized by contacting for 10 minutes, so Comparative Example 2 Better as a disinfectant cleaner than From these points, the ratio of (organic acid + organic peracid) / hydrogen peroxide in the disinfecting detergent should be 1 or more,
Further, it can be said that it is preferable to set the same ratio to 2 or more.
When disinfecting the dialysis line of an artificial dialysis machine, 10
Being able to complete the sterilization within minutes is a huge advantage in the actual medical field, which is busy and has little time.
【0049】〔人工透析装置の透析ラインの消毒〕
消毒洗浄液として実施例1、参考例2〜5,7及び比較
例2の消毒洗浄剤の1/50液を使用し、人工透析装置
DBB−22(日機装社製)において、透析終了後に前
水洗15分−消毒洗浄液注入15分−一夜貯留−前水洗
30分−透析液置換20分−透析のサイクルを3週間繰
り返し、ラインへの炭酸カルシウムや蛋白質系の汚れの
付着状態を観察すると共に、細菌数とエンドトキシン値
の状況を調べた。また消毒洗浄液の水洗による残留の有
無についても調べた。[Disinfection of the dialysis line of the artificial dialysis device] 1/50 solution of the disinfecting and cleaning agent of Example 1, Reference Examples 2 to 5, 7 and Comparative Example 2 was used as the disinfecting and cleaning liquid, and the artificial dialysis device DBB-22 was used. (Manufactured by Nikkiso Co., Ltd.), after dialysis, 15 minutes of pre-washing-injection of 15 minutes of disinfecting cleaning solution-overnight storage-30 minutes of pre-washing-20 minutes of replacement of dialysate-dialysis cycle repeated for 3 weeks, calcium carbonate and protein to the line The state of adherence of dirt to the system was observed, and the bacterial count and endotoxin level were examined. In addition, the presence or absence of residue after washing with the disinfecting cleaning liquid was also investigated.
【0050】その結果、各実施例の消毒洗浄剤を用いた
場合は、いずれもカルシウム塩の付着は認められなかっ
たが、比較例2の消毒洗浄剤を用いた場合はチューブに
炭酸カルシウムと考えられるカルシウム塩の付着が認め
られた。しかるに、蛋白質系の汚れは、各実施例及び比
較例2の消毒洗浄剤のいずれにおいても認められなかっ
た。一方、透析終了時には細菌としてPseudomonas aeru
ginosaや Klebsiellapneumoniaeが検出されたが、各実
施例及び比較例2のいずれの消毒洗浄剤を用いた場合で
も、消毒洗浄液を注入して水洗後のサンプリングからは
認められず、エンドトキシン値は25〜45EU/lと
低値を示した。また、活性酸素は、水洗10分後に過酸
化水素として0.5ppm以下となり、PHは15分後
に水洗水であるRO(逆浸透)水のPHと同値になった
ことから、30分水洗によれば消毒洗浄液の残留を確実
に防止できることが示唆される。従って、本発明の実施
例の消毒洗浄剤を用いることにより、透析ラインは極め
て清浄な状態に維持されることが明らかである。As a result, when the disinfecting detergent of each example was used, no calcium salt was found to adhere, but when the disinfecting detergent of Comparative Example 2 was used, the tube was considered to be calcium carbonate. Adhesion of calcium salts was observed. However, protein-based stains were not found in any of the disinfecting and cleaning agents of Examples and Comparative Example 2. On the other hand, at the end of dialysis, Pseudomonas aeru
Although ginosa and Klebsiella pneumoniae were detected, even when any of the disinfecting detergents of Examples and Comparative Example 2 was used, it was not observed in the sampling after injecting the disinfecting detergent solution and washing with water, and the endotoxin level was 25 to 45 EU. It showed a low value of 1 / l. Also, the active oxygen was 0.5 ppm or less as hydrogen peroxide after 10 minutes of washing with water, and the PH became the same value as the pH of RO (reverse osmosis) water which was the washing water after 15 minutes. For example, it is suggested that the disinfection cleaning liquid can be reliably prevented from remaining. Therefore, it is clear that the dialysis line can be kept extremely clean by using the disinfecting detergent of the embodiment of the present invention.
【0051】〔内視鏡の消毒洗浄〕
検査に使用後の内視鏡の外部を水洗し、全管路洗浄具を
取り付けて内部の各管路に送水して前洗浄を行ったの
ち、送気して水を除いた。そして、実施例1及び参考例
1,3,5の消毒洗浄剤を各々水で希釈した1/33液
を用い、それぞれ全管路洗浄具より内部の各管路に注液
して完全に満たした上で、この内視鏡の全体を各々の1
/33液中に浸漬し、10分後に取り出して外部及び内
部を水洗した。この消毒洗浄後の水洗に無菌水を使用
し、採取した水洗水についてSCPDL寒天平板培地に
よる細菌試験と潜血反応による血液蛋白質の除去性を調
べた。その結果、消毒洗浄前に細菌試験と潜血反応は陽
性を示したが、いずれの消毒洗浄剤を用いた場合も、消
毒洗浄後には陰性となった。[Disinfection and Cleaning of Endoscope] After washing the outside of the endoscope used for inspection, all pipe line cleaning tools are attached, water is supplied to each pipe line inside, and pre-cleaning is performed. Carefully removed the water. Then, 1/33 liquid obtained by diluting each of the disinfecting and cleaning agents of Example 1 and Reference Examples 1, 3, and 5 with water was poured into each of the inner pipes from the whole pipe cleaning tool to completely fill the pipes. And then replace the entire endoscope with one
It was dipped in the / 33 liquid and taken out after 10 minutes, and the outside and the inside were washed with water. Sterile water was used for the washing with water after the disinfection and washing, and the collected washing water was examined for a bacterial test by SCPDL agar plate medium and the removability of blood proteins by occult blood reaction. As a result, the bacterial test and occult blood reaction were positive before disinfecting and cleaning, but were negative after disinfecting and cleaning using any of the disinfecting and cleaning agents.
【0052】[0052]
【発明の効果】請求項1の発明によれば、人工透析装置
及びその周辺機器、内視鏡等を始めとする種々の医療機
器の消毒洗浄において、一段階洗浄によって強力な除菌
洗浄効果が得られ、カルシウム塩の大きく多量な析出物
をも容易に除去可能であり、且つ洗浄剤の保存安定性に
特に優れ、取扱いにおける安全性が高く、環境汚染の問
題のない消毒洗浄手段が提供される。According to the invention of claim 1, in the disinfection and cleaning of various medical equipment such as artificial dialysis equipment and its peripheral equipment, endoscopes, etc., a strong disinfection cleaning effect is obtained by one-step cleaning. The obtained disinfecting and cleaning means is capable of easily removing a large amount of a large amount of a calcium salt precipitate, has excellent storage stability of the cleaning agent, has high safety in handling, and has no problem of environmental pollution. It
【0053】請求項2及び請求項3の発明によれば、上
記消毒洗浄剤として、特に保存安定性及びカルシウム塩
の除去性に優れるものが提供される。According to the inventions of claims 2 and 3, as the above-mentioned disinfecting detergent, there is provided one having excellent storage stability and calcium salt removability.
【0054】請求項4の発明によれば、上記消毒洗浄剤
として、特に殺菌性及びカルシウム塩溶解性に優れるも
のが提供される。According to the fourth aspect of the present invention, as the above-mentioned disinfecting detergent, one having excellent bactericidal property and calcium salt solubility is provided.
【0055】請求項5の発明によれば、上記の消毒洗浄
剤によって医療機器の確実な殺菌洗浄を能率よく安全に
行える。According to the fifth aspect of the present invention, the above disinfecting and cleaning agent can surely and safely sterilize and clean medical equipment.
【0056】請求項6の発明によれば、上記の消毒洗浄
剤によって特に人工透析装置の透析ラインの確実な殺菌
洗浄を能率よく安全に行える。According to the sixth aspect of the present invention, the above disinfecting and cleaning agent enables efficient and safe sterilization and cleaning of the dialysis line of the artificial dialysis machine.
【0057】請求項7の発明によれば、上記の消毒洗浄
剤によって特に内視鏡の確実な殺菌洗浄を能率よく安全
に行える。According to the seventh aspect of the present invention, the disinfecting and cleaning agent described above enables reliable and sterilizing and cleaning of the endoscope particularly efficiently and safely.
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.7 識別記号 FI A61L 2/16 A61L 2/16 Z A61M 1/14 563 A61M 1/14 563 C11D 7/18 C11D 7/18 7/26 7/26 7/34 7/34 7/38 7/38 (56)参考文献 特開 平2−193905(JP,A) 特開 昭62−190122(JP,A) 特開 平4−69235(JP,A) 特開 平8−19593(JP,A) 特開 平8−224299(JP,A) 特開 平4−135559(JP,A) 特開 平7−233396(JP,A) 特公 平6−99716(JP,B2) 特表 平2−502532(JP,A) 特表 平8−500843(JP,A) 特表 平8−508916(JP,A) (58)調査した分野(Int.Cl.7,DB名) A61L 2/18 A61L 2/16 A61B 1/12 A61M 1/14 563 C11D 7/26 C11D 7/38 C11D 7/18 C11D 7/34 A01N 59/00 A01N 37/16 A01N 37/02 ─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. 7 Identification symbol FI A61L 2/16 A61L 2/16 Z A61M 1/14 563 A61M 1/14 563 C11D 7/18 C11D 7/18 7/26 7 / 26 7/34 7/34 7/38 7/38 (56) Reference JP-A-2-193905 (JP, A) JP-A-62-190122 (JP, A) JP-A-4-69235 (JP, A) ) JP 8-19593 (JP, A) JP 8-224299 (JP, A) JP 4-135559 (JP, A) JP 7-233396 (JP, A) JP 6- 99716 (JP, B2) Special table 2-502532 (JP, A) Special table 8-500843 (JP, A) Special table 8-508916 (JP, A) (58) Fields investigated (Int.Cl. 7 , DB name) A61L 2/18 A61L 2/16 A61B 1/12 A61M 1/14 563 C11D 7/26 C11D 7/38 C11D 7/18 C11D 7/34 A01N 59/00 A01N 37/16 A01N 37/02
Claims (7)
0%、有機過酸0.4〜3.4%、及び安定化剤として
の2−アミノエタンスルホン酸又はその塩0.002〜
1%を含み、(有機酸+有機過酸)/過酸化水素の重量
比が1以上である水溶液からなる医療機器用消毒洗浄
剤。1. Hydrogen peroxide 3.5 to 6%, organic acid 5 to 3
0%, organic peracids from 0.4 to 3.4%, and as a stabilizer
2-aminoethanesulfonic acid or its salt 0.002-
A disinfecting and cleaning agent for medical devices, which comprises an aqueous solution containing 1% and having a weight ratio of (organic acid + organic peracid) / hydrogen peroxide of 1 or more.
機器用消毒洗浄剤。2. The disinfectant cleaner for medical equipment according to claim 1, wherein the organic acid is acetic acid.
1〜6%であるコハク酸との2成分からなる請求項1記
載の医療機器用消毒洗浄剤。3. The content of the organic acid in acetic acid and the aqueous solution is 0.
The disinfectant cleaning agent for medical devices according to claim 1, comprising two components of succinic acid of 1 to 6%.
量比が2以上である請求項1〜3のいずれかに記載の医
療機器用消毒洗浄剤。4. The weight of (organic acid + organic peracid) / hydrogen peroxide
Disinfectant cleaners for medical instruments according to any one of the amount ratio of 2 or more der Ru claims 1-3.
療機器用消毒洗浄剤を水で20〜100倍に希釈し、こ
の希釈液を用いて医療機器の消毒洗浄を行うことを特徴
とする医療機器の消毒洗浄方法。 5. The doctor according to any one of claims 1 to 4.
Dilute the disinfectant cleaner for medical equipment 20 to 100 times with water,
Disinfecting and cleaning medical equipment using diluted solution
The method of disinfecting and cleaning medical equipment.
ある請求項5記載の医療機器の消毒洗浄方法。6. The medical device is a dialysis line of an artificial dialysis machine.
A method for disinfecting and cleaning a medical device according to claim 5 .
医療機器の消毒洗浄方法。7. A disinfecting and cleaning method of the medical device according to claim 6, wherein the endoscopic medical devices.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP23872397A JP3370571B2 (en) | 1997-09-03 | 1997-09-03 | Disinfectant cleaning agents for medical equipment and disinfecting cleaning methods |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP23872397A JP3370571B2 (en) | 1997-09-03 | 1997-09-03 | Disinfectant cleaning agents for medical equipment and disinfecting cleaning methods |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH1176380A JPH1176380A (en) | 1999-03-23 |
| JP3370571B2 true JP3370571B2 (en) | 2003-01-27 |
Family
ID=17034311
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP23872397A Expired - Lifetime JP3370571B2 (en) | 1997-09-03 | 1997-09-03 | Disinfectant cleaning agents for medical equipment and disinfecting cleaning methods |
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| Country | Link |
|---|---|
| JP (1) | JP3370571B2 (en) |
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| Publication number | Publication date |
|---|---|
| JPH1176380A (en) | 1999-03-23 |
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