JP5587168B2 - Cleaning composition for medical equipment - Google Patents

Description

  The present invention relates to a cleaning composition for medical devices and a cleaning method for medical devices.

  Medical devices are reused after cleaning and disinfection after use. If the cleaning is insufficient, the disinfecting effect is lowered, so that a high cleaning power is required as a medical device cleaning agent. On the other hand, members using materials that easily corrode such as anodized are also used in medical instruments. Medical devices are repeatedly cleaned and disinfected and reused. However, if the surface is corroded by cleaning, there is a problem that the medical devices cannot be reused. This is particularly a problem with very expensive medical instruments such as endoscopes.

  Patent Document 1 discloses a cleaning composition for medical devices containing a polyoxyethylene-polyoxypropylene block polymer, a polyoxyalkylene alkyl ether, an alkanolamine, and an inorganic alkali agent. When such a cleaning agent is used, the alumite portion is gradually corroded when repeatedly cleaned. As a technique for the purpose of preventing corrosion of alumite or the like, Patent Document 2 discloses an alkaline cleaner comprising an alkali component and a specific hydroxyl group-containing component such as a tri- to octavalent polyhydric alcohol. However, it is a type of cleaning agent used in undiluted solutions for semiconductors such as photoresists. In medical equipment cleaning, it is diluted 50 to 1000 times, so this composition can be used for cleaning medical equipment. There is no balance between strength and anodizing. Patent Document 2 is a cleaning agent used for cleaning an electronic component such as a liquid crystal panel, and is used without dilution. On the other hand, in a medical instrument washer, the detergent is generally used diluted 100 to 500 times, and the usage method and concentration are completely different. Patent Document 3 discloses that an additive containing a specific dibasic acid, alkanolamine, or silicate is used as a cleaning agent for aluminum products. However, the alkaline detergent composition of Patent Document 3 cannot sufficiently wash fixed protein stains such as coagulated blood. As described above, no cleaning agent for a medical instrument washer has been found so far that has excellent coagulating blood detergency and excellent metal anticorrosive properties such as alumite.

JP 2009-144070 A JP 2004-2778 A JP 2008-297469 A

  The subject of this invention is providing the washing | cleaning composition for medical devices which was excellent in the detergency, and excellent in metal anticorrosion property, such as alumite, and the cleaning method of a medical device.

  The present invention comprises (A) alkanolamine (hereinafter referred to as component (A)) 3 to 30% by mass, (B) nonionic surfactant (hereinafter referred to as component (B)) 0.5 to 20% by mass, ( C) It is related with the cleaning composition for medical devices containing 3-50 mass% of polyhydric alcohol more than tetravalence [henceforth (C) component].

  The present invention also relates to a method for cleaning a medical instrument using a medical instrument washer using a diluted cleaning solution obtained by diluting the cleaning composition for a medical instrument of the present invention 50 to 1000 times with water.

  ADVANTAGE OF THE INVENTION According to this invention, the washing | cleaning composition for medical devices which was excellent in the detergency and was excellent in metal corrosion resistance, such as alumite, and the cleaning method of a medical device are provided.

<Cleaning composition for medical device>
[Component (A)]
The component (A) of the present invention is an alkanolamine. The alkanolamine as the component (A) exhibits an effect on the blood contaminants that have undergone denaturation and fixation, and also acts as a buffer that suppresses a decrease in pH when the soil load increases. Examples of the alkanolamine include those represented by the general formula N (R ¹ ) (R ² ) (R ³ ). R ¹ is a hydrocarbon group having 1 to 8 carbon atoms containing 1 to 3 OH groups, and R ² and R ³ are each independently a hydrogen atom, an alkyl group having 1 to 4 carbon atoms or 1 to 1 carbon atoms. 4 alkanol groups. R ¹ is preferably a C 2-4 alkanol group, and R ² and R ³ are preferably hydrogen atoms. Examples of the alkanolamine of the general formula include monoethanolamine, monopropanolamine, monoisopropanolamine, diethanolamine, triethanolamine, N-methylpropanolamine, N-dimethylethanolamine, 2-amino-2-methyl-1-propanol, Among these, monoethanolamine, monopropanolamine, monoisopropanolamine, and trishydroxyaminomethane are preferable from the viewpoint of detergency, and monoethanolamine is most preferable because of its high ability to remove denatured blood stains.

  The content of the component (A) is 3 to 30% by mass, preferably 5 to 25% by mass, in the medical device cleaning composition of the present invention from the viewpoint of the stability of the cleaning liquid and the ability to remove denatured blood stains. More preferably, it is the range of 7-20 mass%.

[(B) component]
The component (B) of the present invention is a nonionic surfactant. As the nonionic surfactant of component (B), polyoxyalkylene alkyl ether, polyalkylene glycol, alkylamine oxide, polyoxyalkylene alkyl phenyl ether, fatty acid polyoxyethylene ester, fatty acid sorbitan ester, fatty acid, polyoxyalkylene sorbitan ester , Fatty acid saccharide ester, alkyl polysaccharide, alkyl glyceryl ether, fatty acid alkanolamide and the like. From the viewpoint of the effect of removing protein stains, one or more nonionic surfactants selected from the group consisting of the following (1) to (4) are preferred.

(1) Polyoxyalkylene ether represented by the following general formula (1-1) RO- (AO) _s -H (1-1)
(R represents a hydrocarbon group having 6 to 24 carbon atoms, A represents an alkanediyl group having 2 to 4 carbon atoms. S represents the average number of moles added of the alkanediyloxy group, and is a number from 1 to 40.)
(2) Polyalkylene glycols represented by the following general formulas (2-1) to (2-2) HO— (EO) _o — (PO) _p — (EO) _q —H (2-1)
HO- (PO) _p- (EO) _q- (PO) _r- H (2-2)
(EO represents an ethanediyloxy group, PO represents a propanediyloxy group, and o, p, q, and r represent the average number of moles added, and each independently represents a number of 3 to 100.)
(3) Alkylamine oxide having a hydrocarbon group having 6 to 16 carbon atoms (4) Alkyl glyceryl ether having a hydrocarbon group having 6 to 12 carbon atoms

  In the polyoxyalkylene ether of (1), the R group of the general formula (1-1) is a linear or branched hydrocarbon, a saturated or unsaturated hydrocarbon, from the viewpoint of detergency and foam characteristics. A linear or branched alkyl group or an alkenyl group is preferable, and a linear or branched alkyl group is more preferable. Carbon number of R group is 6-24, 6-18 are preferable, 8-14 are more preferable, and 8-10 are still more preferable. A is an alkanediyl group having 2 to 4 carbon atoms, and preferably 2 or 3 carbon atoms from the viewpoints of detergency and foam characteristics. s shows the average addition mole number of alkanediyloxy group, is the number of 1-40, 2-30 are preferable and 5-20 are more preferable. When a plurality of alkanediyl groups are included, the addition form may be block addition, random addition, or both.

Examples of suitable polyoxyalkylene ether (1) include polyoxyalkylene ethers represented by the following general formula (1-1-1).
RO-[(EO) _l / (PO) _m ] -H (1-1-1)
(R is a hydrocarbon group having 6 to 18 carbon atoms, EO represents an ethanediyloxy group, PO represents a propanediyloxy group, l, m represents the average number of added moles of EO and PO, and l represents 1 to 1 20, m is a number from 0 to 20. “/” is a symbol indicating that EO and PO may be random or block, and the order in which EO and PO are added does not matter.)

  The R group of the polyoxyalkylene ether represented by the general formula (1-1-1) may be linear or branched, but is preferably an alkyl group or an alkenyl group, and more preferably an alkyl group. The carbon number of the R group is 6 to 18, preferably 6 to 14, and more preferably 8 to 14. Moreover, l is a number of 1-20, the number of 2-15 is preferable, and the number of 2-10 is more preferable. m is a number from 0 to 20, preferably a number from 1 to 20, more preferably a number from 2 to 15, and still more preferably a number from 2 to 10. The ratio of l to m is preferably 3/1 to 1/3, more preferably 2/1 to 1/2. The addition form of EO and PO may be random addition or block addition.

  In the polyalkylene glycol represented by the general formulas (2-1) and (2-2) in (2), EO represents an ethanediyloxy group, PO represents a propanediyloxy group, and o, p, q, and r are Average number of moles added, each independently a number from 3 to 100, more preferably from 5 to 30. The ratio of (o + q) / p or the ratio of q / (p + r) is preferably 3/1 to 1/3, and more preferably 2/1 to 1/2. The polyalkylene glycols represented by the general formulas (2-1) and (2-2) are available from BASF under the trade names of Pluronic and Pluronic R, for example.

  The amine oxide (3) has at least one hydrocarbon group having 6 to 16 carbon atoms, preferably 6 to 14 carbon atoms, and more preferably 8 to 12 carbon atoms. The hydrocarbon group is an alkyl group or an alkenyl group, preferably an amine oxide having a linear or branched alkyl group, more preferably a linear alkyl group. Moreover, as for substituents other than a C6-C16 hydrocarbon group, a C1-C3 alkyl group is preferable.

  The glyceryl ether (4) has a hydrocarbon group having 6 to 12 carbon atoms, and the hydrocarbon group preferably has 6 to 10 carbon atoms, more preferably 8 to 10 carbon atoms. The hydrocarbon group is an alkyl group or an alkenyl group, preferably a linear or branched alkyl group, more preferably a linear alkyl group.

  In general, there are many medical instrument cleaners, particularly endoscope cleaners, whose temperature is not controlled at the time of cleaning. When washing is performed at room temperature, even when bubbles are not a problem, the bubbles are difficult to disappear when the water temperature is lowered.

  On the other hand, in order to increase the cleaning power, the water jetted at a high pressure is constantly circulating in the cleaning machine, and it is very easy to foam. When the bubbles build up, the physical force of ultrasonic waves and water flow is eased by the bubbles, and it becomes difficult to be transmitted to the surface of the medical device and the cleaning power is reduced. In addition, the water level sensor for detecting the supply and discharge of the cleaning water provided in the washing machine of the medical instrument causes false detection and the cleaning is stopped. The same problem is also observed when extremely low hardness water such as RO water or ion exchange water is used. Therefore, it is preferable that foaming is suppressed even when water having a low hardness of 5 ° C. is used.

  From such a viewpoint, as the nonionic surfactant, among the nonionic surfactants (1) to (4), from the viewpoint of the effect of removing protein stains, the nonionic surfactant is selected from the group consisting of (1) to (3). One or more selected nonionic surfactants are preferred, and (1) to (3) may be used in combination as appropriate. In addition, one or more nonionic surfactants selected from (1) are more preferable. Among these, among the nonionic surfactants of (1), a nonionic surfactant in which R in the general formula (1-1) is a hydrocarbon group having 6 to 16 carbon atoms is preferable. To 14 are more preferable, and those having 8 to 14 carbon atoms and having a branched chain are more preferable.

  (B) Content of a component is 0.5-20 mass% in the cleaning composition for medical devices of this invention from a viewpoint of detergency, Preferably it is 1-10 mass%, More preferably, it is 3-8. It is the range of mass%.

[Component (C)]
As the (C) component tetrahydric or higher polyhydric alcohol, a compound having 4 to 10 hydroxy groups in the molecule is preferable, and a compound containing no nitrogen atom is preferable. Moreover, the carbon number of (C) component is 4-12, Furthermore, 5-8 are preferable. Examples of the component (C) include sorbitol, xylitol, glucose, erythritol, pentaerythritol, trehalose, maltitol, sucralose, diglycerin, triglycerin, pentanetetraol, hexanetetraol, octanetetraol, tetrahydroxybenzene and the like. . The component (C) is preferably a saccharide, more preferably a polyhydric alcohol selected from sugar alcohols. Further, the component (C) is preferably non-reducing from the viewpoint of preventing coloring of the cleaning agent due to reaction with alkanolamine over time. Furthermore, sorbitol and xylitol are more preferable from the viewpoint of anticorrosion of alumite.

  The content of the component (C) is 3 to 50% by mass, preferably 5 to 40% by mass, and more preferably 10 to 30% by mass in the cleaning composition for medical devices of the present invention from the viewpoint of anodized anticorrosion. Range.

  The medical device cleaning composition of the present invention requires a sufficient amount of the component (C) relative to the component (A) in order to prevent metal corrosion, and the (C) / (A) mass ratio, The ratio of the content of the component (C) to the content of the component (A) is preferably 0.5 or more, more preferably 1 to 10, and still more preferably 1 to 3.

[Other ingredients]
The cleaning composition for medical devices of the present invention has (D) 2 to 8 carbon atoms and 1 to 1 in the molecule from the viewpoint that the components (A) to (C) can be blended more stably without separation even at high temperatures. It preferably contains a solubilizer selected from compounds having two hydroxy groups (hereinafter referred to as component (D)). (D) As a component, although C1-C4 lower alcohol, such as ethanol and isopropanol, methyl cellosolve, etc. can be used, Preferably it is a C3-C8 compound which has two hydroxy groups in a molecule | numerator. It is. Compounds having two hydroxy groups in the molecule include dipropylene glycol, 1,3-butylene glycol, 1,2-butylene glycol, dibutylene glycol, 1,6-hexanediol, 1,2-hexanediol, propylene Glycol and the like. The content of the component (D) is preferably 1 to 60% by mass, more preferably 3 to 50% by mass, and further preferably 5 to 30% in the medical device cleaning composition of the present invention from the viewpoint of blending stability. It is the range of mass%.

  The medical device detergent composition of the present invention can contain an enzyme from the viewpoint of improving the detergency for proteins. Examples of the enzyme include protease, amylase, lipase, cellulase and the like. Among them, protease and alkaline protease are preferable.

  The alkaline protease is preferably any enzyme as long as it has an optimum pH from neutral to alkaline, and a plurality of alkaline proteases satisfying this condition can be used in combination. The alkaline protease is preferably a subtilisin protease derived from Bacillus SP, and among them, a subtilisin protease derived from Bacillus Halodurans or Bacillus clausii is preferred. Examples of commercially available alkaline proteases include Alcalase, Sabinase, Evalase, Esperase, Cannase, Obozyme, and Perfect, Properase available from Genencor International, available from Novozymes Japan. Moreover, the alkaline protease described in JP 2007-61101 A can also be suitably used.

  In addition, the content of alkaline protease (proteolytic activity) in the diluted cleaning solution used in the present invention is preferably 0.01 to 200 PU per kg of diluted cleaning solution, from the viewpoint of the effect of removing the fixed protein and cost, and 0.05 to 100 PU. Is more preferable, 0.1 to 50 PU is more preferable, and 0.5 to 20 PU is particularly preferable.

The proteolytic activity (PU / g) is measured by the following method.
1 mL of 50 mmol / L borate buffer solution (pH 10.5) containing casein (Hammerstein: Merck) at a concentration of 1 w / v% was kept at 30 ° C. for 5 minutes, and then mixed with 0.1 g of enzyme solution. The reaction is carried out at 30 ° C. for 15 minutes. Add 2 mL of the reaction stop solution (0.11 mol / L trichloroacetic acid-0.22 mol / L sodium acetate-0.33 mol / L acetic acid) and let stand at room temperature for 10 minutes. Next, the acid-denatured protein was filtered (No. 2 filter paper; manufactured by Whatman), and an alkaline copper solution [1 w / v% potassium tartrate / sodium tartrate aqueous solution: 1 w / v% copper sulfate aqueous solution: sodium carbonate was added to 0.5 mL of the filtrate. 0.1 mol / L aqueous sodium hydroxide solution (sodium carbonate concentration 2 w / v%) = 1: 1: 100 (V / V)] 2.5 mL is added, and the mixture is kept at 30 ° C. for 10 minutes. Further, 0.25 mL of a diluted phenol reagent [phenol reagent (manufactured by Kanto Chemical Co., Ltd.) diluted twice with ion-exchanged water] is added, and the mixture is incubated at 30 ° C. for 30 minutes, and then the absorbance at 660 nm of this sample is measured. Moreover, after mixing a reaction stop liquid with said enzyme reaction system, what added an enzyme solution is measured similarly as a blank. Next, the amount of acid-soluble proteolysate that has been liberated (the amount converted to tyrosine) is obtained from the difference in absorbance between the sample and the blank, and this is the reaction time (in this case: 15 minutes) and the amount of enzyme solution (this In the case of conditions: Dividing by 0.1 g), the proteolytic activity value can be determined. Note that 1 PU is the amount of enzyme that liberates an acid-soluble proteolytic product corresponding to 1 mmol of tyrosine per minute under the above reaction conditions.

  In addition to this, the cleaning composition for a medical device of the present invention contains components such as a metal sequestering agent, an anticorrosive agent, a colorant, a flavoring agent, a viscosity, a regulator, and a solubilizer as necessary. Can do.

  The form of the cleaning composition for a medical device of the present invention is preferably a liquid (which may contain dispersed particles). In the case of a liquid, the medical device cleaning composition of the present invention preferably contains 5 to 70% by mass of water, more preferably 10 to 50% by mass, and still more preferably 15 to 30% by mass. Moreover, when it is liquid and contains water, the cleaning composition for medical devices of the present invention preferably has a pH of 25 ° C. of 10 to 13, more preferably 10.5 to 12.5, and still more preferably 11 to 12. It is.

  The cleaning composition for medical devices of the present invention may be used as it is, but usually a diluted cleaning solution prepared by diluting the cleaning composition with water is used for cleaning. Although the dilution rate is not limited, it is assumed that the dilution is usually about 50 to 1000 times. The pH at the time of cleaning is also important for the cleaning power, and the cleaning composition for medical devices of the present invention has a pH of 9.5 or more at 25 ° C. at a diluted solution diluted 200 times with water, and further 10.0. The above is desirable. The upper limit of the pH of the 200-fold diluted solution is preferably 12 or less from the viewpoint of preventing corrosion of metals used in endoscopes and medical instruments.

  Examples of medical instruments that are the subject of the present invention include steel instruments such as scissors, forceps, and insulators, resin instruments such as catheters, tubes, and bite blocks, and rigid or flexible endoscopes. The medical device cleaning composition of the present invention is preferably used for an endoscope. Moreover, it may be for an automatic washing machine for these medical instruments, and more preferably for an automatic washing machine for an endoscope.

<Cleaning method for medical devices>
In the method for cleaning a medical instrument of the present invention, the medical instrument is cleaned by a medical instrument washer using a diluted cleaning solution obtained by diluting the cleaning composition for medical instrument of the present invention 50 to 1000 times with water. The diluted cleaning liquid preferably contains 0.002 to 1% by mass of the component (B). The pH of the diluted cleaning solution is preferably 9 to 12, more preferably 9.5 to 11.5, and even more preferably 10 to 11. It is preferable to dilute the cleaning composition for a medical device of the present invention with water so that the content and pH of the component (B) are such.

  The cleaning composition for medical devices shown in Table 1 was prepared, and the cleaning properties and anodized anticorrosive properties were evaluated by the following methods. The results are shown in Table 1. In addition, pH was measured using HORIBA, Ltd. pH meter F-21.

<Cleanability>
A model soil described in EN / ISO15883-5 Annex R consisting of glycerin, serum, mucin, flour and safranin was applied to a Teflon test piece at a rate of 10 mg / cm ² and dried at room temperature for 1 hour. Used for experiments. The cleaning was carried out by fixing in an endoscope cleaning / disinfecting device OER-2 manufactured by Olympus Medical Systems Co., Ltd., and setting the cleaning time to 10 minutes. After washing, the test piece was taken out and rinsed gently with ion-exchanged water in a separately prepared water tank. After drying, determine whether there is any residual dirt visually, and if there is no visible residue, immerse in Coomassie Protein Assay Reagent (reagent supplied with the protein quantification kit, manufactured by Thermo Scientific) for 3 minutes ( CBB staining), and after rinsing with ion-exchanged water, the dyeing state was determined according to the following criteria. In the test, five test pieces were used, and the result was an average value.
Judgment criteria 5: Residual dirt is hardly observed even visually or after CBB staining.
4: No residue is visually observed, but protein residue is partially observed in CBB staining.
3: No residue is visually observed, but protein residue is observed on the entire surface by CBB staining. 2: A slight residue is visually observed. 1: A large amount of blood is visually observed. If it exists, it is judged that it is at a level where there is no problem in re-use and can be cleaned well.

<Anodized corrosion resistance>
The medical device detergent composition was diluted with ion-exchanged water so as to be 0.5% by mass, and a 20 gwp glass screw tube No. A volume of 50 mm, a width of 20 mm, and a thickness of 1 mm of alumite standard test plate (manufactured by Nippon Test Panel Co., Ltd.) weighed in advance was stored for 4 days at 50 ° C. while being immersed in about half. After storage, the test plate was taken out, washed thoroughly in running water, sufficiently dried, weighed, and the change in mass was measured. When the mass change is 7 mg or less, it is judged that there is no significant problem with the corrosion protection of anodized in normal cleaning.

Nonionic surfactant: In general formula (1-1-1), R is a branched alkyl group having 12 to 14 carbon atoms, l is 7, m is 7.5, EO and PO are EO, PO in this order. Nonionic surfactant (Softanol 7085 (manufactured by Nippon Shokubai Co., Ltd.))

Claims (7)

(A) 3 to 30% by mass of alkanolamine, (B) 0.5 to 20% by mass of a nonionic surfactant represented by the following general formula (1-1-1), and (C) a polyvalent value of 4 or more. A cleaning composition for medical devices containing 3 to 50% by mass of alcohol.
RO-[(EO) _l / (PO) _m ] -H (1-1-1)
(R is a hydrocarbon group having 6 to 18 carbon atoms, EO represents an ethanediyloxy group, PO represents a propanediyloxy group, l, m represents the average number of added moles of EO and PO, and l represents 1 to 1 20, m is a number from 1 to 20. “/” is a symbol indicating that EO and PO may be random or block, and the addition order of EO and PO is not limited.) (C) / (A) Mass ratio is 0.5 or more, The cleaning composition for medical devices of Claim 1. (C) / (A) Mass ratio is 10 or less, The cleaning composition for medical devices of Claim 1 or 2. The cleaning composition for medical devices according to any one of claims 1 to 3 , wherein the diluted solution diluted 200-fold with water has a pH of 9.5 or higher at 25 ° C. (C) is the polyhydric alcohol chosen from sugar alcohol, The cleaning composition for medical devices in any one of Claims 1-4 . (D) The cleaning composition for a medical device according to any one of claims 1 to 5, comprising a solubilizer selected from compounds having 2 to 8 carbon atoms and having 1 to 2 hydroxy groups in the molecule. object. A method for cleaning a medical instrument using a medical instrument washer using a diluted cleaning solution obtained by diluting the cleaning composition for a medical instrument according to any one of claims 1 to 6 50 to 1000 times with water.