JP2012140484A - Cleanser composition for medical equipment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an enzyme-containing cleanser composition for medical equipment, excellent in cleansing force and excellent in enzyme storage stability.SOLUTION: The cleanser composition for medical equipment contains 1 to 30 mass% of an organic alkali compound (A), 1 to 50 mass% of a compound (B) having 4 to 10 hydroxy groups in the molecule, an enzyme (C), and 1 to 30 mass% of water, and has a pH of 10.5 to 13 at 25°C.

Description

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

  Conventionally, neutral enzyme cleaners or non-enzymatic alkaline cleaners have been used as medical device cleaners. Examples of dirt that adheres to medical devices and is difficult to remove include coagulated blood stains. In order to remove this dirt, the liquidity is made alkaline, and when the enzyme is used in combination, excellent detergency can be obtained. However, if the enzyme such as protease is made alkaline, the enzyme activity tends to be inactivated, so it is stored neutral. When using an alkaline enzyme, the enzyme-containing solution and the alkaline agent are usually mixed immediately before use. If an enzyme can be blended stably even in an alkaline cleaning solution, an alkaline enzyme cleaning solution can be easily prepared simply by dilution. As a method of blending an enzyme with an alkaline detergent, a liquid detergent composition using a buffer system of alkanolamine and boric acid and using a polyol as a stabilizer is known (Patent Document 1). In addition, as a method for enhancing the storage stability of the enzyme solution, a method of combining a large amount of propylene glycol or glycerin with boric acid to inhibit the enzyme activity of protease, a non-reducing sugar alcohol such as sorbitol and boric acid Have been proposed (Patent Documents 2 and 3).

JP-A-2-45599 JP-A-8-224288 JP 11-116991 A

  However, in the method of Patent Document 1, when diluted at the time of use, the pH becomes lower than the range of an alkaline agent suitable for cleaning, and cleaning with an alkali amount effective for cleaning cannot be performed. Further, in this technique, the enzyme activity of propylene glycol and boric acid is inhibited to prevent self-digestion when protease is used. Therefore, at a relatively low temperature of about 40 ° C. shown in the example of Patent Document 1. The storage stability of the enzyme is good, but at higher temperatures (for example, 50 ° C.), the protease is not self-digested, the higher-order structure of the enzyme changes and the enzyme is denatured. Or quickly become inactive. Assuming temperature conditions during product transportation and storage in the summer and tropical regions, storage stability at 40 ° C. is not sufficient, and storage stability at higher temperatures is required.

  The techniques of Patent Documents 2 and 3 are techniques for stabilizing the enzyme near neutrality, and the enzyme is rapidly deactivated under high alkali and high temperature conditions.

  Thus, an enzyme-containing detergent composition that contains an effective amount of alkali sufficient for washing and is stable even when stored at, for example, about 50 ° C. has not been found so far.

  An object of the present invention is to provide an enzyme-containing cleaning composition for a medical instrument that has excellent detergency such as protein stains and has excellent enzyme storage stability even when stored at high alkalis and high temperatures.

  The present invention relates to an organic alkali compound (A) (hereinafter referred to as component (A)) of 1 to 30% by mass and a compound (B) having 4 to 10 hydroxy groups in the molecule (hereinafter referred to as component (B)). 1 to 50% by mass, enzyme (C) [hereinafter referred to as component (C)], and water 1 to 30% by mass, 25 ° C. pH 10.5 to 13 detergent composition Related to things.

  ADVANTAGE OF THE INVENTION According to this invention, the washing | cleaning composition for medical instruments containing the enzyme which was excellent in the detergency of protein dirt etc. and was excellent in the preservation stability of an enzyme also in the preservation | save at a high alkali and high temperature is provided.

<(A) component>
An organic alkali compound is used as the alkali agent. The use of inorganic alkali compounds such as potassium hydroxide and sodium carbonate significantly inhibits enzyme stability. Examples of the organic alkali compound include alkanolamine, alkylamine, monoalkyl dialkanolamine, and the like, and alkanolamine is most preferable from the viewpoint of enzyme stability. 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.

<(B) component>
Examples of the compound having 4 to 10 hydroxy groups in the molecule include hexitols (sorbitol, allitol, dulcitol, galactitol, glucitol, mannitol, alititol, iditol), pentitols (xylitol, arabinitol, ribitol), tetritols ( Erythritol, threitol), pentaerythritol, trehalose, maltitol, sucralose, inositol, diglycerin, triglycerin, tetraglycerin, cyclohexanetetraol and the like. From the viewpoint of enzyme stability, compounds having 5 to 8 hydroxy groups in the molecule are preferred. Further, the component (B) that is preferably a compound not containing a nitrogen atom is preferably a saccharide, and more preferably a sugar alcohol. More preferred are hexitols or pentitols. In addition, the component (B) preferably contains no aldehyde group in the molecule and is not reducible from the viewpoint of preventing coloring due to the Maillard reaction of the organic alkali compound over time. Those having higher solubility in water or water-soluble solvents can be blended in larger amounts in the cleaning composition. From these viewpoints, sorbitol and xylitol are particularly preferable. Moreover, it is preferable from the point of the mixing | blending stability of a cleaning agent that carbon number of (B) component is 12 or less. The number of carbon atoms is preferably 4 or more. (B) The compound having 4 to 10 hydroxy groups in the molecule is a substance that has a very high affinity with water, and the presence of the compound in the vicinity of the enzyme instead of water improves the high-temperature stability of the enzyme. To do.

<(C) component>
Examples of the enzyme include protease, lipase, amylase, cellulase and the like, and protease, and further alkaline protease is preferable.

  The alkaline protease is preferably any enzyme as long as it has an optimum pH from neutral to alkaline, and a combination thereof is also possible. 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. Commercially available alkaline proteases include, for example, alkaline proteases described in JP-A-2007-61101, alcalase, sabinase, evalase, esperase, cannase, ovozyme, and Genencor International, available from Novozymes Japan. There are available Plafects, Properases, etc.

  When alkaline protease is used as the component (C), the medical device cleaning composition of the present invention has an alkaline protease content of 0.1 to 50% by mass, more preferably 0.5 to 30% by mass, and further 1 to 20% by mass. It is preferable to contain. Further, the content (proteolytic activity) of the alkaline protease is preferably 10 to 20000 PU, more preferably 50 to 10,000 PU per 1 kg of the cleaning composition for a medical device of the present invention, from the viewpoint of the effect of removing the fixed protein and cost. 100 to 5000 PU is more 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 performed at 30 ° C. for 15 minutes. Add 2 mL of the reaction stop solution (0.11 mol / L trichloroacetic acid-0.22 mol / L sodium acetate-0.33 mol / L acetic acid) and let stand at room temperature for 10 minutes. Next, the acid-denatured protein was filtered (No. 2 filter paper; manufactured by Whatman), and an alkaline copper solution [1 w / v% potassium tartrate / sodium tartrate aqueous solution: 1 w / v% copper sulfate aqueous solution: sodium carbonate was added to 0.5 mL of the filtrate. 0.1 mol / L aqueous sodium hydroxide solution (sodium carbonate concentration 2 w / v%) = 1: 1: 100 (V / V)] 2.5 mL is added, and the mixture is kept at 30 ° C. for 10 minutes. Further, 0.25 mL of a diluted phenol reagent [phenol reagent (manufactured by Kanto Chemical Co., Ltd.) diluted twice with ion-exchanged water] is added, and the mixture is incubated at 30 ° C. for 30 minutes, and then the absorbance at 660 nm of this sample is measured. Moreover, after mixing a reaction stop liquid with said enzyme reaction system, what added an enzyme solution is measured similarly as a blank. Next, the amount of acid proteolytic product 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. Divide by (in the case of this condition: 0.1 g) to determine the proteolytic activity value. 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.

<Other ingredients>
The medical device cleaning composition of the present invention preferably contains a surfactant (D) [hereinafter referred to as the component (D)] from the viewpoint of enhancing cleaning properties.

  Examples of the surfactant include nonionic surfactants, anionic surfactants, cationic surfactants, and amphoteric surfactants, and nonionic surfactants are preferable from the viewpoint of enzyme stability.

  Nonionic surfactants include 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, Examples thereof include alkyl polysaccharides, alkyl glyceryl ethers, and fatty acid alkanolamides. 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 and m represent the average number of added moles of EO and PO, and l and m are It is independently a number from 1 to 20. “/” is a symbol indicating that EO and PO may be random or block, and the order of addition of EO and PO 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 7 to 10. The R group is particularly preferably an alkyl group having 8 to 10 carbon chains having a branched chain. Moreover, l and m are the numbers of 1-20 independently, the number of 2-15 is preferable, and the number of 3-10 is more preferable. 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.

Furthermore, particularly preferred polyoxyalkylene ethers of (1) include polyoxyalkylene ethers represented by the following general formulas (1-1-2) and (1-1-3).
_{RO- (EO) la - (PO} ) m - (EO) lb -H (1-1-2)
(R is a hydrocarbon group having 6 to 18 carbon atoms, EO represents an ethanediyloxy group, PO represents a propanediyloxy group, la, lb, and m represent the average number of added moles of EO and PO, la, lb and m are each independently a number from 1 to 20, and la + lb is 2 to 20. The addition form of EO and PO is block addition in the order of EO-PO-EO.)
RO-[(EO) ₁ / (PO) _m ] -H (1-1-3)
(R represents a branched alkyl group having 7 to 10 carbon atoms, EO represents an ethanediyloxy group, PO represents a propanediyloxy group, l, m represents the average number of moles of EO and PO, and l, m is independently a number from 3 to 10. “/” is a symbol indicating that EO and PO may be random or block, and the order of addition of EO and PO is not limited.)

  The R group of the polyoxyalkylene ether represented by the general formula (1-1-2) is preferably a linear or branched alkyl group or alkenyl group, and more preferably a branched alkyl group. The carbon number of the R group is 6 to 18, preferably 6 to 14, and more preferably 7 to 10. La, lb and m are each independently a number from 1 to 20, preferably a number from 2 to 15, more preferably a number from 3 to 10, and la + lb is from 2 to 20; Is more preferable. The ratio of (la + lb) to m is preferably 3/1 to 1/3, more preferably 2/1 to 1/2.

  Moreover, the polyoxyalkylene alkyl ether represented by the general formula (1-1-3) is available from BASF under the trade name of pullulafic, for example.

  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. Especially, among the nonionic surfactant of (1), the nonionic surfactant whose R in General formula (1-1) is a C6-C14 hydrocarbon group is preferable, and C7-10 More preferably, those having 7 to 10 carbon atoms and having a branched chain are preferred, and those having 8 to 9 carbon atoms and having a branched chain are particularly preferred.

  The medical device cleaning composition of the present invention preferably further contains a water-soluble solvent (E) [hereinafter referred to as component (E)] from the viewpoints of blending stability and enzyme stability. By adding the water-soluble solvent, the amount of water in the cleaning composition is reduced, whereby the hydrolysis of the enzyme is suppressed and the storage stability of the enzyme can be enhanced.

  As a water-soluble solvent, a C1-C10 water-soluble solvent is mentioned. Specifically, lower alcohols having 1 to 4 carbon atoms such as ethanol and isopropanol, methyl cellosolve, and the like can be used. In order to improve enzyme stability, a compound having two hydroxy groups in the molecule, More preferably, it is a compound having 3 to 6 carbon atoms and having two hydroxy groups in the molecule. Examples of the compound having two hydroxy groups in the molecule include dipropylene glycol, 1,3-butanediol, 1,2-butanediol, dibutylene glycol, 2,4-pentanediol, 1,2-pentanediol, , 5-pentanediol, 3-methyl-1,3-butanediol, 3-methyl-2,4-pentanediol, 3-methyl-1,3-pentanediol, 2-methyl-2,4-pentanediol, Examples include 1,6-hexanediol, 1,2-hexanediol, glycerin monopentyl ether, and propylene glycol. More preferably, it is a compound having 4 to 6 carbon atoms and having two hydroxyl groups in the molecule, dipropylene glycol, 1,3-butanediol, 3-methyl-1,3-butanediol, 3-methyl-1 , 3-pentanediol, 2-methyl-2,4-pentanediol, and the like. Particularly preferred are dipropylene glycol and 1,3-butanediol. Since these have an intermediate hydrophilicity / hydrophobicity balance between the component (B) and the component (D), they can prevent the separation of the component (B) and the component (D) when stored at a high temperature and can improve the blending stability.

  The cleaning composition for a medical device of the present invention can contain components such as a metal sequestering agent, a colorant, a rust inhibitor, and an antioxidant as necessary.

<Composition of cleaning composition for medical device>
The medical device cleaning composition of the present invention contains 1 to 30% by mass, preferably 3 to 25% by mass, and more preferably 5 to 20% by mass of the component (A). Moreover, the cleaning composition for medical devices of this invention contains (B) component 1-50 mass%, Preferably it is 4-40 mass%, More preferably, it contains 10-30 mass%. Moreover, the cleaning composition for a medical device of the present invention preferably contains 0.5 to 30% by mass, more preferably 1 to 20% by mass of the component (C). Moreover, when it contains (D) component, the content is 0.5-30 mass% in the cleaning composition for medical devices of this invention, Furthermore, 1-20 mass%, Furthermore, 3-10 mass%. Is preferred. Moreover, when it contains (E) component, the content is 5-80 mass% in the cleaning composition for medical devices of this invention, Furthermore, 10-60 mass%, Furthermore, 20-50 mass% is preferable. .

  By adding the component (E), even when the water content is low, a larger amount of the component (B) can be added, and the stability becomes better. In the case of containing the component (E), the mass ratio of (B) / (E) is 1/1 to 1/20, further 1/1 to 1/10, and further 1/2 to improve the enzyme stability. ~ 1/5 is preferred.

  Moreover, the cleaning composition for medical devices of this invention contains 1-30 mass% of water, Preferably it is 2-20 mass%, More preferably, it contains 3-15 mass%. In the present invention, it is important that the ratio of water is low. Water is necessary for dissolving the component (B) and keeping the cleaning composition for medical devices uniform. However, if the amount of water is too large, the stability of the higher-order structure of the enzyme decreases. Moreover, if it is a protease, autolysis is accelerated | stimulated. For this reason, the water content in the cleaning composition for medical devices of the present invention is preferably in the above range. In addition, the larger the amount of the component (B), the higher the enzyme stability. On the other hand, water is necessary to keep it uniform, so the ratio of the component (B) to water is important. In order to satisfy such conditions, the mass ratio of (B) / water is preferably 1/2 to 10/1, more preferably 2/3 to 5/1, and still more preferably 1/1 to 3/1. .

  The form of the cleaning composition for a medical instrument of the present invention is preferably a liquid composition (which may contain dispersed particles) from the viewpoint of ease of supply in an automatic cleaning machine and prevention of undissolved residue. .

  The medical device cleaning composition of the present invention has a pH at 25 ° C. of 10.5 to 13, preferably 11 to 12.5, more preferably 11 to 12. The pH of the stock solution is very important for enzyme stability, and if it is in the above range, it has the alkalinity necessary for washing and the enzyme stability is also good.

  Although the cleaning composition for medical devices of the present invention may be used as it is, a treatment liquid prepared by diluting the cleaning composition with water is usually 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 it is desirable that the cleaning composition for medical devices of the present invention has a pH of 9.5 or more at 25 ° C. in a 200-fold dilution with water. Further, from the viewpoint of preventing the corrosion of the medical device, the upper limit value of the pH of the 200-fold diluted product is preferably 11 or less.

  The medical device cleaning composition of the present invention preferably has a smaller content of the inorganic electrolyte. As stabilizers for enzyme-containing cleaning compositions, boric acid, borax, calcium chloride, and the like are often used. However, since the cleaning composition for medical devices of the present invention has a low water content, Such substances are difficult to dissolve. Even if it dissolves in an alkali like boric acid, if the content in the composition increases, the stability of the enzyme decreases due to the effect of increasing the salt concentration. Commercially available enzyme solutions are often pre-added with these substances as enzyme stabilizers, so it is inevitable that they are mixed in as a carry-over component to some extent. It is preferable that components are not contained as much as possible. Therefore, the cleaning composition for a medical device of the present invention preferably has an inorganic electrolyte content other than the component (A) of 1% by mass or less, more preferably 0.3% by mass or less, and substantially does not contain it. Is more preferable.

  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. The cleaning is performed by bringing the cleaning composition for medical device of the present invention or the treatment liquid diluted with water into contact with the medical device. The cleaning composition or the treatment solution is contacted with a site of these medical instruments, such as protein stains derived from blood, for example, by applying, dipping or spraying. Can be applied. The temperature of the cleaning composition or treatment solution is preferably 5 to 60 ° C., more preferably 15 to 50 ° C., from the viewpoint of the optimum enzyme conditions and the ability to clean protein stains. The pH is preferably 9.5 to 11.5, more preferably 10 to 11. The contact time is preferably 30 seconds to 30 minutes, more preferably 1 minute to 15 minutes.

  The cleaning compositions for medical devices shown in Tables 1 to 3 were prepared, and the storage stability of the enzyme and the cleaning power after storage were evaluated by the following methods. The results are shown in Tables 1-3. In addition, pH was measured using HORIBA, Ltd. pH meter F-21.

<Enzyme storage stability>
The cleaning composition for medical equipment whose enzyme activity was measured in advance was stored at 50 ° C. for 1 week, and the enzyme activity was measured again. Compared with the enzyme activity before storage, the residual activity was expressed in% compared with the initial activity. The measurement method of enzyme activity was the measurement method of “proteolytic activity” described in the text (however, “enzyme solution” is read as “cleaning composition for medical device”).

<Detergency>
The cleaning effect against protein stains derived from blood was evaluated by the following method.

[I] Visual determination method and protein staining method After adding 7.5 μL of protamine sulfate solution to 0.5 mL of heparin-treated sheep blood, the mixture was immediately stirred. This was uniformly applied to a polycarbonate plate at a rate of 10 μL / cm ² and dried at room temperature for 2 hours to obtain a test piece.

  The test piece was fixed in the endoscope cleaning / disinfecting device OER-2 manufactured by Olympus Medical Systems Co., Ltd., and the cleaning time was set to 10 minutes for cleaning. After washing, the washing machine was stopped, 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 blood visually, and if there is no visible residue, immerse in Coomassie Protein Assay Reagent (reagent supplied with 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. The test was conducted five times, and the average value is shown in Table 1.

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: Residue is not observed visually, but with CBB staining, protein residue is observed on the entire surface 2: Slight residue is visually observed 1: A large amount of blood residue is visually observed.
If the evaluation score is 4 or more, it is judged that there is no problem at the time of reuse, and that it has been satisfactorily washed.

* 1 Everase, manufactured by Novozyme, alkaline protease, enzyme activity 12 PU / g
* 2 Softanol EP7085, manufactured by Nippon Shokubai Co., Ltd., R in general formula (1-1-1) is a branched alkyl group having 12 to 14 carbon atoms, l is 7, m is 7.5, EO and PO are Nonionic surfactants arranged in block order in the order of EO and PO * 3 Not evaluated because they do not dissolve uniformly * 4 Not evaluated because they do not contain enzymes

Claims (12)

1 to 30% by mass of the organic alkali compound (A), 1 to 50% by mass of the compound (B) having 4 to 10 hydroxy groups in the molecule, 1 to 30% by mass of the enzyme (C), and water The cleaning composition for medical devices whose pH of 25 degreeC is 10.5-13. Furthermore, detergent composition for medical devices of Claim 1 containing surfactant (D). The cleaning composition for medical devices according to claim 2, wherein the surfactant (D) is a nonionic surfactant. Furthermore, the cleaning composition for medical devices of any one of Claims 1-3 containing a water-soluble solvent (E). The cleaning composition for medical devices according to claim 4, wherein the mass ratio of (B) / (E) is from 1/1 to 1/20. The cleaning composition for medical devices according to claim 4 or 5, wherein the water-soluble solvent (E) is a compound having two hydroxy groups in the molecule. The cleaning composition for medical devices according to any one of claims 1 to 6, wherein the mass ratio of (B) / water is 1/2 to 10/1. The cleaning composition for medical devices according to any one of claims 1 to 7, wherein the content of the inorganic electrolyte is 1% by mass or less. The cleaning composition for medical devices according to any one of claims 1 to 8, wherein the organic alkali compound (A) is an alkanolamine. The cleaning composition for medical devices according to any one of claims 1 to 9, wherein the compound (B) having 4 to 10 hydroxy groups in the molecule is a saccharide. The cleaning composition for medical devices according to any one of claims 1 to 10, wherein the enzyme (C) is an alkaline protease. The medical agent cleaning composition according to any one of claims 1 to 11, which is used for an endoscope.