JP2008274015A - Detergent for medical equipment - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a detergent washing staining such as a protein and a fat deposited on medical equipment such as an artificial dialyser and an endoscope and preventing re-decomposition of the staining. <P>SOLUTION: The detergent for the medical equipment is used, which contain a mercaptoalkylsulfonic aicd represented by following general formula (1) or its salt (P) and/or a mercaptoalkylcarboxylic acid represented by following general formula (2) or its salt (Q) as indispensable components. HS-(CH<SB>2</SB>)<SB>m</SB>-SO<SB>3</SB><SP>-</SP>-B<SP>+</SP>(1). HS-(CH<SB>2</SB>)<SB>n</SB>COO<SP>-</SP>-B<SP>+</SP>(2). (wherein m represents an integer of 1-24, n represents an integer of 1-24, B<SP>+</SP>represents a cation in which a proton or a base is dissociated). <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

   The present invention relates to a cleaning agent for medical devices. More specifically, clean dirt such as protein and fat attached to parts such as medical devices such as artificial dialysis machines, endoscopes, and dental treatment equipment, or tubes attached to them, and re-attach this dirt. It relates to a cleaning agent to prevent.

  Artificial dialysis for blood washing is a treatment method in which the blood of a patient is indirectly contacted with a dialysate through a semipermeable membrane to remove waste products in the blood, adjust the salt concentration, and remove water.

Various stains adhere to the artificial dialysis machine and the pipes accompanying it. For example, in addition to bacteria entering from an open part such as a tank, protein stains derived from blood or the like, fat, etc., calcium carbonate or the like adheres.
As a method for cleaning and disinfecting an artificial dialysis machine and its peripheral devices,
(1) A method in which sodium hypochlorite is used for the purpose of washing and disinfecting waste products such as proteins filtered from the patient's body, and a method using acetic acid for the purpose of washing calcium carbonate,
(2) A method in which a peracetic acid aqueous solution is used for the purpose of disinfection and washing of calcium carbonate, and a method of using sodium hypochlorite for the purpose of washing waste products such as proteins filtered from the patient's body (for example, , See Patent Document 1),
(3) Disinfecting, washing calcium carbonate, and washing waste products such as proteins filtered from the patient's body at once using an aqueous solution that has been improved by adding an inorganic acid such as phosphoric acid to an aqueous solution of peracetic acid. There are ways to do it.
However, the method (1) and the method (2) not only cause deterioration of equipment parts and piping due to the strong corrosiveness that is a characteristic of sodium hypochlorite, but also two types of cleaning methods. Therefore, there is a problem that work is complicated and a great deal of labor and time are consumed. Further, in an actual dialysis treatment site, treatment may be performed until late at night, and two types of cleaning methods may not be performed continuously. Furthermore, there is also a problem that chlorine is discharged as a waste liquid without being treated, thereby adversely affecting the environment.

Endoscopes as medical devices are inserted into a patient's body and used, so various types of dirt such as body fluids and wastes adhere to the site of use. Disinfection to prevent infection is also necessary, and generally there is a method in which dirt is washed with a surfactant, proteolytic enzyme or the like and then disinfected with a bactericide such as glutaraldehyde.
However, the conventional washing method using glutaraldehyde is highly toxic to glutaraldehyde itself, and requires great care to ensure safety for workers, and because of the strong coagulation action of proteins, body fluids and the like have adhered. There is a problem that dirt is hard to remove.

Further, it contains hydrogen peroxide 3.5-6%, organic acid 5-30%, and organic peracid 0.4-3.4%, and the weight ratio of (organic acid + organic peracid) / hydrogen peroxide is A disinfectant cleaning agent for medical devices composed of an aqueous solution of 1 or more has been proposed (see, for example, Patent Document 2).
However, although the disinfectant cleaner for medical equipment containing hydrogen peroxide, organic acid and organic peracid does not contain environmentally hazardous substances such as phosphoric acid, it does not have sufficient cleaning power for protein and other waste products and calcium carbonate. Have a problem.

Furthermore, a bactericidal cleaning composition containing peracetic acid, acetic acid, hydrogen peroxide and an inorganic acid has been proposed (see, for example, Patent Document 3).
As for the germicidal detergent composition containing peracetic acid, acetic acid, hydrogen peroxide and inorganic acid, for example, in the examples, a germicidal detergent composition containing 20% or 40% phosphoric acid is disclosed. If a large amount of phosphoric acid is used in this way, phosphorus is a representative substance that is an environmentally hazardous substance. Therefore, it is inevitable that cleaning by this method will have a great influence on the natural environment.

JP-A-8-224299 Japanese Patent Laid-Open No. 11-76380 JP 2003-292996 A

  Accordingly, an object of the present invention is to provide a safe and environmentally friendly cleaning agent for medical equipment that does not contain an alkaline agent or an acid, has an excellent cleaning power, and is safe. In particular, a wide range of medical equipment such as artificial dialysis machines, endoscopes, and dental treatment equipment, and parts such as tubes and sealed containers that are associated with them, and are not cartridges or disposals, so that parts that require cleaning It is intended to provide a cleaning agent for medical devices that exhibits excellent performance in

The inventors of the present invention have reached the present invention as a result of studies to achieve the above object.
That is, the present invention is a medical device cleaning agent containing, as an essential component, mercaptoalkylsulfonic acid or a salt thereof (P) and / or mercaptoalkylcarboxylic acid or a salt thereof (Q) having a specific chemical structure.

  The cleaning agent for medical devices of the present invention does not require the use of an alkaline substance and can be used in a neutral pH region, so that corrosion of metal parts and resins of medical devices can be suppressed. In addition, it is a clean cleaning agent that is friendly to the earth because the environmental impact of the waste liquid after cleaning is small. In addition, since this detergent has a very high detergency against both protein and fat stains, it is particularly useful for artificial dialysis machine detergents that require complete removal of residual stains and a short-term washing effect. Furthermore, even if the cleaning temperature is increased, there is no problem of corrosion due to alkaline substances. Therefore, the cleaning agent of the present invention can obtain a higher cleaning degree by using it at a high temperature.

The medical device cleaning agent of the present invention is a cleaning agent containing a surfactant containing a mercapto group, which is used when cleaning proteins and fat stains adhering to the medical device, specifically, Mercaptoalkylsulfonic acid represented by the following general formula (1) or a salt thereof (P), mercaptoalkylcarboxylic acid represented by the following general formula (2) or a salt thereof (Q), and a mixture thereof as essential components It is characterized by.
_{HS- (CH 2) m -SO 3} - · B + (1)
^{_{HS- (CH 2) n COO -}} · B + (2)
(In the formula, m represents an integer of 1 to 24; n represents an integer of 1 to 24; B ⁺ represents a proton or a cation having a base dissociated.)

The mercaptoalkylsulfonic acid or salt (P) of the present invention is a mercaptoalkylsulfonic acid represented by the above general formula (1) or a salt thereof.
M in the formula is usually an integer of 1 to 24, preferably 1 to 12, and more preferably 2 to 8. If m exceeds 24, the solubility is insufficient, which is not suitable.

B ⁺ in the formula represents a proton or a cation having a base dissociated.
Furthermore, those pK _b at 25 ° C. The base is 5.0 or less. More preferably, pKb is 3.0 or less.

Here, the pK _b represents a base dissociation constant, if the phase dissociation and pKb the lowest base dissociation constant.

Further, the pK _b of 5.0 or less bases, essentially represents the strong base, examples of such bases include inorganic bases and organic bases.

When B ⁺ is a cation from which an inorganic base is dissociated, BOH dissociates in an aqueous solution by an equilibrium reaction as shown in the following formula.

The equilibrium constant _Kb of this equilibrium is expressed by the following equation.
K _b = [B ⁺ ] [OH ⁻ ] / [BOH]
That value of pK _b represents a strong base as low.

When B ⁺ is a cation from which an organic base is dissociated, B dissociates in an aqueous solution by an equilibrium reaction as shown in the following formula.

The equilibrium constant _Kb of this equilibrium is expressed by the following equation.
K _b = [B ⁺ ] [OH ⁻ ] / [B]
That value of pK _b represents a strong base as low.

Here, specific examples of the inorganic base include alkali metals such as sodium (pK _b 0.2) and potassium (pK _b 4.1).
Specific examples of the organic base include organic amines such as ammonia (pK _b 4.8) and methylamine (pK _b 3.4); guanidine (pK _b 1.5), arginine (pK _b 1.5) and the like. The amidine-type compound of these is mentioned.

  The mercaptoalkylcarboxylic acid or salt (Q) of the present invention is a mercaptoalkylcarboxylic acid represented by the general formula (2) or a salt thereof.

  N in the formula is usually an integer of 1 to 24, preferably 1 to 12, and more preferably 1 to 8. If it exceeds 24, the solubility is insufficient, which is not suitable.

B ⁺ in the formula is the same as in the case of (P) described above.

  In the present invention, the addition amount of mercaptoalkylsulfonic acid or a salt thereof (P) is preferably 0.001 to 10 parts, more preferably 0.01 to 1 part with respect to 100 parts of water. If the amount added is less than 0.001 part, the detergency is insufficient, and if it exceeds 10 parts, it tends to remain in the medical device, which is not suitable.

  In the present invention, the addition amount of mercaptoalkylcarboxylic acid or salt (Q) thereof is preferably 0.001 to 10 parts, more preferably 0.01 to 1 part, from the viewpoint of detergency. If the amount added is less than 0.001 part, the detergency is insufficient, and if it exceeds 10 parts, it tends to remain in the medical device, which is not suitable.

  The cleaning agent of the present invention is not particularly limited as long as it can maintain the stability of the cleaning agent, but is preferably used at a pH of 5.5 to 9.5 from the viewpoint of corrosiveness to metals.

  The cleaning agent of the present invention may be liquid or solid. If it is in a solid state, it is dissolved in water to make it easy to use.

  The detergent of the present invention may further contain other surfactants, chelating agents and antifoaming agents in order to improve detergency.

Other surfactants include nonionic surfactants, and generally known nonionic surfactants can be used.
For example, polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, polyoxyalkylene dialkyl ether, polyoxyethylene alkenyl ether, polyoxyalkylene alkyl phenyl ether, pluronic block polymer, tetronic block polymer, reverse pluronic type Block polymer, reverse tetronic block polymer, sucrose fatty acid ester, sorbitan fatty acid ester, polyethylene glycol fatty acid ester, glycerin fatty acid ester, polyglycerin fatty acid ester, propylene glycol fatty acid ester, polypropylene glycol fatty acid ester, fatty acid ester, coconut fatty acid diethanolamide (1: 1), palm fatty acid diethanol (1: 2), lauric acid diethanolamide, lauric acid myristic acid diethanolamide, myristic acid diethanolamide, oleic acid diethanolamide, palm kernel fatty acid diethanolamide and other fatty acid alkanolamides, alkyl glucosides, amine oxides, etc. can give. These nonionic surfactants may be used alone or in combination of two or more.

The cleaning agent of the present invention may further contain a bactericidal agent in order to obtain sufficient bactericidal properties.
Although it does not specifically limit when using as a disinfectant in the range which does not have a corrosive problem, A cationic surfactant is preferable. Examples of the cationic surfactant include a monoalkyl quaternary ammonium type surfactant (such as benzalkonium chloride) and a dialkyl quaternary ammonium type surfactant (such as didecyldimethylammonium chloride salt).

Examples of the chelating agent include aminopolyacetic acid and salts thereof, organic acid salts, amino acids and salts thereof, and ethylenediaminetetraacetic acid tetrasodium and sodium citrate are preferable.
Examples of the antifoaming agent include polyethylene glycol and polypropylene glycol, and polyethylene glycol is preferable.

An example of the cleaning method of the present invention will be described below, but is not limited thereto.
There is a method of passing the cleaning liquid containing the cleaning agent for medical device of the present invention into the equipment and rinsing with water, and thereby, protein stains and fat stains of the medical device can be efficiently removed.
Moreover, the cleaning agent for medical devices of this invention can also be used at high temperature, and this further improves a washability.

  The medical device cleaning agent of the present invention is a medical device cleaning agent that exhibits excellent performance in cleaning devices and parts that require cleaning because they are not cartridges or disposal. In particular, it can be preferably used for cleaning a wide range of medical devices such as an artificial dialysis machine, an endoscope, and a dental treatment device, and parts such as a tube and a sealed container attached thereto.

  The following examples further illustrate the invention, but the invention is not limited thereto.

Production Example 1 (Synthesis of sodium mercaptopropionate)
Mercaptopropionic acid (manufactured by Tokyo Chemical Industry Co., Ltd.) (1.06 g) is placed in a 200 mL beaker, 100 g of ion exchange water is added and dissolved, 0.36 g of sodium hydroxide is added, and a magnetic stir bar is used at 40 ° C. and 200 rpm. It stirred for 10 minutes with the magnetic stirrer at the rotation speed. Thereafter, water was removed by evaporation using an evaporator to dryness to obtain sodium mercaptopropionate of the present invention.

<Create test pieces for protein contamination evaluation>
As a protein stain model substance, 1.5 ml of a 100 mg / mL lysozyme aqueous solution was applied to a glass plate of 5 cm × 2 cm × 2 mm and dried in a vacuum dryer at 120 ° C. and 0.01 MPa for 1 hour to fix the lysozyme. . The glass plate was washed lightly for 1 minute and dried again in a vacuum dryer at 120 ° C. and 0.01 MPa for 1 hour to produce a glass plate with protein stains attached.

<Making test pieces for fat stain evaluation>
1 g of rice starch was dissolved in 20 g of water and stirred for 3 minutes at 80 ° C. to gelatinize. To this, 20 g of beef tallow heated and melted and well stirred were used as fat stains for this test. This fat stain was applied to a 5 cm × 2 cm × 2 mm glass plate and allowed to dry at room temperature to produce a glass plate to which the fat stain was adhered.

Example 1 (Sodium mercaptopropyl sulfonate)
In a 200 mL beaker, 0.14 g of sodium mercaptopropyl sulfonate and 199.9 g of ionic water are added and dissolved, one glass plate for protein stain evaluation and fat stain evaluation and a magnetic stirrer are placed, and 25 ° C., 200 rpm The mixture was stirred for 10 minutes with a magnetic stirrer at a rotation speed of.
After stirring, the glass plate was taken out, rinsed lightly with water, and again dried at 120 ° C. for 30 minutes in a vacuum dryer.
Also about the glass plate for fat dirt evaluation. The same operation was performed.

Example 2 (Sodium mercaptopropionate)
Instead of 0.14 g of sodium mercaptopropyl sulfonate, 0.10 g of sodium mercaptopropionate prepared in the production example was used, and the same procedure as in Example 1 was carried out. Each glass plate was washed.

Comparative Example 1 (Sodium propanesulfonate)
Instead of sodium mercaptopropylsulfonate 0.14 g, the same procedure as in Example 1 was carried out except that sodium propanesulfonate (manufactured by Wako Pure Chemical Industries, Ltd.) having no mercapto group was changed to 0.12 g.

Comparative Example 2 (Sodium propionate)
Instead of sodium mercaptopropyl sulfonate 0.14 g, the same procedure as in Example 1 was carried out except that the salt was changed to 0.08 g sodium propionate (manufactured by Wako Pure Chemical Industries, Ltd.) having no mercapto group.

<Method for evaluating protein contamination>
First, the protein stain removal rate was calculated by the following formula.
Removal rate (%) = {[(A) − (C)] / [(A) − (B])} × 100
However, A: Weight of glass plate after adhesion of dirt (g)
B: Weight of the first glass plate (g)
C: Weight of glass plate after washing (g)

Next, it evaluated on the following scales based on the removal rate of this protein stain | pollution | contamination.
○ ... removal rate: 80% or more Δ ... removal rate: 50% or more and less than 80% × ... removal rate: less than 50%

<Evaluation method of fat stain>
First, the fat soil removal rate was calculated using the same calculation formula as the protein soil removal rate described above.
Next, it evaluated on the following scales based on the removal rate of this fat stain.
○ ... removal rate: 80% or more Δ ... removal rate: 50% or more and less than 80% × ... removal rate: less than 50%

  As shown in Table 1, it can be said that the compound containing a thiol group of the present invention has a high cleaning effect as a cleaning agent for medical devices because it has a high cleaning effect on both protein soil and fat soil. On the other hand, the comparative compound containing no thiol group is inferior in the cleaning effect on protein stains.

  The cleaning agent for medical devices of the present invention is a safe and environmentally friendly cleaning agent that does not contain an alkali agent or an acid, has an excellent cleaning power, and is safe. In particular, since it has an excellent detergency against protein stains, stains such as enzymes that are firmly attached to medical devices can be washed. Further, since there is no problem such as corrosion due to an alkaline substance, the cleaning agent of the present invention can obtain a higher degree of cleaning by using it at a high temperature. Therefore, it can be used particularly for an artificial dialysis machine.

Claims (2)

Mercaptoalkylsulfonic acid represented by the following general formula (1) or a salt thereof (P) and / or mercaptoalkylcarboxylic acid represented by the following general formula (2) or a salt thereof (Q) as an essential component A cleansing agent for medical devices.
_{HS- (CH 2) m -SO 3} - · B + (1)
^{_{HS- (CH 2) n COO -}} · B + (2)
(In the formula, m represents an integer of 1 to 24; n represents an integer of 1 to 24; B ⁺ represents a cation in which a proton or a base is dissociated.) The medical device cleaning agent according to claim 1, wherein the base B has a pK _b (25 ° C) of 0 to 5.0.