JP2859834B2 - Cleaning agent for artificial dialysis equipment - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

[0001] The present invention relates to a cleaning agent for an artificial dialysis device.

[0002]

2. Description of the Related Art An artificial dialysis device is used for treatment for relieving renal damage. Blood and dialysate are brought into contact with each other through a filter (semi-permeable membrane) in the device, and the difference in solute concentration between the two solutions is measured. By removing uremic substances from the blood,
It corrects electrolyte and acid-base equilibrium.

[0003] Proteins, fats, calcium, magnesium, and the like are deposited on pipes and other parts of such an artificial dialysis machine that come into contact with blood or dialysate, which hinders the normal operation of the machine. In addition to the need for a washing treatment to remove deposited substances, a sterilization treatment is also required to prevent secondary infection.

[0004] Generally, as a detergent used in an artificial dialysis apparatus, various surfactants including a chelating agent and comprising the same components as detergents for laboratory instruments have been used.

[0005] Further, as a disinfectant used by being mixed with a cleaning agent for an artificial dialysis device, chlorine-based oxidizing substances such as sodium hypochlorite, sodium chlorite and chlorine dioxide;
Also, aldehydes such as formalin and glutaraldehyde, or acidic substances such as sulfites, hyposulfites, acetic acid, hydrochloric acid, sulfuric acid, and organic acids, phenols and alcohols are known.

[0006]

However, the above-mentioned cleaning agent for a conventional artificial dialysis device corrodes the metal material (stainless steel, aluminum, etc.) that constitutes the main part of the artificial dialysis device when it comes into contact with it. There is a problem that there is a possibility.

That is, a cleaning agent for an artificial dialysis device includes:
In particular, strong detergency is required to quickly and surely wash proteins and mineral components (calcium, magnesium, sodium, etc.), but contradictory properties such as physical properties that do not corrode metals are also required.

[0008] Further, the cleaning agent is likely to come into contact with the skin of a person who handles the cleaning agent. In such a case, the cleaning agent also needs to have a property of reducing degreasing and irritation.

[0009] With regard to the bactericidal properties required together with the cleaning action, it is required that protection against infection against certain pathogens such as various viruses and MRSA (methicillin-resistant Staphylococcus aureus) is required.

It is necessary to consider the following properties from the viewpoint of safety and the like.

[0011] No emission of gas or toxic or harmful substances such as halogen oxides due to chemical reaction during treatment, No emission of harmful substances when used in combination with other cleaning agents or disinfectants, artificial dialysis Therefore, it is an object of the present invention to solve the above-mentioned problems and to make the cleaning agent for an artificial dialysis device shorter in terms of protein and mineral components. It has a cleaning effect that is efficient in time, has a sterilizing effect, and has a property of not corroding metal materials (stainless steel, aluminum, copper, etc.).

It is another object of the present invention to provide a cleaning agent for an artificial dialysis apparatus which has good physical properties and has little defatting or stimulating action on the skin and has good handling properties.

[0013]

In order to solve the above-mentioned problems, the present invention comprises a water-soluble surfactant having an HLB value of 7 or more, a bactericide, and an organic acid and a salt thereof.
This was a cleaning agent for an artificial dialysis device, which was blended so that the H value was 2 to 5.

Or a water-soluble surfactant having an HLB value of 7 or more, a bactericide and a hydrophilic organic solvent thereof,
The cleaning agent for an artificial dialysis device was prepared by mixing an organic acid and a salt thereof so as to have a pH value of 2 to 5.

[0015]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The water-soluble surfactant used in the present invention can be used without any limitation. In particular, if the surfactant is a nonionic surfactant or an amphoteric surfactant, the residual amount after the washing treatment is reduced. It is preferred because it is less, has little pH dependency, and has excellent compatibility with ionic substances and germicides.

A water-insoluble surfactant having an HLB value of less than 7 is not preferably used in the present invention.
This is because, in combination with the oily dirt component, the dirt builds up and does not contribute to the detergency.

Specific examples of the water-soluble surfactant that can be used in the present invention are listed below by type. Examples of the anionic surfactant include linear alkylbenzene sulfonates, alkyl sulfates, alkyl ether sulfates, alkyl sulfonates, α-olefin sulfonates, alkyl phosphates, alkyl diphenyl ether disulfonates, and alkyl ether fatty acids. Salts, acyl glutamates and the like.

Examples of the nonionic surfactant include polyoxyethylene alkyl ether, polyoxyethylene alkylphenol ether, fatty acid alkanolamide, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid ester, and polyoxyethylene glyceryl monoalkyl. Chelates, alkylamine oxides, polyoxyethylene polyoxypropylene block-type ethers, ethylene glycol alkylates and the like can be mentioned.

Examples of the amphoteric surfactant include imidazolinium betaine, alkylaminoacetate betaine, amidopropyl betaine, alkyl betaine, and polyalkylaminoethylglycine.

The amount of such a water-soluble surfactant is as follows:
In the detergent composition, approximately 3 to 30% by weight may be used as a guide. Usually, it is blended in accordance with conditions such as stability with other chemicals, dilution concentration according to product design, and price balance. The amount is not strictly limited.

The organic acid used in the present invention is acidic among organic compounds, and is specifically an organic compound having carboxylic acid, sulfonic acid, phenol, or the like as a functional group. Specific examples of such organic acid compounds include:
Citric acid, malic acid is tartaric acid, lactic acid, gluconic acid, hydroxyacetic acid, acetic acid, maleic acid, succinic acid, flop propionic acid, oxalic acid, amino acid, such as adipic acid, fumaric acid. Among them, organic acids belonging to the oxycarboxylic acid are preferable because they have high safety, do not have an odor, and have good compatibility with other components.

When such an organic acid is blended so as to maintain the pH of the detergent on the acidic side, it can improve the cleaning properties of the surfactant by decomposing and peptizing the deposits containing proteins, calcium, magnesium and the like. There is an action to keep it suitable for the action.

Further, since such an organic acid reacts with an alkali agent and coexists with its salts, it has a pH buffering action and can exhibit cleaning properties very effectively.

Examples of the alkaline agent include sodium hydroxide, potassium hydroxide, magnesium hydroxide, aqueous ammonia, triethanolamine, monoisopropanolamine, and alkylamine (2-8 carbon atoms). Among them, salts of sodium, potassium, and ammonium are excellent in terms of safety, particularly safety to the human body, small residual amount after washing treatment, and good storage stability.

The pH is adjusted to 2 to 5 by using the organic acid and the alkali agent together. That is, the effective hydrogen ion concentration range (AHICA) of the cleaning agent of the present invention is pH
When the pH value is within the above-mentioned predetermined range, the washing property for removing unnecessary compounds such as calcium and magnesium in blood and urine is improved, the amino acid polymer is easily decomposed, and the sterilization is performed. The stability of the agent is also improved.

The bactericides used in the present invention include, for example, chlorhexidine gluconate, isopropylmethylphenol, diphenhydramine hydrochloride, trichlorohydroxydiphenyl ether (CIBA GEIG, Switzerland).
Y) (registered trademark: Irgasan DP-300), trichlorocarbanilide (abbreviation: TCC), hexachlorophene, parachloromethaxylenol, benzothiazole, α-bromocyanamide aldehyde, halogenated phenol derivative (Doctoref, Germany) Raschig:
Laluven) and the like.

The following surfactants can also be used as germicides. That is, benzalkonium chloride, didecyl dimethyl ammonium chloride, dioctyl dimethyl ammonium chloride, tetradecyl dimethyl benzyl ammonium chloride, didecyl dimethyl pyridinium chloride, aminoethyl glycine,
Examples include cationic or zwitterionic compounds such as cetyltrimethylammonium bromide.

The hydrophilic organic solvent used in the present invention acts as a water-solubilizing agent when the above-mentioned bactericide alone is hardly soluble in water, and decomposes and dissolves dirt substances deposited on the artificial dialysis device. It promotes glue action and also acts as a stabilizer for the whole water-soluble washing liquid.

Examples of such a hydrophilic organic solvent include diethylene glycol monobutyl ether, propylene glycol monobutyl ether, propylene glycol monomethyl ether, triethylene glycol monoethyl ether, 1,4-dioxane, ethylene glycol monomethyl ether acetate, N-methyl- 2-pyrrolidone, 1,3-dimethyl-2-imidazolidinone, phenoxyethanol, methyl ethyl ketone, benzyl alcohol, dimethylacetamide, tetrahydrofuran, diacetone alcohol, acetate, methoxymethylbutanol, and the like. Ether and pyrrolidone compounds are preferred in terms of safety, odorlessness, environmental preservation and the like.

The amount of such an organic solvent is from 5 to 30.
Weight% is used as a standard recipe, and this recipe can be used as a guide for appropriately increasing or decreasing the recipe.

In the present invention, the following additives may be added in addition to the above-mentioned essential components to such an extent that the effects of the present invention are not impaired.

As additives, sequestering agents (chelating agents) include EDTA-2Na, EDTA-2K, potassium pyrophosphate, sodium acid phosphate, nitrilotriacetic acid (NTA), Rochelle salt, thallium nitrate, magnesium citrate and the like. And natural enzymes include protease, lipase, amylase and the like.

Examples of the oxidizing or reducing bleaching agents include potassium persulfate, sodium perborate, hydrogen peroxide, sodium percarbonate, sodium sulfite, sodium thiosulfate and the like. Glycerin, ethylene glycol (# 200 to # 1
000), propylene glycol, hexylene glycol, 1,3-butylene glycol, dipropylene glycol, urea, pyrrolidone carboxylate, sodium lactate and the like.

As thickeners, carboxymethyl cellulose (CMC) carboxy polymer, ethyl cellulose, methyl cellulose, xanthan gum, guar gum,
Gum arabic, dextrin, dialdehyde starch,
Ramzan gum, food colors, flavono, carotene,
Purple root, chlorophyll and the like.

[0035]

【Example】

[Examples 1 to 4, Comparative Examples 1 to 4] The raw materials shown in Table 1 were collectively and uniformly mixed at the mixing ratio shown in the same table to produce a detergent for an artificial dialysis device.

The fungicide Irgasan in the table is triclohydroxydiphenyl ether (trade name: Irgasan D, manufactured by CIBA GEIGY, Switzerland).
P-300), and surfactant A is polyoxy (EO)
= 10) shows ethylene lauryl ether, and surfactant B shows polyoxyethylene polyoxypropylene glycol (Pluronic L-64, manufactured by Asahi Denka Co., Ltd.).

[0037]

[Table 1]

The obtained cleaning agent for an artificial dialysis device was washed with water for 5 hours.
It was diluted 0-fold, that is, a 2% aqueous solution of the stock solution having the above-mentioned composition was accommodated in a washing liquid tank attached to an artificial dialysis device, and ordinary washing treatment was performed at a liquid temperature of 20 ° C. or 35 ° C.

As a comparative reference example, a 500-fold diluted aqueous solution of sodium hypochlorite (NaOCl), a 1 / 2N aqueous solution of acetic acid, and a commercially available test tube cleaner for physics and chemistry were washed under the same conditions. It was subjected to processing.

The evaluation of the detergency was carried out by (a) protein,
(B) Divided into calcium and performed in the following manner, and the results are summarized in Table 2.

(A) Evaluation of Detergency for Proteins The piping (Iwaki Co., 1.7 mm inner diameter, 65 mm length) after the washing treatment was heated at 100 ° C. for 3 hours together with 10 ml of 5 / 2N NaOH to remove residual proteins. After being dissolved by hydrolysis and neutralized with 10 ml of 30% acetic acid, ninhydrin (NIN) using norleucine was used.
(HYDRIN) coloration was performed, colorimetrically measured at 570 nm, and the amount of protein (g / cm ³ ) remaining after washing was examined.

(B) Evaluation of Detergency for Calcium Calcium detected by chelate titration was indicated by +, and non-calculated was indicated by-.

[0043]

[Table 2]

As is clear from the results shown in Table 2, Comparative Examples 1 and 2 having a pH outside the predetermined range and Comparative Examples 3 and 4 containing no hydrophilic organic solvent or bactericide were inferior in detergency against calcium compounds. However, Examples satisfying all the conditions were excellent in detergency against proteins and calcium compounds.

Next, a stainless steel (SUS304) test piece (50 mm) was added to the cleaning agents of Examples 1-4 and Comparative Examples 1-4.
× 50mm × 10mm), aluminum test piece (50m
mx 50 mm x 10 mm) or copper test piece (50 mm
.Times.50 mm.times.20 mm) were immersed at 40. +-. 2.degree. C. for 10 days, and the weight change (weight loss mg) of the test piece before and after the test was examined. The results are shown in Table 3.

[0046]

[Table 3]

As is evident from the results shown in Table 3, Comparative Examples 1 to 4 all had a high degree of damage to aluminum and copper. Also, acetic acid and sodium hypochlorite had a particularly high degree of damage to copper. On the other hand, it can be seen that Examples 1 to 4 satisfying all the conditions have a very low degree of damage to any metal as compared with the comparative example.

Next, in order to examine the bactericidal activity of the detergents of Examples 1 to 4 and Comparative Examples 1 to 4, the minimum inhibitory concentration (MIC) of the following strains was examined. (+ Mark:
And the results are shown in Table 4. The minimum growth inhibitory concentration was defined as the minimum concentration at which growth was inhibited after the bacterial solution for inoculation was spread and cultivated on a hand-pulled medium to which a test article was added to an arbitrary concentration.

(A) Staphylococcus aureus (Staphylococcus aureus 209P)
JC-1) (b) Echerichia coli
NIHJ JC-2) (c) Proteus vulgaris (Proteus vulg)
aris OX-19) (d) Pseudomonas aeruginosa
s aeruginosa IO3451) (e) Salmonella paratych (Salmonella)
ella paratyphi AP-5304) In Table 4, Tego-51 is manufactured by Goldschmidt, Germany: Tego-51 (dodecyl (aminoethyl) glycine hydrochloride 60% by weight and tetradecyl (aminoethyl) glycine hydrochloride 40). % Of the mixture).

[0050]

[Table 4]

As is clear from the results shown in Table 4, the minimum inhibitory concentrations of Comparative Examples 1 to 4 against the above strains were 100 times higher than those of any of the strains.
Showed good bactericidal activity against all strains even at a 100-fold dilution.

[Examples 5 to 7, Comparative Examples 5 and 6] The raw materials shown in Table 5 were collectively and uniformly mixed at the mixing ratio shown in the same table to produce a detergent for an artificial dialysis device.

The bactericide Irgasan in the table refers to trichlorohydroxydiphenyl ether (trade name: Irgasan DP-300, manufactured by Ciba Geigy, Switzerland), and surfactant C is polyoxyethylene (EO = 1).
0) indicates oleyl ether, and surfactant D indicates polyoxyethylene (EO = 5) coconut fatty acid monoethanolamide.

[0054]

[Table 5]

With respect to the obtained HCl (3N) of Examples 5 to 7, Comparative Examples 5 and 6, and Comparative Reference Example, the detergency against calcium was evaluated.

That is, the evaluation was performed by forming a metallic soap in a polypropylene test tube with a hardness of 100 ° PH and a soap solution, and aging at 40 ° C. for 7 days to form adhered dirt on the polypropylene surface. The obtained detergent was made into a 10-fold diluted aqueous solution, immersed in the diluted aqueous solution for 10 minutes or 30 minutes, and then thoroughly washed with water to determine the residual calcium by chelate titration. The results of this chelate titration method are shown in Table 6 in terms of concentration ppm.

[0057]

[Table 6]

As is evident from the results in Table 6, Comparative Example 5 containing no surfactant or Comparative Example 6 containing no organic acid and alkali agent and having a pH value outside the predetermined range was used. In many cases, and was inferior in detergency of attached dirt. On the other hand, Examples 5 to 7 satisfying all conditions
Showed almost no residual calcium and showed an excellent cleaning effect.

Further, the obtained Examples 5 to 7, Comparative Example 5,
With respect to HCl (3N) of No. 6 and Comparative Reference Example, the detergency of blood was evaluated.

That is, 0.15 ml of blood was dropped on a clean slide glass and left to dry for 48 hours. In addition, a 10-fold diluted aqueous solution of the washing solution was prepared in a beaker, and the slide glass was immersed in the aqueous solution and allowed to stand, and the time required for complete (100%) washing (dissolution) was measured. These results are shown in the graph of FIG.

From the results shown in FIG. 1, it can be seen that blood can be washed in Examples 5 to 7 in a short time of about half the immersion time as compared with Comparative Examples 5 and 6.

Further, the obtained Examples 5 to 7, Comparative Example 5,
6 and the comparative reference example, HCl (3N) was evaluated for metal corrosion.

That is, stainless steel (SUS304)
Each of a test piece (50 mm × 50 mm × 10 mm), an aluminum test piece (50 mm × 50 mm × 10 mm), or a copper test piece (50 mm × 50 mm × 20 mm)
It was immersed at 5 ° C. for 7 days, and the change in weight (weight loss%) of the test piece before and after the test was examined.

From the results shown in FIG. 2, it can be seen that Examples 5 to 7 are compared with Comparative Example 5 containing no surfactant or Comparative Example 6 containing no organic acid and alkaline agent and having a pH value outside the predetermined range. Low metal corrosion, stainless steel, aluminum,
The reduction was% for all copper.

[0065]

As described above, the present invention comprises a water-soluble surfactant having a predetermined HLB value, an organic acid and a salt thereof, and a bactericide, or if necessary, a hydrophilic organic solvent. And a cleaning agent for artificial dialysis equipment adjusted to a predetermined pH value, so that it has a short and efficient cleaning action on proteins and mineral components, and has a bactericidal action, and also has a metallic material. (Stainless steel, aluminum, copper, etc.) has the advantage of being a cleaning agent for an artificial dialysis device having a property of not corroding.

Since the pH is adjusted to a predetermined value,
With the above benefits, there is little degreasing and irritation to the skin
There is also an advantage that it becomes a cleaning agent for an artificial dialysis device with good handling properties.

[Brief description of the drawings]

FIG. 1 shows the blood detergency of Examples and Comparative Examples,
Chart showing the relationship between cleaning rate and slide glass immersion time

FIG. 2 shows the corrosiveness to metals of Examples and Comparative Examples,
Chart showing the relationship between the weight loss% and the number of days of immersion of the test piece

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-4-135559 (JP, A) JP-A-52-151294 (JP, A) JP-A-53-99696 (JP, A) JP-A 52-151696 125475 (JP, A) JP-A-7-233396 (JP, A) JP-A 64-80406 (JP, A) JP-A 62-89602 (JP, A) JP-A 54-58686 (JP, A) (58) Field surveyed (Int.Cl. ⁶ , DB name) B01D 65/06 A61M 1/14

Claims (2)

(57) [Claims] 1. A water-soluble surfactant having an HLB value of 7 or more, a bactericide, an organic acid and an alkali agent are blended so as to have a pH of 2 to 5, and the organic acid and its sodium salt are mixed.
Um, potassium, magnesium or ammonium
A cleaning agent for artificial dialysis equipment that is made to coexist with salt . 2. Nonionic surfactant or amphoteric surfactant
Containing a water-soluble surfactant having an HLB value of 7 or more, a bactericide and a hydrophilic organic solvent thereof, and blending an organic acid and an alkali agent so that the pH value becomes 2 to 5 ;
Organic acids and their sodium and potassium salts, magnesium
A cleaning agent for an artificial dialysis device, which is made to coexist with a salt or an ammonium salt .