JP4633482B2 - Medical disinfectant cleaning composition - Google Patents

Description

  The present invention relates to a medical sterilization detergent composition that reduces the risk of infection of workers by performing sterilization and cleaning simultaneously when cleaning a medical instrument soiled with a body fluid such as blood by surgery or inspection, and facilitates instrument cleaning. Related to things.

  When manually cleaning medical equipment and other medical equipment after use, it is common practice to immerse the equipment in a detergent solution before washing to dissolve the attached and dried blood stains. A detergent containing an enzyme (protease) has been used. In recent years, the problem of nosocomial infection has increased, and reducing the risk of infection in various situations has become an essential issue in hospitals. It is considered that the probability of infection is high when manually washing a medical device that is contaminated with blood after surgery, that is, a bacterium or virus that may become an infectious agent may be present in the blood. Immediately after use, for example, an aldehyde-containing disinfectant to reduce the risk of infection, blood is coagulated by the disinfectant and the soil swelling effect due to immersion is lost. To do.

In order to solve these problems, Patent Document 1 proposes a detergent using a combination of an ionic surfactant, an alkanolamine and a proteolytic enzyme. Patent Document 2 discloses a neutral to weakly alkaline endoscope cleaning agent containing a protease, a polyoxyethylene-polyoxypropylene block polymer and an enzyme stabilizer.
Special table hei 9-512586 JP 2001-31999 A

  However, in Patent Document 1, it is still necessary to perform immersing after sterilization, which does not lead to simplification of the cleaning process and is not preferable for medical staff. Moreover, when diluting and dipping the cleaning device of Patent Document 1 or 2 after the operation, it is not considered that the risk of infection can be reduced because no bactericidal component is added.

  Then, this invention makes it a subject to provide the medical sterilization cleaning composition which shows the outstanding sterilization effect and washing | cleaning effect with respect to the medical device which the bodily fluid adhered even by simple operation, such as immersion.

The present invention comprises (a) an acidic substance (hereinafter referred to as component (a)), (b) a basic substance (hereinafter referred to as component (b)), (c) a proteolytic enzyme, and (d) polylysine, chlorohexidine and The present invention relates to a medical disinfectant composition comprising one or more quaternary ammonium salt disinfectants selected so that (a) + (b) is 0.5 mol / kg or more.

  In addition, the present invention provides at least one or more selected from (c) proteolytic enzyme (hereinafter referred to as (c) component), (d) polylysine, chlorohexidine and quaternary ammonium salt fungicide [hereinafter referred to as (d) component. And a medical disinfectant cleaning composition containing 0.5 mol / kg or more of an ionic substance.

  Moreover, this invention relates to the method of wash | cleaning a medical instrument using the medical disinfection cleaning composition of the said invention.

  Moreover, this invention mixes (a) component, (b) component, (c) component, (d) component, and water so that an ionic substance may be 0.5 mol / kg or more, and for medical use. The present invention relates to a method for producing a sterilizing detergent composition.

  According to the medical disinfectant cleaning composition of the present invention, a simple operation such as immersion in a diluting solution is sufficient for a medical device to which a body fluid such as blood, which may be contaminated with bacteria or viruses, is attached. Cleaning and sterilization can be performed simultaneously. For this reason, the burden on the manual cleaning of the medical staff can be reduced, and at the same time, the risk of infection can be reduced. Moreover, the composition of the present invention is also excellent in enzyme stability.

<(A) component>
The component (a) is a substance that exhibits acidity in water. Any acid can be used, regardless of whether it is an organic acid or an inorganic acid, and a part of the hydrogen atom of the acid may be substituted with a metal atom or the like. Species or two or more species can be used, but preferably phosphoric acids (specifically, 1 potassium phosphate, 1 sodium phosphate, phosphoric acid, etc.), boric acid, carbonic acid, aminocarboxylic acid, oxycarboxylic acid Acids having chelating ability such as tartaric acid, malic acid, citric acid, etc., and succinic acid can be used. Preferred are monopotassium phosphate, citric acid, and carbonic acid. In addition, (c) component, (d) component, (e) component mentioned later, and the substance containing a bivalent metal are excluded from (a) component.

<(B) component>
Component (b) is a substance that exhibits alkalinity in water, and any base can be used regardless of whether it is an organic base or an inorganic base, and one or more can be used, but preferably a metal phosphate. Salts (specifically dipotassium phosphate, disodium phosphate, etc.), metal carbonates (specifically sodium carbonate, potassium carbonate, etc.), amines (specifically monoethanolamine, diethanolamine, triethanolamine) Etc.) can be used. Preferred are monoethanolamine and sodium carbonate. The component (b) excludes the component containing the component (c), the component (d), the component (e) described later, and a divalent metal.

  The ionic substance referred to in the present invention refers to a substance that can dissociate in water, but the state in the composition is not limited. However, (c) component, (d) component, (e) component mentioned later, and the substance containing a bivalent metal are excluded from an ionic substance. In addition, neutral salts such as mirabilite are included in ionic substances.

<(C) component>
The component (c) may be any component as long as it has an optimal proteolytic activity from neutral to alkaline pH, but the activity at pH 8.5 (40 ° C.) is 100 to 20000 AHU (1 kg of enzyme concentrate 1 kg). In addition, those of 200 to 10,000 AHU are preferable in terms of detergency and economy. This activity was measured by the Anson hemoglobin method. As the component (c), for example, sabinase, everase (manufactured by Novozyme), bioprelase 30G, bioprelase APL-30 (manufactured by Nagase ChemteX), enchilon SA (manufactured by Toto Kasei Kogyo Co., Ltd.), GODO-BAP (joint sake company) Manufactured), Purefect 4000L (manufactured by Genencor Kyowa), corolase 7089, corolase TS (manufactured by AB Enzymes) and the like. (C) 1 type (s) or 2 or more types can be used for a component.

<(D) component>
The component (d) is a fungicide, and one or more selected from polylysine, chlorohexidine and quaternary ammonium salt type fungicides are used. As a quaternary ammonium salt, a dimethyldialkyl (C6-C20) ammonium salt, a benzethonium salt, and a benzalkonium salt (for example, benzalkonium chloride, etc.) are preferable. As the component (d), polylysine is preferable from the viewpoint of cleaning effect.

  Polylysine is classified into α-polylysine and ε-polylysine depending on the binding state. In the present invention, it is desirable to use ε-polylysine from the viewpoint of safety.

  The component (d) is contained in the composition in an amount of 0.01 to 1% by weight, more preferably 0.02 to 0.5% by weight, particularly 0.02 to 0.25% by weight. This is preferable.

  The medical disinfectant cleaning composition of the present invention preferably contains (e) an enzyme stabilizer [hereinafter referred to as (e) component] from the viewpoint of stabilizing the enzyme. Examples of the component (e) include calcium or a salt thereof (for example, calcium chloride, calcium lactate and the like, zwitterionic compounds (for example, glycine and betaine)), and calcium or a salt thereof is preferably used. Can be used to stabilize the enzyme activity by blending in the composition at a concentration of 0.01 to 2% by weight, and further 0.05 to 1% by weight. A cleaning composition can be provided, and one or more components (e) can be used.

<Medical disinfectant cleaning composition>
In the medical disinfectant cleaning composition of the present invention, the concentration (a) + (b) of the component (a) and the component (b) in the final composition is 0.5 mol / kg or more, preferably 0.5. Each component is blended so as to be ˜5 mol / kg, more preferably 1 to 3.5 mol / kg. It is preferable from the viewpoint of detergency that both are contained in a molar ratio of (a) / (b) of 0.01 to 10, and more preferably 0.05 to 1 after satisfying this concentration.

  The amount of component (a) is preferably 0.01 to 20% by weight, more preferably 0.1 to 15% by weight, and particularly preferably 0.5 to 10% by weight in the composition on a weight basis. . Moreover, the compounding quantity of (b) component becomes like this. Preferably it is 0.1-30 weight%, More preferably, it is 0.5-25 weight%, Especially preferably, it is 0.5-20 weight%.

  The amount of component (a) is preferably 5 mmol / kg to 2 mol / kg, more preferably 10 mmol / kg to 1.5 mol / kg, particularly preferably 50 mmol / kg in the composition on a molar basis. kg to 1 mol / kg. The amount of component (b) is preferably 10 mmol / kg to 3 mol / kg, more preferably 50 mmol / kg to 2.5 mol / kg, particularly preferably in the composition on a molar basis. 50 mmol / kg to 2 mol / kg.

  The medical disinfectant cleaning composition of the present invention contains 0.5 mol / kg or more of an ionic substance, but 0.5 to 5 mol / kg, and further 0.5 to 3.5 mol / kg. Is preferable from the viewpoint of detergency. The amount of the ionic substance in the composition can be calculated as it is if the formulation is known, and even if the formulation is unknown, it can be calculated by a technique such as analyzing the composition directly or analyzing the evaporation residue. As the analyzer, liquid chromatography or the like can be used.

  In the medical disinfectant cleaning composition of the present invention, the pH of the stock solution is preferably 7 to 10 at 25 ° C. and can be used as a stock solution or a cleaning solution diluted with water or the like. The pH of the aqueous solution obtained by diluting the sterilizing detergent composition 100 to 500 times (25 ° C.) is preferably 7 to 9. In general, for sterilization and cleaning of medical devices to which body fluid such as blood adheres, high alkalinity is considered advantageous in terms of cleaning power, but it may cause rusting in medical devices and reduce enzyme storage stability. It is difficult to use a composition in a high alkali region. In the range of pH 7 to 9, there is no problem of rust generation, but the cleaning power is disadvantageous. However, in the present invention, the combination of the components (a) to (d), particularly the concentrations of the components (a) and (b). By increasing the ionic strength within the above range and containing the component (c), it is possible to synergistically improve the detergency even in such a pH range, and by selecting the component (d), excellent bactericidal power can be obtained. It can also be obtained at a predetermined dilution.

  The medical disinfectant cleaning composition of the present invention is preferably used as a cleaning solution having a pH of 7-9 after being diluted 100 to 500 times with water. In particular, the cleaning liquid preferably contains 0.2 to 100 ppm, more preferably 0.4 to 50 ppm, and still more preferably 0.4 to 25 ppm of component (d), especially polylysine.

  In addition to the above components, a surfactant can be used in the medical sterilizing detergent composition of the present invention in order to reduce the surface tension and increase the permeability to dirt. Moreover, polyhydric alcohols, such as propylene glycol, ethylene glycol, and sorbitol, can be used as a solubilizer.

  In the cleaning method using the medical disinfectant cleaning composition of the present invention, a cleaning solution at 20 to 50 ° C. was prepared by diluting the composition 100 to 500 times with water, and this cleaning solution was used in an operating room or the like. It is preferable to immerse medical instruments such as forceps, tweezers, and coopers to which body fluid such as blood adheres. In this method, it is preferable that the entire medical instrument is immersed in the cleaning liquid, and the immersion time is preferably 5 to 30 minutes. As a result, the medical instrument can be washed, and the ability of bacteria or viruses in body fluids such as blood to be immediately inhibited.

Example 1 and Comparative Examples 1-3
A 400-fold diluted aqueous solution of the medical disinfectant cleaning composition shown in Table 1 was prepared, and this was used as a cleaning liquid for evaluation, and antibacterial power and cleaning power were measured by the following methods. The evaluation cleaning solution was prepared using 4 ° DH hard water for evaluation of detergency, and 0.2% by weight aqueous solution of horse blood for evaluation of antibacterial activity. Moreover, the enzyme stability of the composition of Table 1 was measured by the method shown below. These results are shown in Table 1.

(1) Detergency evaluation model soil, 1500 rpm, the precipitate portion 40 wt% of the horses banked blood was centrifuged at 10 min homogeneously mixed, smeared with 20μL of the breadth of the 2 cm ² on a stainless steel plate (SUS430), 80 ° C. It was heat-denatured in 1 hour.

  First, the model soil is immersed in 4 ° DH hard water at 40 ° C. for 10 minutes, and then ATP in horse blood remaining unwashed on the stainless steel plate is developed with luciferase and quantified. This is taken as a control (washing rate 0%). On the other hand, the amount of ATP when the dirt is completely removed (cleaning rate 100%) is zero. From these ATP amounts, the predetermined APT amount can be converted into a cleaning rate (by a calibration curve method).

  The amount of ATP after immersion for 10 minutes in a cleaning solution for evaluation in which a cleaning composition was added to 4 ° DH hard water so as to have a predetermined concentration was similarly determined, and the cleaning rate was calculated from the value.

(2) Evaluation of antibacterial activity 10 ³ to 10 ⁴ / mL of various microorganisms (S. aureus, P. aureginosa, C. albicans) in the cleaning solution for evaluation, and room temperature (25 ° C.) And left for 1 hour. The number of viable bacteria in the subsequent washing solution for evaluation was applied to an SCD-LP plate and colonies detected by culturing at 35 ° C. for 48 hours were counted. The value obtained by subtracting the ratio of the value to the initial number of bacteria from 1 was defined as antibacterial activity.

(3) Enzyme stability evaluation The protease activity after storing the medical germicidal detergent composition of Table 1 at 50 ° C for 3 days was measured by the Anson hemoglobin method.

(Note) In the table, Evalase is a protease concentrate manufactured by Novozyme (enzyme concentration 4 wt%) [activity at pH 8.5 (40 ° C.) is 2150 AHU (per kg enzyme concentrate)], and polyoxyethylene alkyl The ether is polyoxyethylene lauryl ether having an average addition mole number of ethylene oxide of 12.

Examples 2-5 and Comparative Examples 4-6
A 200-fold diluted aqueous solution of the medical disinfectant cleaning composition shown in Table 2 was prepared, and this was used as a cleaning liquid for evaluation. These results are shown in Table 2.

(Note) In the table, sabinase is a protease concentrated solution (enzyme concentration 4% by weight) manufactured by Novozyme, Inc. [activity at pH 8.5 (40 ° C.) is 8400 AHU (per kg enzyme concentrated solution)], and corolase 7089 is Protease concentrated solution (enzyme concentration: 5% by weight) manufactured by AB Enzymes, Inc. (activity at pH 8.5 (40 ° C.) is 490 AHU (per kg of enzyme concentrated solution)).

Claims (8)

(A) An acidic substance selected from monopotassium phosphate, monosodium phosphate, phosphoric acid, boric acid, carbonic acid, tartaric acid, malic acid, citric acid, and succinic acid , (b) dipotassium phosphate, disodium phosphate , sodium carbonate, potassium carbonate, monoethanolamine, diethanolamine, and a basic material selected from triethanolamine, (c) a proteolytic enzyme, (d) is Poririji emissions, and water, (a) + (b) is 1 to 3.5 mol / k g, and (a) / (b) Ri is Na formulated such that the molar ratio of 0.05, containing 0.01 to 0.25 wt% (d) is A medical disinfectant cleaning composition. Medical germicidal detergent composition of Claim 1 Symbol placement is used as a cleaning liquid for pH 7-9. The medical disinfectant cleaning composition according to claim 1 or 2 , further comprising (e) an enzyme stabilizer. Furthermore, the medical disinfection cleaning composition of any one of Claims 1-3 containing surfactant. Furthermore, the medical disinfection cleaning composition of any one of Claims 1-4 containing a solubilizer. The medical disinfectant cleaning composition according to any one of claims 1 to 5 , which is used as a cleaning liquid diluted 100 to 500 times with water. A method of immersing and cleaning a medical instrument in a cleaning solution having a pH of 7 to 9 prepared by diluting the medical sterilizing detergent composition according to any one of claims 1 to 6 with water 100 to 500 times . (A) An acidic substance selected from monopotassium phosphate, monosodium phosphate, phosphoric acid, boric acid, carbonic acid, tartaric acid, malic acid, citric acid, and succinic acid , (b) dipotassium phosphate, disodium phosphate , sodium carbonate, potassium carbonate, monoethanolamine, diethanolamine, and a basic material selected from triethanolamine, (c) a proteolytic enzyme, (d) is Poririji emissions, and water, (a) + (b) is 1 -3.5 mol / kg, (a) / (b) is mixed in a molar ratio of 0.05-1 and the content of (d) is 0.01-0.25 wt% , The method to manufacture the medical disinfection cleaning composition of any one of Claims 1-6 .