JPS6132360B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Technical Field The present invention relates to enzyme-containing cleaning compositions useful for pre-sterilization of medical equipment and tools.

BACKGROUND OF THE INVENTION Cleaning compositions are used to remove proteinaceous contaminants (blood, tissue debris) from the surfaces of medical equipment and tools.

Enzyme-containing cleaning compositions generally comprise a surfactant, sodium phosphate, sodium silicate, sodium carbonate, sodium sulfate, and an enzyme preparation.
The latter usually comprises several components, most often alkaline protease and amylase.
In detergent solutions these enzyme preparations are rapidly inhibited and are also unable to adequately hydrolyze protein contaminants. Blood and tissue debris still remain on the surfaces of surgical instruments. Inadequate cleaning of surgical instruments contributes to the complication of intensive sepsis during the postoperative period. To prevent long-term inhibition phenomena, enzyme stabilizers are incorporated into enzyme-containing detergent compositions. Incorporation of stabilizers complicates the procedure for manufacturing cleaning compositions and further increases their manufacturing costs.

The use of hydrogen peroxide in combination with cleaning agents is known. Although hydrogen peroxide makes it possible to remove all protein contaminants, it leads to corrosion of the metal surfaces of medical devices, so medical devices and tools made from special alloys and carbon steel only have a short lifespan. It only has .

Many enzyme-containing detergent compositions are well known to those skilled in the art. Accordingly, cleaning compositions are known for removing protein contaminants from processing equipment prior to cleaning the equipment. (U.S. Patent B-458819C1.252-
545). The composition comprises an anionic surfactant, a water-soluble inorganic phosphate, sodium metasilicate, sodium carbonate, an enzyme preparation, and alkaline protease. sodium chloride or sodium sulfate,
Polyhydric alcohols are also used as enzyme stabilizers. The alkaline protease is present in the detergent composition in an amount to ensure proteolytic enzyme activity of the composition up to 500-1000 Delft units/g.

This composition cannot completely remove complex protein contaminants (blood and tissue debris) from medical instruments.
Furthermore, the enzyme in this composition is insufficiently stable. Stabilizers should be incorporated into the composition to maintain enzyme activity.

Other enzyme-containing detergent compositions based on surfactants are known. (French patent 2371510
C1C11D). The composition contains alkaline protease and/or amylase. The enzyme preparation has an alkaline protease activity of 1000-1500000 units/g and an amylase activity of 10-10000 units/g.

Since enzyme-containing cleaning compositions have limited combinations of enzymes, it is impossible to remove all protein contaminants from medical instruments and tools. Furthermore, enzymes have insufficient stability, so they must be incorporated into cleaning compositions in large amounts.

Enzyme-containing detergent compositions containing non-ionic surfactants, alkaline proteases and amylases are also known; enzyme-containing detergent compositions have a protease activity of 1 Kg expressed in Anson units and 150 Kilo Novo (Kilo Novo) units. ) units of amylase activity (French patent
2355908C1, C11D). This enzymatic cleaner composition also cannot effectively remove protein contaminants from medical devices.

Still other enzyme-containing cleaning compositions are known for cleaning manufacturing equipment contaminated with proteins or starches. The compositions contain nonionic and anionic surfactants, especially sodium dodecylbenzenesulfonate, sodium tripolyphosphate and/or sodium vulconate, sodium silicate, sodium carbonate, sodium sulfonate, and enzyme preparations. The latter contains alkaline protease and amylase. The composition also incorporates stabilizers against proteases. Polyethylene glycol, calcium chloride, citrate and acetate are used as such stabilizers. Sodium chloride, citrate and acetate are used as stabilizers for amylase. The composition also contains antifoaming agents such as fatty acid diethanolamides (West German patent application
2259201C1, 23C2).

This cleaning composition is unable to completely clean medical equipment from difficult-to-remove contaminants such as blood and tissue debris due to the presence of only two enzymes - alkaline protease and amylase. Furthermore, proteases and amylases have insufficient stability. In order to adequately ensure the effectiveness of these enzymes, stabilizers should be added to the detergent. This complicates the procedure and increases manufacturing costs for the manufacture of enzyme-containing detergent compositions.

OBJECTS OF THE INVENTION The present invention provides an enzyme-containing cleaning composition for pre-sterilizing medical instruments and instruments, which can completely remove protein and fat contaminants from medical instruments and instruments, and which is economically useful. Its purpose is to provide.

Structure and Effects of the Invention The purpose of the present invention is to provide a method for pre-sterilizing medical instruments and tools containing enzyme preparations containing anionic surfactants, sodium phosphate, sodium silicate, sodium carbonate, sodium sulfate, and alkaline protease and amylase. An enzyme-containing detergent composition, wherein the composition also contains a soap comprising a sodium salt of a fatty acid, and the enzyme preparation further comprises the following component proportions (% by weight): alkaline protease 30-60 neutral protease 27-45 Elastase 0.01-5.00 Collagenase 0.001-4.00 Leucine acinopeptidase 0.0001-0.011 Carboxypeptidase 0.04-0.15 Fibrinolytic enzyme 0.002-1.500 Lipase 0.5-2.0 Amylase aase, elastase, collagenase , leucine aminopeptidase, carboxypeptidase, fiber reassembling enzyme, and lipase, and the enzyme-containing cleaning composition has the following component ratios (wt%): Anionic surfactant 4.0 to 6.0 Sodium phosphate 30.0 to 35.0 Sodium silicate 20.0 This is achieved by the enzyme-containing composition characterized in that it has the following: -25.0 sodium carbonate 19.0-22.0 fatty acid sodium salt-containing soap 2.0-4.0 enzyme preparation 0.5-2.0 sodium sulfate balance.

As anionic surfactants the use of sodium alkylbenzenesulfonates or alkylsulfates based on kerosene, n-paraffins, propylene tetramers, alpha-olefins is proposed.

The anionic surfactant present in an amount of 4.0 to 6.0% by weight in the cleaning composition allows standard contaminants to be washed off from a variety of objects as a result of the reduction in surface tension at the interface of the object to be cleaned.

As the sodium phosphate, for example, sodium tripolyphosphate, trisodium phosphate, and tetrasodium pyrophosphate can be used.

The sodium phosphate present in an amount of 30.0 to 35.0% by weight in the enzyme-containing detergent composition ensures water softening, a decoagulating effect with respect to hydrophilic contaminants, and prevents hygroscopicity and agglomeration of the detergent composition. It is undesirable to use phosphate in an amount exceeding 35% by weight because of contamination of waste water; use of sodium phosphate in an amount less than 30% in an enzyme-containing detergent composition does not ensure a sufficient cleaning effect. Examples of the sodium silicate include sodium metasilicate, hydrated sodium sesquisilicate, and purified sodium forthosilicate. The silicates present in the cleaning composition in an amount of 20.0 to 25.0% by weight can protect the medical instruments and equipment from corrosion during cleaning and also prevent agglomeration of the final cleaning composition. The use of sodium silicate in amounts less than 200% by weight does not ensure protection against corrosion of medical instruments and equipment, while the use of this component in amounts greater than 25.0% by weight results in the inhibition of enzymes in the cleaning composition.

By incorporating sodium carbonate in an amount of 19.0 to 22.0% by weight into an enzyme-containing cleaning composition, an enzyme-alkaline base material that can most effectively remove contaminants can be produced.

It is not preferable that this component exceeds 22.0% by weight. This is because in this case it reduces the activity of the enzyme preparation, whereas its use in amounts less than 19.0% by weight causes a decrease in the proteolytic activity of the composition.

The presence of a soap comprising a fatty acid sodium salt in an amount of 2.0 to 4.0% by weight in an enzyme-containing cleaning composition reduces foaming in the case of mechanical cleaning of medical instruments.

Soaps are end products obtained by conventional methods such as saponification of vegetable oils and animal fats with caustic soda or calcined sodium. For the production of soap, in addition to vegetable and animal oils, oil substitutes are used, which include synthetic acids with 13 to 18 carbon atoms,
Tall oil is a waste product in the production of naphthalene, rosin, and cellulose.

Sodium sulfate is a filler in the cleaning composition according to the invention.

As explained above, enzyme preparations consist of complexes of compounds. The enzyme preparation incorporates seven proteolytic enzymes (proteases) that ensure the hydrolysis of various protein contaminants. Five of these seven proteases are stable in alkaline media. These proteases are: alkaline protease, elastase,
collagenase, leucine aminopeptidase, carboxypeptidase. These have a PH of 10.5 to 1.5
to ensure the stability of the enzyme preparation. Lipases incorporated into enzyme preparations contribute to the hydrolysis of fatty contaminants on the surfaces of medical devices and equipment. Amylase also promotes hydrolysis of carbohydrate contaminants on the surfaces of medical devices.

The total amount of enzyme preparation in the enzyme-containing detergent composition according to the present invention ranges from 0.5 to 2.0% by weight. Alkaline protease activity is per gram of composition
1000 FOLP units (The procedure for determining the proteolytic activity by the FOLP method is described below). It is estimated that it contains a non-ionic surfactant in an amount of 2% by weight.

As nonionic surfactants, for example monoalkyl ethers of polyethylene glycols based on primary aliphatic alcohols C _o H _2o+1 O(C ₂ H ₄ O) _n
H (in the formula, n = 10 to 18, m = 8 to 10: polyoxyethylene glycol ether of synthetic fatty acid monoethanolamide C _o H _{o +1} CONHCH ₂ CH ₂ O
( _C2H4O ) _nH (in the formula _, n=10-16, m=5-6) can be used.

The use of nonionic surfactants in the amounts described above enhances the cleaning action of anionic surfactants. The nonionic surfactants are used in the case of protein and fat contaminants that are difficult to remove from the surfaces of medical devices and equipment.

The use of anionic and nonionic surfactants, as well as sodium phosphates and silicates, sodium carbonate, enzyme preparations and sodium sulfate in enzyme-containing detergent compositions is well known to those skilled in the art.

However, none of these agents ensures complete removal of protein and fat contaminants from medical instruments and equipment. This is due to the fact that anionic surfactants and sodium phosphate suppress the activity of enzyme preparations to some extent. Sodium silicate and sodium carbonate exhibit the strongest inhibitory effect on enzyme preparations (up to 20-40%). Only by using the enzyme-containing detergent composition according to the invention containing known components in predetermined proportions can protein and fat contaminants be completely removed. This is because the surfactants, sodium phosphate and silicate, sodium carbonate and sodium phosphate, together with the selection of the components and proportions of the composition, do not substantially inhibit the enzyme preparation and ensure its stability and high properties. It is.

Enzyme-containing cleaning compositions for pre-sterilization of medical instruments and equipment contain a wide range of enzymes.

Because of this, enzyme-containing cleaning compositions are highly effective in cleaning protein and fatty contaminants from the surfaces of medical instruments and tools. Therefore, this composition provides 100% complete removal of blood, tissue debris and other contaminants during both manual and mechanical cleaning. Purity is controlled by the ortho-toluidine test.

As already explained above, the enzyme preparation according to the invention contains seven proteolytic enzymes: alkaline protease, elastase, collagenase, leucine aminopeptidase, fibrinolytic enzyme. This combination of other proteases allows for a high and sufficient hydrolysis of various protein contaminants, mainly blood, into water-soluble amino acids and peptides that are easily removed by washing solutions.

The presence of an alkali-resistant protease in the enzyme-containing detergent composition imparts high alkali resistance to the enzyme-containing detergent composition according to the invention at a pH of 10.0 to 11.5. Due to this, the enzyme-containing detergent composition has high stability during manufacture (100%), high stability during storage (95-100%) and high stability in solution (85-92%). Furthermore, the enzyme-containing detergent composition according to the invention has a sufficiently high proteolytic stability of -1000 FOLP units/g, which corresponds to 4500 Delft units/g. Due to the high stability and activity of the cleaning composition, its consumption can be reduced by a factor of 4 to 500 compared to known compositions.

The enzyme-containing detergent composition according to the present invention maintains its activity for a long period of time and therefore does not require any stabilizers for it, thus simplifying the manufacturing process of the composition and further reducing the manufacturing cost considerably. can. Furthermore, the use of hydrogen peroxide, which leads to corrosion of medical instruments and tools, is avoided.

The amount of phosphate in the enzyme-containing detergent compositions according to the invention is substantially lower than in prior art compositions, which is also an advantage. This is because increasing the phosphate content has a detrimental effect on the activity and stability of the enzyme preparation and also promotes beneficial growth of algae in the reservoir.

A slight increase in the amount of sodium silicate compared to known cleaning compositions makes it possible to use the enzyme-containing cleaning composition according to the invention to corrode the metal surfaces of medical instruments and devices during treatment. It is possible to ensure protection from

The method for producing the enzyme-containing cleaning composition for preliminary sterilization of medical instruments and tools according to the present invention is simple and can be carried out by known methods. According to one embodiment, the raw materials are charged to a reaction mixer in the following order: soap, surfactant, water, sodium carbonate, sodium sulfate, sodium phosphate, sodium silicate.

If nonionic surfactants are used, they are charged into the reaction mixer together with the anionic surfactant. Components can be measured using automatic dispensing equipment.

While feeding the starting materials to the reactor, the components are continuously mixed and the mixture is heated to a temperature of 80-90 DEG C. by hot water circulating in the water jacket of the reaction mixer. After charging all ingredients, the resulting mass is stirred for an additional 10-15 minutes and then subjected to atomization. The latter is "Lurgy" or "Kesner"
It is carried out in a type of plant. Drying of the material can be done continuously or discontinuously. The incoming gas has a temperature of 250-420℃, and the drying temperature is 150℃
~180℃. The powder obtained is then fed into an ager bin. From this ager bin, the powder is fed to the mixing drum through a feeder and band type weighing-metering device. The enzyme preparation is simultaneously fed into the mixing drum through a metering device. From the mixing drum, the prepared enzyme-containing cleaning composition is fed through a system of conveyor mechanisms into bottles for small and large volume packaging.

According to another aspect of the invention, the dry ingredients are charged to a drum-type mixer in the following order: sodium phosphate, sodium carbonate, surfactant, powdered soap, sodium sulfate, sodium silicate and enzyme preparation. .

Stirring and mixing of the ingredients takes place for 20 minutes.

After the enzyme-containing detergent composition is mixed, it is discharged into a bottle using a scraper-type conveyor, from which the prepared enzyme-containing detergent composition is distributed to automatic packaging units.

Method for Determining Proteolytic Activity (FOLP Method) Proteolytic activity characterizes the ability of an enzyme preparation to catalyze the proteolytic index into peptides and amino acids and is expressed in protease units per gram of preparation.

The amount of such enzyme as a unit of proteolytic activity under strict standard conditions: at a temperature of 40 °C, 10.5
Protein (casein) at PH and 1 hour hydrolysis time
is estimated to catalyze the hydrolysis of 1 g of

Preparation of solution of enzyme-containing detergent composition From standard sample, enzyme-containing detergent composition 100
g is taken out and then ground into powder in a grinder. 10 g of the enzyme-containing detergent composition is dissolved in distilled water, and then the volume of the solution is made up to 100 ml. Make many diluted solutions from the resulting solution (1:10, 1:5, 1:4
etc).

In the solution to be analyzed, the amount of enzyme-containing detergent composition calculated for 2 ml of reaction mixture is 3 mg.
should not exceed.

Preparation of a 1% solution of casein (substrate) 2 g of casein powder was placed in a 300 ml conical flask and then 140 ml of carbonate-carbonate buffer with a pH of 10.7 were added. Place the flask on a magnetic shaker and then stir the solution for 30 minutes. Thereafter, the flask containing the substrate was placed in a water bath at a temperature of 70°C with stirring to ensure complete dissolution and the substrate was then heated to a temperature of 40°C; at this temperature the hydrogen ion concentration (PH) was 10.5 (if necessary) by adding a 1N solution of sodium oxide (NaOH). The substrate solution was then transferred from the conical flask to a 200 ml lightweight flask and then diluted with a 0.2 M solution of carbonate-bicarbonate buffer at 180 mL.
Make the volume ~190ml. Thereafter, the casein solution was cooled with circulating water to a temperature of 20°C, and the dissolved amount of the substrate was adjusted using a 0.2M carbonate-bicarbonate buffer solution.
The volume should be 200ml. The storage time of the substrate in the refrigerator is no more than 2 days.

Carbonate-bicarbonate buffer with PH of 10.7 0.2
Solution Preparation For the production of carbonate-bicarbonate buffer, 45 ml of a 0.2M solution of sodium carbonate, Na ₂ CO ₃ and 5 ml of a 0.2M solution of sodium bicarbonate, NaHCO ₃ were charged into a 200 ml lightweight flask, and then the solution volume was Bring up to the mark using distilled water.

Preparation of phorin solution To prepare the basic phorin solution, 700 ml of distilled water.
Pour into a 1500 ml flask and add 100 g of sodium tungstate followed by 25 g of sodium molybdate. Then 50 ml of 85% orthophosphoric acid (specific gravity 1.689) and 100 ml of concentrated hydrochloric acid are added to the mixture.

The mixture is heated to reflux over a low flame for 10 hours. 150g lithium sulfate, 50ml distilled water and 4-5 liquid bromine
Add drops to the cooled mixture. Heat the mixture to reflux over a low flame for 15-20 minutes to remove excess bromine. Store the solution in a dark glass flask in the refrigerator. After storage for 2-3 months, 1-2 drops of bromine should be added to the solution, which is then boiled again. A cloudy solution or a change in color from yellow to fringe is a sign of unsuitability.

A working solution is prepared from the base solution by diluting it with water in a ratio of 1:3 before analysis.

Procedure for determination of proteolytic activity: 5 ml of substrate is injected into test tubes with a height of 150-180 mm and a diameter of 15-18 mm, followed by 5 hours at a temperature of 40°C in an ultrathermostat. keep.
Add 2.5 ml of distilled water to the first test tube, record the time, stir the contents and keep in the ultrathermostat for 60 minutes at a temperature of 40°C. To the other test tube, add a 2.5 ml portion of the solution of the diluted enzyme-containing detergent composition described above, record the time again,
The contents are stirred thoroughly and then set for hydrolysis at a temperature of 40°C for 60 minutes. After the hydrolysis time (60 minutes) has elapsed, add 5 ml of trichloroacetic acid 0.3M solution.
is added to each tube, starting with the first one (control), to stop the fermentation reaction and precipitate the unhydrolyzed protein (casein). The mixture is mixed vigorously and then held in an ultrathermostat at a temperature of 40°C for 15 minutes to ensure complete precipitation.

The filtrate is then filtered using filter paper and the amount of hydrolyzed protein is determined in the filtrate with respect to tyrosine.
For this purpose, 2 ml of the filtrate was poured into test tubes and then each test tube was filled with sodium carbonate.
5 ml of 0.5M solution and 1 of the furin solution used
ml was slowly added with continuous stirring and kept at a temperature of 40°C for 30 minutes in an ultrathermostat (for coloration); then using a cell with a distance between working surfaces of 5 mm, Photometric measurements are carried out using a photoelectric colorimeter under a wavelength of 656-677 nm. Readings are taken from the drum on the right side of the device.

The optical density of the test solution is determined relative to the control test (water).

Substitute the optical density (d) obtained from the measurement into the following formula to determine the proteolytic activity of the enzyme-containing detergent composition: PA = (4.7 x D + 0.1)/n x 1000 units. /g (where PA is the protein activity of the enzyme-containing detergent composition; D is the optical density of the enzyme preparation within 2 ml of the reaction mixture; mg: 4.7 and 0.1 are the degree of protein hydrolysis versus protein hydration; It is a constant factor obtained empirically from studies regarding the amount of enzyme preparation consumed for degradation: 1000 is the factor for converting g to mg).

The optimal range for estimating the optical density of enzyme preparations is D
=0.15 to 0.35.

EXAMPLES In order to understand the invention even better, examples of the invention are described below in a non-limiting manner.

Example 1 An enzyme-containing cleaning composition for pre-sterilization of medical instruments and tools is prepared, which contains the following components (% by weight): Sodium dodecylbenzenesulfonate 4.0 Soap 2.0 Tripolyphosphate Sodium 35.0 Sodium metasilicate 20.0 Sodium carbonate 19.0 Sodium enzyme preparation 0.5 Sodium sulfate Balance The enzyme preparation has the following components (% by weight): Alkaline protease 30.0 Neutral protease 45.0 Elastase 5.0 Collagenase 4.0 Leucine aminopeptidase 0.011 Carboxypeptidase 0.1 5 Fibrinolysis Enzyme 1.5 Lipase 2.0 Amylase Balance To produce this enzyme-containing cleaning composition, the raw materials are fed into the reaction mixer in the following order using an automatic metering device: 142 kg of sodium dodecyl sulfonate;
Soap 91.5Kg, water 1518Kg, sodium carbonate 108Kg
Kg, sodium sulfate 665Kg, sodium tripolyphosphate 1120Kg, sodium metasilicate 640Kg. The components are fed with stirring and mixing is heated to a temperature of 80 DEG to 90 DEG C. with hot water circulating in the water jacket of the reaction mixer. After charging all ingredients, the 4800Kg amount of material is stirred for an additional 10-15 minutes.
After stirring, the material is fed from the mixer through the pipe system to a distribution vessel; from the distribution vessel the material is fed under pressure to the spray nozzle of the drying tower. Drying of materials is based on the principle of "convection" within the drying zone.
It is carried out in an air stream at a temperature of 150-180 ° C. The dry powder is fed from the paper bottom of the drying tower onto a belt conveyor and then from a system of conveyor mechanisms to an argar bin; from this argar bin the powder is fed via a feeder and a belt type weighing device to a drum type mixer.

The enzyme preparations are fed simultaneously into the same mixer via a dispenser and a belt-type weighing device. The amount of enzyme preparation is 16Kg. After mixing,
An amount of 3200 kg of enzyme-containing detergent composition with 10% moisture is transferred through a system of conveyor mechanism into large volumes (20-25 kg back) or small volumes (500-700 g).
packaging).

Enzyme preparations are prepared by growing the bacterium Bacillus subtilis (Bacillus subtilis) in a liquid medium containing necessary additives such as a source of nitrogen, carbohydrates, phosphorus, and B vitamins.
Subtilis) is submerged in culture at a temperature of 37°C with continuous stirring and aeration for 42 to 44 hours. Under such conditions, enzyme propagation takes place therein. Once maximum protein hydrolysis activity is achieved, fermentation is stopped. For this purpose, the enzyme preparation is recovered after fermentation and then purified.
The biomass is separated from the obtained culture liquid by centrifugation, and the centrifuged concentrate is filtered under sterile conditions. The mother liquor is then passed through an ultrafiltration membrane. The ultra-concentrated product obtained in this way is dried by a spray method, and then 50,000 to 100,000 FOLP units/
The enzyme-containing detergent composition is shaped into granules having a size of 0.2 to 1.5 mm and having an enzyme activity of 1.5 g.

Example 2 An enzyme-containing cleaning composition for pre-sterilization of medical instruments and instruments is prepared containing the following components (% by weight): Alkyl sulfate 4.0 Polyethylene glycol ester of the synthetic fatty acid monoethanolamide 2.0 Soap 4.0 Sodium tripolyphosphate 30.0 Sodium metasilicate 25.0 Sodium carbonate 22.0 Enzyme preparation 1.0 Sodium phosphate Balance.

The enzyme preparation contains the following components (% by weight): Alkaline protease 50.0 Neutral protease 35.0 elastase 2.5 Collagenase 2.0 Leucine aminopeptidase 0.005 Carboxypeptidase 0.08 Fibrinolytic enzyme 0.75 lipase 1.0 Amylase remainder.

The enzyme-containing detergent composition is prepared as described in Example 1 above. The amount of ingredients is as follows: alkali sulfate 365.7Kg; soap
128Kg; Synthetic resin acid monoethanolamide polyethylene glycol ether 65Kg; Water 1240Kg;
Sodium carbonate 704Kg; Sodium sulfate 527Kg; Sodium tripolyphosphate 960Kg; Sodium metasilicate 720Kg.

The amount of enzyme preparation used is 32Kg, and its hydrolytic activity is 100000 FOLP units/g.

Example 3 An enzyme-containing cleaning agent for pre-sterilization of medical instruments and tools is produced, consisting of the following components (% by weight): Sodium alkylbenzene sulfonate 3.0 Polyethylene glycol monomer based on primary aliphatic alcohols Alkyl ether 2.0 Soap 3.0 Sodium tripolyphosphate 32.0 Sodium silicate 23.0 Sodium carbonate 21.0 Enzyme preparation 2.0 Sodium sulfate Balance.

The enzyme preparation has the following composition (% by weight): alkaline protease 60 Neutral protease 27 Elastase 0.01 Collagenase 0.001 Leucine aminopeptidase 0.0001 Carboxypeptidase 0.04 Fibrinolytic enzyme 0.02 Lipase 0.5 Amylase remainder.

The enzyme-containing detergent composition is prepared as described in Example 1. The amounts of ingredients used are as follows: Sodium alkylbenzene sulfonate
213.4Kg; Monoalkyl ether of polyethylene glycol based on primary aliphatic alcohol66.9
Kg; Soap 137.3Kg; Water 1562Kg; Sodium carbonate
672Kg; Sodium sulfate 687.3Kg; Sodium tripolyphosphate 1024Kg; Sodium silicate 373.3Kg.

The amount of enzyme preparation used was 64 kg, and its proteolytic activity was 50000 FOLP units/g.

Example 4 An enzyme-containing cleaning composition for pre-sterilization of medical instruments and tools is produced, consisting of the following components (wt%): Sodium dodecylbenzene sulfate 5.3 Soap 3.0 Sodium tripolyphosphate 33.0 Sodium metasilicate 20.0 Sodium carbonate 20.0 Enzyme Preparation 2.0 Sodium Sulfate Balance The enzyme preparation has the composition described in Example 3 above. The enzyme-containing detergent composition is produced by blending. For this purpose, 206.3 Kg of sodium tripolyphosphate, 125.0 Kg of sodium carbonate and 36.8 Kg of sodium dodecylbenzene sulfate are charged into a drum-type mixer together with 26.8 Kg of powdered soap, 92 Kg of sodium sulfate and 125 Kg of sodium metasilicate.
The enzyme preparation is then charged into the mixer in an amount of 12.5 Kg: its proteolytic activity is 1000 FOLP units/g. Mix the ingredients for 20 minutes. After the blending of the final purified product is completed, the final product is conveyed into bottles by a scraper conveyor and then filled with powder.

All the above-mentioned formulations (Examples 1-4) of enzyme-containing cleaning compositions were tested on medical instruments and medical equipment at temperatures of 40-50°C under both manual and mechanical cleaning conditions. Completely remove protein and fat contaminants from equipment.

The extent of contaminant removal is controlled by the ortho-toluidine test.

The bacterium Bac.Subtilis,
The enzyme preparations obtained by submerged culture for 42 to 44 hours at a temperature of 37° C. under continuous aeration have the composition of each enzyme described in Examples 1 to 4 above.

Claims (1)

[Claims] 1. An enzyme-containing cleaning agent for pre-sterilization of medical instruments and tools containing an enzyme preparation containing an anionic surfactant, sodium phosphate, sodium silicate, sodium carbonate, sodium sulfate, and alkaline protease and amylase. A composition, wherein the composition also contains a soap comprising a sodium salt of a fatty acid, and the enzyme preparation further comprises the following component proportions (% by weight): alkaline protease 30-60 neutral protease 27-45 elastase 0.01-5.00 Collagenase 0.001-4.00 Leucine aminopeptidase 0.0001-0.011 Carboxypeptidase 0.04-0.15 Fibrinolytic enzyme 0.002-1.500 Lipase 0.5-2.0 Amylase As shown in the remainder, neutral protease, elastase, collagenase , leucine amino The enzyme-containing detergent composition contains peptidase, carboxypeptidase, fibrinolytic enzyme, and lipase, and further has the following component ratios (wt%): Anionic surfactant 4.0-6.0 Sodium phosphate 30.0-35.0 Sodium silicate 20.0- 25.0 sodium carbonate 19.0-22.0 fatty acid sodium salt-containing soap 2.0-4.0 enzyme preparation 0.5-2.0 sodium sulfate the balance. 2. The enzyme-containing composition according to claim 1, wherein the composition further contains a nonionic surfactant in an amount of 1 to 2% by weight of the anionic surfactant. 3. The nonionic surfactant according to claim 1, wherein monoalkyl ether of polyethylene glycol based on primary aliphatic alcohol, polyoxyethylene glycol ether of monoethanolamide of synthetic fatty acid is used. Enzyme-containing composition.