KR20170060679A - Manufacturing method of hydrophile film for blood sugar strip using for measuring blood sugar level - Google Patents

Manufacturing method of hydrophile film for blood sugar strip using for measuring blood sugar level Download PDF

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KR20170060679A
KR20170060679A KR1020150165121A KR20150165121A KR20170060679A KR 20170060679 A KR20170060679 A KR 20170060679A KR 1020150165121 A KR1020150165121 A KR 1020150165121A KR 20150165121 A KR20150165121 A KR 20150165121A KR 20170060679 A KR20170060679 A KR 20170060679A
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film
strip
hydrophilic film
blood glucose
surfactant
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KR1020150165121A
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구자범
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주식회사 세화무역
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B38/00Ancillary operations in connection with laminating processes
    • B32B38/16Drying; Softening; Cleaning
    • B32B38/164Drying
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04Interconnection of layers
    • B32B7/12Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/14Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers
    • B32B37/24Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with at least one layer not being coherent before laminating, e.g. made up from granular material sprinkled onto a substrate
    • B32B2037/243Coating
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/04Endocrine or metabolic disorders
    • G01N2800/042Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism

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Abstract

The present invention relates to a method for producing a hydrophilic film for a blood glucose measurement strip, a hydrophilic film for a blood glucose measurement strip produced by the method, and a strip for measuring blood glucose comprising the hydrophilic film, wherein the base film is subjected to plasma treatment or corona treatment It is possible to manufacture a strip having a reduced manufacturing cost by improving the adhesion to each layer layer of the strip without the same step, and it is possible to move the blood at a constant speed in the strip and maintain a low scattering degree.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to a method for producing a hydrophilic film for a blood glucose measurement strip,

The present invention relates to a method for producing a hydrophilic film for a blood glucose measurement strip, wherein the hydrophilic film is prepared by mixing a surfactant and a solvent, and when the base film is coated, To a process for producing a hydrophilic film for a strip.

Currently, the World Diabetes Federation warns that the number of diabetic patients in the world will surpass more than 360 million in the next 20 years, and the number of diabetic patients is increasing every year by 8.6%. In other words, the environmental factors such as high caloric value, high fat, high protein diet, lack of exercise, and stress due to westernization of dietary habits in the modern age are greatly contributing to the increase in the number of diabetic patients every year. Technology is becoming important.

Thus, one of the methods for diagnosing disease or health condition is a blood glucose meter which is capable of easily checking health condition and disease through blood collection. Here, the blood glucose meter is a device for measuring the concentration of sugar in the blood, and displays the blood glucose value by inserting the blood into the blood glucose meter by inserting the blood glucose into the blood glucose strip. Before this blood glucose meter appeared, I had to go to the hospital to check my health condition, but now I can use my blood glucose meter to check my health with my blood glucose meter. At this time, the blood glucose strip inserted into the blood glucose meter is a once-consuming consumable, and it is required to continuously develop the product when the number of diabetic patients requiring three or more blood glucose checks per day is increasing.

Generally, a plasma treatment is applied to one surface of a substrate film to produce a strip for measuring glucose, and then a hot melt adhesion step is performed, and the plasma treatment is a manufacturing step for improving adhesion. U.S. Pat. No. 7,738,190 attempts to corrode one side of a PET film to improve the adhesive strength in order to produce a strip for measuring blood glucose. However, the problem arises that the manufacturing cost increases as the manufacturing step for manufacturing a strip for measuring blood glucose is added, and such a problem can give a great economic burden to a diabetic patient who needs three or more blood glucose checks every day.

Therefore, it is an urgent matter to study a method for simplifying the production of a strip for measuring blood glucose.

It is an object of the present invention to provide a method for producing a hydrophilic film for a blood glucose measurement strip.

Another object of the present invention relates to a strip for measuring blood glucose comprising a hydrophilic film for a blood glucose measurement strip and a hydrophilic film for the blood glucose measurement strip.

It is still another object of the present invention to provide a strip for measuring blood glucose which improves the adhesion of each layer layer of the strip to the base film without any steps such as plasma treatment or corona treatment.

According to one embodiment of the present invention, there is provided a process for preparing a mixture comprising: a) mixing 0.001 to 20% by weight of a surfactant and 80 to 99.999% by weight of a solvent; b) sealing the upper portion of the container containing the mixture of step a), followed by primary stirring; c) after the step of stirring in step b), moving to the coating line, followed by secondary stirring; d) after the secondary agitation in the step c), coating the base film with 2 to 30 占 퐉 and coating; And e) hot-air drying at 100 to 150 ° C. The present invention relates to a method for producing a hydrophilic film for a blood glucose measurement strip.

In one embodiment of the present invention, the primary stirring step of the step b) is completed when the sample is collected in the absence of the upper layer separation in 40 to 60 minutes after the sample is collected. .

In one embodiment of the present invention, the hot air drying in step e) is a hot air drying for 2 to 20 minutes.

In one embodiment of the present invention, the base film of step d) is not subjected to a plasma treatment, and a method for producing a hydrophilic film for a blood glucose measurement strip.

In one embodiment of the present invention, the surfactant is at least one selected from the group consisting of sulfate, glucoside, betaine, succinate, amide, amine, stearate, lecithin, distearate, glycol, sorbate, The present invention relates to a method for producing a hydrophilic film for a blood glucose measurement strip.

In one embodiment of the present invention, the surfactant is selected from the group consisting of ammonium lauryl sulfate, Alkyl Poly Glucosides, Arachidyl glucoside, Cetearyl glucoside, But are not limited to, Cocoamidoproply betaine, Disodium laurethsulfosuccinate, Ethoxylated Alkyl-amine, Glyceryl stearate, Hydrogenated lecithin, Polyglyceryl 3-methylglucose distearate, Poly Ethylene Glycol, Poly propylene glycol, Polysorbate, Sorbitan stearate, ), Sorbitan isostearate, sodium coco-sulfate, and their horns To any one selected from the group consisting of water or more in a method for producing a hydrophilic film for blood glucose test strip.

In one embodiment of the present invention, the solvent is at least one selected from the group consisting of C 1 to C 4 alcohols, cellosolves, acetone, and mixtures thereof.

In one embodiment of the present invention, the solvent is at least one selected from the group consisting of ethyl alcohol, methyl cellosolve, isopropyl alcohol, acetone, and mixtures thereof.

In one embodiment of the present invention, polyglyceryl 3-methylglucose distearate, polyethyleneglycol, polypropylene glycol, and polypropylene glycol are used as the surfactant in step a) , Polysorbate and a mixture thereof, it is dissolved in methyl cellosolve and then mixed with a solvent, and the dissolution in the methyl cellosolve is carried out by adding methyl cellosolve to the surfactant in a weight of 2 to 4 times The present invention also relates to a method for producing a hydrophilic film for a blood glucose measurement strip.

In one embodiment of the present invention, a hydrophilic film for a blood glucose measurement strip is prepared by the above-described method.

According to an embodiment of the present invention, there is provided a strip for measuring blood glucose comprising a hydrophilic film, a base film, and an adhesive layer, wherein the hydrophilic film is a base film on one surface of which is coated with a hydrophilic film, An enzyme layer is formed on the upper surface of the electrode layer, and the hydrophilic film and the base film are adhered to each other by an adhesive layer, and the adhesive layer is formed by a hot-melt process in which a hydrophilic film, Strips.

According to an embodiment of the present invention, the strip for measuring blood glucose is a strip for measuring blood glucose having a distilled water drop diameter of 4 to 12 mm and a contact angle of water of 25 to 32 °.

Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention and claims.

The embodiments of the present invention are described in order to more fully explain the present invention to those skilled in the art, and the following embodiments may be modified into various other forms, It is not limited to the embodiment. Rather, these embodiments are provided so that this disclosure will be more faithful and complete, and will fully convey the scope of the invention to those skilled in the art.

In the drawings, the thickness and size of each layer are exaggerated for convenience and clarity of description, and the same reference numerals refer to the same elements in the drawings. As used herein, the term "and / or" includes any and all combinations of one or more of the listed items.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a," "an," and "the" include singular forms unless the context clearly dictates otherwise. Also, " comprise "and / or" comprising "when used herein should be interpreted as specifying the presence of stated shapes, numbers, steps, operations, elements, elements, and / And does not preclude the presence or addition of one or more other features, integers, operations, elements, elements, and / or groups.

In one embodiment of the present invention, there is provided a process for preparing a mixture comprising: a) mixing 0.001 to 20% by weight of a surfactant and 80 to 99.999% by weight of a solvent; b) sealing the upper portion of the container containing the mixture of step a), followed by primary stirring; c) after the step of stirring in step b), moving to the coating line, followed by secondary stirring; d) after the secondary agitation in the step c), coating the base film with 2 to 30 占 퐉 and coating; And e) hot-air drying at 100 to 150 ° C. The present invention relates to a method for producing a hydrophilic film for a blood glucose measurement strip. When the amount of the surfactant is less than 0.001, hydrophilicity is not expressed. When the surfactant is contained in an amount exceeding 20%, the adhesive strength is decreased.

The step a) is a step of mixing a surfactant and a solvent. An impeller (mixing blade) is put into a plastic container for mixing and the upper part is sealed. Thereafter, the completion of the primary agitation step in step b) is determined by time and sampling, and it is judged whether or not the upper layer separation occurs after the sampling. When the primary stirring step is completed, the stirred mixture is transferred to a coating line for coating the base film, followed by secondary stirring. After the secondary agitation, the substrate film is coated before the upper separation occurs.

When the thickness of the coating is less than 2 탆, the function of transporting blood is insufficient and the measurement of blood glucose of the strip is not easy. There is a problem in that the profit on the cost is not large. The base film of the step d) is not subjected to plasma treatment. Prior to coating a hydrophilic film in the manufacture of a general strip, the base film was subjected to plasma treatment or corona treatment, then a hydrophilic film was coated and then an adhesive layer was formed to improve the adhesion. However, in the case of the present invention, unlike the existing strip, the base film is not subjected to the plasma treatment, the adhesion can be improved, and the cost can be saved because there is no plasma treatment step. The step of drying in the step of e) is carried out at a temperature of 100 to 150 ° C. When the drying temperature is lower than 100 ° C, there is a problem that it takes a long time to dry after coating the substrate film. There is a problem that the profit on the cost is not large.

According to an embodiment of the present invention, whether or not the stirring of step b) has been completed may be such that the first stirring step of step b) is completed when the sample is not separated from the upper layer within 40 to 60 minutes after the sample is collected And a method for producing a hydrophilic film for a blood glucose measurement strip. The primary stirring step is for mixing the surfactant and the solvent. When the stirring time is not sufficient, the surfactant and the solvent are not mixed. After the stirring is stopped, when the sample is taken and the upper layer separation is observed, The upper layer separation occurs 40 minutes before the start. More preferably, it is preferable that the upper layer separation does not occur after 60 minutes have elapsed, but there is a problem with an increase in stirring time. It is preferable that the agitation time of the step b) suitable for not causing the upper layer separation to take place within 40 to 60 minutes is 20 to 40 minutes. More preferably 25 to 35 minutes.

In an embodiment of the present invention, the hot air drying in the step e) is a hot air drying for 2 to 20 minutes, preferably a hot air drying for 3 to 15 minutes. When the hot air drying time is less than 2 minutes, there is a problem that the hydrophilic film coated on the base film is not completely dried, and when the drying time is more than 20 minutes, there is a problem that the profit for the cost is not large.

In one embodiment of the present invention, the surfactant is selected from the group consisting of sulfate, glucoside, betaine, succinate, amide, amine, stearate, lecithin, distearate, glycol, sorbate, And more specifically the surfactant is selected from the group consisting of ammonium lauryl sulfate, Alkyl Poly Glucosides, Arachidyl glucoside, Cetearyl glucoside, But are not limited to, Cocoamidoproply betaine, Disodium laurethsulfosuccinate, Ethoxylated Alkyl-amine, Glyceryl stearate, Hydrogenated lecithin, Polyglyceryl 3-methylglucose distearate < RTI ID = 0.0 > , Polyethyleneglycol, polypropylene glycol, polysorbate, sorbitan stearate, sorbitan isostearate, sodium coco-sulfate (for example, Sodium coco-sulfate, and mixtures thereof.

In one embodiment of the present invention, the solvent is at least one selected from the group consisting of C 1 to C 4 alcohols, cellosolves, acetone, and mixtures thereof. More specifically, the solvent is selected from the group consisting of ethyl alcohol, methyl cellosolve, Propyl alcohol, acetone, and mixtures thereof.

In one embodiment of the present invention, polyglyceryl 3-methylglucose distearate, polyethyleneglycol, polypropylene glycol, and polypropylene glycol are used as the surfactant in step a) , Polysorbate and a mixture thereof, it is dissolved in methyl cellosolve and then mixed with a solvent, and the dissolution in the methyl cellosolve is carried out by adding methyl cellosolve to the surfactant in a weight of 2 to 4 times .

The step a) is a step for mixing the surfactant and the solvent. The surfactant and the solvent are mixed without any special procedure, and then the prepared mixture is prepared through steps b) to e). Polyglyceryl 3-methylglucose distearate, Poly Ethylene Glycol, Polypropylene Glycol, Polysorbate, and Polysaccharide may be used as the surfactant. When a mixture is included, the surfactants do not dissolve in a solvent, so that they are difficult to mix even if they are mixed directly with a solvent and stirred. Thus, the surfactant may be dissolved in methyl cellosolve, mixed with another solvent, or used only as a solvent. In order to increase the solubility of the surfactant and the methyl cellosolve, the weight of methyl cellosolve relative to the surfactant is 2 to 4 times, more preferably 2 times.

The present invention relates to a hydrophilic film for a blood glucose measurement strip prepared by the above-described method.

According to an embodiment of the present invention, there is provided a strip for measuring blood glucose comprising a hydrophilic film, a base film, and an adhesive layer, wherein the hydrophilic film is a base film on one surface of which is coated with a hydrophilic film, An enzyme layer is formed on the upper surface of the electrode layer, and the hydrophilic film and the base film are adhered to each other by an adhesive layer, and the adhesive layer is formed by a hot-melt process in which a hydrophilic film, Strips. The hydrophilic film is a hydrophilic film for a blood glucose measurement strip prepared by the above production method. In order to increase the adhesive strength, the surface of the substrate film is subjected to a pretreatment such as a plasma treatment before the coating of the substrate film so as to bond the hydrophilic film to the base film. It makes it rough to increase the adhesion. In this method, a step for bonding is added to raise the manufacturing cost. However, before the hydrophilic film according to an embodiment of the present invention is coated on the substrate film, the adhesion between the hydrophilic film and the base film can be improved without performing a pretreatment such as a separate plasma treatment, and a pretreatment step such as plasma treatment The manufacturing cost can be lowered.

According to an embodiment of the present invention, a strip for measuring blood glucose is a strip for measuring blood glucose having a distilled water drop diameter of 4 to 12 mm and a contact angle of water of 25 to 32 °. In order to measure blood glucose, blood must move above a certain level when dropped on the strip. If it moves below 4 mm, the movement distance is too short to measure blood glucose. In addition, if the length of the drop diameter exceeds 12 mm, there is a problem in that the profit on the cost is not large. When the contact angle of water is more than 32 DEG, the hydrophilicity of the film is low and the surface wettability is poor. When the contact angle is less than 25 DEG, there is a problem in that the profit for the cost is not large.

The present invention relates to a method for producing a hydrophilic film for a blood glucose measurement strip, a hydrophilic film for a blood glucose measurement strip produced by the method, and a strip for measuring blood glucose comprising the hydrophilic film, wherein the base film is subjected to plasma treatment or corona treatment It can improve the adhesion to each layer layer of the strip without the same step, move the blood at a constant speed in the strip, and keep the scattering rate low.

1 is a flowchart of a method for manufacturing a hydrophilic film for a blood glucose measurement strip according to an embodiment of the present invention.
Figure 2 is for a strip structure.
3 is a cross-sectional view of a top layer 100 including a base film and a hydrophilic film in a strip structure.
4 is a cross-sectional view of a middle layer 200 including an adhesive layer in a strip structure.
5 is a cross-sectional view of a base layer 300 including a base film and an electrode layer in a strip structure.
6 is a cross-sectional view of the strip structure.
7 is a plan view of the strip structure.
1: Printing surface
2: first base film
3: hydrophilic membrane
4: First adhesive layer
5: Second base film
6: Second adhesive layer
7: Electrode printing
8: Electrode
9: Base film
10: Transparent section
11: Starting point of blood flowing section
12: Arrival point of blood flowing section

Hereinafter, the specific structure and function of the present invention will be described in more detail with reference to Examples and Experimental Examples. However, the following examples and experimental examples are only illustrative of the present invention, but are not limited thereto.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a flowchart of a method for producing a hydrophilic film for a blood glucose measurement strip according to an embodiment of the present invention. FIG. a) preparing a mixture (S100) by mixing 0.001 to 20% by weight of a surfactant and 80 to 99.999% by weight of a solvent; b) sealing the upper portion of the container containing the mixture of step a), followed by primary stirring (S200); c) a step (S300) of stirring after the stirring in the step b), followed by a second stirring after moving to the coating line; d) a step (S400) of coating the base film with 2 to 30 占 퐉 after the second stirring of the step c); And e) hot air drying at 100 to 150 캜 (S500).

Wherein the surfactant is selected from the group consisting of sulfate, glucoside, betaine, succinate, amide, amine, stearate, lecithin, distearate, glycol, sor Wherein the surfactant is at least one selected from the group consisting of ammonium lauryl sulfate, Alkyl Poly Glucosides, arachidyl glucoside, Cetearyl glucoside, Cocoamidoproply betaine, Disodium laurethsulfosuccinate, Ethoxylated Alkyl-amine, Glyceryl stearate (glyceryl stearate) stearate, hydrogenated lecithin, polyglyceryl 3-methylglycol But are not limited to, polyglyceryl 3-methylglucose distearate, polyethyleneglycol, polypropylene glycol, polysorbate, sorbitan stearate, sorbitan iso Wherein the solvent is selected from the group consisting of C 1 to C 4 alcohols, cellosolves, acetone, and mixtures thereof, wherein the solvent is selected from the group consisting of Sorbitan isostearate, Sodium coco-sulfate, , And more specifically, the solvent is at least one selected from the group consisting of ethyl alcohol, methyl cellosolve, isopropyl alcohol, acetone, and mixtures thereof.

When the surfactant is contained in an amount of less than 0.001% by weight, the surfactant contained in the mixture of step a) is too small to exhibit the performance of the surfactant, that is, the hydrophilic film is not present. When the surfactant is contained in an amount exceeding 20% There is a problem that the adhesive strength between the hydrophilic film and the first adhesive layer 4 in the structure of the strip (see FIG. 2) is significantly reduced. That is, the first adhesive layer 4 should be formed using a hot-melt adhesive or a double-faced tape on the hydrophilic film, but when the surfactant is contained in an amount exceeding 20% by weight, the adhesive strength is decreased to form the first adhesive layer 4 there is a problem.

The step d) coating the base film with the base film in a thickness of 2 to 30 탆 (S400) after the second agitation in the step c) may be carried out by a conventional coating method known in the art such as a dip coating, Various methods such as coating, roll coating, comma coating, casting or a mixing method thereof can be used without limitation.

2, the structure of a general strip includes a top layer 100 comprising a first base film and a hydrophilic film, a middle layer 200 comprising a first adhesive layer, a second base film and a second adhesive layer And a base layer 300 including an electrode print and a base film.

The structure of each layer for the upper layer 100, the intermediate layer 200, and the base layer 300 in the structure of the general strip shown in FIG. 2 is shown in FIG. 3 to FIG. 6 is a diagram showing the overall structure of a strip according to the first embodiment of the present invention. In this figure, a printed surface 1, a first base film 2, a hydrophilic film 3, a first adhesive layer 4, a second base film 5, 6, an electrode print 7, an electrode 8, and a base film 9. In a general strip production step, the first base film is subjected to a plasma treatment, which is carried out for two effects. The first is to increase the adhesion between the respective layer layers according to the structure of the strip of FIG. 2, and the second is for the surface cleaning effect. The base film generally uses a PET film, and when the surface of the PET film is roughened by plasma treatment, the adhesion is improved. Also, through surface cleaning, when blood is dropped, it facilitates the movement of blood so that the enzyme reaction can be read. However, the method of producing a hydrophilic film according to the manufacturing method according to an embodiment of the present invention exhibits a high adhesive force without applying a plasma treatment to the PET film in order to coat the PET film. That is, in comparison with the strip produced by the plasma treatment, the strip produced by the manufacturing method according to the embodiment of the present invention has improved adhesion of each layer layer.

In addition, the blood must move from the starting point 11 of the blood flow section to the arrival point 12 of the blood flow section as shown in FIG. 7, and the change of the enzyme can be read by moving at least 5 mm or more. The hydrophilic film produced according to an embodiment of the present invention allows the blood to move more than 5 mm at a constant rate and has properties that do not affect the reaction between the enzyme and blood.

The electrode plate on the base film may be formed by a method of bonding using an adhesive layer or by a method of printing without forming an adhesive layer.

In addition, the blood can be moved at a constant speed in the strip, and the scattering coefficient can be approximated to 10%. In other words, when the variance and the distribution are given as the numerical value indicating the dispersion of the data, the dispersion degree refers to the degree of dispersion of the variance to the center value of the distribution, Can be low.

Hereinafter, methods and properties of a hydrophilic film for a blood glucose measurement strip according to the present invention will be described with reference to examples.

[ Example  One]

Blood glucose measurement For strip  Preparation of hydrophilic film

[ Manufacturing example  One]

A surfactant is put into a plastic container in a solvent to prepare a mixture, an impeller (stirring blade) is put into the plastic container, and the upper portion is sealed with a lap. Stir for 30 minutes. After the completion of the stirring, a sample is taken and placed in a transparent flask, and the time for the upper layer separation to occur is checked. After about 60 minutes, the upper layer separation did not occur, and the primary stirring step was completed. The mixture in which the primary agitation step was completed was moved to the coating line and subjected to secondary agitation. Then, before the upper layer separation occurred, the PET film was coated to a thickness of 10 탆 and hot-air dried at a temperature of 120 캜 for 10 minutes to prepare a hydrophilic film.

The specific surfactant and solvent content are shown in Table 1 below.

ingredient Production Example 1 Production Example 2 Production Example 3 Production Example 4 Surfactants Ammonium lauryl sulfate < RTI ID = 0.0 > 0.0002
weight%
- - One
weight%
Alkyl Poly Glucosides < RTI ID = 0.0 > 0.0002
weight%
- - One
weight%
Arachidyl glucoside < RTI ID = 0.0 > - 0.05
weight%
- One
weight%
Cetearyl glucoside < RTI ID = 0.0 > - 0.05
weight%
- One
weight%
Cocoamidoproplybetaine < / RTI > 0.0002
weight%
- - One
weight%
Disodium laurethsulfosuccinate (Disodium laureth sulfosuccinate) - 0.05
weight%
- One
weight%
Ethoxylated Alkyl-amine < RTI ID = 0.0 > - - - One
weight%
Glyceryl stearate (glyceryl stearate) - 0.05
weight%
- One
weight%
Hydrogenated lecithin < RTI ID = 0.0 > 0.0002
weight%
- - One
weight%
Polyglyceryl 3-methylglucose distearate < RTI ID = 0.0 > - - 2
weight%
3
weight%
Poly Ethylen Glycol - - 0.5
weight%
2
weight%
Polypropylene glycol - - 0.5
weight%
One
weight%
Polysorbate - - 2
weight%
One
weight%
Sorbitan stearate - 0.05
weight%
- 2
weight%
Sorbitan isostearate < RTI ID = 0.0 > 0.0002
weight%
- - One
weight%
Sodium coco-sulfate - 0.05
weight%
- One
weight%
solvent Ethyl alcohol 40
weight%
40
weight%
40
weight%
40
weight%
Methyl cellosolve 30.5
weight%
- 10
weight%
14
weight%
Isopropyl alcohol 15.499
weight%
20.7
weight%
19
weight%
20
weight%
Acetone 14
weight%
39
weight%
16
weight%
6
weight%

[ Manufacturing example  5]

Manufacture of strips for blood glucose measurement

An enzyme layer was formed on the upper surface of the base film on which the electrodes were printed. The base film on which the enzyme layer was formed and the hydrophilic film prepared in Production Examples 1 to 4 were bonded by a hot-melt method. The hot melt adhesive was formed so as to have a groove in the width direction.

[Comparative Example 1]

A PET film was subjected to plasma treatment and coated with ethylene vinyl acetate to prepare a hydrophilic film.

[Comparative Example 2]

A PET film was prepared in the same manner as in Production Example 1, except that the PET film was subjected to plasma treatment before being coated.

[ Example  2]

Evaluation of properties of hydrophilic film for blood glucose measurement strip

1. Adhesion evaluation

The adhesive force of the strip for blood glucose measurement prepared in Production Example 5 and Comparative Example 1 was used to evaluate the adhesive strength.

Generally, the blood sugar check adhesive strength tensile system is kept at a minimum range of 500 g, and when it is less than 500 g, it is considered that no adhesion occurs.

Production Example 1 Production Example 2 Production Example 3 Production Example 4 Comparative Example 1 Comparative Example 2 Adhesion 800g ~ 1kg 650 ~ 900g 600 ~ 750g 500 ~ 700g 500 ~ 900g 900g ~ 1.5kg

And in the case of Comparative Example 1, 500 g to 900 g. Comparative Example 1 and Preparation Example 1 to Preparation Example 4 were carried out in the same manner as in Production Example 1, except that in Production Example 1, 800 g to 1 kg, Production Example 2 was 650 g to 900 g, Production Example 3 was 600 g to 750 g, All were measured to be over 500 g. In the case of Comparative Example 2, in which the hydrophilic coating liquid was prepared in the same manner as in Production Example 1, and the PET film was subjected to plasma treatment, a hydrophilic film was also measured at 900 g to 1.5 kg. But does not show a large difference as compared with Production Example 1. That is, generally, plasma treatment or corona treatment is performed before coating the hydrophilic film to increase the adhesive strength, but the hydrophilic film produced according to one embodiment of the present invention will exhibit sufficient adhesion even without such pretreatment.

2. Measurement of drop diameter and water contact angle of 5 ㎕ distilled water

5 占 퐇 of distilled water was dropped on the hydrophilic film for strips prepared in Production Examples 1 to 4 to measure the size of the drop diameter. The wet film was first pressed with a tissue paper, . The contact angle was measured with a goniometer over time. On Eye Conditions In a capture bubble method, which is desirable for simulation, contact bubbles injected with a syringe were contacted with a film immersed in Milli-Q water, and the contact angle was measured.

Surfactant concentration 5 드 Drop diameter of distilled water Contact angle Production Example 1 0.001 wt% 4.0 to 5.0 mm 30 ° ± 2 Production Example 2 0.3 wt% 6.0 to 9.0 mm 29.5 ° ± 2 Production Example 3 5 wt% 7 ~ 10mm 29 ° ± 2 Production Example 4 20 wt% 10 to 12 mm 27.5 ° ± 2

The results of measurement of the drop diameter of the hydrophilic films prepared in Production Examples 1 to 4 are shown in Table 3 above. According to Table 3, the hydrophilic film prepared according to Preparation Examples 1 to 4, when 5 占 퐇 of distilled water was dropped, was observed in a range of 4 mm to 4 mm when the distilled water was dropped. 12 mm.

As a result of measuring the contact angle of water, the contact angle of the hydrophilic film for strips prepared in Production Examples 1 to 4 was measured at 27.5 to 30 °. The more the surfactant is included, the lower the contact angle, but not more than 5%.

However, as shown in Table 3, when the concentration range of the surfactant is included in the range of 0.3 wt% to 5 wt%, the range of the drop diameter of the distilled water of the hydrophilic film is measured to be about 6.0 to 10 mm, and the contact angle is 29 to 29.5 2 < / RTI > As shown in the above table, when the concentration range of the surfactant is less than 0.3% by weight, the drop diameter of the blood in the strip is too small to measure blood glucose. When the concentration of the surfactant is more than 5% by weight The diameter of drop is 10 to 12 mm and the contact angle is 27.5 ° ± 2. In this case, due to the drop diameter size and contact angle, it flows too quickly and does not sufficiently react with the enzyme on the strip, , The concentration range of the surfactant contained in the hydrophilic film of the strip is from 0.001 wt% to 20 wt%, preferably from 0.3 wt% to 5 wt%. When the concentration range of the surfactant is 0.3 wt% to 5 wt%, the flow rate of the distilled water is 2 mm / s to 3.5 mm / s. When the flow rate is less than 2 mm / s, Time is too long, and if it exceeds 3.5 mm / s, the flow rate is too fast and the enzyme and reaction may not be sufficiently occurred.

Generally, the lower the value of the contact angle, the greater the hydrophilicity of the film and the better the surface wettability. The contact angle and the size of the drop diameter of the distilled water depending on the concentration range of the surfactant contained in the hydrophilic film. Reflecting these characteristics, the magnitude of the drop diameter of the blood and the contact angle can be controlled by varying the concentration of the surfactant contained in the hydrophilic film. As a result, by controlling the size and contact angle of the drop diameter of the blood, the flow rate of the blood on the strip can be controlled.

Claims (12)

a) mixing 0.001 to 20% by weight of a surfactant and 80 to 99.999% by weight of a solvent to prepare a mixture;
b) sealing the upper portion of the container containing the mixture of step a), followed by primary stirring;
c) after the step of stirring in step b), moving to the coating line, followed by secondary stirring;
d) after the secondary agitation in the step c), coating the base film with 2 to 30 占 퐉 and coating; And
and e) subjecting it to hot air drying at 100 to 150 ° C.
The method according to claim 1,
The primary stirring step of step b) may be carried out after collecting the sample,
Wherein the sample is completed when the upper layer separation does not occur within 40 to 60 minutes.
The method according to claim 1,
Wherein the hot air drying in the step (e) is a hot air drying for 2 to 20 minutes.
The method according to claim 1,
Wherein the base film in step d) is not subjected to plasma treatment.
The method according to claim 1,
Wherein the surfactant is at least one selected from the group consisting of sulfate, glucoside, betaine, succinate, amide, amine, stearate, lecithin, distearate, glycol, sorbate, (2).
5. The method of claim 4,
The surfactant may be selected from the group consisting of ammonium lauryl sulfate, Alkyl Poly Glucosides, Arachidyl glucoside, Cetearyl glucoside, Cocoamidoproply Betaine, Disodium laurethsulfosuccinate, ethoxylated alkyl-amine, glyceryl stearate, hydrogenated lecithin, polyglyceryl 3-methyl < RTI ID = 0.0 > But are not limited to, polyglyceryl 3-methylglucose distearate, polyethyleneglycol, polypropylene glycol, polysorbate, sorbitan stearate, sorbitan isostearate, Sorbitan isostearate, sodium coco-sulfate, and mixtures thereof. Wherein the hydrophilic film is a hydrophilic film.
The method of claim 1, wherein
Wherein the solvent is at least one selected from the group consisting of C 1 to C 4 alcohols, cellosolves, acetone, and mixtures thereof.
The method of claim 6, wherein
Wherein the solvent is at least one selected from the group consisting of ethyl alcohol, methyl cellosolve, isopropyl alcohol, acetone, and mixtures thereof.
The method of claim 1, wherein
Polyglyceryl 3-methylglucose distearate, Poly Ethylene Glycol, Polypropylene Glycol, Polysorbate, and the like are used as the surfactant in the step a) And mixtures thereof, they are dissolved in methyl cellosolve, then mixed in a solvent,
Wherein the dissolution in the methylcellosolve comprises 2 to 4 times the weight of methylcellosolve relative to the surfactant.
A hydrophilic film for a blood glucose measurement strip produced by the manufacturing method according to any one of claims 1 to 8. A strip for measuring blood glucose comprising a hydrophilic film, a base film and an adhesive layer,
Wherein the hydrophilic film is coated on one side of the base film with a hydrophilic film,
The base film is a base film on which an electrode layer is formed, an enzyme layer is formed on an upper surface of the electrode layer,
Wherein the hydrophilic film and the base film are bonded by an adhesive layer,
Wherein the adhesive layer is formed by a hot-melt process of a hydrophilic film that has not been subjected to plasma treatment before coating the substrate film.
12. The method of claim 11,
Wherein the blood glucose measuring strip has a distilled water drop diameter of 4 to 12 mm and a contact angle of water of 25 to 32 °.
KR1020150165121A 2015-11-25 2015-11-25 Manufacturing method of hydrophile film for blood sugar strip using for measuring blood sugar level KR20170060679A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112162095A (en) * 2020-09-24 2021-01-01 上海印标包装有限公司 Hydrophilic film and manufacturing method thereof
CN115850766A (en) * 2022-11-15 2023-03-28 电子科技大学长三角研究院(湖州) Preparation method and application of gradient polar gel

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112162095A (en) * 2020-09-24 2021-01-01 上海印标包装有限公司 Hydrophilic film and manufacturing method thereof
CN115850766A (en) * 2022-11-15 2023-03-28 电子科技大学长三角研究院(湖州) Preparation method and application of gradient polar gel
CN115850766B (en) * 2022-11-15 2023-11-07 电子科技大学长三角研究院(湖州) Preparation method and application of gradient polar gel

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