JPH09138228A - Test pipe and wrapping body for the test piece - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a test piece in which the function of an inspection part is not spoiled even when a wrapping body is opened and shut repeatedly and which can be housed in a small measuring instrument. SOLUTION: In a test piece, the circumference of an inspection part 1 installed on a substrate sheet 2 is surrounded by a preservation stabilization function part 3 such as a desciccating agent, a deoxidizer or the like, or the circumference of an inspection part 1 installed on a substrate sheet 2 having a prescribed preservation stabilization function such as a desciccating agent, a deoxidizer of the like is surrounded by a barrier. In a wrapping body for test pieces, a plurality of test pieces constituted in this manner are stacked and bonded in such a way that the surface of every preservation stabilization function part 3 or every barrier comes into contact with the rear surface of every substrate sheet 1 in the upper part and the lower part and that every inspection part 1 is sealed airtightly so as to be wrapped.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a test piece for detecting a specific substance contained in a sample such as body fluid or food, and a packaging body in which a plurality of the test pieces are stacked and stored.

[0002]

2. Description of the Related Art Physiologically active substances such as enzymes and immunological substances, along with subsequent reaction substances such as redox substances and immobilization materials,
Research and development for forming an inspection portion of a test piece by fixing, printing, or coating on a support have been actively conducted. These test pieces are widely used in fields such as clinical tests, food control, and nutrition control for the purpose of detecting specific substances in samples such as body fluids and foods.

However, many of the physiologically active substances and redox substances used as the material for the test piece are largely affected by atmospheric humidity and oxygen and lose their original functions. Accurate detection cannot be expected with a material that has lost its function, which causes an erroneous judgment. Therefore, preservation management is also important for maintaining the quality of the test piece. Therefore, a storage stabilizer having a high barrier property is usually used by enclosing a storage stabilizer such as a desiccant or an oxygen scavenger.

Therefore, in consideration of the above points, most of the test pieces are stored in a packaging material such as a glass bottle or a film packaging material. In the case of a glass bottle, a plurality of test pieces can be stored and stable at the same time. The agent is enclosed and sealed with a stopper. In the case of a film packaging material, an individual packaging form in which a storage stabilizer is enclosed in each test piece is often adopted. However, the method of individually packaging the test piece and the storage stabilizer in a glass bottle, a film packaging material or the like has the following problems. It damages or loses the inspection part which the inner surface of the glass bottle or the film packaging material contacts. The enclosed storage stabilizer (drying agent, oxygen absorber, etc.) damages or loses the inspection part. In the case of a glass bottle, a test piece damages or loses the inspection part of another test piece. In the case of a film packaging material, the enclosed portion of the inspection unit pushes up the film and projects. Therefore, the inspection unit is likely to receive pressure from the outside of the package. In particular, the protruding portion of the inspection portion of another package, and further the protruding portion of the storage stabilizer (drying agent, oxygen absorber, etc.) damages or loses the inspection portion.

Further, in the method of storing a plurality of test pieces in a glass bottle, the stopper is opened each time the test piece is taken out, so that the frequency of contact between the test piece and the outside air naturally increases. as a result,
The deterioration of the inspection part of the test piece is accelerated. On the other hand, in the case of individual wrapping by film wrapping, the amount of wrapping by individual wrapping increases although there is no concern that the test piece will be opened until immediately before use. Further, regardless of whether a glass bottle or a film packaging material is used, a step of enclosing a storage stabilizer such as a desiccant or an oxygen scavenger is required, which is a practical problem in terms of workability and cost.

[0006] These test strips detect a substance to be detected from a reaction generated in the test section by dropping or sucking a sample into the test section. This detection reaction is a color development reaction of a dye, and in many test pieces that do not require high detection sensitivity, the color development color tone is visually judged. On the other hand, in the case of a color-developing test piece that requires high detection sensitivity, a measuring device that optically measures the color tone of the color is required. Further, when the detection reaction is a current value, a measuring device for measuring an electrochemical response value is required. In recent years, a measuring instrument for this test piece has been reduced in size for individuals, and an instrument that is easy to carry or portable has been developed.

When carrying or carrying such a small measuring device, it is necessary to carry or carry the measuring device together with the glass bottle in which the above-mentioned test piece is stored or the package of the film packaging material. Conventionally, it has been impossible to accommodate the package of these test pieces in the measuring instrument because the measuring instrument is miniaturized. In addition, storing the test piece alone in the measuring instrument, that is, simulating the measuring instrument itself as a package, requires an operation that opens and closes after each use, similar to the method of storing in a glass bottle. , Becomes a problem.

[0008]

SUMMARY OF THE INVENTION Therefore, in order to solve the above-mentioned problems, the present invention solves the above-mentioned problems by contacting the inner surface of a glass bottle or film packaging material with the inspection portion, the contact between the enclosed storage stabilizer and the inspection portion, and the exterior of the package. There is no damage or loss of the inspection part due to pressure from the, etc., and the function of the inspection part is not impaired even if the package is repeatedly opened and closed, and a plurality of test pieces and multiple test pieces that can be stored in a small measuring instrument, It is an object of the present invention to provide a package that is packaged in a laminated state, and further to provide a package that has a simplified packaging process.

[0009]

According to the present invention, in order to solve the above-mentioned problems, the periphery of an inspection part installed on a substrate sheet is surrounded by a storage stability function part such as drying and deoxidizing. Or, a test piece installed on a substrate sheet that has a storage stability function such as drying and deoxidization. A test piece surrounded by a barrier around the test piece, and the test piece is sealed by laminating and bonding the test piece. It is a package formed by packaging.

[0010]

BEST MODE FOR CARRYING OUT THE INVENTION The present invention will be described below with reference to the drawings. FIG. 1 and FIG. 2 are perspective explanatory views of a test piece. The test piece shown in FIG. 1 has an inspection unit 1 on a substrate sheet 2, and a storage stability function unit 3 having a drying or deoxidizing function is installed so as to surround four sides of the inspection unit 1. In the test piece shown in FIG. 2, the inspection unit 1 is provided on the substrate sheet 4 having a storage stability function such as drying or deoxidation, and the barrier units 5 are installed so as to surround the inspection unit 1 on all sides.

FIG. 3 is an explanatory sectional view showing an embodiment of the test piece package according to the present invention. A bundle 7 of test pieces is provided with a peelable adhesive layer 6 on top of the storage stability function part 3 and the barrier part 5 installed so as to surround the four sides of the inspection part 1.
It shows a form in which a plurality of test pieces are stacked in the same direction and the test part is enclosed by a substrate sheet of another test piece. The uppermost test piece is provided with only the substrate sheet without the inspection section. Each bundle 7 of these test pieces is peeled off from the lower test piece one by one and used. Therefore, even when the package is repeatedly opened and closed, the inspection unit does not come into contact with the outside air. In FIG. 3, the bundle 7 of test pieces is packaged in the glass bottle 8, but a soft packaging material such as a film with a zipper can be packaged in the same manner, and even if it is repeatedly opened and closed, the inspection part may come into contact with the outside air. Absent.

The storage stability function part 3 and the substrate sheet 4 having the same function can be easily formed by cutting a commercially available desiccant sheet or oxygen absorber sheet.
It can also be formed by melting or mixing a desiccant or oxygen scavenger material with the pelletized thermoplastic resin at the same time.
The desiccant material is silica gel, calcium chloride, calcium oxide, diphosphorus pentoxide, magnesium oxide, alumina, anhydrone, dehydrite, etc., and the oxygen absorber material is iron powder, iron compound, L-ascorbic acid, sugar, catechol. Etc. can be used.

FIG. 4 is a perspective view showing an embodiment of the measuring device 9 for the test piece, and the accommodating portion 10 for the bundle 7 of the test pieces is installed in the measuring device. As described above, by stacking the test pieces having a storage stability function, the test pieces can be stored in the accommodating portion of the measuring instrument, and the test piece and the measuring instrument can be always carried or carried at the same time.

In the present invention, the test piece having the above-mentioned storage stability function part or the substrate sheet having the same function is laminated and adhered, and the test part is sealed, so that the test part can be shielded from the outside air. There is no need for individual packaging of the pieces.

[0015]

【Example】

<Example 1> Milky polyethylene pellets and a fine powdery silica gel as a desiccant were kneaded and then heat-melted at 240 ° C and screen-printed in a square shape on a polyethylene sheet (thickness 188 µm) (screen plate: 100 mesh, sol thickness 80 μm) and dried to form a storage stability function part. The compounding ratio was 40 parts by weight of silica gel with respect to 400 parts by weight of polyethylene pellets.

A glucose detection ink having the following composition was prepared, and screen-printed on the center of the storage stability function part of the polyethylene sheet (screen plate: 200 mesh, sol thickness 50 μm, drying: 60 ° C. for 30 minutes). . Finally, it was cut into sticks to obtain glucose test pieces. <Glucose detection ink composition> -Citric acid 0.30 parts by weight-Sodium citrate 1.10 parts by weight-Sodium dodecyl sulfate 0.50 parts by weight-Butyl cellosolve 26.55 parts by weight-Polyvinyl acetal resin 1.85 parts by weight- o-Tolidine 0.75 parts by weight Microcrystalline cellulose 15.62 parts by weight Glucose oxidase 0.50 parts by weight Peroxidase 0.41 parts by weight

The surface of the storage-stabilizing functional part of the prepared glucose test piece was coated with a peelable adhesive, 5 glucose test pieces were laminated as shown in FIG. 3, and only a polyethylene sheet was placed on the uppermost test piece. Were laminated. The stacked glucose test specimen bundles were enclosed in glass bottles.

After enclosing the glucose test piece, the glass bottle was stored in an environment of temperature 25 ° C. and humidity 60% RH, the glass bottle was opened every 24 hours, the glucose test piece was taken out, and the color tone of the test piece was measured. did. Immediately after the production, the color tone of the test portion of the glucose test piece was an unused color and white, and when the test portion was dipped in a glucose solution of 100 mg / dl, a deep blue color tone was exhibited. The unused color and the color tone were used as initial values, and the color tone was measured under the same conditions thereafter (La
b color system). Then, the change in color tone (ΔE) from the initial value before storage was calculated (see Table 1).

<Comparative Example> The glucose test pieces prepared in the examples were sealed in a glass bottle without being adhered. After encapsulation, as in the example, the sample was stored in an environment of a temperature of 25 ° C. and a humidity of 60% RH, and an unused color tone and a developed color tone were measured every 24 hours, and a color tone change (ΔE) from an initial value before storage was obtained. Was calculated.

As shown in Table 1, in comparison with the comparative example, in the first embodiment, the inspection part is closed by the storage stability function part, so that the unused color with respect to the initial value is set despite the repeated opening and closing operations. The change in color tone of color development was reduced. The color change of the unused color is caused by the color change of O-tolidine, which is a redox dye, and the color change of the color development color is due to the decrease in the activity of glucose oxidase. In each case, the result is that the barrier property from the outside is increased by stacking the test pieces having the storage stability function part mixed with silica gel which is a desiccant as in Example 1.

[0021]

[Table 1]

In the above embodiment, the case where the tip end shape of the substrate sheet and the storage function stabilizing portion or the barrier portion is composed of three sides that are orthogonal to each other has been described, but the shape is not limited to this and, for example, a circle. It may be arcuate or semicircular.

[0023]

According to the first aspect of the present invention, the periphery of the inspection unit installed on the substrate sheet is surrounded by a storage stabilizing function unit for drying and deoxidizing, or a storage stabilizing function such as drying and deoxidizing is provided. Since the inspection part installed on the substrate sheet is surrounded by a barrier, the storage stabilizer does not damage the inspection part in the package, and the storage function stabilization part or barrier functions as a spacer. Therefore, there is no damage or loss of the inspection part due to contact between the inner surface of the glass bottle or the film packaging material and the inspection part, contact between the enclosed storage stabilizer and the inspection part, and pressure from the outside of the package, and claim 2 According to the invention of claim 3, since the substrate sheet has a portion which is not surrounded by the storage stable function portion or the barrier, the portion functions as a knob, and the inspection portion can be easily carried without being damaged. From According to the above, since the test piece is laminated and adhered to seal the inspection part, the inspection part does not come into contact with the outside air even if the package is repeatedly opened and closed, and the function of the inspection part of the test piece is not impaired. Absent. Further, since it is possible to store a plurality of test pieces, it is possible to reduce the packaging material and the packaging process, and if a functional portion as a knob is provided, it is easy to take out one by one from the laminated and bonded state. Furthermore, instead of the package, it can be stored in the container of the measuring instrument, and since the test pieces are stacked and adhered, if they are stored in a small measuring instrument, they are always carried along with the measuring instrument. can do.

[Brief description of the drawings]

FIG. 1 is a perspective view showing an example of a glucose test piece according to the present invention.

FIG. 2 is a perspective view showing another example of the glucose test piece according to the present invention.

FIG. 3 is a cross-sectional view showing an example of a test piece package according to the present invention.

FIG. 4 is a perspective view showing an example of a measuring instrument 9 for a test piece according to the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Inspection part 2 ... Substrate sheet 3 ... Storage stability function part 4 ... Substrate sheet having a storage stability function 5 ... Barrier 6 ... Adhesive layer 7 ... Bundle of test pieces 8 ... Glass bottle 9 ... Measuring instrument 10 ... Test piece storage section

Claims (5)

[Claims] 1. An inspection unit installed on a substrate sheet is surrounded by a storage stability function unit for drying and deoxidizing.
Alternatively, the test piece is characterized in that a periphery of an inspection part installed on a substrate sheet having a storage stability function such as drying and deoxidization is surrounded by a barrier. 2. The test piece according to claim 1, wherein the substrate sheet has a portion which is not surrounded by the storage stability function portion or the barrier. 3. A plurality of test pieces according to claim 1 or 2, which are stacked and adhered so that the upper surface of the storage stability function part or the barrier and the lower surface of the substrate sheet are in contact with each other, and the test part is hermetically sealed. A package of test pieces formed by packaging. 4. The packaging is a bag, wherein the packaging is a bag.
A package of the described test piece. 5. The package for a test piece according to claim 3, wherein the package is a bottle with a lid.