JPH06167490A - Test piece for detecting occult blood in feces - Google Patents

Abstract

PURPOSE:To simply detect occult blood in a short time and to easily discard it by sequentially laminating a developing layer, a reagent layer and a waterproof.protective layer in this order on a support of a water dispersive base material. CONSTITUTION:Water soluble paper to be dissolved rapidly in water is combined with water soluble adhesive, and coated on both side surfaces with resin to delay dispersing time. With water dispersive base material having rigidity as a support, a developing layer 6, a reagent layer 8 are laminated thereon. The layer 8 is so covered with a waterproof and protective layer (transparent resin film) 7 as not to be brought into direct contact with face nor city water (developing liquid) to easily identify its color development. Further, specimen solution is once passed through the layer 6, and reaches the layer 8 in a state that substance such as iron ions, etc., for disturbing normal color development of dye in the specimen is reduced, sucked from its back surface to be reacted. Thus, the reaction occurs in a state that contaminated color and disturbing substance are less, and a color development error is small, and its decision is facilitated. Since the support is water soluble, a test piece can be discarded in a toilet.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a test strip for detecting occult blood in feces, and more particularly to a test strip for detecting fecal occult blood for OTC (overall drug).

[0002]

2. Description of the Related Art Detection of occult blood in fecal excrement is a very valuable means for diagnosing many pathological conditions such as digestive system. Conventionally, blood in feces has been detected by collecting feces with a tool such as a stick, applying the feces on a test device, and then adding a reaction solution to cause a reaction. At this time, the used stick and test device are thrown away in a waste basket or the like, and cannot be thrown directly into the sewer such as in a toilet bowl.

As described above, the conventional test tools (stool collection stick, test device and reaction solution) are complicated to operate at the time of use, and additionally have restrictions on disposal, so that they can be easily tested at home. Not suitable as

[0004]

In view of the above circumstances, the present inventors have conducted earnest research to develop a test piece that can detect fecal occult blood easily and in a short time, and that can be easily discarded. As a result, the present invention has been completed.

[0005]

The present invention is a test strip for detecting fecal occult blood, which has a spreading layer, a reagent layer, and a waterproof / protective layer sequentially laminated on a water-dispersible substrate. The test strip for detecting fecal occult blood of the present invention is a test strip for detecting fecal occult blood, which has a rigid, water-dispersible substrate as a support, and a spreading layer, a reagent layer, and a waterproof / protective layer on the support. The OTC is characterized in that it is provided in a laminated form in this order, and the test piece itself is a toilet bowl.
It is a test piece for detecting fecal occult blood.

In the test strip for detecting fecal occult blood of the present invention,
As the water-dispersible substrate, for example, water-soluble paper which is rapidly dissolved in water is stuck to two sheets with a water-soluble adhesive to form an interleaving paper,
A processed paper or the like that is coated with various resins on both sides to delay the dispersion time and has rigidity is used. As the spreading layer, a phase containing a carrier that captures iron ions such as carboxymethyl cellulose calcium salt (hereinafter referred to as “CMC-Ca”) can be used. Also, the spreading layer is not a phase formed by the patterning treatment, but a sheet base material that captures iron ions, such as CMC-C.
You may stick and use the base material paper-made by a.

Further, an oxidizing catalyst such as ascorbic acid oxidase or an oxidizing agent such as iodate may be added to the reagent layer as a component for oxidizing ascorbic acid. The test piece for detecting fecal occult blood for OTC of the present invention will be described below with reference to the drawings. As shown in FIGS. 1 and 2, the test piece for detecting fecal occult blood for OTC according to the present invention has an integrated shape in which a test device is provided at the tip of a stool collection tool, and a single test piece is used for the entire configuration test tool. Has become.

Further, in the test piece for detecting fecal occult blood for OTC of the present invention, the reagent layer (8) directly has feces or tap water (developing solution).
The structure is such that the upper portion of the reagent layer is covered with a waterproof / protective layer (transparent resin coating) (7) so as not to touch. That is, when the sample (feces and tap water) is directly applied to the reagent layer, it is difficult to distinguish the color due to the stain color.
The colorimetric part) is coated with a transparent / hydrophobic resin to protect it.

In addition, by passing the sample solution once through the spreading layer (5, 6 or 6 '), the sample solution is prepared in a state in which the substance (iron ion etc.) which inhibits the normal color development of the dye in the sample is reduced. The reagent reaches the reagent layer (8) and is then sucked up from the back surface of the reagent layer (8) to cause a reaction. As a result, the reagent layer (8) undergoes a reaction in a state where the reagent layer (8) has a small amount of stain and an interfering substance, and the color error is small, so that the test piece can be easily determined.

In addition, this test piece has a shape such that the feces can be quantitatively collected in the grooves of the waterproof / protective layer and the development layer (on the development layer) by directly inserting it into the feces and wiping it with a paper or the like. Then, by subsequently attaching the test device section to tap water, the sample solution permeates the reagent layer from all directions through the spreading layer and is sucked up, which enables clear and quick determination.

As the water- soluble paper, for example, basic water-soluble paper CD-2, MDP or neutral water-soluble paper CD-2N (pot amount: 120 g / m ² ) manufactured by Mishima Paper Co., Ltd. is used as a water-based adhesive or It is possible to use a sheet which is interleaved with a water-soluble adhesive (two sheets etc.). Water-soluble paper (CD-2 or MDP), which is an acidic resin base material, is a strong alkaline paper. Therefore, although it is a water-insoluble resin in a neutral or acidic solution, by coating a water-soluble paper with an acidic resin that dissolves in water in an alkaline solution, moisture dispersion (moisture resistance The expansion and contraction of the paper due to the change in the water content of the paper due to the fluctuation) and the addition of rigidity are performed.

As the acidic resin, carboxymethyl ethyl cellulose resin, hydroxypropyl methyl cellulose phthalate resin, hydroxypropyl methyl cellulose acetate succinate resin, cellulose acetate phthalate resin, acetic acid trimellitic acid cellulose resin, acetate phthalate polyvinyl alcohol resin, methacrylic acid copolymer resin. Half-esters of synthetic acidic resins such as (methacrylic acid + methyl acrylate, methyl methacrylate, ethyl acrylate or ethyl methacrylate), natural acidic resins such as shellac resin, and various copolymers with acid anhydride rings with lower to middle alcohols. The acidified resin or the like is used alone or as a mixture of two or more kinds alone or in combination with any resin. Further, a water-soluble neutral resin such as copolyvidone resin (vinylpyrrolidone + vinyl acetate) or (vinyl alcohol + vinyl acetate) copolymer resin can be added to the water-soluble paper after processing in an arbitrary ratio for the purpose of increasing plasticity. .

Neutral resin A water-soluble paper treated with only an acid resin has a characteristic of the surface of the substrate (having an acidic group), a property when wet with water (weak water resistance) and a delay of dispersion time. Does not show sufficient results.
Further, if the water-soluble paper is directly coated with a neutral resin having a low hygroscopic property (water-insoluble), it will become a base material that is very hardly soluble in water. However, water-soluble paper that has been once coated with acidic resin and water-insoluble neutral resin as the upper layer (water-dispersible base material) has a water-soluble base material (paper) surface, but It becomes a controlled base material that disperses in water over time. Furthermore, since the surface layer of the base material is neutral, it is also suitable as a reagent base material. Further, for the purpose of adjusting the dispersion time in water, a highly hygroscopic (water-soluble neutral resin) can be added to the water-insoluble resin at an arbitrary ratio.

As the neutral resin, ethyl cellulose resin, butyral resin, cellulose acetate resin, acrylate copolymer resin (ethyl acrylate +
(Methyl methacrylate), polyester resin, vinyl acetate resin, highly hygroscopic polyvinylpyrrolidone resin, copolyvidone resin (vinylpyrrolidone + vinyl acetate),
(Vinyl alcohol + vinyl acetate) Copolymer resin, hydroxypropylcellulose resin, hydroxypropylmethylcellulose resin, hydroxyethylmethylcellulose resin and the like are used alone or as a mixture of two or more kinds alone or in combination with any resin.

Production of Water-Soluble Substrate A water-dispersible substrate can be obtained by impregnating or coating water-soluble paper with a solution containing the above resin. As the impregnation / application method, printing method, coating method (for example, coating method such as roll, spray, dip and solid)
Are used.

[0016] As development layer spreading layer is preferably applied spreading layer printing ink composition. The printing ink composition for the spreading layer is a composition in which CMC-Ca capable of adsorbing iron ions and the like, hydroxyapatite as a porous material, a surfactant and a binder are dissolved or dispersed in a non-aqueous solvent.

[0017] The reagent layer a reagent layer, preferably, fecal occult blood detection printing ink composition is applied. The printing ink composition for detecting fecal occult blood comprises a composition for detecting occult blood, a pH buffer, a binder, an adsorbent and a superabsorbent resin, which is capable of making a detectable response in the presence of a peroxidative active substance. It is a powder dissolved or dispersed in a non-aqueous solvent.

[0018] The transparent-hydrophobic resin used as waterproof protective layer waterproof protective layer, such as ethyl cellulose, cellulose acetate, nitrocellulose, urethane resin, polyester resin, fluorine resin and the like. Production of test strip for detecting fecal occult blood The following is an example of a method for producing the test strip for detecting fecal occult blood.

Basic water-soluble paper made with CMC-Ca 2
Both sides of the interleaving paper, which is obtained by laminating the sheets with a water-soluble adhesive, are sequentially coated with an acidic resin and a water-insoluble neutral resin. Then, using a screen printing machine, after sequentially printing the developing layer printing ink composition and the fecal occult blood detection printing ink composition,
After the coating treatment with the waterproof / protective layer coating solution, each imprinted portion is cut into an appropriate size and perforated to prepare a test piece for detecting fecal occult blood as shown in FIG.

In the same manner as above, after coating treatment with an acidic resin and a water-insoluble neutral resin in sequence, the base material for the spreading layer is laminated with a water-soluble adhesive, and then the fecal occult blood is detected using a screen printing machine. After printing the printing ink composition for water and coating with the coating solution for waterproof / protective layer, each facet is cut to an appropriate size, perforated, and the test for detecting fecal occult blood as shown in FIG. 2 is performed. Pieces can also be manufactured.

[0021]

The present invention will be described in more detail with reference to the following examples, but the scope of the present invention is not limited to the following examples. (Example 1) (A) Preparation of coating solution A first coating solution, a second coating solution, a third coating solution and a fourth coating solution having the following compositions were prepared. 1st coating solution composition ◎ 80 parts by weight of acidic resin solution (Rack Coat 50, manufactured by Nippon Shellac Co., Ltd.) ◎ 20 parts by weight of isopropyl alcohol ◎ Polyethylene glycol (PEG) 6,000 3 parts by weight ◎ Acrylic N-methylol acrylamide 20 parts by weight Graft copolymer resin solution (LH-48, manufactured by Soken Kagaku Co., Ltd.) ◎ Cotton fiber softener 4 parts by weight (Softex A211, manufactured by Kao Co., Ltd.) ◎ Sorbitan monopalmitate 2 parts by weight (Reodol SP-P10, manufactured by Kao Co., Ltd.) ◎ Aerosil R972D 1 part by weight (Nippon Aerosil Co., Ltd.) Second coating solution composition ◎ Methyl ethyl ketone (MEK) 32.0 parts by weight ◎ Denatured ethanol (EOH) 48.0 parts by weight ◎ Water resistance Neutral resin ethyl cellulose 20.0 parts by weight (N-10-G, manufactured by Shin-Etsu Chemical Co., Ltd.) ◎ Fluorine-based methylmethac Rate graft copolymer 20.0 parts by weight Resin solution (LF-40, manufactured by Soken Kagaku Co., Ltd.) ◎ Sorbitan monopalmitate 2.0 parts by weight ◎ Aerosil R972D 1.0 parts by weight ◎ Fluorescent brightener 0.2 parts by weight (Ubitex OB, Ciba Geigy) 3rd coating solution composition ◎ EOH 40.0 parts by weight ◎ MEK 40.0 parts by weight ◎ Water-soluble neutral resin copolyvidone 10.0 parts by weight (Kollidon VA64, manufactured by BASF Corporation) ◎ Water-resistant neutral resin ethyl cellulose 5.0 parts by weight (N-22-G, manufactured by Shin-Etsu Chemical Co., Ltd.) ◎ sorbitan monopalmitate 2.0 parts by weight ◎ Aerosil R972D 0.5 parts by weight Fourth coating solution composition ◎ 2-butoxyethanol 40.0 parts by weight ◎ MEK 40.0 parts by weight ◎ in water resistance Resin ethyl cellulose 20.0 parts by weight (N-22-G, manufactured by Shin-Etsu Chemical Co., Ltd.) Copolymer 20.0 parts by weight Resin solution (LF-40, manufactured by Soken Chemical Industry Co., Ltd.) (B) Preparation of precision mixed treatment powder Hi-X200J (precision powder mixer, manufactured by Nisshin Engineering Co., Ltd.) Using this, precision mixing treatment was performed under the following conditions to prepare precision mixing treatment powder.

Treatment conditions: Treatment amount per time: about 500 g, rotation speed of stirring blade: 6,000 rpm, treatment time: 5 minutes, rotation shaft angle of 0 °, and nitrogen gas was replaced in the tank during treatment. CMC-Ca powder (200 mesh passing product) 500g and Aerosil R972D 50g were put into a 3 liter poly container and pre-mixed by hand, then transferred to Hi-X200J,
The precise mixing process was performed under the above processing conditions.

Subsequently, 250 g of the above treated mixed powder and 250 g of calcium phosphate (TPC) were put into a 3 liter poly container and premixed by hand, then transferred to Hi-X200J,
Precise mixing treatment was carried out under the above treatment conditions to obtain a precision mixing treatment powder. (C) Preparation of Development Ink Printing Ink Composition A development layer printing ink composition having the following composition was prepared.

Composition of printing ink composition for spreading layer ◎ 1-hexanol (HexOH) 40.0 parts by weight butyl butyl cellosolve acetate (BcAc) 11.7 parts by weight ◎ 20% lauryl sulfate triethanolamine 5.0 parts by weight (in HexOH) ◎ in water resistance Resin ethyl cellulose 2.0 parts by weight (G-200-N, manufactured by Hercules Co., Ltd.) ◎ Acid resin hydroxypropyl methyl cellulose 1.0 part by weight phthalate (HP-55, manufactured by Shin-Etsu Chemical Co., Ltd.) ◎ Water-soluble neutral resin hydroxypropyl cellulose 0.3 parts by weight (HPC-H, manufactured by Nippon Soda Co., Ltd.) ◎ Hydroxyapatite (HAP) 15.0 parts by weight (for column chromatography, manufactured by Wako Pure Chemical Industries, Ltd.) ◎ Precision-mixed powder (obtained with (B) above) 25.0 parts by weight [CMC-Ca / TPC / Aerosil R972D = 10/10/1 (w / w)] (CMC-Ca 200 mesh passing product, da Isel Chemical Industry Co., Ltd. (D) Preparation of printing ink composition for detecting fecal occult blood The printing ink composition for detecting fecal occult blood was prepared having the following composition.

Composition of printing ink composition for detecting fecal occult blood (1) 3,3 ′, 5,5′-tetramethylbenzidine 1.33 (2) mixed solution 26.80 [Butyl cellosolve acetate (BCA) 8.00] [20% PEG2,000 (HexOH, 20 → 100 medium) 9.93] [20% Emal TD (HexOH, 20 → 100 medium) 8.87] (3) 10% 2,2'-methylenebis (6-t-butyl-p-2.22 cresol) (Tokyo) Kasei Kogyo Co., Ltd. (BCA, 10 → 100 medium) (4) 2% ascorbic acid stearate solution 5.5 (HexOH, 2 → 100 medium) (5) Calcium phosphate / Sumikagel SP-510 20.0 (1/1, w) / W) Mixed powder (6) Buffer slurry 9.49 [Citric acid 3] [Sodium citrate 12] [HexOH 35] [BCA 15] (7) Ascorbate oxidase (200U / mg) 0.70 (ASO, Asahi Kasei Co., Ltd. )) (8) HAP (200 mesh passing product) 10.0 (for column chromatography, Wako Pure) (9) Binder resin 15.78 [HexOH 200] [BCA 85] [Polyvinylpyrrolidone 50] (90KPVP, manufactured by BASF Ltd.) [Saponified butyral resin 10] (BX-1, Sekisui Chemical ( Ltd.) [Triethyl citrate 6] (10) Microcapsules 15.00 [Arabic gum 10.49] [Cumene hydroperoxide 3.38] [6- Methoxyquinoline 1.13] 106.82 parts by weight In addition, the calcium phosphate / Sumikagel SP-5 used above.
A 10 (1/1, w / w) mixed powder was prepared as follows.

Using a precision powder mixer Hi-X 200 (manufactured by Nisshin Engineering Co., Ltd.), the mixture was mixed under the following conditions in a reaction tank in which air was replaced with nitrogen gas, and the target powder mixture was obtained. Got Powder calcium phosphate: 200g Sumikagel SP-510: 200g (Sumikagel SP-510: Super absorbent resin, Sumitomo Chemical Co., Ltd.)
Rotation speed High speed dispersion blade: 6,000 rpm Low speed dispersion blade: Reverse rotation Rotation axis: 0 ° Treatment time: 5 minutes (E) Manufacture of water-soluble base material 120 MDP of basic water-soluble paper is pasted with water-soluble adhesive Both sides of the paper (2 sheets) were impregnated with the first coating solution using the roll coating method to convert the water-soluble paper into a plastic. Subsequently, similarly, a roll coating method was used to perform double-sided coating treatment with the second coating solution to obtain a water-soluble base material (water-dispersible base material) in which the dispersion time in water was controlled (delayed). (F) Production of base material for spreading layer The back surface of the neutral water-soluble paper 60CD-2N was subjected to coating treatment with the third coating solution using a roll coating method. Then, similarly, using the roll coating method, the third
The surface was partially coated with the coating solution to obtain a base material for the spreading layer. (G) Production of test strip for detecting fecal occult blood A printing ink composition for developing layer and a print ink composition for detecting fecal occult blood were used on the water-soluble substrate (A2 version) obtained in (E) using a screen printer. Printed sequentially. Then, after pattern-wise coating with the fourth coating solution,
Cut each imposition part to B6 size, make perforations, and
A test piece for detecting fecal occult blood as shown in (3) was manufactured.

(Example 2) The water-soluble base material (A2 version) obtained in Example 1 (E) was laminated with the water-soluble pressure-sensitive adhesive to the spreading layer base material obtained in Example 1 (F). Then, using a screen printer, the printing ink composition for detecting fecal occult blood was printed. Then, after performing a patterning treatment with the fourth coating solution, each imprinted portion was cut into B6 size and perforated, and a test piece for detecting fecal occult blood as shown in FIG. 2 was manufactured.

[0028]

According to the test strip for detecting fecal occult blood of the present invention, fecal occult blood can be detected easily and in a short time, and the reaction can be carried out in a state where the reagent layer is free from stains and interfering substances. The occurrence of color error is small, and the judgment is easy. Moreover, the test piece after the inspection can be directly thrown into the toilet bowl.

[Brief description of drawings]

FIG. 1 is a view showing a preferred specific example of the test strip for detecting fecal occult blood of the present invention.

FIG. 2 is a diagram showing a preferred specific example of the test strip for detecting fecal occult blood of the present invention.

Claims (4)

[Claims] 1. A test strip for detecting fecal occult blood, which comprises a spreading layer, a reagent layer, and a waterproof / protective layer sequentially laminated on a water-dispersible substrate. 2. The test strip for detecting fecal occult blood according to claim 1, wherein the spreading layer is a phase containing a carrier that captures iron ions. 3. The test strip for detecting fecal occult blood according to claim 1, wherein the spreading layer is a sheet base material that captures iron ions. 4. The test strip for detecting fecal occult blood according to claim 1, wherein the reagent layer contains a component that oxidizes ascorbic acid.