阅读说明：本技术 一种用于体外诊断的钾离子定量检测干片及其制备方法 (Potassium ion quantitative detection dry tablet for in vitro diagnosis and preparation method thereof ) 是由 甘斌 武伟民 李菁杨 于 2020-05-20 设计创作，主要内容包括：本发明公开了一种用于体外诊断的钾离子定量检测干片及其制备方法,包括上外壳和下外壳,所述上外壳和下外壳之间设置有两个离子选择电极,每个电极均包括缬氨霉素、半透膜层、氯化银电极层、基准层、支持层和树脂层,所述上外壳和下外壳之间相互贴合,所述上外壳的中心位置开设有滴加孔,所述上外壳上对称设置有两个盐桥,所述下外壳的中心位置开设有透光孔,所述盐桥、半透膜层、树脂层、氯化银电极层、支持层和基准层之间通过涂布工艺分层贴合在一起。本发明,该方法制作的干片化学试剂性能优越、试剂稳定、储存时间长、方便携带,完全实现即时即地检测的目标。(The invention discloses a potassium ion quantitative detection dry sheet for in vitro diagnosis and a preparation method thereof, wherein the potassium ion quantitative detection dry sheet comprises an upper shell and a lower shell, two ion selective electrodes are arranged between the upper shell and the lower shell, each electrode comprises valinomycin, a semi-permeable membrane layer, a silver chloride electrode layer, a reference layer, a support layer and a resin layer, the upper shell and the lower shell are mutually attached, a dripping hole is formed in the center of the upper shell, two salt bridges are symmetrically arranged on the upper shell, a light transmission hole is formed in the center of the lower shell, and the salt bridges, the semi-permeable membrane layer, the resin layer, the silver chloride electrode layer, the support layer and the reference layer are attached together in a layered mode through a coating process. The dry chemical reagent prepared by the method has the advantages of excellent performance, stable reagent, long storage time and convenient carrying, and completely realizes the aim of immediate detection.)

1. A potassium ion quantitative detection dry plate for in vitro diagnosis, which comprises an upper shell (3) and a lower shell (7), it is characterized in that two ion selective electrodes are arranged between the upper shell (3) and the lower shell (7), each electrode comprises valinomycin, a semi-permeable membrane layer (4), a silver chloride electrode layer (5), a reference layer (6), a support layer (8) and a resin layer (9), the upper shell (3) and the lower shell (7) are mutually attached, the central position of the upper shell (3) is provided with a dripping hole (2), two salt bridges (1) are symmetrically arranged on the upper shell (3), a light hole is arranged at the center of the lower shell (7), the salt bridge (1), the semi-permeable film layer (4), the resin layer (9), the silver chloride electrode layer (5), the support layer (8) and the reference layer (6) are laminated and attached together through a coating process.

2. The dry plate for quantitative determination of potassium ions for in vitro diagnosis according to claim 1, wherein the silver chloride electrode layer (5) is coated on the PET plate by silver paste coating technology, and the thickness of the silver layer is 100 um.

3. The dry plate for quantitative determination of potassium ions for in vitro diagnosis according to claim 1, wherein the reference layer (6) comprises a biological agent.

4. The dry plate for quantitative potassium ion detection for in vitro diagnosis according to claim 1, wherein the semi-permeable membrane layer (4) has a wet membrane thickness of 50-200 μm and a dry membrane thickness of 20-100 μm.

5. The dry plate for quantitative determination of potassium ions for in vitro diagnosis according to claim 1, wherein the salt bridge (1) is a layer of filtration membrane, and the filtration membrane comprises a mixed fiber microporous filtration membrane, a polypropylene filtration membrane, a polyethersulfone filtration membrane, a polyvinylidene fluoride filtration membrane, a polytetrafluoroethylene filtration membrane, and a nylon filtration membrane.

6. The dry plate for quantitative determination of potassium ions for in vitro diagnosis according to claim 1, characterized in that the support layer (8) is made of transparent plastic.

7. The dry plate for quantitative determination of potassium ion in vitro diagnosis as claimed in claim 1, wherein the resin layer (9) is a novel resin system using water instead of organic solvent as dispersion medium, including epoxy resin, alkyd resin, polyester resin, polyurethane resin, modified polybutadiene resin.

8. The dry plate for quantitative potassium ion detection for in vitro diagnosis according to claim 1, wherein the upper housing (3) and the lower housing (7) are mainly made of plastic material, the upper housing (3) and the lower housing (7) are bonded together by ultrasonic bonding, and the reagent is fixed between the upper housing (3) and the lower housing (7).

9. The method for preparing the potassium ion quantitative determination dry plate for in vitro diagnosis according to claim 1, which comprises the following steps:

the method comprises the following steps: uniformly coating the resin solution on a substrate, flatly paving and fixing the silver chloride electrode layer (5) on the resin layer (9) to enable the silver chloride electrode layer to be flat and free from tilting, then drying for 40min at room temperature, and adhering the silver chloride electrode layer (5) and the resin layer (9) together after drying;

step two: coating a reference layer (6) solution on the silver chloride electrode layer (5), drying for 30min under the condition of 45 degrees, and forming the reference layer (6) after drying;

step three: continuously coating the solution of the following semipermeable membrane layer (4) on the dried reference layer (6), drying for 30min in the dark at 25 ℃, and completely drying to obtain the semipermeable membrane layer (4);

step four: and (3) performing demoulding treatment on the manufactured dry sheet, namely finishing the manufacture of the ion selective electrode, cutting the dry sheet into a size of about 7 multiplied by 10mm, placing two sheets into a lower dry sheet shell (7) matched with a machine, cutting off a small section of PES (polyether sulfone) membrane, building an arched salt bridge (1) and placing the salt bridge on the two cut electrode sheets, wherein the aim is to prevent standard liquid and reference liquid from mutually permeating to influence test data, covering the upper dry sheet shell (3) for fixation, recording, sealing and storing, and finishing the manufacture of the dry sheet.

Technical Field

The invention relates to the technical field of dry tablet reagents for ion detection, in particular to a potassium ion quantitative detection dry tablet for in vitro diagnosis and a preparation method thereof.

Background

So-called "dry-patch reagents" are relatively conventional "wet chemistry". The method is a mode that liquid in a detected sample is used as a reaction medium, and an object to be detected directly reacts with a reagent fixed on a carrier, and the method is different from the traditional wet chemistry in the medium participating in the chemical reaction. With the development of technologies such as separation, purification, storage and the like of enzymes in biochemistry, the development of technologies of sensors, photometers, electrodes and the popularization of computers, dry chemistry is rapidly developed, and with the development of biotechnology, immune dry sheets containing enzyme markers, fluorescent markers, particularly colloidal gold or selenium-labeled antibodies (or antigens) developed by utilizing technologies such as immune permeation, immune chromatography and the like can be used for analysis and determination of troponin, special proteins, hormones, certain therapeutic drugs, virus antibodies or antigens and the like.

The multilayer film dry film and the matching instrument thereof adopted by the prior fluorescence photometry are also appeared and are increasingly used, and the vaginitis quintuplet detection reagent of Henan atlas biology company is used for detecting a specific biochemical marker by a dry chemical enzyme method and diagnosing gynecological diseases. After more than 20 years of development, dry chemistry analysis techniques have been widely used to examine various aspects of medicine, including routine biochemistry, endocrine hormone, toxin drug concentration analysis, and special protein immunoassays. However, the requirement of the fluorescence photometry technology on instruments is high, a spectrophotometer capable of being used for detection is expensive in a liquid phase, and the result cannot be stored for a long time; the colloid technology is used as a primary screening diagnostic reagent for the auxiliary treatment of disease diagnosis because the product quality has large difference, the quality cannot be controlled, the quality cannot be ensured, and the phenomenon of back zone exists, and a specimen needs to be diluted and tested, can only be qualitative and cannot be quantitative.

In order to solve the problems, a potassium ion quantitative detection dry tablet for in vitro diagnosis and a preparation method thereof are provided.

Disclosure of Invention

The invention aims to solve the problems that in the prior art, the requirement of a fluorescence photometry technology on an instrument is higher, a spectrophotometer capable of being used for detection is expensive in a liquid phase, and the result cannot be stored for a long time; the colloid technology has the defects that the product quality is relatively large in difference, the quality cannot be controlled, the quality cannot be ensured, and the phenomenon of back zone exists, a sample needs to be diluted and tested, can only be qualitative and cannot be quantitative, so that the colloid technology is only used as a primary screening diagnostic reagent and is used for auxiliary treatment of disease diagnosis, and the potassium ion quantitative detection dry plate for in vitro diagnosis is provided.

In order to achieve the purpose, the invention adopts the following technical scheme:

the utility model provides a potassium ion quantitative determination dry plate for external diagnosis, includes shell and lower shell, go up the shell and be provided with two ion selective electrodes down between the shell, every electrode all includes valinomycin, semi-permeable rete, silver chloride electrode layer, benchmark layer, support layer and resin layer, go up and laminate each other between shell and the lower shell, the central point that goes up the shell puts and has seted up the dropwise add hole, it is provided with two salt bridges to go up the symmetry on the shell, the light trap has been seted up to the central point of shell down, pass through coating technology layering laminating together between salt bridge, semi-permeable rete, resin layer, silver chloride electrode layer, support layer and the benchmark layer.

Preferably, the silver chloride electrode layer is coated on the PET sheet by adopting a silver paste coating technology, and the thickness of the silver layer is 100 um.

Preferably, the reference layer comprises potassium chloride, hydrophilic polymers and other necessary biological agents.

Preferably, the semi-permeable membrane layer has a wet membrane thickness of 50-200 μm and a dry membrane thickness of 20-100 μm.

Preferably, the salt bridge is a layer of filtering membrane, and the filtering membrane comprises a mixed fiber microporous filtering membrane, a polypropylene filtering membrane, a polyether sulfone filtering membrane, a polyvinylidene fluoride filtering membrane, a polytetrafluoroethylene filtering membrane and a nylon filtering membrane.

Preferably, the support layer is made of transparent plastic.

Preferably, the resin layer is a novel resin system using water as a dispersion medium instead of an organic solvent, and includes epoxy resin, alkyd resin, polyester resin, polyurethane resin, and modified polybutadiene resin.

Preferably, the upper shell and the lower shell are mainly made of plastic materials, the upper shell and the lower shell are attached together in an ultrasonic attaching mode, and the reagent is fixed between the upper shell and the lower shell.

The invention discloses a preparation method of a potassium ion quantitative detection dry tablet for in vitro diagnosis, which is characterized by comprising the following steps:

the method comprises the following steps: uniformly coating the resin solution on a substrate, flatly paving and fixing the silver chloride electrode layer on the resin layer to ensure that the silver chloride electrode layer is flat and does not tilt, then drying the silver chloride electrode layer for 40min at room temperature, and adhering the dried silver chloride electrode layer and the resin layer together;

step two: coating a reference layer solution on the silver chloride electrode layer, drying for 30min at the temperature of 45 ℃, and forming a reference layer after drying;

step three: continuously coating the semi-permeable membrane layer solution on the dried reference layer, drying in dark at 25 ℃ for 30min, and completely drying to obtain the semi-permeable membrane layer;

step four: and (3) performing demoulding treatment on the manufactured dry sheet, namely finishing the manufacture of the ion selective electrode, cutting the dry sheet into a size of about 7 multiplied by 10mm, placing two sheets into a lower shell of the dry sheet matched with a machine, cutting off a small section of PES (polyether sulfone) membrane, and putting an arched salt bridge on the two cut electrode sheets so as to prevent standard liquid and reference liquid from mutually permeating to influence test data, covering the upper shell for fixing, recording, sealing and storing, and finishing the manufacture of the dry sheet.

Compared with the prior art, the invention has the beneficial effects that:

1. the dry tablet prepared by the method has the advantages of excellent chemical reagent performance, stable reagent, long storage time and convenient carrying, and completely realizes the target of immediate detection.

2. Taking out the dry plate according to the required amount, heating for 1h, putting the dry plate into a detection machine, dripping 10 microliters of reference solution and whole blood/plasma/urine on two sides respectively, and detecting for 1min30s to obtain a result. And (5) judging a result: referring to the reference value range, the out-of-range is an abnormal value.

Drawings

FIG. 1 is a flow chart of a potassium ion quantitative determination dry tablet for in vitro diagnosis and a preparation method thereof according to the present invention.

In the figure: 1 salt bridge, 2 dropping holes, 3 upper shells, 4 semi-permeable membrane layers, 5 silver chloride electrode layers, 6 reference layers, 7 lower shells, 8 supporting layers and 9 resin layers.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments.

In the description of the present invention, it is to be understood that the terms "upper", "lower", "front", "rear", "left", "right", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention.

Referring to fig. 1, a potassium ion quantitative determination dry plate for in vitro diagnosis comprises an upper shell 3 and a lower shell 7, wherein two ion selective electrodes are arranged between the upper shell 3 and the lower shell 7, each electrode comprises valinomycin, a semi-permeable membrane layer 4, a silver chloride electrode layer 5, a reference layer 6, a support layer 8 and a resin layer 9, the upper shell 3 and the lower shell 7 are mutually attached, a dripping hole 2 is formed in the center of the upper shell 3, two salt bridges 1 are symmetrically arranged on the upper shell 3, a light-transmitting hole is formed in the center of the lower shell 7, and the salt bridges 1, the semi-permeable membrane layer 4, the resin layer 9, the silver chloride electrode layer 5, the support layer 8 and the reference layer 6 are laminated together through a coating process;

the silver chloride electrode layer 5 is formed by coating a PET sheet by adopting a vacuum coating technology or a silver paste coating technology, the thickness of a silver layer is 100 mu m, after drying in the dark place, the PET sheet covered with the silver layer is subjected to mask treatment at the interval of 10mm, the PET sheet with the mask is immersed in 0.1mol/L KCl solution, is subjected to anodic oxidation for 10-20 minutes under the condition of 0.01A, and is taken out and dried in the dark place;

the reference layer 6 comprises necessary biological agents such as potassium chloride, hydrophilic polymers and the like;

the semi-permeable membrane layer 4 comprises valinomycin, a porous membrane material, tetrahydrofuran and the like, wherein the porous membrane material comprises cellulose acetate, polystyrene, polyethylene glycol and the like, and can be a mixture of one or more materials, the wet film thickness of the reference layer 6 and the semi-permeable membrane layer 4 is 50-200 mu m, and the dry film thickness is 20-100 mu m;

the salt bridge 1 is a layer of filtering membrane, and the filtering membrane comprises a mixed fiber microporous filtering membrane, a polypropylene filtering membrane, a polyether sulfone filtering membrane, a polyvinylidene fluoride filtering membrane, a polytetrafluoroethylene filtering membrane and a nylon filtering membrane;

the supporting layer 8 is made of transparent plastic, and can be made of various transparent plastics, such as Polyethylene (PE), polypropylene (PP), Polyester Methyl Methacrylate (PMMA), Polystyrene (PS), Polycarbonate (PC), polyethylene terephthalate (PET), and the like, preferably PET, the thickness of the supporting layer 8 is 30-200 μm, and 50-150 μm is optimal; the light transmittance of the visible light range is more than 85 percent, the light transmittance is more than 95 percent, the incident light source and the reflected light can be ensured to pass through the supporting layer 8, and the supporting layer 8 and the silver chloride electrode layer 5 can be better adhered together by virtue of the resin layer 9 with the adhesion function, so that the requirements on the material and the performance of the base material are reduced, and the cost is saved;

the resin layer 9 is a novel resin system which takes water to replace an organic solvent as a dispersion medium and comprises epoxy resin, alkyd resin, polyester resin, polyurethane resin and modified polybutadiene resin, the wet film thickness of the resin layer 9 is 10-100 mu m, the dry film thickness is 2-50 mu m, and the effect is better if the film thickness is within 10-20 mu m;

go up shell 3 and lower shell 7 and mainly comprise plastic material, go up shell 3 and lower shell 7 and pass through the laminating mode of supersound and be in the same place, be fixed in reagent between shell 3 and the lower shell 7, it is mainly that protection reagent is in the transportation, store, the deformation that the in-process of test leads to owing to various power, thereby avoid reagent to damage, especially in last machine test, no matter be automatic or semi-automatic send into detection machine with dry piece reagent, dry piece inevitable receives corresponding power, reagent shell can avoid reagent dry piece damaged.

The invention also discloses a preparation method of the potassium ion quantitative detection dry tablet for in vitro diagnosis, which comprises the following steps:

the method comprises the following steps: uniformly coating the resin solution on a substrate, flatly paving and fixing the silver chloride electrode layer 5 on the resin layer 9 to ensure that the silver chloride electrode layer is flat and does not tilt, then drying the silver chloride electrode layer 5 for 40min at room temperature, and adhering the dried silver chloride electrode layer 5 and the resin layer 9 together;

step two: coating a reference layer 6 solution on the silver chloride electrode layer 5, drying for 30min at 45 ℃, and forming a reference layer 6 after drying;

step three: continuously coating the solution of the semi-permeable membrane layer 4 below the dried reference layer 6, drying for 30min in a dark place at 25 ℃, and completely drying to obtain the semi-permeable membrane layer 4;

step four: the manufactured dry plate is subjected to demoulding treatment, namely the manufacture of the ion selective electrode is finished, the ion selective electrode is cut into a size of about 7 multiplied by 10mm, two dry plate pieces are placed in a dry plate lower shell 7 matched with a machine, a small section of PES membrane is cut off, an arched salt bridge 1 is built and placed on the two cut electrode plates, the purpose is to prevent standard liquid and reference liquid from mutually permeating to influence test data, the upper shell 3 is covered for fixing, and the record is recorded, sealed and stored, namely the manufacture of the dry plate is finished

In the invention, the detection dry plate is taken out according to the required amount, the temperature is returned to 1h, the dry plate is put into a detection machine, 10 microliter of reference solution and whole blood/plasma/urine are respectively dripped on two sides, and the result is detected for 1min30 s. And (5) judging a result: the dry chemical reagent prepared by the method has the advantages of excellent performance, stable reagent, long storage time and convenient carrying, and completely realizes the target of immediate detection.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.