CN113588935A - Electrochemical bar-code-free blood glucose test paper and preparation method thereof - Google Patents
Electrochemical bar-code-free blood glucose test paper and preparation method thereof Download PDFInfo
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- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
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Abstract
The invention discloses an electrochemical bar-code-free blood glucose test paper and a preparation method thereof, wherein the blood glucose test paper sequentially comprises a PET substrate, an electrode layer, a notching white glue layer, a hydrophilic film layer and a cover sheet layer from bottom to top; wherein, the electrode layer is printed on the PET substrate, and comprises: the system comprises a pair of HCT silver electrodes, a full blood carbon electrode, a pair of reaction electrodes, a row of code electrodes and insulating ink, wherein the electrodes are independent, the insulating ink covers all the electrodes, and a reaction area and electrode pins of a certain area are exposed; an HCT test area is arranged between the pair of HCT silver electrodes and does not contain any chemical reagent; a reaction area is arranged between the pair of reaction electrodes; the hydrophilic film layer is adhered to the white glue layer of the washing tank, and the bottom end of the reaction area of the hydrophilic film layer is provided with an exhaust hole; the cover sheet layer is adhered to the hydrophilic film layer. The blood glucose test paper of the invention does not need to rely on a Code card, and can correctly carry out HCT compensation, so that the final blood glucose test result is more accurate.
Description
Technical Field
The invention relates to blood glucose test paper, in particular to electrochemical bar-code-free blood glucose test paper and a preparation method thereof.
Background
With the ever-increasing standard of living and the irregular daily work and rest caused by the work pressure, the risk of chronic diseases is increasing, and diabetes is the most typical chronic disease. The monitoring of the blood sugar can better screen and control the blood sugar change of the diabetic, has important guiding significance for the life rule, the activity, the exercise, the diet and the reasonable medication, and can help the diabetic to find problems at any time and get to the hospital for medical treatment in time.
Blood glucose was monitored 7 times a day, before three meals, 2 hours after three meals and before sleep, and also once in the middle of the night if necessary. The significance of monitoring blood glucose at different time periods is different: (1) fasting plasma glucose, which mainly reflects the blood glucose level when there is no dietary load in the basal state, is an important basis for the diagnosis of diabetes; (2) the 2h postprandial blood sugar reflects an important index of the reserve function of islet B cells, namely the capability of food to stimulate B cells to secrete insulin after eating. The blood sugar 2 hours after meal is monitored to find out possible postprandial hyperglycemia, which can better respond to eating and whether the use of hypoglycemic drugs is appropriate, which cannot be reflected by fasting blood sugar; (3) the blood sugar before sleep reflects the control ability of islet B cells on the hyperglycemia after eating late meal, and is the basis for guiding medication at night or injecting insulin dose; (4) the random blood sugar can understand the influence of the organism on the blood sugar under special conditions, such as the amount of meals, drinking, tiredness, illness, mood change, menstrual period and the like. If the blood sugar of a patient is monitored by adopting a large-scale biochemical method, the electrochemical biological monitoring electrode test strip is applied to the market, and a plurality of electrochemical test strips for quickly and conveniently monitoring the blood sugar are produced.
At present, many electrochemical blood glucose test strips on the market have the following defects:
(1) the method is realized by inserting a Code card into an instrument to input the relation between the test current and the concentration, so that each tube of test paper which leaves a factory must be provided with one Code card, and the production cost is high;
(2) the dependence of a user on a Code card is strong during testing, if the Code card is lost, the user cannot perform accurate testing, and meanwhile, the user must read the Code card first and then insert test paper for testing, so that the testing is complicated;
(3) some blood glucose test strips are not compensated by HCT test, so that HCT can influence the accuracy of a final test result, even if HCT test strips share one working electrode, namely, reactants exist on the electrode for testing HCT, and the HCT test strips are not interfered by independent test HCT electrodes, so that the accuracy of the final test result is influenced;
(4) when the user actually tests, the blood volume of the user may not be enough, and the result tested under the condition of insufficient blood suction volume is inaccurate, so that the judgment of the user on the final result may be misled.
Disclosure of Invention
The invention aims to provide an electrochemical bar-Code-free blood glucose test paper and a preparation method thereof, which solve the problems that the existing blood glucose test needs to depend on a Code card and does not have HCT test compensation, not only does not need to depend on the Code card, but also can correctly carry out HCT compensation, and enable the final blood glucose test result to be more accurate.
In order to achieve the purpose, the invention provides an electrochemical bar-code-free blood glucose test paper which sequentially comprises a PET substrate, an electrode layer, a notching white glue layer, a hydrophilic film layer and a cover sheet layer from bottom to top; wherein the electrode layer is printed on the PET substrate, comprising: the system comprises a pair of HCT silver electrodes, a full blood carbon electrode, a pair of reaction electrodes, a row of code electrodes and insulating ink, wherein the electrodes are independent, the insulating ink covers all the electrodes, and a reaction area and electrode pins of a certain area are exposed; an HCT test area is arranged between the pair of HCT silver electrodes and does not contain any chemical reagent; a reaction zone is arranged between the pair of reaction electrodes, and an enzyme layer containing glucose dehydrogenase and potassium ferricyanide covers the reaction zone; the enzyme layer comprises the following components in percentage by volume: 86% phosphate buffer with pH 6.8, 1% surfactant tween 20, 2.5% hydroxyethyl cellulose, 3% glucose dehydrogenase, 7.5% potassium ferricyanide; the siphon reaction zone consists of the HCT test zone and the reaction zone; one end of the PET substrate is a blood sucking end, the other end of the PET substrate is a code electrode end, the blood sucking end is provided with a siphon reaction area inlet, and the code electrode end is provided with the code electrode; the notching white glue layer is adhered to the insulating ink, and hollow areas corresponding to the HCT test area and the reaction area are arranged on the notching white glue layer to form a siphon sampling port; the hydrophilic film layer is adhered to the washout white glue layer, the bottom end of the reaction area of the hydrophilic film layer is provided with an exhaust hole, and the siphon pool is composed of a hollow area of the washout white glue layer, the hydrophilic film layer and the exhaust hole in the hydrophilic film layer; the cover plate layer is adhered to the hydrophilic film layer, and hollow areas corresponding to the HCT test area and the reaction area are arranged on the cover plate layer.
Preferably, the material of the notching white glue layer is a double-sided adhesive tape of a Sowess WH234343 type.
Preferably, the hydrophilic film layer is a 9901P hydrophilic polyester film.
Preferably, the cover sheet is made of synthetic paper.
Preferably, the area of the reaction zone is determined according to a linear relationship of current to concentration.
The invention also aims to provide a preparation method of the electrochemical bar-code-free blood glucose test paper, which comprises the following steps:
(1) printing conductive silver paste, conductive carbon paste and insulating ink on a PET (polyethylene terephthalate) substrate, and forming a pair of reaction electrodes, a pair of HCT (hydrogen chloride) silver electrodes, a full blood carbon electrode and a row of code electrodes on the PET substrate to obtain a PET blood glucose test paper substrate; wherein the reaction electrode, the full blood carbon electrode and the code electrode are obtained by printing conductive carbon paste; the HCT silver electrode is obtained by printing conductive silver paste; the insulating ink covers all the electrodes, and a reaction area of a certain area and each electrode pin are exposed;
(2) carrying out hydrophilic treatment on the reaction zone by using polyvinyl alcohol treatment liquid, and drying;
(3) loading enzyme liquid containing glucose dehydrogenase and potassium ferricyanide into a reaction zone, and drying; wherein the enzyme solution comprises the following components in percentage by volume: 86% phosphate buffer with pH 6.8, 1% surfactant tween 20, 2.5% hydroxyethyl cellulose, 3% glucose dehydrogenase, 7.5% potassium ferricyanide;
(4) after drying the enzyme solution in the reaction zone, a washing groove white glue layer, a hydrophilic film layer and a cover sheet layer are sequentially adhered from bottom to top.
Preferably, in steps (2) and (3), the drying temperature is 50 ℃.
Preferably, in the steps (2) and (3), the drying time is 4-5 min.
The electrochemical bar-Code-free blood sugar test paper and the preparation method thereof solve the problems that the existing blood sugar test needs to depend on a Code card and does not have HCT test compensation, and have the following advantages:
(1) the electrochemical bar-code-free blood glucose test paper disclosed by the invention has a reaction area for independently testing HCT, and no reaction substance is arranged on the HCT testing electrode, so that the HCT testing result is more accurate, more accurate HCT compensation is carried out, and the final blood glucose testing result is more accurate;
(2) according to the electrochemical bar-CODE-free blood glucose test paper, the CODE electrodes are added, the CODE CODEs are identified through different permutation and combination of the CODE electrodes, and the test can be carried out without independently inserting a CODE card for calibration, so that the test process is simpler and faster, and the condition that the test result is inaccurate because the CODE card is lost and cannot be tested or an incorrect CODE card is inserted in the use process is avoided;
(3) according to the electrochemical bar-code-free blood glucose test paper, the full blood electrode is added, when the blood sucking reaction area is full of the reaction area, the full blood trigger electrode is conducted to start detection, if the blood is not full of the blood, the full blood trigger electrode is not conducted, the blood is not full of the blood, and therefore the risk that the blood is misled by an inaccurate test result under the condition that the blood is not full of the blood and is not perceived in the test process can be completely avoided;
(4) the electrochemical bar-code-free blood sugar test paper of the invention uses the silver electrode and the carbon electrode to manufacture the blood sugar test strip, and most of the used reagents are stable and cheap, thus greatly reducing the production cost;
(5) according to the electrochemical bar-CODE-free blood glucose test paper, the CODE electrodes are cut by the laser recorder to realize different permutation and combination of the CODE electrodes to identify different CODE CODEs, the function of singly inserting the CODE card to identify the CODE CODEs at present is integrated on the test paper, the CODE card does not need to be inserted to identify the CODE CODEs during detection, so that the detection process is simpler, and the cost and the time for manufacturing the CODE card are saved;
(6) the electrochemical bar-code-free blood glucose test strip realizes the bar-code-free test of blood glucose, enables the operation of a user to be more convenient and faster, increases an independent HCT test area, enables the HCT test result to be more accurate, automatically realizes HCT compensation, finally enables the test result to be more accurate, integrates the functions of detecting whether the blood absorption amount is sufficient and the like into the blood glucose test strip in a unified way, and simultaneously provides a manufacturing method of the test strip.
Drawings
Fig. 1 is a schematic structural diagram of the electrochemical bar-code-free blood glucose test strip of the present invention.
FIG. 2 is a schematic diagram of the electrochemical bar-code-free blood glucose test strip of the present invention.
FIG. 3 is a schematic side view of the electrochemical bar-code-free blood glucose test strip of the present invention.
Fig. 4 is a schematic structural diagram of a CODE according to the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
An electrochemical bar-code-free blood glucose test paper is shown in figures 1-3, and comprises a PET substrate 7, an electrode layer, a notching white glue layer 8, a hydrophilic film layer 9 and a cover sheet layer 10 from bottom to top in sequence. Wherein the electrode layer is printed on the PET substrate 7, it comprises: the detection device comprises a pair of HCT silver electrodes 4, a full blood carbon electrode 3, a pair of reaction electrodes 2, a row of code electrodes 1 and insulating ink 5, wherein the electrodes are independent and are not connected or short-circuited, the two HCT silver electrodes 4 are respectively arranged on two sides of a PET substrate 7, an HCT test area is arranged between the two HCT silver electrodes 4, the two reaction electrodes 2 are arranged between the two HCT silver electrodes 4, the reaction area is arranged between the two reaction electrodes 2, and the full blood carbon electrode 3 is arranged between the two reaction electrodes 2. One end on the PET substrate 7 is a blood sucking end, the other end is a code electrode end, the blood sucking end is provided with a siphon reaction area inlet 11, and the code electrode end is provided with a code electrode 1.
The notching white glue layer 8 is adhered on the insulating ink 5, a hollow-out area corresponding to the HCT test area and the reaction area is arranged on the notching white glue layer, a siphon sampling port 12 is formed, the HCT test area and the reaction area are exposed by the hollow-out area, the HCT (packed red blood cell) test area does not contain any chemical reagent and is independent, and an enzyme layer containing glucose dehydrogenase and potassium ferricyanide covers the reaction area.
The cover sheet layer 10 is adhered to the hydrophilic film layer 9, and a hollow area corresponding to the HCT test area and the reaction area is arranged on the cover sheet layer 10.
The CODE electrodes 1 are identified by different permutation and combination modes (short circuit conditions between the CODE electrodes), as shown in fig. 4, each condition represents a CODE, and any one CODE electrode is connected with a full blood trigger electrode, the instrument can detect the connection of a specific CODE electrode and the full blood trigger electrode for identification, and the connected CODE electrodes represent different types.
The preparation method of the electrochemical bar code-free blood glucose test paper comprises the following specific steps:
(1) printing conductive silver paste, conductive carbon paste and insulating ink on a PET substrate 7 in a screen printing manner to obtain a PET blood glucose test paper substrate; wherein, the electrode is composed of a pair of working electrodes (formed by silk-screen printing of carbon paste), a pair of HCT electrodes (formed by silk-screen printing of silver paste), a full blood trigger electrode (formed by silk-screen printing of carbon paste) and a row of code electrodes (formed by silk-screen printing of carbon paste, 5 electrodes); the HCT electrodes are arranged in the independent reaction areas, the HCT is measured by measuring the impedance of blood, the impedance of the blood is in positive correlation with the HCT, so the HCT can be calculated according to the impedance value, and the instrument can measure the impedance by applying a voltage through the chip; a pair of working electrodes measures the current value generated by the reaction of the glucose in the blood and the enzyme layer of the reaction area so as to calculate the concentration of the glucose in the blood; the full blood electrode judges whether the blood is full or not by detecting the current after the blood is sucked, and if the blood which is not full is not in contact with the full blood electrode, the full blood electrode indicates that the blood is not full; CODE CODEs are distinguished by the CODE electrodes through the permutation and combination of short circuits among the CODE electrodes (10 electrodes in total, 10 pins exist at the interface of the instrument, the instrument can judge the communication mode among the pins corresponding to the CODE electrodes to identify the CODE CODEs), and a CODE card does not need to be inserted for calibration during testing and then the testing is carried out; the insulating ink covers the electrode, exposes a reaction area and an electrode pin with a certain area, and plays a role in protection, and the area of the reaction area is determined according to the linear relation between current and concentration under the reaction area;
(2) preparing a polyvinyl alcohol treatment solution (polyvinyl alcohol is weighed and directly dissolved in purified water), performing hydrophilic treatment on a reaction area by using the treatment solution, and drying in a drying tunnel, wherein the drying temperature of the treatment solution is 50 ℃ and the time is 4 min;
(3) loading the prepared enzyme solution containing glucose dehydrogenase and potassium ferricyanide into a reaction zone by adopting a spotting or printing mode, and drying in a drying tunnel at the drying temperature of 50 ℃ for 5 min. Wherein, the enzyme solution comprises the following components in percentage by volume: 86% phosphate buffer with pH 6.8, 1% surfactant tween 20, 2.5% hydroxyethyl cellulose, 3% glucose dehydrogenase, 7.5% potassium ferricyanide;
(4) after drying the enzyme solution in the reaction zone, sticking a washing tank white glue layer 8, then sticking a hydrophilic film layer 9, and finally sticking a cover sheet layer 10; the material of the washing white glue layer 8 is Sowess WH234343 type double-sided adhesive tape, the hydrophilic film layer 9 is subjected to single-sided hydrophilic treatment, the type of the hydrophilic film is 3M 9901P (purchased from Jianteng, Suzhou), and the material of the cover sheet is synthetic paper.
The application method of the electrochemical bar code-free blood glucose test paper comprises the following specific steps:
during the use, in being inhaled the reaction zone through the siphon effect with the blood sample from the end of inhaling on the PET base plate 10, blood passes through HCT test area at first, the CODE under the different HCT has been burnt into to the instrument the inside, according to the HCT who surveys out, select corresponding CODE, thereby realize HCT compensation according to the HCT automation that measures, then get into the reaction zone and react with glucose dehydrogenase, potassium ferricyanide, when blood is full of the reaction zone, full blood trigger electrode switches on work and shows that the volume of inhaling blood is sufficient, if the volume of inhaling blood is not enough, full blood trigger electrode will not switch on work, then can indicate the volume of inhaling blood is not enough. When the blood sucking amount is enough, the current generated by the reaction is detected, the corresponding bar CODE is selected according to the detected current and the arrangement combination of the corresponding CODE electrode to obtain the concentration of the blood sugar, the proportional relation that the current is in direct proportion to the concentration is a CODE, the corresponding CODE is selected according to the automatic identification of the arrangement combination instrument of the CODE electrode, and the concentration value is converted through the CODE after the current is detected.
In the HCT test zone, HCT compensation is performed by measuring the impedance of blood through HCT electrodes to derive HCT.
In the reaction area, glucose in blood reacts with potassium ferricyanide under the action of glucose dehydrogenase, the potassium ferricyanide is directly reduced into potassium ferrocyanide, the potassium ferrocyanide is oxidized into potassium ferricyanide under the voltage of +400mV, current is generated, and the linear relation between the glucose concentration and the current is selectively determined through the permutation and combination of the code electrodes, so that the glucose concentration is obtained.
The full blood electrode is arranged at the innermost side of the reaction area, full blood suction can contact the full blood electrode to conduct, the full blood suction is indicated, then 400mV of driving voltage is applied between the two reaction electrodes, and if the blood suction amount is not enough, the full blood suction cannot be conducted, and the fact that the blood is not full is indicated.
In the whole test process, a Code card does not need to be independently inserted for calibration, and the most appropriate Code is determined and selected through the arrangement and combination of Code electrodes, so that the function of avoiding bar CODEs is realized.
While the present invention has been described in detail with reference to the preferred embodiments, it should be understood that the above description should not be taken as limiting the invention. Various modifications and alterations to this invention will become apparent to those skilled in the art upon reading the foregoing description. Accordingly, the scope of the invention should be determined from the following claims.
Claims (8)
1. The electrochemical bar-code-free blood glucose test paper is characterized in that the blood glucose test paper sequentially comprises a PET substrate (7), an electrode layer, a notching white glue layer (8), a hydrophilic film layer (9) and a cover sheet layer (10) from bottom to top;
wherein the electrode layer is printed on the PET substrate (7) comprising: the pair of HCT silver electrodes (4), a full blood carbon electrode (3), a pair of reaction electrodes (2), a row of code electrodes (1) and insulating ink (5), wherein the electrodes are independent, the insulating ink (5) covers all the electrodes, and a reaction area and electrode pins of a certain area are exposed; an HCT test area is arranged between the pair of HCT silver electrodes (4), and does not contain any chemical reagent; a reaction area is arranged between the pair of reaction electrodes (2), and an enzyme layer containing glucose dehydrogenase and potassium ferricyanide covers the reaction area; the enzyme layer comprises the following components in percentage by volume: 86% phosphate buffer with pH 6.8, 1% surfactant tween 20, 2.5% hydroxyethyl cellulose, 3% glucose dehydrogenase, 7.5% potassium ferricyanide; the siphon reaction zone consists of the HCT test zone and the reaction zone;
one end of the PET substrate (7) is a blood sucking end, the other end of the PET substrate is a code electrode end, the blood sucking end is provided with a siphon reaction area inlet (11), and the code electrode end is provided with the code electrode (1);
the notching white glue layer (8) is adhered to the insulating ink (5), and hollow areas corresponding to the HCT test area and the reaction area are arranged on the notching white glue layer to form a siphon sampling port (12);
the hydrophilic film layer (9) is adhered to the washout white glue layer (8), the bottom end of the reaction area of the hydrophilic film layer (9) is provided with an exhaust hole (6), and the siphon pool is composed of a hollow area of the washout white glue layer (8), the hydrophilic film layer (9) and the exhaust hole (6) in the hydrophilic film layer (9);
the cover sheet layer (10) is pasted on the hydrophilic film layer (9), and a hollow area corresponding to the HCT test area and the reaction area is arranged on the cover sheet layer.
2. The electrochemical bar-code-free blood glucose test paper of claim 1, wherein the material of the punching groove white glue layer (8) is sogweis WH234343 type double-sided adhesive tape.
3. The electrochemical bar-code-free blood glucose test paper of claim 1, wherein the hydrophilic film layer (9) is 9901P hydrophilic polyester film.
4. The electrochemical bar-code-free blood glucose test paper of claim 1, wherein the cover sheet is synthetic paper.
5. The electrochemical bar-code-free blood glucose test strip of claim 1, wherein the area of the reaction region is determined according to a linear relationship between current and concentration.
6. The method for preparing the electrochemical bar-code-free blood glucose test paper according to any one of claims 1 to 5, wherein the method comprises the following steps:
(1) printing conductive silver paste, conductive carbon paste and insulating ink on a PET (polyethylene terephthalate) substrate (7), and forming a pair of reaction electrodes (2), a pair of HCT silver electrodes (4), a full blood carbon electrode (3) and a row of code electrodes (1) on the PET substrate (7) to obtain a PET blood glucose test paper substrate; wherein the reaction electrode (2), the full blood carbon electrode (3) and the code electrode (1) are obtained by printing conductive carbon paste; the HCT silver electrode (4) is obtained by printing conductive silver paste; the insulating ink covers all the electrodes, and a reaction area of a certain area and each electrode pin are exposed;
(2) carrying out hydrophilic treatment on the reaction zone by using polyvinyl alcohol treatment liquid, and drying;
(3) loading enzyme liquid containing glucose dehydrogenase and potassium ferricyanide into a reaction zone, and drying; wherein the enzyme solution comprises the following components in percentage by volume: 86% phosphate buffer with pH 6.8, 1% surfactant tween 20, 2.5% hydroxyethyl cellulose, 3% glucose dehydrogenase, 7.5% potassium ferricyanide;
(4) after the enzyme liquid in the reaction zone is dried, a washing groove white glue layer (8), a hydrophilic film layer (9) and a cover sheet layer (10) are sequentially adhered from bottom to top.
7. The method for preparing the electrochemical bar-code-free blood glucose test paper according to claim 6, wherein the drying temperature is 50 ℃ in both the steps (2) and (3).
8. The method for preparing the electrochemical bar-code-free blood glucose test paper according to claim 7, wherein in the steps (2) and (3), the drying time is 4-5 min.
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Application publication date: 20211102 |