CN115586234A

Movatterモバイル変換

Info

Publication number: CN115586234A
Application number: CN202211587310.9A
Authority: CN
Inventors: 韩哲勇; 王毅; 吴亚盼; 张莉
Original assignee: Acon Biotech Hangzhou Co Ltd
Current assignee: Acon Biotech Hangzhou Co Ltd
Priority date: 2022-12-12
Filing date: 2022-12-12
Publication date: 2023-01-10

Abstract

The invention provides a biosensor and a preparation method thereof, and the biosensor comprises an electrode system and an insulating layer, wherein the electrode system at least comprises a working electrode and a counter electrode, the working electrode is covered with an electrolyte layer, the electrolyte layer is covered with an oxygen permeable membrane, and the oxygen permeable membrane or the insulating layer comprises an ether-containing organic polymer. The oxygen permeable membrane or the insulating layer containing the ether organic polymer is used, so that the electrode slope can be obviously increased, the measurement accuracy of the sensor is improved, and the oxygen permeable membrane or the insulating layer containing the ether organic polymer can be applied to a blood gas electrolyte analysis system and the like.

Description

Biosensor and preparation method thereof

Technical Field

The invention relates to the technical field of blood gas electrolyte analysis, in particular to a biosensor and a preparation method thereof.

Background

The partial pressure of blood oxygen is one of the indicators of blood gas detection, which can reflect the content of oxygen in blood. Oxygen is a gas necessary for human respiration and energy metabolism, and enters arterial blood through lungs. The normal arterial blood oxygen partial pressure value of human body is 80-105mmHg. Hypoxia can cause damage to the respiratory, digestive, blood and central nervous systems, and even coma of patients. When the partial pressure of blood oxygen is lower than 20mmHg, life is difficult to maintain. Therefore, real-time monitoring of partial pressure of blood oxygen is very important in clinical care.

The partial pressure of oxygen in the blood may be detected by a partial pressure blood oxygen biosensor in combination with a blood gas analyzer. The biosensor for measuring the partial pressure of blood oxygen comprises an electrode system and an insulating layer at the peripheral part of the electrode system. The electrode system generally consists of a working electrode and a counter electrode, and in the case of a three-electrode system, a reference electrode is also included. The working electrode is covered with an electrolyte layer, and the electrolyte layer is covered with an oxygen permeable membrane. The blood is immersed in the oxygen permeable membrane, oxygen in the blood permeates the oxygen permeable membrane, electrochemical reaction is carried out on the working electrode, a current signal which is in linear relation with the blood oxygen partial pressure value is generated, and the oxygen partial pressure is calculated by a blood gas analyzer.

The electrode slope of the biosensor for measuring the partial pressure of blood oxygen is the slope of a fitting curve of a current value generated after a sample reacts on the surface of an electrode and the partial pressure value of oxygen of the sample, the slope is related to the accuracy of the sensor, and when the slope is larger, the accuracy of the sensor is better. In the prior art, the oxygen permeable membrane on the working electrode of the blood oxygen partial pressure biosensor is usually made of silica gel, polytetrafluoroethylene, cellulose acetate (also known as cellulose acetate), polyvinyl chloride and the like, the insulating layer at the peripheral part of the electrode system is generally composed of polyester, polycarbonate, polyvinyl chloride, ceramic, alumina and the like, but the electrode slope of the blood oxygen partial pressure biosensor prepared by using the conventional oxygen permeable membrane/insulating layer materials is smaller, and the sensor precision is not enough.

Disclosure of Invention

In view of the problem of low accuracy of the blood oxygen partial pressure biosensor caused by the conventional oxygen permeable membrane/insulating layer material, the invention adds the organic polymer containing ether in the material of the oxygen permeable membrane or the insulating layer, thereby obviously increasing the electrode slope of the blood oxygen partial pressure biosensor and improving the measurement accuracy of the sensor.

The technical scheme for solving the technical problems is as follows: a biosensor for measuring oxygen partial pressure comprises an electrode system and an insulating layer, wherein the electrode system at least comprises a working electrode and a counter electrode, the working electrode is covered with an electrolyte layer, the electrolyte layer is covered with an oxygen permeable membrane, and the oxygen permeable membrane or the insulating layer comprises an ether-containing organic polymer.

As a preferred embodiment of the biosensor, the oxygen permeable membrane comprises an ether containing organic polymer and the insulating layer does not comprise an ether containing organic polymer.

As a preferred version of the biosensor, the oxygen permeable membrane does not comprise an ether containing organic polymer and the insulating layer comprises an ether containing organic polymer.

As a preferred embodiment of the biosensor, both the oxygen permeable membrane and the insulating layer comprise an ether containing organic polymer.

As a preferred embodiment of the biosensor, the ether-containing organic polymer is selected from thermoplastic silicone polyether polyurethane or polyether sulfone or epoxy resin.

As a preferable scheme of the biosensor, the concentration of the thermoplastic organic silicon polyether polyurethane is 0.5-10%.

As a preferable scheme of the biosensor, the concentration of the thermoplastic organic silicon polyether polyurethane is 0.8-6.0%.

The invention also provides a preparation method of the biosensor for measuring the oxygen partial pressure, which comprises the following steps:

step 1: forming an electrode system by electroplating or chemical plating or screen printing, wherein the electrode system at least comprises a working electrode and a counter electrode;

and 2, step: adding an insulating material to an outer peripheral portion of the electrode system to form an insulating layer;

and 3, step 3: preparing an electrolyte solution in advance, wherein the electrolyte solution uniformly covers the working electrode to form an electrolyte layer;

and 4, step 4: preparing an oxygen permeable membrane solution in advance, wherein the oxygen permeable membrane solution uniformly covers the electrolyte layer to form an oxygen permeable membrane;

wherein the oxygen permeable membrane or insulating layer comprises an ether containing organic polymer.

As a preferred version of the method of manufacturing the biosensor, the oxygen permeable membrane comprises an ether containing organic polymer and the insulating layer does not comprise an ether containing organic polymer.

As a preferable mode of the manufacturing method of the biosensor, the oxygen permeable membrane does not include an ether-containing organic polymer, and the insulating layer includes an ether-containing organic polymer.

As a preferred embodiment of the method for producing the biosensor, both the oxygen permeable membrane and the insulating layer comprise an ether-containing organic polymer.

As a preferable embodiment of the preparation method of the biosensor, the ether-containing organic polymer is selected from thermoplastic silicone polyether polyurethane or polyether sulfone or epoxy resin.

As a preferable scheme of the preparation method of the biosensor, the concentration of the thermoplastic organic silicon polyether polyurethane is 0.5-10%.

As a preferable scheme of the preparation method of the biosensor, the concentration of the thermoplastic organic silicon polyether polyurethane is 0.8-6.0%.

As a preferable scheme of the preparation method of the biosensor, the oxygen permeable membrane is one layer, two layers or multiple layers.

The beneficial effects of the invention are: the oxygen permeable membrane or the insulating layer material containing the ether organic polymer is used in the biosensor, specifically, the oxygen permeable membrane is a thermoplastic organic silicon polyether polyurethane oxygen permeable membrane or polyether sulfone oxygen permeable membrane, and the insulating layer is an epoxy resin insulating layer, so that the electrode slope of the biosensor can be obviously increased, and the sensor precision is improved.

Drawings

FIG. 1 is a top view of a biosensor according to the present invention;

FIG. 2 isbase:Sub>A cross-sectional view taken along A-A of FIG. 1;

FIG. 3 is a schematic diagram of the operation of the biosensor;

FIG. 4 is a plot of the fit of the biosensors of example 1 with TSPU2080A oxygen permeable membrane, TSPCU2090 oxygen permeable membrane and oxygen impermeable membrane;

FIG. 5 is a curve fitted to biosensors of example 2 containing different concentrations of TSPU2080A oxygen permeable membranes;

FIG. 6 is a curve fit for the oxygen permeable membrane containing polyethersulfone, oxygen permeable membrane containing TSPCU2090 and oxygen-free membrane biosensors of example 3;

FIG. 7 is a top view of a biosensor containing an epoxy insulating layer;

FIG. 8 isbase:Sub>A cross-sectional view taken along A-A of FIG. 7;

fig. 9 is a fitted curve of four biosensors including an epoxy resin-containing insulating layer and a TSPU2080A oxygen permeable membrane, an epoxy resin-containing insulating layer and a TSPCU2090 oxygen permeable membrane, a Gwent insulating layer and a TSPU2080A oxygen permeable membrane, and a Gwent insulating layer and a TSPCU2090 oxygen permeable membrane.

Detailed Description

The present invention will be described in detail with reference to specific examples. These specific examples are given by way of illustration only, and are not intended to exclude other specific embodiments which would be apparent to a person skilled in the art from the combination of the prior art and the present invention.

Abiosensor 100 for measuring oxygen partial pressure, as shown in FIGS. 1 and 2, includes a workingelectrode 1, acounter electrode 2, aninsulating layer 3, anelectrolyte layer 4, an oxygenpermeable membrane 5, and asubstrate 6. The material of the workingelectrode 1 is selected from materials having good conductivity, such as gold, silver, copper, platinum, carbon, and the like. The material of thecounter electrode 2 is silver. The workingelectrode 1 and thecounter electrode 2 are formed on the surface of thesubstrate 6, the workingelectrode 1 and thecounter electrode 2 are connected with thepin 8 through thelead 7, and the electric signals of the workingelectrode 1 and thecounter electrode 2 are connected with an external testing device through thelead 7 and thepin 8, so as to obtain the current value generated by the sample when the surface of the workingelectrode 1 reacts. Theinsulating layer 3 covers the peripheral portions of the workingelectrode 1, thecounter electrode 2, and thepin 8 on thebase material 6, and exposes the workingelectrode 1, thecounter electrode 2, and thepin 8. Theelectrolyte layer 4 covers the surface of the workingelectrode 1, the oxygenpermeable membrane 5 covers the surface of theelectrolyte layer 4, and the oxygenpermeable membrane 5 protects theelectrolyte layer 4 and allows oxygen in the sample to permeate.

The working process of thebiosensor 100 is as follows: as shown in fig. 3, first, a calibration solution with a known oxygen partial pressure value is injected into theflow channel 1004 through a calibrationsolution injection port 1001 to cover the regions of the workingelectrode 1 and thecounter electrode 2, an external test device is connected to the workingelectrode 1 and thecounter electrode 2 through apin 8 and alead 7 to form a test loop, a potential of-0.8V is applied to the workingelectrode 1, and a potential of 0V is applied to the counter electrode, so that a potential difference of 0.8V is formed between the workingelectrode 1 and thecounter electrode 2. After the potential difference is applied for 0.8s, the current value between the workingelectrode 1 and thecounter electrode 2 at the moment is read on an external testing device, and the standard curve of the oxygen partial pressure electrode is corrected. After the calibration is finished, the calibration solution is pushed into thewaste liquid area 1003, the sample solution is injected into theflow channel 1004 through the testsolution filling port 1002 to cover the areas of the workingelectrode 1 and thecounter electrode 2, and the external test device is connected with the workingelectrode 1 and thecounter electrode 2 through thepin 8 and thelead 7 to form a test loop and read a current signal.

EXAMPLE 1 biosensor containing Ether-based oxygen permeable Membrane (thermoplastic Silicone polyether polyurethane oxygen permeable Membrane)

In this example 1, the slopes of fitted curves of the current values of the electrodes (i.e., the current values generated after the reaction of the sample on the electrode surface) and the oxygen partial pressure values of the sample in three types of biosensors including an ether-based oxygen-permeable membrane, an ether-free oxygen-permeable membrane, and an oxygen-free membrane were compared. The oxygen permeable membrane containing ether group is a thermoplastic organic silicon polyether polyurethane oxygen permeable membrane, the oxygen permeable membrane containing no ether group is a thermoplastic organic silicon polycarbonate polyurethane oxygen permeable membrane, and the preparation steps of the three biosensors are as follows.

The preparation of the biosensor containing ether-based oxygen permeable membrane (thermoplastic silicone polyether polyurethane oxygen permeable membrane) comprises the following steps.

(1) Forming a gold layer on thebase material 6 by an electroplating or chemical plating method to be used as a workingelectrode 1, alead 7 and apin 8; a silver layer is formed on thebase 6 as thecounter electrode 2 by electroplating, electroless plating, or screen printing.

(2) The insulatinglayer 3 is formed by applying insulating ink to the peripheral portions of the workingelectrode 1, thecounter electrode 2 and thepin 8 on thebase material 6 by a screen printing method and drying. The insulating ink is selected from D2070423P5 Polymer Dielectric products of Gwent group company, UK, abbreviated as Gwent insulation.

(3) An electrolyte slurry is disposed and anelectrolyte layer 4 is formed. The preparation method of the electrolyte layer slurry comprises the following steps: potassium chloride was dissolved in deionized water to form an electrolyte solution with a potassium chloride concentration of 0.22M. 0.2M glycine and appropriate potassium hydroxide were added to the electrolyte solution as a buffer to bring the pH of the electrolyte solution to 8.4. 0.274g of sodium cellulose, 0.040g of cellulose and 0.363g of polyvinylpyrrolidone are dissolved in 36.2 g of deionized water and are stirred uniformly to be used as a solution of a film forming agent and a thickening agent. And (3) uniformly mixing 2.4g of electrolyte solution and 1.2g of film-forming agent and thickening agent solution to form electrolyte layer slurry, and finally adding surfactant Triton. Diluting Triton into 10% aqueous solution, adding 0.02g of the aqueous solution into the electrolyte slurry, uniformly mixing, and dropwise adding the mixture onto the surface of the workingelectrode 1 by using a liquid dropping machine. The electrolyte slurry covers the surface of the workingelectrode 1, and is dried by an oven to form anelectrolyte layer 4.

(4) 0.05g of thermoplastic silicone polyether polyurethane (selected fromPurSil 2080A UR TSPU products of DSM Biomedical B.V. company, TSPU2080A for short) is dissolved in 1.950g of isophorone, oxygen permeation membrane solution with the concentration of 2.5% is formed, a liquid dispenser is used for dropwise adding the oxygen permeation membrane solution on theelectrolyte layer 4, and the oxygen permeation membrane is formed through drying of an oven, so that the biosensor containing the TSPU2080A oxygen permeation membrane is prepared.

The preparation of a biosensor without an ether-based oxygen permeable membrane (thermoplastic silicone polycarbonate polyurethane oxygen permeable membrane) included the following steps.

Steps (1), (2) and (3) are the same as steps (1), (2) and (3) of the biosensor containing the TSPU2080A oxygen permeable membrane. And (4): 0.05g of thermoplastic organosilicon polycarbonate polyurethane (selected from CarboSil 20 90A UR TSPCU of DSM biomedicalal B.V. company, TSPCU2090 for short) is dissolved in 1.950g of N, N-dimethylacetamide to form an oxygen-permeable membrane solution with the concentration of 2.5%, the oxygen-permeable membrane solution is dripped on theelectrolyte layer 4 by using a liquid dripping machine, and an oxygen-permeable membrane is formed by drying in an oven, so that the biosensor containing the TSPCU2090 oxygen-permeable membrane is prepared.

The preparation of the oxygen-permeable membrane-free biosensor comprises the following steps.

The biosensor without the oxygen permeable membrane is prepared through the steps (1), (2) and (3) of the biosensor with the TSPU2080A oxygen permeable membrane.

The prepared biosensors containing the TSPU2080A oxygen permeable membrane, the TSPCU2090 oxygen permeable membrane and the oxygen-free membrane are connected with an external test device to respectively test 5 sample solutions with different oxygen partial pressure values, the biosensors generate current signals which are in linear relation with the oxygen partial pressure values of the samples, and the external test device reads the current values. Each sample was tested 4 times and the average of the current levels was taken. The standard value of the oxygen partial pressure of 5 sample solutions was measured by an ABL80 blood gas analyzer of Leber, denmark. The fitted curves of the three biosensors were plotted with the oxygen partial pressure measured by the ABL80 analyzer as the horizontal axis and the current average value measured by the test apparatus as the vertical axis, and the obtained data are shown in table 1 and fig. 4. The negative sign in the current and the slope only represents the current direction, and the comparison of the slopes refers to the comparison of the absolute values of the current and the slope.

TABLE 1

The data result of example 1 shows that the electrode slope of the biosensor containing the ether-based oxygen permeable membrane (TSPU 2080A oxygen permeable membrane) is the largest and is-0.0088, which is obviously larger than the electrode slope of the biosensor containing the TSPCU2090 oxygen permeable membrane and the oxygen-free oxygen permeable membrane, and the CV value of the biosensor containing the TSPU2080A oxygen permeable membrane is the smallest and is 5.4%, which has better precision. From this, it is found that when the oxygen permeable membrane material of the biosensor contains an ether group, the efficiency of the electrode can be significantly increased and the sensor accuracy is better.

Example 2 biosensor containing different concentrations of TSPU2080A oxygen permeable membranes

In this example 2, biosensors including TSPU2080A oxygen permeable membranes with different concentrations were prepared, the preparation steps were the same as those of the biosensors including TSPU2080A oxygen permeable membranes in example 1, and only the masses of TSPU2080A and isophorone in step (4) were changed to make the concentrations of the oxygen permeable membranes 0.8%, 1.0%, 2.0%, 2.5%, 3.0%, 4.0%, and 6.0%, respectively. The fitting curves of the biosensors containing the TSPU2080A oxygen permeable membranes with different concentrations are drawn according to the method of the fitting curve of the current value and the oxygen partial pressure value in the example 1, and the results are shown in the table 2 and the figure 5.

TABLE 2

The data effect of theembodiment 2 shows that when the concentration of TSPU2080A is 0.8% -6.0%, biosensors containing TSPU2080A oxygen permeation membranes all have larger electrode slopes and better sensor precision.

EXAMPLE 3 biosensor containing Ether-based oxygen permeable Membrane (polyethersulfone oxygen permeable Membrane)

In this example 3, the slopes of the fitted curves of the current values of the electrodes (i.e., the current values generated after the reaction of the sample on the electrode surface) and the oxygen partial pressure values of the sample in three biosensors including an ether-based oxygen permeable membrane (polyethersulfone oxygen permeable membrane), an ether-based oxygen permeable membrane-free oxygen permeable membrane (TSPCU 2090 oxygen permeable membrane) and an oxygen permeable membrane-free oxygen permeable membrane were compared.

The preparation of the biosensor containing ether-based oxygen permeable membrane (polyether sulfone oxygen permeable membrane) comprises the following steps.

The steps (1), (2) and (3) are the same as the steps (1), (2) and (3) of the biosensor containing the TSPU2080A oxygen permeable membrane. And (4): 0.05g of polyethersulfone is dissolved in 1.950g of N, N-dimethylacetamide to form an oxygen-permeable membrane solution with the concentration of 2.5 percent, the oxygen-permeable membrane solution is dripped on theelectrolyte layer 4 by using a liquid dropping machine, and the oxygen-permeable membrane is formed after drying in an oven, thus preparing the biosensor containing the polyether sulfone oxygen-permeable membrane.

The results of the curve fitting of the biosensor containing the polyethersulfone oxygen-permeable membrane were plotted according to the curve fitting method of the current value and the oxygen partial pressure value in example 1, and compared with the curve fitting of the biosensor containing the TSPCU2090 oxygen-permeable membrane and the oxygen-impermeable membrane in example 1 are shown in Table 3 and FIG. 6.

TABLE 3

The data result of example 3 shows that the electrode slope of the biosensor containing the polyethersulfone oxygen-permeable membrane is the largest and is-0.0080, which is obviously larger than the electrode slope of the biosensor containing the TSPCU2090 oxygen-permeable membrane and the oxygen-free membrane, and the CV value of the biosensor containing the polyethersulfone membrane is the smallest and is 5.7%, so that the biosensor has better precision. From this, it is found that when the oxygen permeable membrane material of the biosensor contains an ether group, the efficiency of the electrode can be significantly increased and the sensor accuracy is better.

Example 4 biosensor containing epoxy-based insulating layer (epoxy resin insulating layer)

This example 4 compares the slopes of four biosensors, namely, an oxygen-permeable membrane containing a common insulating layer and TSPU2080A, an oxygen-permeable membrane containing a common insulating layer and TSPCU2090, an oxygen-permeable membrane containing an epoxy group and TSPU2080A, and an oxygen-permeable membrane containing an epoxy group andTSPCU 2090. The common insulating layer was the Gwent insulating layer in examples 1, 2 and 3 above, and the insulating ink was polyester, polyvinyl chloride, polycarbonate, ceramic, alumina, and contained no epoxy group. In thisembodiment 4, the epoxy-containing insulating layer is an epoxy resin insulating layer.

The preparation of the biosensor containing the epoxy resin insulating layer and the TSPU2080A oxygen permeable membrane comprises the following steps.

(1) A gold layer is formed by an electroplating or electroless plating method as the workingelectrode 1, and a silver layer is formed by an electroplating or electroless plating method as thecounter electrode 2.

(2) An insulating sheet containing epoxy resin was adhered to the outer peripheral portions of the workingelectrode 1 and thecounter electrode 2 to form an insulatinglayer 3 and expose the workingelectrode 1 and thecounter electrode 2.

(4) 0.05g of TSPU2080A is dissolved in 1.950g of isophorone to form an oxygen permeable membrane solution with the concentration of 2.5%, the oxygen permeable membrane solution is dripped on theelectrolyte layer 4 by using a liquid dropping machine, and the oxygen permeable membrane is formed after drying in an oven, namely the biosensor containing the epoxy resin insulating layer and the TSPU2080A oxygen permeable membrane is prepared.

The preparation of the biosensor containing the epoxy resin insulation layer and the TSPCU2090 oxygen permeable membrane comprises the following steps.

The preparation steps (1), (2) and (3) are the same as the preparation steps (1), (2) and (3) of the biosensor containing the epoxy resin insulating layer and the TSPU2080A oxygen permeable membrane. And (4): 0.05g of TSPCU2090 is dissolved in 1.950g of N, N-dimethylacetamide to form an oxygen permeable membrane solution with the concentration of 2.5%, the oxygen permeable membrane solution is dripped on theelectrolyte layer 4 by using a liquid dropping machine, and the oxygen permeable membrane is formed after drying in an oven, namely the biosensor containing the epoxy resin insulating layer and the TSPCU2090 oxygen permeable membrane is manufactured.

The top view and the cross-sectional view of the biosensor containing an epoxy resin insulating layer in this example 4 are shown in FIGS. 7 and 8.

The fitting curves of the biosensors including the epoxy resin insulating layer and the TSPU2080A oxygen permeable membrane and including the epoxy resin insulating layer and the TSPCU2090 oxygen permeable membrane were drawn according to the method of the fitting curves of the current and the oxygen partial pressure in example 1, and compared with the fitting curves of the biosensors including the Gwent insulating layer and the TSPU2080A oxygen permeable membrane, including the Gwent insulating layer and the TSPCU2090 oxygen permeable membrane in example 1, and the results are shown in table 4 and fig. 9.

TABLE 4

The data result of example 4 shows that the electrode slope of the biosensor containing the epoxy resin insulating layer and the TSPU2080A oxygen-permeable membrane is-0.0115, which is obviously greater than the electrode slope (-0.0088) of the biosensor containing the Gwent insulating layer and the TSPU2080A oxygen-permeable membrane; similarly, the electrode slope (-0.0077) of the biosensor containing the epoxy insulation layer and the TSPCU2090 oxygen permeable membrane was also greater than the electrode slope (-0.0046) of the biosensor containing the Gwent insulation layer and the TSPCU2090 oxygen permeable membrane. From this, it is understood that when the insulating layer of the biosensor contains an epoxy group, the efficiency of the electrode can be significantly increased and the sensor accuracy is better.

Example 5 biosensor containing TSPU2080A oxygen permeable Membrane for detecting oxygen partial pressure value of sample

5 samples having different oxygen partial pressure values were taken, and the oxygen partial pressure values of the 5 samples were measured by an ABL80 blood gas analyzer of Denmark Rayleigh, and were 40 mmHg, 98 mmHg, 167 mmHg, 249 mmHg, and 397mmHg, respectively. The biosensor containing TSPU2080A oxygen permeable membrane prepared in example 1 was used to measure the oxygen partial pressure values of the 5 samples, each sample was measured 4 times, and the average value was taken as the oxygen partial pressure value, and the results are shown in Table 5.

TABLE 5

The data result of example 5 shows that the biosensor containing the TSPU2080A oxygen permeable membrane has better detection accuracy when measuring oxygen partial pressure of low concentration, medium concentration and high concentration, and the CV value is smaller.

Claims

1. A biosensor comprises an electrode system and an insulating layer, wherein the electrode system at least comprises a working electrode and a counter electrode, the working electrode is covered with an electrolyte layer, the electrolyte layer is covered with an oxygen permeable membrane, and the oxygen permeable membrane or the insulating layer comprises an ether-containing organic polymer.

2. The biosensor of claim 1, wherein the oxygen permeable membrane comprises an ether-containing organic polymer and the insulating layer does not comprise an ether-containing organic polymer; or the oxygen permeable membrane does not comprise an ether containing organic polymer and the insulating layer comprises an ether containing organic polymer; or both the oxygen permeable membrane and the insulating layer comprise an ether containing organic polymer.

3. Biosensor according to claim 1 or 2, wherein the ether containing organic polymer is selected from thermoplastic silicone polyether polyurethane or polyether sulfone or epoxy.

4. The biosensor of claim 3, wherein the concentration of the thermoplastic silicone polyether polyurethane is 0.5-10%.

5. The biosensor of claim 4, wherein the concentration of the thermoplastic silicone polyether polyurethane is 0.8% -6.0%.

6. A method for preparing a biosensor, comprising the steps of:

step 2: adding an insulating material to an outer peripheral portion of the electrode system to form an insulating layer;

and step 3: preparing an electrolyte solution in advance, wherein the electrolyte solution uniformly covers the working electrode to form an electrolyte layer;

7. The method of claim 6, wherein the oxygen permeable membrane comprises an ether-containing organic polymer and the insulating layer does not comprise an ether-containing organic polymer; or the oxygen permeable membrane does not comprise an ether containing organic polymer and the insulating layer comprises an ether containing organic polymer; or both the oxygen permeable membrane and the insulating layer comprise an ether containing organic polymer.

8. The method of claim 6 or 7, wherein the ether-containing organic polymer is selected from a thermoplastic silicone polyether polyurethane or polyether sulfone or epoxy resin.

9. The method of claim 8, wherein the concentration of the thermoplastic silicone polyether polyurethane is 0.5-10%.

10. The method of claim 9, wherein the concentration of the thermoplastic silicone polyether polyurethane is 0.8-6.0%.