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CN114002292B - Saliva blood glucose correction device and method - Google Patents

Saliva blood glucose correction device and method Download PDF

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Publication number
CN114002292B
CN114002292B CN202111289765.8A CN202111289765A CN114002292B CN 114002292 B CN114002292 B CN 114002292B CN 202111289765 A CN202111289765 A CN 202111289765A CN 114002292 B CN114002292 B CN 114002292B
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saliva
glucose
test paper
processing unit
blood glucose
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CN114002292A (en
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王松
林清进
陈明
田晖
刘伟强
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Anxuyuan Biotechnology Shenzhen Co ltd
Guangxi Zhongheng Innovation Pharmaceutical Research Co ltd
Shenzhen Research Institute Tsinghua University
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Anxuyuan Biotechnology Shenzhen Co ltd
Guangxi Zhongheng Innovation Pharmaceutical Research Co ltd
Shenzhen Research Institute Tsinghua University
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3274Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/416Systems
    • G01N27/49Systems involving the determination of the current at a single specific value, or small range of values, of applied voltage for producing selective measurement of one or more particular ionic species
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Biotechnology (AREA)
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  • Microbiology (AREA)
  • Food Science & Technology (AREA)
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Abstract

The invention discloses a saliva blood sugar correction device which comprises a shell, a detection processing unit, saliva glucose test paper and a display unit, wherein the shell is provided with a plurality of keys, a battery groove, a battery cover and a saliva glucose test paper inserting port, the detection processing unit is respectively and electrically connected with the display unit, the keys and the saliva glucose test paper to send a starting signal or receive information, and the display unit is connected with the detection processing unit to receive the saliva glucose value from the detection processing unit for display. The saliva blood sugar correction device provided by the invention does not need to be carried out in an invasive blood sampling measurement mode during ordinary blood sugar detection, so that the sanitation problem and the psychological problem of a patient in the blood sampling process are greatly avoided.

Description

Saliva blood glucose correction device and method
Technical Field
The invention relates to the technical field of blood sugar detection, in particular to a saliva blood sugar correction device and method.
Background
Today, people have become one of the major causes of diabetes in the world because of the change of eating habits and life-style, and the incidence of diabetes persists Pan Sheng, so people gradually recognize the importance of blood glucose control. The existing mature glucometer mainly comprises two types of invasive detection and non-invasive detection, wherein the invasive detection mainly comprises a glucose oxidase electrode measurement method and a glucose dehydrogenase electrode measurement method, and each measurement is carried out by taking blood from fingertips by taking blood, and then the blood is dripped on test paper to carry out measurement so as to obtain the blood glucose value; the greatest disadvantage of this embodiment is that not all testers can accept the short pricking pain when blood is taken, and the blood taking needle can only be used once, and the blood taking needle is used up and needs to be discarded, so that the resource waste is caused.
The non-invasive test is mainly optical blood glucose test, and uses a projection fixed light wave to the fingertip to detect the reflected wave of the blood vessel, and uses the obtained optical parameter to correct the blood glucose value. The biggest disadvantage of the implementation is that the sizes and the shapes of the fingertips of each person are different, and the blood vessels are different in depth, so that the consistency of detection results is affected, and the accuracy is low; in addition, the interference of external environment light is difficult to avoid during detection, and the instability of the embodiment is further emphasized; in addition, optical correction must be performed on the instrument at regular time, which causes inconvenience in use.
Disclosure of Invention
The invention mainly aims to provide a saliva blood sugar correction device and a saliva blood sugar correction method, which can effectively solve the problems in the background technology.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
the saliva blood glucose correction device comprises a shell, a detection processing unit, saliva glucose test paper and a display unit, wherein the shell can be formed by mutually assembling two half shells, the shell is provided with a plurality of keys, a battery groove, a battery cover and a saliva glucose test paper inserting port, the specific position of the saliva glucose test paper inserting port corresponds to the detection processing unit, the display unit is arranged on the surface of the shell, and the saliva glucose test paper is inserted into the saliva glucose test paper inserting port in the shell;
the detection processing unit is arranged in the shell and is respectively and electrically connected with the display unit, the key and the saliva glucose test paper to send a starting signal or receive information, the detection processing unit comprises a microprocessor chip, the microprocessor chip can be provided with a memory unit or is matched with an external memory unit for implementation, the detection processing unit is pre-stored with a saliva glucose reference table, the saliva glucose reference table records the comparison relation between a plurality of blood glucose values and electrochemical parameters acquired by the detection processing unit, the processing detection processing unit can provide the blood glucose values based on the saliva glucose reference table when receiving the electrochemical parameters, and the detection processing unit can correct the saliva glucose reference table based on the saliva glucose reference table when receiving the corrected blood glucose values and the electrochemical parameters;
the display unit is connected with a detection processing unit so as to receive the saliva glucose value from the detection processing unit for display.
As a further improvement of the above scheme, the power supply mode of the detection processing unit is battery power supply or direct current power supply adapter power supply, and the detection processing unit supplies power to the display unit.
As a further improvement of the above scheme, the saliva glucose test paper is composed of a plastic sheet, a silver/silver chloride printed circuit layer, an insulating layer, a graphene conductive ink layer, and an enzyme mixture (EMM) layer.
As a further improvement of the above, the conductive ink layer has a Counter Electrode (CE) and at least one Working Electrode (WE) electrode.
As a further improvement of the scheme, the first working electrode and the second working electrode are covered with a graphene conductive oil film and an enzyme mixture.
As a further improvement of the above scheme, the graphene conductive oil film consists of 1mg/ml graphene and 0.2mg/ml conductive ink.
As a further improvement to the above protocol, the enzyme mixture consisted of 50mM potassium ferrocyanide, 50mM phosphate buffer, 1.6Units/ul Aspergillus niger glucose oxidase, and 2.5Units/ul horseradish peroxidase.
A saliva blood glucose correction method comprising the steps of:
step one, saliva glucose test paper is provided for collecting saliva of a human body, a Working Electrode (WE) on the saliva glucose test paper is detected and sampled to generate an electrochemical parameter, and the electrochemical parameter is compared based on a saliva glucose reference table to obtain a blood glucose value;
step two: the blood glucose meter is used for taking blood and detecting by blood glucose test paper to obtain corrected blood glucose values, saliva of the same person is sampled by saliva glucose test paper, and a group of electrochemical parameters are generated after detection;
step three: calibrating the parameters stored in the blood glucose reference table according to the calibrated blood glucose value and the electrochemical parameters;
step four: a group of artificial saliva with standard glucose concentration is utilized, a group of electrochemical parameters are obtained after the reaction and detection of saliva glucose test paper, and a blood glucose reference table is established according to the parameters;
step five: and (3) detecting electrochemical signals at different times after a group of PBS BUFFER (phosphate BUFFER solution) with standard glucose concentration reacts by saliva glucose test paper to obtain a plurality of groups of electrochemical parameters, and performing data analysis according to the parameters to establish a blood glucose calculation formula.
As a further improvement of the above solution, the step one of collecting saliva from a human body specifically comprises: the saliva glucose test strip is directly contained in a sublingual or parotid position to obtain saliva of a human body, or the saliva is collected in a sampling box or a sampling tube in advance, and a reaction area of the test strip is wetted by using a proper tool such as a pipette.
As a further improvement of the above-mentioned solution, the subject first washes his mouth before taking the saliva in said step one.
Compared with the prior art, the invention has the following beneficial effects:
1. the invention does not need to be carried out in an invasive blood sampling measurement mode during normal blood sugar detection, thereby greatly avoiding the sanitary problem and psychological problem of patients in the blood sampling process
2. The correction method provided by the invention is used for correcting the accuracy of the saliva glucose detection device by matching blood sampling measurement with saliva measurement, providing the reference blood glucose data known by consumers, and avoiding the cognition and introduction obstacle of new technology.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed for the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic diagram showing the overall structure of saliva glucose test paper of a saliva blood glucose calibration device according to the present invention;
FIG. 2 is a schematic diagram showing the composition and structure of saliva glucose test paper of a saliva blood glucose correction device according to the present invention;
FIG. 3 is a schematic diagram showing the electrode function of saliva glucose test paper of a saliva blood glucose calibration device according to the present invention;
FIG. 4 is a block diagram showing a saliva blood glucose calibration device according to the present invention;
FIG. 5 is a flow chart of a saliva glucose calibration method according to the present invention.
In the figure: 15. saliva glucose test paper; 151. a plastic sheet; 152. a printed circuit layer of silver/silver chloride; 153. an insulating layer; 154. a graphene conductive ink layer; 155. an enzyme mixture (EMM) layer; 156. a filter pad; 157. a plastic strip; 158. a plastic cover; 1541. a Counter Electrode (CE); 1542. a working electrode (WE 1); 1543. a Reference Electrode (RE); 1544. and a second working electrode (WE 2).
Detailed Description
The invention is further described in connection with the following detailed description, in order to make the technical means, the creation characteristics, the achievement of the purpose and the effect of the invention easy to understand.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", "front", "rear", "both ends", "one end", "the other end", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific direction, be configured and operated in the specific direction, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "provided," "connected," and the like are to be construed broadly, and may be fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
The technical scheme of the invention is further described below with reference to the accompanying drawings.
Examples
1-4, the saliva blood glucose correction device comprises a shell, a detection processing unit, saliva glucose test paper 15 and a display unit, wherein the shell can be formed by mutually assembling two half shells, the shell is provided with a plurality of keys, a battery groove, a battery cover and a saliva glucose test paper 15 inserting port, the specific position of the saliva test paper inserting port corresponds to the detection processing unit, the display unit is arranged on the surface of the shell, and the saliva glucose test paper 15 is inserted into the saliva glucose test paper 15 inserting port in the shell;
the detecting and processing unit is arranged in the shell and is respectively and electrically connected with the display unit, the keys and the saliva glucose test paper 15 to send a starting signal or receive information, the detecting and processing unit comprises a microprocessor chip, the microprocessor chip can be provided with a memory unit or is matched with an external memory unit for implementation, the detecting and processing unit stores a saliva glucose reference table in advance, the saliva glucose reference table records the comparison relation between a plurality of blood glucose values and electrochemical parameters obtained by the detecting and processing unit, the detecting and processing unit can provide the blood glucose values based on the saliva glucose reference table when receiving the electrochemical parameters, and the detecting and processing unit 12 can correct the saliva glucose reference table based on the saliva glucose reference table when receiving the corrected blood glucose values and the electrochemical parameters;
the display unit is connected with the detection processing unit so as to receive the saliva glucose value from the detection processing unit for display.
The power supply mode of the detection processing unit is battery power supply or direct current power supply adapter power supply, and the detection processing unit supplies power to the display unit.
The saliva glucose test strip 15 is composed of a plastic sheet 151, a silver/silver chloride printed circuit layer 152, an insulating layer 153, a graphene conductive ink layer 154, an enzyme mixture (EMM) layer 155, a filter pad 156, a plastic strip 157, and a plastic cover 158.
The conductive ink layer has four electrodes of a Counter Electrode (CE) 1541, a first working electrode (WE 1) 1542, a Reference Electrode (RE) 1543, and a second working electrode (WE 2) 1544.
The first working electrode 1542 and the second working electrode 1544 are covered with a graphene conductive oil film and an enzyme mixture.
The graphene conductive oil film consists of 1mg/ml graphene and 0.2mg/ml conductive ink.
The enzyme mixture consisted of 50mM potassium ferrocyanide, 50mM phosphate buffer, 1.6Units/ul Aspergillus niger glucose oxidase, and 2.5Units/ul horseradish peroxidase.
As shown in fig. 5, a saliva blood sugar correction method includes the steps of:
step one, providing saliva glucose test paper 15 to collect saliva of a human body, detecting and sampling a Working Electrode (WE) on the saliva glucose test paper 15 to generate an electrochemical parameter, and comparing the electrochemical parameter based on a saliva glucose reference table to obtain a blood glucose value; the saliva collection for human body is specifically as follows: the saliva glucose test paper 15 is directly contained in the sublingual or parotid gland position to obtain saliva of a human body, or the saliva is collected in a sampling box or a sampling tube in advance, and a reaction area of the test paper is wetted by using a proper tool such as a pipetting gun and the like; before taking saliva, the person to be tested should rinse his mouth
Step two: the blood glucose meter is used for blood sampling and detection by blood glucose test paper to obtain corrected blood glucose values, saliva of the same person is sampled by saliva glucose test paper 15, and a group of electrochemical parameters are generated after detection;
step three: calibrating the parameters stored in the blood glucose reference table according to the calibrated blood glucose value and the electrochemical parameters;
step four: a group of artificial saliva with standard glucose concentration is utilized, a group of electrochemical parameters are obtained after the reaction and detection of saliva glucose test paper 15, and a blood glucose reference table is established according to the parameters;
step five: the method comprises the steps of utilizing a group of PBS BUFFER (phosphate BUFFER solution) with standard glucose concentration, detecting electrochemical signals at different times after the reaction of saliva glucose test paper 15 to obtain a plurality of groups of electrochemical parameters, and establishing a blood glucose calculation formula by performing data analysis according to the parameters.
In a specific use process, a detection processing unit is provided to sample a first working electrode (WE 1) 1542 on a saliva glucose test strip 15 to generate the electrochemical parameter, and compare the electrochemical parameter based on the saliva glucose reference table to obtain the blood glucose value, more specifically, the saliva glucose detection method of the present invention can be implemented with the saliva glucose detection device, and is implemented initially, a person to be detected can rinse the mouth first, then place the saliva glucose test strip 15 into the mouth to collect saliva, then insert the saliva glucose test strip 15 into the saliva glucose detection device to start or wake up the saliva glucose detection device, so that the detection processing unit samples the first working electrode (WE 1) 1542 on the saliva glucose test strip 15 to obtain the electrochemical parameter of the working electrode, and thereafter, the detection processing unit 12 obtains the saliva glucose value based on the comparison of the electrochemical parameter of the working electrode based on the saliva glucose reference table, after calculation, and then sends the detection result to a display unit to store the detection result, and corrects the saliva glucose table when necessary, and then enters a standby mode to complete the standby mode, or the standby mode can be completed after the saliva glucose test strip 15 is turned off.
The foregoing has shown and described the basic principles and main features of the present invention and the advantages of the present invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims (5)

1. The utility model provides a saliva blood sugar correcting unit, includes casing, detection processing unit, saliva glucose test paper and display element, its characterized in that: the shell can be formed by mutually assembling two half shells, the shell is provided with a plurality of keys, a battery groove, a battery cover and a saliva glucose test paper inserting port, the specific position of the saliva test paper inserting port corresponds to the detection processing unit, the display unit is arranged on the surface of the shell, and the saliva glucose test paper is inserted into the saliva glucose test paper inserting port in the shell;
the detection processing unit is arranged in the shell and is respectively and electrically connected with the display unit, the key and the saliva glucose test paper to send a starting signal or receive information, the detection processing unit comprises a microprocessor chip, the microprocessor chip can be provided with a memory unit or is matched with an external memory unit for implementation, the saliva glucose reference table is stored in advance and records the comparison relation between a plurality of blood glucose values and electrochemical parameters acquired by the detection processing unit, the detection processing unit can provide the blood glucose values based on the saliva glucose reference table when receiving the electrochemical parameters, and the detection processing unit can correct the saliva glucose reference table based on the corrected blood glucose values and the electrochemical parameters when receiving the corrected blood glucose values and the electrochemical parameters;
the display unit is connected with a detection processing unit to receive the saliva glucose value from the detection processing unit for display;
the saliva glucose test paper consists of a plastic sheet, a silver/silver chloride printed circuit layer, an insulating layer, a graphene conductive ink layer, an enzyme mixture EMM layer, a filter pad, a plastic strip and a plastic cover;
the conductive ink layer has a counter electrode CE and at least one working electrode WE;
the first working electrode WE1 and the second working electrode WE2 are covered with a graphene conductive oil film and an enzyme mixture;
the enzyme mixture consists of 50mM potassium ferrocyanide, 50mM phosphate buffer, 1.6Units/ul Aspergillus niger glucose oxidase and 2.5Units/ul horseradish peroxidase;
the graphene conductive oil film consists of 1mg/ml graphene and 0.2mg/ml conductive ink.
2. A saliva blood glucose correction device as defined in claim 1, wherein: the power supply mode of the detection processing unit is battery power supply or direct current power supply adapter power supply, and the detection processing unit supplies power to the display unit.
3. A method of correcting blood glucose in saliva based on the device of claim 1 or 2, characterized by: the method comprises the following steps:
step one, saliva glucose test paper is provided for collecting saliva of a human body, a first working electrode WE1 on the saliva glucose test paper is detected and sampled to generate an electrochemical parameter, and the electrochemical parameter is compared based on a saliva glucose reference table to obtain a blood glucose value;
step two: the blood glucose meter is used for taking blood and detecting by blood glucose test paper to obtain corrected blood glucose values, saliva of the same person is sampled by saliva glucose test paper, and a group of electrochemical parameters are generated after detection;
step three: calibrating parameters stored in the saliva glucose reference table according to the calibrated blood glucose value and the electrochemical parameters;
step four: a group of artificial saliva with standard glucose concentration is utilized, a group of electrochemical parameters are obtained after the reaction and detection of saliva glucose test paper, and a blood glucose reference table is established according to the parameters;
step five: and (3) detecting electrochemical signals at different times after a group of phosphate BUFFER PBS BUFFER with standard glucose concentration reacts by saliva glucose test paper to obtain a plurality of groups of electrochemical parameters, and performing data analysis according to the parameters to establish a blood glucose calculation formula.
4. A saliva blood glucose correction method according to claim 3, wherein: in the first step, saliva is collected from a human body specifically as follows: the saliva glucose test strip is directly contained in a sublingual or parotid position to obtain human saliva, or saliva is collected in a sampling box or a sampling tube in advance, and a reaction area of the test strip is wetted by using a proper tool.
5. A saliva blood glucose correction method according to claim 3, wherein: before saliva is obtained in the first step, a person to be tested needs to rinse the mouth.
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