A rapid blood sugar test strip and preparation method thereof

Abstract

The invention belongs to the technical field of blood glucose test strips, and specifically relates to a rapid detection blood glucose test strip and a preparation method thereof; the invention consists of a blood glucose test strip impregnation solution and a test strip substrate, wherein the test strip substrate consists of 10-20% graphite powder, 10-15% polyurethane resin, 5-10% polybutylene terephthalate, 5-10% polypropylene terephthalate, 5-10% polyethylene, 5-10% hydroxyethyl cellulose and 45-60% ethylene glycol butyl ether; the blood glucose test strip impregnation solution consists of 40-45% phosphate buffer, 2-3% glucose The invention discloses a blood glucose test strip comprising glucose dehydrogenase, 40-45% normal saline, 0.5-1% iron oxide, 0.5-1% cobalt oxide, 2-3% ascorbic acid and 1-3% m-xylylenediamine. The blood glucose test strip prepared by the invention can provide more reliable results even when blood glucose fluctuates greatly, has good stability and is less affected by environmental factors, can give results within four to five seconds, and has reliable measurement results, which is convenient for users to understand blood glucose levels in a timely manner, and can help patients take prompt measures to avoid crisis situations when hypoglycemia or hyperglycemia symptoms occur.

Description

Technical Field

[0001] The invention belongs to the technical field of blood sugar test strips, and in particular relates to a rapid blood sugar test strip and a preparation method thereof. Background Art

[0002] Diabetes, as a chronic metabolic disease, has been recorded as early as ancient times. With the deepening of understanding of diabetes, regular monitoring of blood sugar is considered to be the key to managing diabetes, and changes in blood sugar levels are closely related to the health status of diabetic patients. Initially, blood sugar monitoring relied on chemical analysis in the laboratory. Patients had to draw blood and send samples to the laboratory for analysis. This method was time-consuming and inconvenient. With the development of electronic technology, the advent of portable blood glucose meters enabled patients to monitor their blood sugar at home, but laboratory reagents were still required. With the advent of blood glucose test strips, users drop blood on the test strips and then read the results in combination with the blood glucose meter. This innovation greatly simplified the process of diabetes management. With the development of technology, the accuracy and sensitivity of test strips have been continuously improved. Today, test strips usually use the principle of biochemical reactions to react blood sugar with specific enzymes to generate measurable signals to analyze the user's blood sugar content to predict diabetes.

[0003] Chinese patent publication number CN113588935A discloses an electrochemical barcode-free blood glucose test strip and a preparation method thereof, which covers an enzyme membrane on a PET substrate and performs test compensation through HCT to obtain more accurate test results. However, the preparation process is complicated during use and the use process is complicated and cannot meet the purpose of rapid detection. Chinese patent publication number CN111366623A discloses an electrochemical blood glucose test strip with a temperature label, a preparation process and a method of use. However, problems such as inaccuracy, low sensitivity and long detection time still occur during use.

[0004] In view of the above technical defects, a solution is now proposed. Summary of the invention

[0005] The purpose of the present invention is to provide a rapid blood sugar test strip and a preparation method thereof, which has higher sensitivity and detection accuracy and faster reaction time in conventional detection.

[0006] To achieve the above-mentioned purpose, the present invention adopts the following technical scheme: a rapid blood glucose test strip is composed of a blood glucose test strip impregnation liquid and a test strip substrate, wherein the test strip substrate is obtained by coating a test strip substrate coating liquid on a processed paper substrate, and the test strip substrate coating liquid is composed of the following percentage components: 10-20% graphite powder, 10-15% polyurethane resin, 5-10% polyethylene terephthalate, 5-10% polypropylene terephthalate, 5-10% polyethylene, 5-10% hydroxyethyl cellulose and 45-60% ethylene glycol butyl ether;

[0007] The preparation method of the test paper substrate coating liquid comprises the following steps:

[0008] A1: Add polyurethane resin and ethylene glycol butyl ether into a three-necked flask with a thermometer and a magnetic stirrer and heat at an angle of 30°, and stir at a temperature of 75-80°C and a stirring rate of 600-900 rpm for 30 minutes;

[0009] A2: Adjust the reaction temperature to 85-98°C, add polyethylene terephthalate and polytrimethylene terephthalate, use a reflux condenser to reflux the reaction, adjust the speed of the magnetic stirrer to 400-600 rpm, stir and reflux the reaction for 1-2 hours;

[0010] A3: Add hydroxyethyl cellulose to a three-necked flask, adjust the reaction temperature to 70-90°C, set the magnetic stirrer to 600-800 rpm, stir the reaction under reflux for 1-2 hours, and cool the reaction product to room temperature after the reaction is completed;

[0011] A4: Add polyethylene and graphite powder into a three-necked flask, adjust the reaction temperature to 80-95°C, set the magnetic stirrer to 800-1000 rpm, and stir for 1-2 hours;

[0012] A5: Transfer the reaction product to a homogenizer, use steam heating, adjust the temperature of the homogenizer to 60-70°C, homogenize for 30 minutes, then transfer the homogenized reaction product to a vacuum degassing machine, adjust the vacuum degree of the vacuum degassing machine to 0.05-0.1MPa, and perform vacuum degassing for 0.5-1h to obtain the test paper substrate coating liquid.

[0013] Furthermore, the test paper substrate is obtained by coating the test paper substrate coating liquid on the processed paper substrate, and the coating thickness is 0.05-0.1mm; the processed paper substrate is made of base paper through bleached chemical pulp, and the basis weight is 30g / m 2 -80g / m 2 .

[0014] Further, the blood glucose test strip impregnation solution is composed of the following percentage components: 40-45% phosphate buffer, 2-3% glucose dehydrogenase, 40-45% normal saline, 1-2% cobalt oxide, 2-3% ascorbic acid and 1-3% m-xylylenediamine;

[0015] The preparation method of the blood glucose test paper impregnation solution comprises the following steps:

[0016] B1: Glucose dehydrogenase, ascorbic acid, m-xylylenediamine and physiological saline are added into a reaction kettle, and the reaction kettle is placed on a magnetic stirrer, heated in a water bath, the temperature is set to 35-45°C, the speed is set to 600-800 rpm, and stirred for 25-30 min to obtain material 1;

[0017] B2: Mix cobalt oxide and phosphate buffer and add them into a reactor. Place the reactor on a magnetic stirrer, heat it in a water bath, set the temperature to 55-65°C, set the speed to 1000-1200 rpm, and stir for 45-60 min to obtain material 2;

[0018] B3: Cool material 1 and material 2 to room temperature, mix material 1 and material 2 after cooling to room temperature, place in a magnetic stirrer, set the speed to 600-800rpm and stir for 30min, after material 1 and material 2 are mixed, use ammonia water and 9% glacial acetic acid to adjust the pH to 6.5-7 to obtain the blood glucose test strip impregnation solution.

[0019] Furthermore, a method for preparing a rapid blood sugar test strip comprises the following steps:

[0020] C1: Immerse the test paper substrate in the blood glucose test paper immersion solution for 30-60 minutes;

[0021] C2: The impregnated test paper substrate is placed in a room temperature environment and air-dried for 2-3 hours to obtain a rapid blood glucose test paper.

[0022] Further, the graphite powder is graphite powder with a specification of 2000 mesh; the glucose dehydrogenase is water-soluble glucose dehydrogenase powder with a purity of 99%; the ascorbic acid is water-soluble L-ascorbic acid powder; the cobalt oxide is cobalt trioxide powder with a specification of 300 mesh;

[0023] In summary, due to the adoption of the above-mentioned technical scheme, the beneficial effect of the present invention is that the blood glucose test strip prepared by the present invention can still provide more reliable results when the blood glucose fluctuates greatly, has good stability and is less affected by environmental factors, can give results within four to five seconds, and the measurement results are reliable and convenient for users to understand the blood glucose level in time, which can help patients take quick measures when symptoms of hypoglycemia or hyperglycemia occur to avoid crisis situations. DETAILED DESCRIPTION

[0024] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the present invention is further described below in conjunction with specific embodiments and diagrams.

[0025] The experimental methods in the following examples, unless otherwise specified, are conventional methods, and are performed according to the techniques or conditions described in the literature in the field or according to the product instructions. The materials and reagents used in the following examples, unless otherwise specified, can be obtained from commercial channels.

[0026] Example 1, 1: 150 g of polyurethane resin and 600 ml of ethylene glycol butyl ether were added to a three-necked flask with a thermometer and a magnetic stirrer and heated, and stirred at 80°C and a stirring rate of 900 rpm for 30 min;

[0027] 2: Adjust the reaction temperature to 90°C, add 50g of polyethylene terephthalate and 50g of polytrimethylene terephthalate, use a reflux condenser to reflux the reaction, adjust the speed of the magnetic stirrer to 600rpm, stir and reflux for 2h;

[0028] 3: Add 50g of hydroxyethyl cellulose into a three-necked flask, adjust the reaction temperature to 90°C, set the magnetic stirrer to 800rpm, stir and react for 2h under reflux, and cool the reaction product to room temperature after the reaction is completed;

[0029] 4: Add 50g polyethylene and 110g graphite powder into a three-necked flask, adjust the reaction temperature to 95°C, set the magnetic stirrer to 1000rpm, and stir the reaction for 1.5h;

[0030] 5: Transfer the reaction product to a homogenizer, use steam heating, adjust the temperature of the homogenizer to 70°C, homogenize for 30 minutes, then transfer the homogenized reaction product to a vacuum degassing machine, adjust the vacuum degree of the vacuum degassing machine to 0.1MPa, and perform vacuum degassing for 1 hour;

[0031] 6: The degassing reaction product is coated on a processed paper substrate using a coating machine, with a coating thickness of 0.1 mm. After coating, Example 1 is obtained.

[0032] Table 1, reagent parameters used in Example 1

[0033]

[0034] Example 2

[0035] 1: Add 100g polyurethane resin and 600ml ethylene glycol butyl ether into a three-necked flask with a thermometer and a magnetic stirrer and heat it at a temperature of 80°C and a stirring rate of 900rpm for 30min;

[0036] 2: Adjust the reaction temperature to 98°C, add 50g of polyethylene terephthalate and 50g of polytrimethylene terephthalate, use a reflux condenser to reflux the reaction, adjust the speed of the magnetic stirrer to 600rpm, stir and reflux the reaction for 1h;

[0037] 3: Add 80g of hydroxyethyl cellulose into a three-necked flask, adjust the reaction temperature to 90°C, set the magnetic stirrer to 800rpm, stir and react for 2h under reflux, and cool the reaction product to room temperature after the reaction is completed;

[0038] 4: Add 50g polyethylene and 100g graphite powder into a three-necked flask, adjust the reaction temperature to 95°C, set the magnetic stirrer to 1000rpm, and stir for 2h;

[0039] 5: Transfer the reaction product to a homogenizer, use steam heating, adjust the temperature of the homogenizer to 70°C, homogenize for 30 minutes, then transfer the homogenized reaction product to a vacuum degassing machine, adjust the vacuum degree of the vacuum degassing machine to 0.1MPa, and perform vacuum degassing for 1 hour;

[0040] 6: The degassing reaction product is coated on a processed paper substrate using a coating machine, with a coating thickness of 0.05 mm. After coating, Example 2 is obtained.

[0041] Table 2, reagent parameters used in Example 2

[0042]

[0043] Example 3

[0044] 1: Add 30g of glucose dehydrogenase, 30g of ascorbic acid, 10g of m-xylylenediamine and 450ml of normal saline into a reactor, place the reactor on a magnetic stirrer, heat in a water bath, set the temperature to 35°C, set the speed to 800rpm, and stir for 30min to obtain material 1;

[0045] 2: Mix 20 g of cobalt oxide and 450 ml of phosphate buffer and add them into a reactor. Place the reactor on a magnetic stirrer, heat it in a water bath, set the temperature to 55°C, set the speed to 1200 rpm, and stir for 60 min to obtain material 2;

[0046] 3: Cool material 1 and material 2 to room temperature, mix material 1 and material 2 after cooling to room temperature, place in a magnetic stirrer, set the speed to 800 rpm and stir for 30 minutes, after material 1 and material 2 are mixed, use ammonia water and 9% glacial acetic acid to adjust the pH to 6.5, then soak Example 1 in it for 60 minutes and place in room temperature environment to air dry for 2 hours to obtain Example 3.

[0047] Table 3, reagent parameters used in Example 3

[0048]

[0049] Example 4

[0050] 1: Add 30g of glucose dehydrogenase, 10g of ascorbic acid, 20g of m-phenylenediamine and 400ml of normal saline into a reactor, place the reactor on a magnetic stirrer, heat in a water bath, set the temperature to 37°C, set the speed to 800rpm, and stir for 30min to obtain material 1;

[0051] 2: 10 g of cobalt oxide and 450 ml of phosphate buffer were mixed and added to a reactor. The reactor was placed on a magnetic stirrer, heated in a water bath, the temperature was set to 65° C., the speed was set to 1000 rpm, and stirred for 45 min to obtain material 2;

[0052] 3: Cool material 1 and material 2 at room temperature, mix material 1 and material 2 after cooling to room temperature, place in a magnetic stirrer, set the speed to 800 rpm and stir for 30 minutes, after material 1 and material 2 are mixed, use ammonia water and 9% glacial acetic acid to adjust the pH to 6.8. Then, immerse Example 2 in it for 60 minutes and air-dry at room temperature for 3 hours to obtain Example 4.

[0053] Table 4, reagent parameters used in Example 4

[0054]

[0055] Comparative Example 1

[0056] Example 1 of Chinese patent publication number CN113588935A was selected as comparative example 1.

[0057] Comparative Example 2

[0058] Example 1 of the Chinese patent with publication number CN111366623A was selected as comparative example 2.

[0059] Physical performance test:

[0060] The resistivity of the blood glucose test strips prepared in Example 3, Example 4, Comparative Example 1 and Comparative Example 2 was tested by a four-probe method, and the resistivity was retested by the same method after being placed at room temperature for 6 months; the enzyme film layer of the blood glucose test strips prepared in Example 3, Example 4, Comparative Example 1 and Comparative Example 2 was rubbed 10 times to observe whether the dried enzyme film was detached from the substrate, so as to evaluate the adhesion of the enzyme film; the sensitivity of the blood glucose test strips was calculated using an electrochemical base station test.

[0061] Table 5, Physical properties test results

[0062]

[0063] From the analysis of Table 5, it can be seen that the enzyme membrane layer of the blood glucose test strips prepared in Example 3 and Example 4 is not easy to fall off under the action of external force and has a low resistivity, and has good sensitivity and stability during normal use.

[0064] Response time and accuracy test:

[0065] Glucose and 0.9% NaCl solution were used to prepare blood glucose quality control solutions of different concentrations, and baking soda and normal saline were used to adjust the pH to 7.35±0.05. The commercially available Yuyueyuezhun type 1 710 household code-free blood glucose meter was used to test the blood glucose content using Example 3, Example 4, Comparative Example 1, Comparative Example 2 and self-contained blood glucose test strips, and the response time was recorded.

[0066] Table 6. Response time test results

[0067]

[0068] Table 7, Accuracy test results

[0069]

[0070] By analyzing Table 6 and Table 7, it can be seen that the blood glucose test strips prepared in Example 3 and Example 4 have faster response time and response accuracy than those prepared in Comparative Example 1 and Comparative Example 2.

[0071] The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A rapid blood sugar test strip, characterized in that: The invention is composed of two parts: a blood glucose test paper impregnation liquid and a test paper substrate, wherein the test paper substrate is obtained by coating a test paper substrate coating liquid on a processed paper substrate, and the test paper substrate coating liquid is composed of the following percentage components: 10-20% graphite powder, 10-15% polyurethane resin, 5-10% polyethylene terephthalate, 5-10% polypropylene terephthalate, 5-10% polyethylene, 5-10% hydroxyethyl cellulose and 45-60% ethylene glycol butyl ether; the blood glucose test paper impregnation liquid is composed of the following percentage components: 40-45% phosphate buffer, 2-3% glucose dehydrogenase, 40-45% physiological saline, 1-2% cobalt oxide, 2-3% ascorbic acid and 1-3% m-xylylenediamine; The preparation method of the test paper substrate coating liquid comprises the following steps: A1: Add polyurethane resin and ethylene glycol butyl ether into a three-necked flask with a thermometer and a magnetic stirrer and heat at an angle of 30°, and stir at a temperature of 75-80°C and a stirring rate of 600-900 rpm for 30 minutes; A2: Adjust the reaction temperature to 85-98°C, add polyethylene terephthalate and polytrimethylene terephthalate, use a reflux condenser to reflux the reaction, adjust the speed of the magnetic stirrer to 400-600 rpm, stir and reflux the reaction for 1-2 hours; A3: Add hydroxyethyl cellulose to a three-necked flask, adjust the reaction temperature to 70-90°C, set the magnetic stirrer to 600-800 rpm, stir the reaction under reflux for 1-2 hours, and cool the reaction product to room temperature after the reaction is completed; A4: Add polyethylene and graphite powder into a three-necked flask, adjust the reaction temperature to 80-95°C, set the magnetic stirrer to 800-1000 rpm, and stir for 1-2 hours; A5: The reaction product is transferred to a homogenizer, heated with steam, and the temperature of the homogenizer is adjusted to 60-70°C. The homogenization is performed for 30 minutes. The homogenized reaction product is then transferred to a vacuum degassing machine, and the vacuum degree of the vacuum degassing machine is adjusted to 0.05-0.1 MPa. The vacuum degassing is performed for 0.5-1 hour to obtain a test paper substrate coating liquid. The preparation method of the blood glucose test paper impregnation solution comprises the following steps: B1: Glucose dehydrogenase, ascorbic acid, m-xylylenediamine and physiological saline are added into a reaction kettle, and the reaction kettle is placed on a magnetic stirrer, heated in a water bath, the temperature is set to 35-45°C, the speed is set to 600-800 rpm, and stirred for 25-30 min to obtain material 1; B2: Mix cobalt oxide and phosphate buffer and add them into a reactor. Place the reactor on a magnetic stirrer, heat it in a water bath, set the temperature to 55-65°C, set the speed to 1000-1200 rpm, and stir for 45-60 min to obtain material 2; B3: Cool material 1 and material 2 to room temperature, mix material 1 and material 2 after cooling to room temperature, place in a magnetic stirrer, set the speed to 600-800rpm and stir for 30min, after material 1 and material 2 are mixed, use ammonia water and 9% glacial acetic acid to adjust the pH to 6.5-7 to obtain the blood glucose test strip impregnation solution.

2. A rapid blood sugar test strip according to claim 1, characterized in that: The hydroxyethyl cellulose is a water-dispersible, stable, cationic, hydrophilic milky white powder with a solid content of 40-45%.

3. A rapid blood sugar test strip according to claim 1, characterized in that: The test paper substrate is obtained by coating the test paper substrate coating liquid on the processed paper substrate, and the coating thickness is 0.05-0.1 mm.

4. A rapid blood sugar test strip according to claim 1, characterized in that: The processed paper substrate is made of base paper through bleached chemical pulp, with a basis weight of 30g / m 2 -80g / m 2 .

5. A rapid blood sugar test strip according to claim 1, characterized in that: The graphite powder is graphite powder with a specification of 2000 meshes.

6. A rapid blood sugar test strip according to claim 1, characterized in that: The glucose dehydrogenase is water-soluble glucose dehydrogenase powder with a purity of 99%.

7. A rapid blood sugar test strip according to claim 1, characterized in that: The ascorbic acid is water-soluble L-ascorbic acid powder.

8. A rapid blood sugar test strip according to claim 1, characterized in that: The cobalt oxide is cobalt trioxide powder with a specification of 300 meshes.

9. The method for preparing a rapid blood sugar test strip according to claim 1, characterized in that: The following steps are involved: C1: Immerse the test paper substrate in the blood glucose test paper immersion solution for 30-60 minutes; C2: The impregnated test paper substrate is placed in a room temperature environment and air-dried for 2-3 hours to obtain a rapid blood glucose test paper.

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