CN1447113A - Test paper matched to blood sugar tester and its preparing method - Google Patents
Test paper matched to blood sugar tester and its preparing method Download PDFInfo
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- CN1447113A CN1447113A CN 03116172 CN03116172A CN1447113A CN 1447113 A CN1447113 A CN 1447113A CN 03116172 CN03116172 CN 03116172 CN 03116172 A CN03116172 A CN 03116172A CN 1447113 A CN1447113 A CN 1447113A
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Abstract
Blood sugar test device accessory test paper is to print working electrode, reference electrode and electric circuit on base plate printed with guide line connecting with read-out meter on one end, the working and the reference electrodes are printed on carbon coating formed on the base plate conductive silver layer, biological enzyme, medium and adhesive are sprayed on the working electrode. Combining silk screen and spary printing the test paper is process and silk screening is limitted on printing conductive circuit, separating sensitive biologic element, from the silk material to print on electrode supporter by uncontacting spray controlled by computer.
Description
Technical field
What the present invention relates to is a kind of test paper and preparation method thereof, and supporting test paper of particularly a kind of blood glucose monitoring system and preparation method thereof belongs to the biosensor technique field.
Background technology
China's diabetic has surpassed 4,000 ten thousand according to statistics, annually also increases with 1.5% speed of development.One of effective means of control of diabetes development is to implement blood sugar test to reach strict control medication and diet, keeps the stable of patient's glycemic index.Its supporting test paper of some blood glucose meter of Chu Xianing adopts compound silk-screen technology in the market, and this blood sugar test paper complex manufacturing technology needs special material, and cost and rejection rate are all higher, are difficult to realize at home industrialization.Find by literature search, U.S. Patent number is: 6241862, patent name is: Disposable teststrips with integrated reagent/blood separation layer (the deserted test paper with complex reagent and blood bed separation), introduced the system that a kind of multilayer film legal system is equipped with the blood sugar electrode in this patent, its objective is to allow tested Glucose Liquid can diffuse to reaction interval easily, improve measuring accuracy and the sex purpose of less haemolysis to reach.But this method adopts multilayer silk-screen technology, and needs to be printed on the same substrate with ink for screen printing of different nature, causes complicated silk-screen manufacture craft, brings certain difficulty for the post-production and the encapsulation of test paper, and is unfavorable for large-scale production.
Summary of the invention
The objective of the invention is to overcome deficiency of the prior art; supporting test paper of a kind of blood glucose monitoring system and preparation method thereof is provided; after making this test paper in a single day contact human body fluid; can on corresponding supporting testing tool, conveniently read test result intuitively; its method for making is simple; make things convenient for post-production and encapsulation, help large-scale production.
The present invention is achieved by the following technical solutions, and test paper of the present invention comprises: a substrate, as the PVC substrate; Be printed on a working electrode on the substrate; Be printed on a reference electrode on the substrate; Be printed on electric loop on the substrate, so that with the continuous blood sugar test of finishing of testing tool; End at substrate is printed on the lead that connects with the readout meter epiphase.Working electrode and reference electrode are respectively to be imprinted on the carbon coating that forms on the substrate conductive silver layer, be coated with the biology enzyme of catalysis blood-glucose reaction on the working electrode, as glucose oxidase, and a kind of medium and binder that can between enzymic catalytic reaction center and electrode, carry out electron transport, so constitute a circuit loop, according to the height of concentration of glucose in the blood, produce the current signal of corresponding size during reaction, and the detection of tested instrument is read.This test paper has omitted separation layer and insulation course, and is simple in structure, and tested material can be lactic acid, cholesterol or glucose, and the enzyme of use can be Lactate Oxidase, cholesterol oxidase and glucose oxidase.
Working electrode is the double-deck conductive film of a kind of serigraphy on holder, comprises the enzyme of catalysis biochemical reaction and the medium that can carry out electron transport between enzymic catalytic reaction is with electrode in spraying printing on the conductive film.This working electrode can transmit the electric current that produces behind the enzymic catalytic reaction.Working electrode and contrast electrode are close, and two electrodes constitute an effecting reaction zone, after connecting with tester, form effective body fluid components test macro.
The present invention adopts bio-sensing and electrochemical principle, make above-mentioned test paper by the method that silk screen and spraying printing combine, serigraphy is confined to print the conducting wire, only play the conducting effect, relatively more responsive biological elements such as enzyme, conducting medium and binder etc. are separated from wire printing material, adopt non-contacting spraying method to be printed on the electrode support substrate, the quantity for spray and the spray area of sprayed on material are accurately controlled by computer fully.
Below the inventive method is further described, concrete steps are as follows:
(1) hydroxyethyl cellulose of adding 1.2-2.5% in the silk-screen conductive carbon ink, the electronic conduction carrier material of adding 10-20%, as the benzoquinones or the potassium ferricyanide, mixing is standby;
(2) metal of 200-400 order number or nylon polyester material silk screen are fixed on square light-weight metal frame and add, in the darkroom, coat Kodak's photoresists, drying for standby;
(3) working electrode and the reference electrode negative film with computer drawing places on the photoresists, and under 20-40 watt of uviol lamp exposure 15-30 minute, remove the unhardened photoresists that covered by the electrode negative film with the giant flushing, dry back forms the silk-screen template;
(4) the silk-screen template that will have working electrode and a reference electrode figure is installed on the automatic screen printer standby;
(5) be the Lactate Oxidase of 10-30 international unit with activity or active be the glucose oxidase of 200-500 international unit for the cholesterol oxidase of 12-25 international unit or activity, allocate in the phosphate buffer of every liter of 50-120 mM, add every liter of 200-800 milligram of the benzoquinones or the potassium ferricyanide simultaneously, it is standby fully to shelve 4 ℃ of refrigerators after the dissolving.
Working electrode adopts screen printing technique that conductive silver material and conductive carbon material are imprinted on the substrate earlier; Enzyme and electron transit mediator such as the benzoquinones or the potassium ferricyanide are printed in spraying then, and reference electrode is also made with identical method.
The printing ink that is used for spraying printing comprises: liquid adhesive, conducting objects solution and enzyme.The material of substrate can be a kind of good toughness, the polymeric material that insulativity is high, and such as Polyvinylchloride, polyester or polycarbonate.
The present invention has substantive distinguishing features and marked improvement, and the inventive method is confined to print the conducting wire with serigraphy, only plays the conducting effect, makes requirement thereby reduced technology; Wire printing material and screen printing device needn't specially be processed, and can obtain by commercially available channel, and cost is very low; Relatively more responsive biological elements such as enzyme, conducting medium and binder etc. are separated from wire printing material, be printed on the electrode support substrate with non-contacting spraying method, eliminated the adverse effect that composite filament India side formula is brought biological sensitive materials because of contact printing repeatedly; Because the spraying printing technology is reached perfection, the material that spray can accurately be controlled its quantity for spray and area by computer fully, and the precision of final products and repeatability are fully ensured.After in a single day test paper of the present invention contacts human body fluid, can conveniently on corresponding supporting testing tool read test result intuitively, method for making is simple, the precision height, and cost is low, makes things convenient for post-production and encapsulation, helps large-scale production.
Description of drawings
Fig. 1 test paper structural representation of the present invention
Embodiment
As shown in Figure 1, test paper of the present invention comprises: a substrate 1, be printed on a working electrode 2 on the substrate 1, be printed on a reference electrode 3 on the substrate 1, be printed on electric loop on the substrate 1, end at substrate 1 is printed on the lead 4 that connects with the readout meter epiphase, working electrode 2 and reference electrode 3 are respectively to be imprinted on the carbon coating that forms on substrate 1 conductive silver layer, be coated with the biology enzyme of catalysis blood-glucose reaction on the working electrode 2, as glucose oxidase, and a kind of medium and binder that can between enzymic catalytic reaction center and electrode, carry out electron transport, so constitute a circuit loop, according to the height of concentration of glucose in the blood, produce the current signal of corresponding size during reaction, and the detection of tested instrument is read.Tested material can be lactic acid, cholesterol or glucose, and the enzyme of use can be Lactate Oxidase, cholesterol oxidase and glucose oxidase.
Working electrode 2 is a kind of serigraphy double-deck conductive films 5 on holder, and the spraying printing comprises the enzyme of catalysis biochemical reaction and the medium that can carry out electron transport between enzymic catalytic reaction is with electrode on conductive film 5.Working electrode 2 is close with contrast electrode 3, and two electrodes constitute an effecting reaction zone, after connecting with tester, forms effective body fluid components test macro.
Content in conjunction with the inventive method provides following examples, and the present invention is further illustrated.
Embodiment 1: tygon (PVC) sheet material, it is standby to be cut into 150 * 150 centimeters substrates in advance.
(1) hydroxyethyl cellulose of adding 1.2% in 1 gram silk-screen conductive carbon ink (ACHESON Acheson423 SS), the electronic conduction carrier material benzoquinones of adding 10%, mixing is standby.
(2) metal of 200 order numbers or nylon polyester material silk screen are fixed on square light-weight metal frame and add, in the darkroom, coat Kodak's photoresists, drying for standby.
(3) working electrode and the reference electrode negative film with computer drawing places on the photoresists, and exposure is 15 minutes under 20 watts of uviol lamps.Remove the unhardened photoresists that covered by the electrode negative film with giant flushing.Dry back forms the silk-screen template.
(4) the silk-screen template that will have working electrode and a reference electrode figure is installed on (moral gram DEK-245) type automatic screen printer standby.
(5) be that the Lactate Oxidase of 10 international units is allocated in the phosphate buffer of every liter of 50 mM with activity, add 200 milligrams every liter of benzoquinones simultaneously.It is standby fully to shelve 4 ℃ of refrigerators after the dissolving.
On above-mentioned automatic screen printing machine, add conductive silver ink (ACHESON Acheson 427 SS) and carry out print conductive circuits; Dry back adds above-mentioned hybrid conductive silk-screen carbon ink on automatic screen printing machine, the silver-colored line of ink marker road of before having printed is covered, and makes working electrode and reference electrode respectively.The electrode of having printed need be held in 60 ℃ of baking ovens and solidify 30 minutes, forms 50 pairs of work and reference electrode on each sheet PVC substrate, takes out standby then.Making can be tested lactic acid, during the enzyme test peper of cholesterol and glucose, take out Manufactured element task electrode and reference electrode, mixed liquor in above-mentioned (5) is added in the holding bottle of the automatic accurate spraying instrument in hundred roads (BIODOT-3000), by computer installation spacing and drop size, evenly be sprayed on the working electrode made and the setting position of reference electrode then.This position is positioned at the interval of the about 5 * 5mm of working reaction end of working electrode and reference electrode.
After above-mentioned electrode was made drying, the polyester nethike embrane that an about 10mm is wide covered on the reaction zone, was printed on the non-reactive site of work and reference electrode then with the empire silk printing ink, exposed reaction interval.The electrode slice that prints of spraying drying at room temperature 3 hours under drying condition.It is long with shearer the test pieces of drying to be cut into 35mm, the test-strips finished product that 0.8mm is wide.
With Manufactured test-strips, place tester and apply the 220mV operating voltage for two sections at working electrode and reference electrode, measure the lactic acid of variable concentrations, the result shows that reaction took place after 10 seconds, shows to make good test repeatability and the correlativity of electrode.Through relatively with Biochemical Analyzer, get 50 parts of lactic acid control liquids and 50 parts of patient's blood sample lactic acid contrast tests respectively, the relative standard deviation that its correlativity γ reaches 0.9567 test-strips is CV≤6.5%.
Embodiment 2: polyester (PET) sheet material, it is standby to be cut into 150 * 150 centimeters substrates in advance.
(1) hydroxyethyl cellulose of adding 1.8% in silk-screen conductive carbon ink (ACHESON Acheson423 SS), the electronic conduction carrier material benzoquinones of adding 15%, mixing is standby.
(2) metal of 300 order numbers or nylon polyester material silk screen are fixed on square light-weight metal frame and add, in the darkroom, coat Kodak's photoresists, drying for standby.
(3) working electrode and the reference electrode negative film with computer drawing places on the photoresists, and exposure is 25 minutes under 20 watts of uviol lamps.Remove the unhardened photoresists that covered by the electrode negative film with giant flushing.Dry back forms the silk-screen template.
(4) the silk-screen template that will have working electrode and a reference electrode figure is installed on (moral gram DEK-245) type automatic screen printer standby.
(5) be that the cholesterol oxidase of 25 international units is allocated in the phosphate buffer of every liter of 50 mM with activity, add 800 milligrams every liter of benzoquinones simultaneously.It is standby fully to shelve 4 ℃ of refrigerators after the dissolving.
Method for makings such as spraying are with example 1, with the test-strips of making, place tester and apply the 300mV operating voltage for two sections at working electrode and reference electrode, measure the cholesterol of variable concentrations respectively, the result shows that reaction took place after 20 seconds, shows to make good test repeatability and the correlativity of electrode.Through relatively with Biochemical Analyzer, get 30 parts of cholesterol control liquids and 20 parts of patient's blood sample cholesterol contrast tests, its correlativity γ reaches 0.967, and the relative standard deviation of test-strips is CV≤5.7%.
Embodiment 3: polyphenol ester (PP) sheet material, it is standby to be cut into 150 * 150 centimeters substrates in advance.
(1) hydroxyethyl cellulose of adding 2.5% in the silk-screen conductive carbon ink, the electronic conduction carrier material potassium ferricyanide of adding 20%, mixing is standby;
(2) metal of 400 order numbers or nylon polyester material silk screen are fixed on square light-weight metal frame and add, in the darkroom, coat Kodak's photoresists, drying for standby;
(3) working electrode and the reference electrode negative film with computer drawing places on the photoresists, and exposure is 30 minutes under 40 watts of uviol lamps, removes the unhardened photoresists that covered by the electrode negative film with giant flushing, and dry back forms the silk-screen template;
(4) the silk-screen template that will have working electrode and a reference electrode figure is installed on the automatic screen printer standby;
(5) be that the glucose oxidase of 30 international units is allocated in the phosphate buffer of every liter of 120 mM with activity, add 600 milligrams every liter of the potassium ferricyanides simultaneously.It is standby fully to shelve 4 ℃ of refrigerators after the dissolving.
Method for makings such as spraying are with embodiment 1, with the test-strips of making, place tester and apply the 400mV operating voltage for two sections at working electrode and reference electrode, measure the glucose of variable concentrations respectively, the result shows that reaction took place after 30 seconds, shows to make good test repeatability and the correlativity of electrode.Through relatively with hospital's Biochemical Analyzer, get 50 parts of glucose control liquids and 50 parts of diabetes patient's blood sample glucose contrast tests respectively, its correlativity γ reaches 0.97, and the relative standard deviation of test-strips is CV≤8.1%.
Claims (9)
1, the supporting test paper of a kind of blood glucose monitoring system, mainly comprise: a substrate (1), be printed on a working electrode (2) on the substrate (1), be printed on a reference electrode (3) on the substrate (1), substrate is printed on electric loop on (1), end at substrate (1) is printed on the lead (4) that connects with the readout meter epiphase, it is characterized in that, working electrode (2) and reference electrode (3) are respectively to be imprinted on the carbon coating that forms on substrate (1) conductive silver layer, be coated with the biology enzyme of catalysis blood-glucose reaction on the working electrode (2), and a kind of medium and binder that can between enzymic catalytic reaction center and electrode, carry out electron transport, so constitute a circuit loop, according to the height of concentration of glucose in the blood, produce the current signal of corresponding size during reaction, and the detection of tested instrument is read.
2, the supporting test paper of blood glucose monitoring system according to claim 1 is characterized in that, tested material is lactic acid, cholesterol or glucose, and the enzyme of use is Lactate Oxidase, cholesterol oxidase and glucose oxidase.
3, the supporting test paper of blood glucose monitoring system according to claim 1, it is characterized in that, working electrode (2) is the double-deck conductive film (5) of a kind of serigraphy on holder, goes up the spraying printing at conductive film (5) and comprises the enzyme of catalysis biochemical reaction and the medium that can carry out electron transport between enzymic catalytic reaction is with electrode.
4, the supporting test paper of blood glucose monitoring system according to claim 1 is characterized in that, working electrode (2) is close with contrast electrode (3), and two electrodes constitute an effecting reaction zone, after connecting with tester, forms effective body fluid components test macro.
5, the supporting test paper of blood glucose monitoring system according to claim 1 is characterized in that, the polymeric material that the material of substrate is a kind of good toughness, insulativity is high, as: Polyvinylchloride, polyester or polycarbonate.
6, the method for making of the supporting test paper of a kind of blood glucose monitoring system, it is characterized in that: adopt bio-sensing and electrochemical principle, make above-mentioned test paper by the method that silk screen and spraying printing combine, serigraphy is confined to print the conducting wire, only as conducting, relatively more responsive biological elements is separated from wire printing material, adopt non-contacting spraying method to be printed on the electrode support substrate, the quantity for spray and the spray area of sprayed on material are accurately controlled by computer fully.
7, the method for making of the supporting test paper of blood glucose monitoring system according to claim 6 is characterized in that concrete steps are as follows:
(1) hydroxyethyl cellulose of adding 1.2-2.5% in the silk-screen conductive carbon ink, the electronic conduction carrier material of adding 10-20%, as the benzoquinones or the potassium ferricyanide, mixing is standby;
(2) metal of 200-400 order number or nylon polyester material silk screen are fixed on square light-weight metal frame and add, in the darkroom, coat Kodak's photoresists, drying for standby;
(3) working electrode and the reference electrode negative film with computer drawing places on the photoresists, and under 20-40 watt of uviol lamp exposure 15-30 minute, remove the unhardened photoresists that covered by the electrode negative film with the giant flushing, dry back forms the silk-screen template;
(4) the silk-screen template that will have working electrode and a reference electrode figure is installed on the automatic screen printer standby;
(5) be the Lactate Oxidase of 10-30 international unit with activity or active be the glucose oxidase of 200-500 international unit for the cholesterol oxidase of 12-25 international unit or activity, allocate in the phosphate buffer of every liter of 50-120 mM, add every liter of 200-800 milligram of the benzoquinones or the potassium ferricyanide simultaneously, it is standby fully to shelve 4 ℃ of refrigerators after the dissolving.
According to the method for making of claim 6 or the supporting test paper of 7 described blood glucose monitoring systems, it is characterized in that 8, working electrode adopts screen printing technique that conductive silver material and conductive carbon material are imprinted on the substrate earlier; Enzyme and electron transit mediator are printed in spraying then, and as the benzoquinones or the potassium ferricyanide, reference electrode is made with identical method.
According to the method for making of claim 6 and the supporting test paper of 7 described blood glucose monitoring systems, it is characterized in that 9, the printing ink that is used for spraying printing comprises: liquid adhesive, conducting objects solution and enzyme.
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| CN 03116172 CN1234873C (en) | 2003-04-03 | 2003-04-03 | Test paper matched to blood sugar tester and its preparing method |
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| CN 03116172 CN1234873C (en) | 2003-04-03 | 2003-04-03 | Test paper matched to blood sugar tester and its preparing method |
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100356168C (en) * | 2003-10-16 | 2007-12-19 | 宇东科技股份有限公司 | Method and apparatus for improving blood measurement reliability using multi-channel circuit |
| CN100374852C (en) * | 2004-11-29 | 2008-03-12 | 清华大学 | Disposable ampere type immunosensor for detecting two or four drops and preparing and using method thereof |
| CN102184313A (en) * | 2011-03-24 | 2011-09-14 | 武汉市思泰利医疗器械发展有限公司 | System and method for identifying multi-type blood glucose test strip |
| CN101315345B (en) * | 2008-07-15 | 2011-09-28 | 四川大学 | Production method for Modified electrode for detecting grape-sugar concentration in non-enzyme condition |
| CN102313766A (en) * | 2011-09-24 | 2012-01-11 | 郑州正泰生物技术有限公司 | Electrode structure of electrochemical blood sugar test paper |
| CN102555384A (en) * | 2011-12-09 | 2012-07-11 | 嘉善德智医疗器械科技有限公司 | Diversion film for quickly detecting test paper as well as preparation method and use method thereof |
| CN104067131A (en) * | 2012-02-10 | 2014-09-24 | 美艾利尔瑞士公司 | Assay and method for determining insulin-resistance |
| CN105067685A (en) * | 2015-07-23 | 2015-11-18 | 武汉大学 | Blood multi-component detection test paper and preparation method thereof |
| US9518951B2 (en) | 2013-12-06 | 2016-12-13 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| CN106546643A (en) * | 2015-09-23 | 2017-03-29 | 香港生产力促进局 | High-sensitivity biological sensor prepared by nano-particle technology and preparation method thereof |
| CN106680347A (en) * | 2017-02-16 | 2017-05-17 | 常州鹤田生物技术有限公司 | Finger blood test strip and use method and preparation method thereof |
| US10571425B2 (en) | 2013-05-09 | 2020-02-25 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| CN114002292A (en) * | 2021-11-02 | 2022-02-01 | 安序源生物科技(深圳)有限公司 | Saliva blood sugar correction device and method |
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2003
- 2003-04-03 CN CN 03116172 patent/CN1234873C/en not_active Expired - Fee Related
Cited By (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100356168C (en) * | 2003-10-16 | 2007-12-19 | 宇东科技股份有限公司 | Method and apparatus for improving blood measurement reliability using multi-channel circuit |
| CN100374852C (en) * | 2004-11-29 | 2008-03-12 | 清华大学 | Disposable ampere type immunosensor for detecting two or four drops and preparing and using method thereof |
| CN101315345B (en) * | 2008-07-15 | 2011-09-28 | 四川大学 | Production method for Modified electrode for detecting grape-sugar concentration in non-enzyme condition |
| CN102184313A (en) * | 2011-03-24 | 2011-09-14 | 武汉市思泰利医疗器械发展有限公司 | System and method for identifying multi-type blood glucose test strip |
| CN102184313B (en) * | 2011-03-24 | 2013-06-05 | 武汉市思泰利医疗器械发展有限公司 | System and method for identifying multi-type blood glucose test strip |
| CN102313766A (en) * | 2011-09-24 | 2012-01-11 | 郑州正泰生物技术有限公司 | Electrode structure of electrochemical blood sugar test paper |
| CN102313766B (en) * | 2011-09-24 | 2013-06-26 | 郑州正泰生物技术有限公司 | Electrode structure of electrochemical blood sugar test paper |
| CN102555384A (en) * | 2011-12-09 | 2012-07-11 | 嘉善德智医疗器械科技有限公司 | Diversion film for quickly detecting test paper as well as preparation method and use method thereof |
| CN104067131A (en) * | 2012-02-10 | 2014-09-24 | 美艾利尔瑞士公司 | Assay and method for determining insulin-resistance |
| US10571425B2 (en) | 2013-05-09 | 2020-02-25 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| US9518951B2 (en) | 2013-12-06 | 2016-12-13 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| US10088444B2 (en) | 2013-12-06 | 2018-10-02 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| CN105067685A (en) * | 2015-07-23 | 2015-11-18 | 武汉大学 | Blood multi-component detection test paper and preparation method thereof |
| CN105067685B (en) * | 2015-07-23 | 2019-01-04 | 武汉大学 | A kind of blood multi-analyte immunoassay test paper and preparation method thereof |
| CN106546643A (en) * | 2015-09-23 | 2017-03-29 | 香港生产力促进局 | High-sensitivity biological sensor prepared by nano-particle technology and preparation method thereof |
| CN106680347A (en) * | 2017-02-16 | 2017-05-17 | 常州鹤田生物技术有限公司 | Finger blood test strip and use method and preparation method thereof |
| CN114002292A (en) * | 2021-11-02 | 2022-02-01 | 安序源生物科技(深圳)有限公司 | Saliva blood sugar correction device and method |
| CN114002292B (en) * | 2021-11-02 | 2024-03-08 | 深圳清华大学研究院 | Saliva blood glucose correction device and method |
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| CN1234873C (en) | 2006-01-04 |
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