JP2013536430A - 所定の校正コードを有する試験ストリップにおける使用のための酵素試薬インク - Google Patents
所定の校正コードを有する試験ストリップにおける使用のための酵素試薬インク Download PDFInfo
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- 238000012360 testing method Methods 0.000 title claims abstract description 63
- 108090000790 Enzymes Proteins 0.000 title claims abstract description 51
- 102000004190 Enzymes Human genes 0.000 title claims abstract description 51
- 239000003153 chemical reaction reagent Substances 0.000 title description 11
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 51
- 239000008103 glucose Substances 0.000 claims abstract description 51
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 77
- 229940088598 enzyme Drugs 0.000 claims description 49
- 229910021485 fumed silica Inorganic materials 0.000 claims description 36
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 25
- 229910052799 carbon Inorganic materials 0.000 claims description 24
- 239000000463 material Substances 0.000 claims description 20
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 17
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- 210000004369 blood Anatomy 0.000 claims description 15
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 14
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- 235000019420 glucose oxidase Nutrition 0.000 claims description 10
- -1 potassium ferricyanide Chemical compound 0.000 claims description 10
- 108010015776 Glucose oxidase Proteins 0.000 claims description 9
- 239000004366 Glucose oxidase Substances 0.000 claims description 9
- 229940116332 glucose oxidase Drugs 0.000 claims description 9
- 239000000126 substance Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- YAGKRVSRTSUGEY-UHFFFAOYSA-N ferricyanide Chemical group [Fe+3].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-] YAGKRVSRTSUGEY-UHFFFAOYSA-N 0.000 claims description 7
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 6
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- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 4
- 150000001875 compounds Chemical class 0.000 claims description 4
- AWDBHOZBRXWRKS-UHFFFAOYSA-N tetrapotassium;iron(6+);hexacyanide Chemical compound [K+].[K+].[K+].[K+].[Fe+6].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-] AWDBHOZBRXWRKS-UHFFFAOYSA-N 0.000 claims description 4
- 239000004349 Polyvinylpyrrolidone-vinyl acetate copolymer Substances 0.000 claims description 3
- 230000003254 anti-foaming effect Effects 0.000 claims description 3
- VWWQXMAJTJZDQX-UYBVJOGSSA-N flavin adenine dinucleotide Chemical compound C1=NC2=C(N)N=CN=C2N1[C@@H]([C@H](O)[C@@H]1O)O[C@@H]1CO[P@](O)(=O)O[P@@](O)(=O)OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C2=NC(=O)NC(=O)C2=NC2=C1C=C(C)C(C)=C2 VWWQXMAJTJZDQX-UYBVJOGSSA-N 0.000 claims description 3
- 235000019162 flavin adenine dinucleotide Nutrition 0.000 claims description 3
- 239000011714 flavin adenine dinucleotide Substances 0.000 claims description 3
- 229940093632 flavin-adenine dinucleotide Drugs 0.000 claims description 3
- 235000019448 polyvinylpyrrolidone-vinyl acetate copolymer Nutrition 0.000 claims description 3
- 239000001509 sodium citrate Substances 0.000 claims description 3
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims description 3
- 229940038773 trisodium citrate Drugs 0.000 claims description 3
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 9
- 108010050375 Glucose 1-Dehydrogenase Proteins 0.000 claims 6
- KJTLSVCANCCWHF-UHFFFAOYSA-N Ruthenium Chemical compound [Ru] KJTLSVCANCCWHF-UHFFFAOYSA-N 0.000 claims 2
- 235000010299 hexamethylene tetramine Nutrition 0.000 claims 2
- 239000004312 hexamethylene tetramine Substances 0.000 claims 2
- VKYKSIONXSXAKP-UHFFFAOYSA-N hexamethylenetetramine Chemical compound C1N(C2)CN3CN1CN2C3 VKYKSIONXSXAKP-UHFFFAOYSA-N 0.000 claims 2
- WUKKREVJKMPFTB-UHFFFAOYSA-N pyrrolo[2,3-h]quinolin-2-one Chemical compound C1=C2N=CC=C2C2=NC(=O)C=CC2=C1 WUKKREVJKMPFTB-UHFFFAOYSA-N 0.000 claims 2
- 229910052707 ruthenium Inorganic materials 0.000 claims 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
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- KDLHZDBZIXYQEI-UHFFFAOYSA-N Palladium Chemical compound [Pd] KDLHZDBZIXYQEI-UHFFFAOYSA-N 0.000 description 2
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- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
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- MMXZSJMASHPLLR-UHFFFAOYSA-N pyrroloquinoline quinone Chemical compound C12=C(C(O)=O)C=C(C(O)=O)N=C2C(=O)C(=O)C2=C1NC(C(=O)O)=C2 MMXZSJMASHPLLR-UHFFFAOYSA-N 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 238000010405 reoxidation reaction Methods 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- VXEGSRKPIUDPQT-UHFFFAOYSA-N 4-[4-(4-methoxyphenyl)piperazin-1-yl]aniline Chemical compound C1=CC(OC)=CC=C1N1CCN(C=2C=CC(N)=CC=2)CC1 VXEGSRKPIUDPQT-UHFFFAOYSA-N 0.000 description 1
- 229910002012 Aerosil® Inorganic materials 0.000 description 1
- RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 description 1
- RGHNJXZEOKUKBD-SQOUGZDYSA-N Gluconic acid Natural products OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 description 1
- 208000013016 Hypoglycemia Diseases 0.000 description 1
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- KXVGTQFNYXBBHD-UHFFFAOYSA-N ethenyl acetate;pyrrolidin-2-one Chemical compound CC(=O)OC=C.O=C1CCCN1 KXVGTQFNYXBBHD-UHFFFAOYSA-N 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 239000003349 gelling agent Substances 0.000 description 1
- 239000000174 gluconic acid Substances 0.000 description 1
- 235000012208 gluconic acid Nutrition 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- WCKWXPBDKSOVOK-UHFFFAOYSA-H hexachlororuthenium Chemical compound Cl[Ru](Cl)(Cl)(Cl)(Cl)Cl WCKWXPBDKSOVOK-UHFFFAOYSA-H 0.000 description 1
- 238000000265 homogenisation Methods 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 230000005660 hydrophilic surface Effects 0.000 description 1
- 230000003345 hyperglycaemic effect Effects 0.000 description 1
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- 239000012212 insulator Substances 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 238000009830 intercalation Methods 0.000 description 1
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/26—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/001—Enzyme electrodes
- C12Q1/005—Enzyme electrodes involving specific analytes or enzymes
- C12Q1/006—Enzyme electrodes involving specific analytes or enzymes for glucose
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical 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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Abstract
【選択図】図1A
Description
δ_150=%偏倚500mg/dl−%偏倚150mg/dl
以下の手順が、本発明の例示的な酵素インクを調製するために使用された。
0.5mLのDC 1500消泡剤(BDH/Merek Ltd.から市販)を7500グラムの水(AnalaR、BDH/Merck Ltd.から入手可能)と組み合わせることにより、PVA−消泡剤−クエン酸溶液を調製した。次に、この溶液に90グラムのPVA(Sigma−Aldrich、分子量85,000〜124,000、87%〜89%加水分解化)を添加し、>7000RPMで2時間にわたって均質化した。均質化の後、81.5グラムのクエン酸を溶液中に混合した。
使用された融合シリカの量が、以下の表1に示されたものであること以外は、実施例1の方法が酵素インクを調製するために用いられた。
Claims (16)
- 酵素インク組成物であって、血液試料中のグルコースを選択的に認識可能である酵素と、介在物質と、前記介在物質の質量移行を調整することが可能である1つ以上の材料と、を含む、これによって、低グルコース値及び高グルコース値のうちの1つ以上に応答する偏倚が、所定の校正コードに関する所定のターゲットの範囲内に入る、酵素インク組成物。
- 前記1つ以上の材料が、第1及び第2のヒュームドシリカを含む、請求項1に記載の酵素インク。
- 前記第1のヒュームドシリカが、約130〜170m2/gのBET測定された表面積と、約0.8〜約1.23重量%の炭素含量と、を含み、前記第2のヒュームドシリカが、約270〜330m2/gのBET測定された表面積と、約1.4〜約2.6重量%の炭素含量と、を含む、請求項2に記載の酵素インク。
- 前記第1のヒュームドシリカが、前記ヒュームドシリカの総量の約99〜約1重量%で存在し、前記第2のヒュームドシリカが、約1〜約99重量%で存在する、請求項3に記載の酵素インク。
- 前記第1のヒュームドシリカが、前記ヒュームドシリカの総量の約75〜約45重量%で存在し、前記第2のヒュームドシリカが、約25〜約55重量%で存在する、請求項3に記載の酵素インク。
- 前記酵素が、グルコースオキシダーゼ、グルコースデヒドロゲナーゼ、ピロロ−キノロン補助因子を伴うグルコースデヒドロゲナーゼ、及びフラビンアデニンジヌクレオチド補助因子を伴うグルコースデヒドロゲナーゼからなる群から選択され、前記介在物質が、フェリシアニド及び三塩化ルテニウムヘキサミンからなる群から選択される、請求項3に記載の酵素インク。
- 前記酵素が、グルコースオキシダーゼであり、前記介在物質がフェリシアニドである、請求項3に記載の酵素インク。
- 酵素インクであって、約0.3質量%の消泡化合物と、約0.6質量%のポリビニルアルコールと、約0.6質量%のクエン酸と、約1.9質量%のクエン酸三ナトリウムと、約0.6質量%のポリビニルピロリドン−酢酸ビニル共重合体と、約3.27質量%のヒドロキシエチルセルロースと、約3.6質量%の、約130〜170m2/gのBET測定された表面積及び約0.8〜約1.23重量%の炭素含量を有する第1のヒュームドシリカと、約1.3質量%の、約270〜330m2/gのBET測定された表面積及び約1.4〜約2.6重量%の炭素含量を有する第2のヒュームドシリカと、約0.03質量%のカリウムヘキサシアノフェレートIIIと、約23質量%のフェリシアン化カリウムと、約2.1質量のグルコースオキシダーゼと、約62.4質量%の水と、を含む酵素インク。
- 少なくとも2つの同一平面上の電極を含む試験ストリップであって、前記電極の少なくとも1つが、血液試料中のグルコースを選択的に認識可能である酵素と、介在物質と、前記介在物質の質量移行を調整することが可能である1つ以上の材料と、を含む酵素インク組成物を含み、これによって、低グルコース値及び高グルコース値のうちの1つ以上に応答する偏倚が、所定のターゲットの範囲内に入る、試験ストリップ。
- 前記1つ以上の材料が、第1及び第2のヒュームドシリカを含む、請求項9に記載の試験ストリップ。
- 前記第1のヒュームドシリカが、約130〜170m2/gのBET測定された表面積と、約0.8〜約1.23重量%の炭素含量と、を含み、前記第2のヒュームドシリカが、約270〜330m2/gのBET測定された表面積と、約1.4〜約2.6重量%の炭素含量と、を含む、請求項10に記載の試験ストリップ。
- 前記第1のヒュームドシリカが、前記ヒュームドシリカの総量の約99〜約1重量%で存在し、前記第2のヒュームドシリカが、約1〜約99重量%で存在する、請求項11に記載の試験ストリップ。
- 前記第1のヒュームドシリカが、前記ヒュームドシリカの総量の約75〜約45重量%で存在し、前記第2のヒュームドシリカが、約25〜約55重量%で存在する、請求項11に記載の試験ストリップ。
- 前記酵素が、グルコースオキシダーゼ、グルコースデヒドロゲナーゼ、ピロロ−キノロン補助因子を伴うグルコースデヒドロゲナーゼ、及びフラビンアデニンジヌクレオチド補助因子を伴うグルコースデヒドロゲナーゼからなる群から選択され、前記介在物質が、フェリシアニド及び三塩化ルテニウムヘキサミンからなる群から選択される、請求項11に記載の試験ストリップ。
- 前記酵素が、グルコースオキシダーゼであり、前記介在物質がフェリシアニドである、請求項11に記載の試験ストリップ。
- 前記酵素インクが、約0.3質量%の消泡化合物と、約0.6質量%のポリビニルアルコールと、約0.6質量%のクエン酸と、約1.9質量%のクエン酸三ナトリウムと、約0.6質量%のポリビニルピロリドン−酢酸ビニル共重合体と、約3.27質量%のヒドロキシエチルセルロースと、約3.6質量%の、約130〜170m2/gのBET測定された表面積及び約0.8〜約1.23重量%の炭素含量を有する第1のヒュームドシリカと、約1.3質量%の、約270〜330m2/gのBET測定された表面積及び約1.4〜約2.6重量%の炭素含量を有する第2のヒュームドシリカと、約0.03質量%のカリウムヘキサシアノフェレートIIIと、約23質量%のフェリシアン化カリウムと、約2.1質量のグルコースオキシダーゼと、約62.4質量%の水と、を含む、請求項11に記載の試験ストリップ。
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US12/861,822 US8409412B2 (en) | 2010-08-23 | 2010-08-23 | Enzymatic reagent inks for use in test strips having a predetermined calibration code |
PCT/GB2011/001245 WO2012025711A1 (en) | 2010-08-23 | 2011-08-19 | Enzymatic reagent inks for use in test strips having a predetermined calibration code |
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US8858884B2 (en) | 2013-03-15 | 2014-10-14 | American Sterilizer Company | Coupled enzyme-based method for electronic monitoring of biological indicator |
US9121050B2 (en) | 2013-03-15 | 2015-09-01 | American Sterilizer Company | Non-enzyme based detection method for electronic monitoring of biological indicator |
CA2940323A1 (en) * | 2014-03-07 | 2015-09-11 | Ascensia Diabetes Care Holdings Ag | Biosensor calibration coding systems and methods |
TWI551860B (zh) | 2015-07-17 | 2016-10-01 | 台欣生物科技研發股份有限公司 | 測試片 |
CN112251069A (zh) * | 2020-10-29 | 2021-01-22 | 郑州百瑞动物药业有限公司 | 一种基于水性丝网印刷技术的酶电极用酶油墨及其制备方法 |
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AU2011294938B2 (en) | 2015-12-17 |
HK1185942A1 (en) | 2014-02-28 |
EP2609424A1 (en) | 2013-07-03 |
KR101836815B1 (ko) | 2018-03-09 |
AU2011294938A1 (en) | 2013-04-11 |
JP5876486B2 (ja) | 2016-03-02 |
RU2541111C2 (ru) | 2015-02-10 |
US8409412B2 (en) | 2013-04-02 |
CA2809085C (en) | 2019-11-12 |
RU2013112863A (ru) | 2014-09-27 |
WO2012025711A1 (en) | 2012-03-01 |
CA2809085A1 (en) | 2012-03-01 |
CN103080745A (zh) | 2013-05-01 |
ES2539229T3 (es) | 2015-06-29 |
US20120043204A1 (en) | 2012-02-23 |
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BR112013004278A2 (pt) | 2016-07-26 |
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