FI109152B - Stabil flytande tromboplastinreagens, förfarande för framställning av denna och diagnostisk utrustning innehållande reagens - Google Patents
Stabil flytande tromboplastinreagens, förfarande för framställning av denna och diagnostisk utrustning innehållande reagens Download PDFInfo
- Publication number
- FI109152B FI109152B FI933441A FI933441A FI109152B FI 109152 B FI109152 B FI 109152B FI 933441 A FI933441 A FI 933441A FI 933441 A FI933441 A FI 933441A FI 109152 B FI109152 B FI 109152B
- Authority
- FI
- Finland
- Prior art keywords
- thromboplastin
- calcium
- rbap
- solution
- reagent
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
-
- 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
- C12Q1/56—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
-
- 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
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/745—Assays involving non-enzymic blood coagulation factors
- G01N2333/7454—Tissue factor (tissue thromboplastin, Factor III)
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/81—Packaged device or kit
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Zoology (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Gastroenterology & Hepatology (AREA)
- Pathology (AREA)
- General Physics & Mathematics (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Food Science & Technology (AREA)
- Cell Biology (AREA)
- Toxicology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Neurosurgery (AREA)
- Pharmacology & Pharmacy (AREA)
- General Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Steroid Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (11)
1. Stabil flytande tromboplastinreagens, känne-tecknad av att den innehäller ett extrakt av trombop-5 lastinvävnad, kalciumjoner, stabiliseringsmedel och anti-mikrobiella medel och kan erhällas med ett förfarande som omfattar följande steg (a) en vävnad som innehäller rikligt med tromboplastin extraheras med en lösning, som innehäller en melo tallklorid och en svag metalljonkelator, i en koncentra- tion i omrädet 25-40 gram vävnad/liter extraktionslösning, (b) utspäds 1:1 med en lösning, som innehäller kalciumjoner och albumin, och (c) inkuberas.
2. Flytande tromboplastinreagens enligt patentkrav 1, kännetecknad av att vävnaden som innehäller rikt-ligt med tromboplastin är ett acetonpulver framställt av kaninhjärna. i
3. Flytande tromboplastinreagens enligt patentkrav 20 1 eller 2, kännetecknad av att kalciumjonerna väljs frän en grupp som innehäller kalciumglukonat, kalciumtart-rat och kalciumlaktat.
. ,*·* 4. Flytande tromboplastinreagens enligt nägot av patentkraven 1 - 3, kännetecknad av att ätminstone 25 ett stabiliseringsmedel väljs frän en grupp som innehäller albumin, natriumpropionat, polyetylenglykol och glukonat-joner. _ .
5. Flytande tromboplastinreagens enligt nägot av patent kraven 1 - 4, kännetecknad av att den dessutom 30 innehäller natriumpropionat som ett reglermedel för pro-: : tombintiden.
6. Förfarande för att framställa en flytande trom boplastinreagens enligt nägot av patentkraven 1-5, ’ kännetecknat av att det uppvisar följande steg: 109152 a) ett acetonpulverextrakt (RBAP) framställt av kaninhjärna tvättas med vatten i en koncentration av cirka 10-40 g RBAP/1, b) det tvättade RBAP-extraktet uppvärms tili cirka 5 25 °C, c) det uppvärmda RBAP-extraktet blandas i en ex-traktionslösning, som innehäller en metallklorid och en svag metalljonkelator, vid en koncentration i omrädet av 25-40 g RBAP/1 extraktionslösning, och uppvärms samtidigt 10 kontinuerligt vid cirka 45 °C, d) lösningen centrifugeras vid en temperatur pä cirka 2-10 °C, e) supernatanten utspäds cirka 1:1 med en lösning som innehäller albumin och kalciumjoner, 15 f) den utspädda supernatanten inkuberas, g) pH regleras tili ungefär neutralt och antimi-krobiella medel tillsätts, h) polyetylenglykol tillsätts cirka 0,1-5 %, i) lösningens protrombintidsvärden bestäms och vid 20 behov j) tillsätts natriumpropionat.
7. Förfarande enligt patentkrav 6, känneteck-j ,,!·* nat av att metallkloriden i steg (c) är natriumklorid, j · · : * : den svaga metalljonkelatorn i steg (c) väljs frän natrium- 25 citrat och natriumoxalat, och kalciumjonerna i steg (e) väljs frän kalciumglukonat, kalciumtartrat och kalciumlak-tat.
. 8. Förfarande enligt patentkrav 6, känneteck- i nat av att i steg (c) innehäller extraktionslösningen ’;·* 30 dessutom kalciumglukonat, kalciumtartrat eller kalciumlak- : ' tat.
9. Förfarande enligt patentkrav 6-8, känne-tecknat att innan natriumpropionat tillsätts, regleras I lösningen med hjälp av en bulkutspädningsfaktor. I * * 109152
10. Flytande tromboplastinreagens enligt nägot av patentkraven 1-5 för användning i ett diagnostiskt för-farande.
11. Diagnostisk utrustning, kännetecknad av 5 att den innehäller en flytande tromboplastinreagens enligt nägot av patentkraven 1-5. > ·
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US92421192 | 1992-08-03 | ||
| US07/924,211 US5358853A (en) | 1992-08-03 | 1992-08-03 | Liquid thromboplastin reagent |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| FI933441A0 FI933441A0 (fi) | 1993-08-02 |
| FI933441A FI933441A (fi) | 1994-02-04 |
| FI109152B true FI109152B (sv) | 2002-05-31 |
Family
ID=25449889
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FI933441A FI109152B (sv) | 1992-08-03 | 1993-08-02 | Stabil flytande tromboplastinreagens, förfarande för framställning av denna och diagnostisk utrustning innehållande reagens |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US5358853A (sv) |
| EP (1) | EP0585987B2 (sv) |
| JP (1) | JP3330685B2 (sv) |
| KR (1) | KR100265531B1 (sv) |
| AT (1) | ATE179759T1 (sv) |
| AU (1) | AU665432B2 (sv) |
| CA (1) | CA2100617C (sv) |
| DE (2) | DE69324745T4 (sv) |
| DK (1) | DK0585987T4 (sv) |
| ES (1) | ES2132174T5 (sv) |
| FI (1) | FI109152B (sv) |
| GR (1) | GR3030728T3 (sv) |
| ZA (1) | ZA935180B (sv) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6379975B1 (en) | 1996-11-27 | 2002-04-30 | T.A.C. Thrombosis And Coagulation Aktiebolag | Methods and reagents for determining protein S |
| CA2288058A1 (en) * | 1997-04-23 | 1998-10-29 | Instrumentation Laboratory, S.P.A. | Recombinant rabbit tissue factor based prothrombin time reagent |
| DE19720853A1 (de) * | 1997-05-17 | 1998-11-19 | Dade Behring Marburg Gmbh | Erhöhung der FVII Empfindlichkeit eines Thromboplastinreagenzes |
| DE19811016A1 (de) * | 1998-03-13 | 1999-09-16 | Dade Behring Marburg Gmbh | Gebrauchsfertiges Prothrombinzeitreagenz auf der Basis von rekombinantem Gewebsfaktor |
| JP2002526557A (ja) | 1998-10-07 | 2002-08-20 | シグマ−アルドリッチ・カンパニー | トロンボプラスチン試薬ならびにそのような試薬の製造および使用方法 |
| US6207661B1 (en) | 1999-02-22 | 2001-03-27 | Baxter International Inc. | Premixed formulation of piperacillin sodium and tazobactam sodium injection |
| US6733985B1 (en) | 1999-05-19 | 2004-05-11 | International Technidyne Corporation | Preparation of stable liquid and dried synthetic prothrombin time reagents |
| US6248353B1 (en) | 1999-12-10 | 2001-06-19 | Dade Behring Inc. | Reconstitution of purified membrane proteins into preformed liposomes |
| US6855509B2 (en) | 2000-12-19 | 2005-02-15 | Instrumentation Laboratory Company | Protein S functional assay and kit therefor |
| US7148067B2 (en) * | 2004-08-31 | 2006-12-12 | The Board Of Trustees Of The University Of Illinois | Thromboplastin reagents |
| EP1853926A2 (en) * | 2005-02-16 | 2007-11-14 | The Board Of Trustees Of The University Of Illinois | Procoagulants based on metal-chelating lipids |
| EP1869082B1 (en) * | 2005-03-04 | 2011-04-13 | The Board Of Trustees Of The University Of Illinois | Coagulation and fibrinolytic cascades modulator |
| US20080003220A1 (en) * | 2006-04-21 | 2008-01-03 | Amgen, Inc. | Buffering agents for biopharmaceutical formulations |
| JP4999613B2 (ja) * | 2007-08-31 | 2012-08-15 | シスメックス株式会社 | 血液凝固測定用試薬及び血液凝固時間測定方法 |
| WO2009046194A2 (en) * | 2007-10-05 | 2009-04-09 | The Board Of Trustees Of The University Of Illinois | Fibrin sealant |
| WO2009061697A1 (en) | 2007-11-09 | 2009-05-14 | The Board Of Trustees Of The University Of Illinois | Anticoagulant antagonist and hemophilia procoagulant |
| DE102007062323A1 (de) * | 2007-12-21 | 2009-06-25 | Siemens Healthcare Diagnostics Products Gmbh | Langzeitstabiles Thromboplastin-Reagenz |
| EP2434290B1 (en) | 2009-05-20 | 2016-02-10 | Sekisui Medical Co., Ltd. | Blood coagulation time prolonging agent |
| JP5589103B2 (ja) * | 2013-01-23 | 2014-09-10 | 株式会社Ｌｓｉメディエンス | 二価金属イオン含有の体外診断用試薬組成物および二価金属イオン由来金属化合物の沈殿防止方法 |
| JP6250306B2 (ja) * | 2013-05-28 | 2017-12-20 | 株式会社Ｌｓｉメディエンス | リポ化トロンボプラスチン含有血液凝固能測定試薬及び測定方法 |
| JP2014197019A (ja) * | 2014-06-30 | 2014-10-16 | 積水メディカル株式会社 | 血液凝固反応における血液凝固時間延長剤 |
| US10877052B2 (en) | 2016-02-12 | 2020-12-29 | Instrumentation Laboratory Company | Two component “mix and use” liquid thromboplastin reagent, methods of making, and methods of use thereof |
| EP3489692A1 (de) | 2017-11-28 | 2019-05-29 | Siemens Healthcare Diagnostics Products GmbH | Prothrombinzeit-reagenz enthaltend einen eisenchelator |
| US20210405072A1 (en) * | 2018-09-25 | 2021-12-30 | Sekisui Medical Co., Ltd. | Method for measuring blood coagulation time |
| CN113005176A (zh) * | 2019-12-20 | 2021-06-22 | 深圳市帝迈生物技术有限公司 | 稳定剂、凝血酶原时间检测试剂及其制备方法、试剂盒 |
| CN111638374B (zh) * | 2020-06-08 | 2022-10-18 | 深圳市国赛生物技术有限公司 | 一种用于测定凝血酶原时间的体外诊断试剂盒 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2516216A (en) * | 1947-06-24 | 1950-07-25 | Sharp & Dohme Inc | Thromboplastin as testing agent |
| US2847350A (en) * | 1954-05-27 | 1958-08-12 | Ortho Pharma Corp | Preparation of highly active thromboplastin |
| US2847347A (en) * | 1954-05-27 | 1958-08-12 | Ortho Pharmacentical Corp | Preparation of improved thromboplastin |
| US2842480A (en) * | 1954-05-27 | 1958-07-08 | Ortho Pharma Corp | Preparation of thromboplastin |
| US2921000A (en) * | 1956-05-22 | 1960-01-12 | Ortho Pharma Corp | Thromboplastin |
| US3522148A (en) * | 1965-08-13 | 1970-07-28 | Dade Reagents Inc | Stabilized thromboplastin preparation |
| DE3113350A1 (de) * | 1981-04-02 | 1982-10-21 | Boehringer Mannheim Gmbh, 6800 Mannheim | Reagens zur optischen bestimmung des blutgerinnungsverhaltens |
| DE3150596A1 (de) * | 1981-12-21 | 1983-06-30 | Boehringer Mannheim Gmbh, 6800 Mannheim | Verfahren zur herstellung von gewebsthromboplastin |
| US4755461A (en) * | 1986-04-17 | 1988-07-05 | Bio/Data Corporation | Tableted blood plasma microconcentrated thromboplastin coagulation reagent |
| EP0396733B1 (en) * | 1988-11-23 | 1994-01-05 | Baxter Diagnostics Inc. | Improved extraction methods for preparing thromboplastin reagents |
| US5270451A (en) * | 1988-11-23 | 1993-12-14 | Baxter Diagnostics Inc. | Extraction method for preparing thromboplastin reagents |
| US5091304A (en) * | 1989-08-21 | 1992-02-25 | International Technidyne Corporation | Whole blood activated partial thromboplastin time test and associated apparatus |
| DE3929329A1 (de) * | 1989-09-04 | 1991-03-07 | Behringwerke Ag | Stabilisierungsmittel zur verbesserung der wiederfindung von gerinnungsfaktoren in blutproben |
| US5281528A (en) * | 1989-12-18 | 1994-01-25 | Warner-Lambert Company | Process for purified thromboplastin for ultra-pure thrombin preparation |
| FR2679251B1 (fr) * | 1991-07-18 | 1993-11-12 | Nord Assoc Essor Transfusion San | Procede de preparation d'un concentre de thrombine humaine destine a un usage therapeutique. |
-
1992
- 1992-08-03 US US07/924,211 patent/US5358853A/en not_active Expired - Lifetime
-
1993
- 1993-07-15 CA CA002100617A patent/CA2100617C/en not_active Expired - Fee Related
- 1993-07-16 ZA ZA935180A patent/ZA935180B/xx unknown
- 1993-07-22 DK DK93202175T patent/DK0585987T4/da active
- 1993-07-22 AT AT93202175T patent/ATE179759T1/de not_active IP Right Cessation
- 1993-07-22 DE DE69324745T patent/DE69324745T4/de not_active Expired - Lifetime
- 1993-07-22 DE DE69324745A patent/DE69324745D1/de not_active Expired - Fee Related
- 1993-07-22 EP EP93202175A patent/EP0585987B2/en not_active Expired - Lifetime
- 1993-07-22 ES ES93202175T patent/ES2132174T5/es not_active Expired - Lifetime
- 1993-07-23 AU AU42158/93A patent/AU665432B2/en not_active Ceased
- 1993-08-02 FI FI933441A patent/FI109152B/sv not_active IP Right Cessation
- 1993-08-02 KR KR1019930014928A patent/KR100265531B1/ko not_active IP Right Cessation
- 1993-08-03 JP JP19255593A patent/JP3330685B2/ja not_active Expired - Fee Related
-
1994
- 1994-06-03 US US08/253,523 patent/US5508170A/en not_active Expired - Fee Related
-
1999
- 1999-07-08 GR GR990401807T patent/GR3030728T3/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JPH06201702A (ja) | 1994-07-22 |
| ATE179759T1 (de) | 1999-05-15 |
| DE69324745T2 (de) | 1999-10-14 |
| ES2132174T3 (es) | 1999-08-16 |
| KR100265531B1 (ko) | 2000-09-15 |
| DK0585987T3 (da) | 1999-11-08 |
| US5358853A (en) | 1994-10-25 |
| EP0585987A1 (en) | 1994-03-09 |
| FI933441A0 (fi) | 1993-08-02 |
| JP3330685B2 (ja) | 2002-09-30 |
| CA2100617A1 (en) | 1994-02-04 |
| DE69324745D1 (de) | 1999-06-10 |
| EP0585987B1 (en) | 1999-05-06 |
| AU4215893A (en) | 1994-02-10 |
| ZA935180B (en) | 1994-05-25 |
| DK0585987T4 (da) | 2005-01-17 |
| FI933441A (fi) | 1994-02-04 |
| CA2100617C (en) | 2003-06-24 |
| KR940005288A (ko) | 1994-03-21 |
| DE69324745T4 (de) | 2006-01-05 |
| ES2132174T5 (es) | 2005-04-16 |
| EP0585987B2 (en) | 2004-09-08 |
| AU665432B2 (en) | 1996-01-04 |
| US5508170A (en) | 1996-04-16 |
| GR3030728T3 (en) | 1999-11-30 |
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| MA | Patent expired |