Dabigatran Etexilate Mesylate

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Dabigatran Etexilate Mesylate Anticoagulant Hauv tsev      


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Dabigatran etexilate mesylate (BIBR 1048MS) yog ib qho tshuaj tiv thaiv kab mob ntawm Dabigatran.Dabigatran etexilate mesylate muaj cov nyhuv anticoagulant thiab siv rau kev tiv thaiv ntawm venousthromboembolism thiab mob stroke vim atrial fibrillation.

Keeb kwm

Nqe lus piav qhia: IC50 Tus Nqi: 4.5nM (Ki);10nM (Thrombin-induced platelet aggregation) [1] Dabigatran yog ib qho kev thim rov qab thiab xaiv, ncaj qha thrombin inhibitor (DTI) tab tom ua tiav kev kho mob siab heev raws li nws qhov ncauj nquag prodrug, dabigatran etexilate.nyob rau hauv vitro: Dabigatran xaiv thiab thim rov qab inhibited tib neeg thrombin (Ki: 4.5 nM) nrog rau thrombin-induced platelet aggregation (IC(50): 10 nM), thaum tsis pom muaj kev cuam tshuam rau lwm cov platelet-stimulating agents.Thrombin tiam hauv platelet. plasma tsis zoo (PPP), ntsuas raws li endogenous thrombin peev xwm (ETP) yog inhibited concentration-dependently (IC(50): 0.56 microM).Dabigatran tau ua kom pom cov nyhuv anticoagulant nyob rau ntau hom hauv vitro, ua ob npaug ntawm lub sijhawm ua haujlwm ib nrab thromboplastin (aPTT), lub sijhawm prothrombin (PT) thiab ecarin clotting lub sij hawm (ECT) hauv tib neeg PPP ntawm qhov ntau ntawm 0.23, 0.83 thiab 0.18 microM, feem. 1].nyob rau hauv vivo: Dabigatran ncua ntev ntawm aPTT koob tshuaj-nyob ntawm seb tom qab txhaj tshuaj hauv cov nas (0.3, 1 thiab 3 mg / kg) thiab rhesus liab (0.15, 0.3 thiab 0.6 mg / kg).Cov koob tshuaj thiab lub sij hawm-dependent anticoagulant tshwm sim tau pom nrog dabigatran etexilate muab qhov ncauj rau cov nas nco qab (10, 20 thiab 50 mg / kg) lossis rhesus liab (1, 2.5 lossis 5 mg / kg), nrog rau qhov siab tshaj plaws tshwm sim ntawm 30 thiab 120 min tom qab kev tswj hwm, feem [1].Cov neeg mob kho nrog dabigatran etexilate tau ntsib tsawg dua ischemic strokes (3.74 dabigatran etexilate vs 3.97 warfarin) thiab tsawg dua ua ke intracranial haemorrhages thiab haemorrhagic strokes (0.43 dabigatran etexilate vs 0.99 warfarin) ib tus neeg mob.Kev sim tshuaj: Kev Ntsuas ntawm Pharmacokinetics thiab Pharmacodynamics ntawm Qhov Ncauj Dabigatran Etexilate hauv Hemodialysis Cov Neeg Mob.Theem 1

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-80 ° C

6 hli
 

-20 ° C

1 hli

Kev sim tshuaj

NCT Num Txhawb nqa Qhov xwm txheej Pib Hnub

Theem

NCT02170792 Boehringer Ingelheim Noj qab nyob zoo Lub Ob Hlis 2001

Theem 1

NCT02170974 Boehringer Ingelheim Noj qab nyob zoo Lub Xya Hli 2004

Theem 1

NCT02170831 Boehringer Ingelheim Noj qab nyob zoo Tsib Hlis 1999

Theem 1

NCT02170805 Boehringer Ingelheim Noj qab nyob zoo Plaub Hlis Ntuj 2001

Theem 1

NCT02170610 Boehringer Ingelheim Noj qab nyob zoo Peb Hlis 2002

Theem 1

NCT02170909 Boehringer Ingelheim Noj qab nyob zoo Kaum Ob Hlis 2004

Theem 1

NCT02171000 Boehringer Ingelheim Noj qab nyob zoo Plaub Hlis Ntuj 2005

Theem 1

NCT02170844 Boehringer Ingelheim Noj qab nyob zoo Lub Rau Hli 2004

Theem 1

NCT02170584 Boehringer Ingelheim Noj qab nyob zoo Lub Ib Hlis 2001

Theem 1

NCT02170935 Boehringer Ingelheim Venous Thromboembolism Plaub Hlis Ntuj 2002

Theem 2

NCT02170636 Boehringer Ingelheim Noj qab nyob zoo Lub Ib Hlis 2002

Theem 1

NCT02170766 Boehringer Ingelheim Noj qab nyob zoo Lub Kaum Hli 2000

Theem 1

NCT02171442 Boehringer Ingelheim Noj qab nyob zoo Plaub Hlis Ntuj 2002

Theem 1

NCT02170896 Boehringer Ingelheim Noj qab nyob zoo Lub Kaum Hli 2001

Theem 1

NCT02173730 Boehringer Ingelheim Noj qab nyob zoo Kaum Ib Hlis 2002

Theem 1

NCT02170623 Boehringer Ingelheim Noj qab nyob zoo Lub Ob Hlis 2002

Theem 1

NCT02170116 Boehringer Ingelheim Noj qab nyob zoo Kaum Ib Hlis 1998

Theem 1

NCT02170597 Boehringer Ingelheim Noj qab nyob zoo Lub yim hli ntuj 2003

Theem 1

NCT01225822 Boehringer Ingelheim Venous Thromboembolism Kaum Ib Hlis 2002

Theem 2

NCT02170701 Boehringer Ingelheim Venous Thromboembolism Lub Kaum Hli 2000

Theem 2

NCT02170740 Boehringer Ingelheim Noj qab nyob zoo Kaum Ib Hlis 1999

Theem 1

NCT02170922 Boehringer Ingelheim Noj qab nyob zoo Lub Xya Hli 1999

Theem 1

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Dabigatran Etexilate Mesylate

CERTIFICATE

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

QUALITY MANAGEMENT

Quality management1

Tswv yim18Quality Consistency Evaluation tej yaam num uas tau pom zoo4, thiab6tej yaam num raug tso cai.

Quality management2

Advanced thoob ntiaj teb kev tswj hwm qhov system tau tso lub hauv paus ruaj khov rau kev muag khoom.

Quality management3

Kev saib xyuas zoo ua haujlwm los ntawm tag nrho lub neej voj voog ntawm cov khoom kom ntseeg tau tias qhov zoo thiab kho cov nyhuv.

Quality management4

Pab Pawg Kev Tswj Xyuas Kev Tswj Xyuas Kev Ua Haujlwm txhawb nqa qhov kev xav tau zoo thaum lub sijhawm thov thiab tso npe.

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