Dabigatran Etexilate Mesylate

Sharax Gaaban:

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Dabigatran Etexilate Mesylate Anticoagulant Guriga Gudihiisa      

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FAAHFAAHINTA SOO SAARKA

Sharaxaad

Dabigatran etexilate mesylate (BIBR 1048MS) waa hadal firfircoon oo afka Dabigatran ah. Dabigatran etexilate mesylate wuxuu leeyahay saameyn xinjirowga lidka ku ah waxaana loo isticmaalaa kahortaga venousthromboembolism iyo istaroog sababa fibrillation atrial.

Gundhig

Faahfaahin: Qiimaha IC50: 4.5nM (Ki); 10nM (Wadarta isu-soo-saarka platelet-ku-kicinta Thrombin) [1] Dabigatran waa dib-u-celin iyo xulasho, xannibaadaha tooska ah ee loo yaqaan 'thrombin inhibitor' (DTI) oo maraya horumarin caafimaad oo horumarsan iyada oo ah firfircoonideeda afka ah, dabigatran etexilate. in vitro: Dabigatran si xulasho iyo dib u celin xinjirowga bini'aadamka (Ki: 4.5 nM) iyo sidoo kale isu-soo-ururinta platelet-ku-kicinta dhiig-baxa (IC (50): 10 nM), iyada oo aan la muujinin wax saameyn ah oo xakameyn ah oo ku saabsan wakiilada kale ee kiciya platelet-ka. - plasma-da (PPP), oo lagu cabiray sida suurtogalka ah ee thrombin thrombin (ETP) ayaa la joojiyay feejignaanta-ku tiirsanaanta (IC (50): 0.56 microM). Dabigatran wuxuu muujiyey saamaynta daawada xinjirowga lidka ku ah ee ku-tiirsanaanta noocyada kaladuwan ee fitamiinada, isagoo labanlaabaya waqtiga firfircoonaanta tromboplastin-ka (aPTT), waqtiga prothrombin (PT) iyo waqtiga xinjirowga ecarin (ECT) ee PPP-ga dadka ee isugu soo ururaya 0.23, 0.83 iyo 0.18 microM, siday u kala horreeyaan 1]. in vivo: Dabigatran wuxuu dheereeyay qiyaasta aPTT-ku-tiirsanaanta ka dib markii maamulka xididka ee jiirka (0.3, 1 iyo 3 mg / kg) iyo daanyeerrada rhesus (0.15, 0.3 iyo 0.6 mg / kg). Qiyaasta- iyo saameynta daawada xinjirowga lidka ku ah waqtiga-ku-tiirsan waxaa lagu arkay dabigatran etexilate oo afka looga qaato jiirka miyir-qabka ah (10, 20 iyo 50 mg / kg) ama daanyeer rhesus (1, 2.5 ama 5 mg / kg), oo leh saameynta ugu badan ee lagu arkay inta udhaxeysa 30 iyo 120 daqiiqad maamulka kadib, siday u kala horreeyaan [1]. Bukaannada lagu daaweeyay dabigatran etexilate khibrad yar oo istaroog ah (3.74 dabigatran etexilate vs 3.97 warfarin) iyo in yar oo isugeyn dhiig bax ah iyo istaroog haemorrhagic ah (0.43 dabigatran etexilate vs 0.99 warfarin) 100kii sano ee bukaanka ah [2]. Tijaabada caafimaadka: Qiimeynta Farmashiistaha iyo Farmashiyada firfircoonaanta Oral Dabigatran Etexilate ee bukaanka Hemodialysis. Wejiga1

Kaydinta

Budada

-20 ° C

3 sano
 

4 ° C

2 sano
Kala dareeraha

-80 ° C

6 bilood
 

-20 ° C

1 bil

Tijaabada Caafimaadka

Lambarka NCT Kafaalasho Xaaladda Taariikhda billowga

Wejiga

NCT02170792 Boehringer Ingelheim Caafimaad qab ah Febraayo 2001

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NCT02170974 Boehringer Ingelheim Caafimaad qab ah Julaay 2004

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NCT02170831 Boehringer Ingelheim Caafimaad qab ah Bishii Meey 1999

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NCT02170805 Boehringer Ingelheim Caafimaad qab ah Abriil 2001

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NCT02170610 Boehringer Ingelheim Caafimaad qab ah Maarso 2002

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NCT02170909 Boehringer Ingelheim Caafimaad qab ah Diisambar 2004

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NCT02171000 Boehringer Ingelheim Caafimaad qab ah Abriil 2005

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NCT02170844 Boehringer Ingelheim Caafimaad qab ah Juun 2004

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NCT02170584 Boehringer Ingelheim Caafimaad qab ah Janawari 2001

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NCT02170935 Boehringer Ingelheim Dhiig-baxa Dhiig-baxa Abriil 2002

Wajiga 2

NCT02170636 Boehringer Ingelheim Caafimaad qab ah Janawari 2002

Wajiga 1

NCT02170766 Boehringer Ingelheim Caafimaad qab ah Oktoobar 2000

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NCT02171442 Boehringer Ingelheim Caafimaad qab ah Abriil 2002

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NCT02170896 Boehringer Ingelheim Caafimaad qab ah Oktoobar 2001

Wajiga 1

NCT02173730 Boehringer Ingelheim Caafimaad qab ah Nofeembar 2002

Wajiga 1

NCT02170623 Boehringer Ingelheim Caafimaad qab ah Febraayo 2002

Wajiga 1

NCT02170116 Boehringer Ingelheim Caafimaad qab ah Nofeembar 1998

Wajiga 1

NCT02170597 Boehringer Ingelheim Caafimaad qab ah Ogast 2003

Wajiga 1

NCT01225822 Boehringer Ingelheim Dhiig-baxa Dhiig-baxa Nofeembar 2002

Wajiga 2

NCT02170701 Boehringer Ingelheim Dhiig-baxa Dhiig-baxa Oktoobar 2000

Wajiga 2

NCT02170740 Boehringer Ingelheim Caafimaad qab ah Nofeembar 1999

Wajiga 1

NCT02170922 Boehringer Ingelheim Caafimaad qab ah Julaay 1999

Wajiga 1

Qaab dhismeedka kiimikada

Dabigatran Etexilate Mesylate

SHAHAADO

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

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