Rivaroxaban lulú

Apejuwe Kukuru:

Orukọ API Itọkasi Sipesifikesonu US DMF  EU DMF  CEP
Rivaroxaban lulú Anticoagulant Ninu Ile TDP    

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Lẹhin

Rivaroxaban lulú, 5-chloro-N - [[(5S) -2-oxo-3- [4- (3-oxomorpholin-4-yl) phenyl] -1,3-oxazolidin-5-yl] methyl] thiophene-2 -carboxamide, jẹ onidalẹkun kekere-molikula kekere ti ifosiwewe Xa eyiti o jẹ ifosiwewe coagulation ni aaye to ṣe pataki ni ọna ọna didin ẹjẹ ti o mu abajade iran ti thrombin ati iṣeto didi. Rivaroxaban lulú sopọ si Tyr288 ni apo S1 ti ifosiwewe Xa nipasẹ ibaraenisepo ti Tyr288 ati aropo chlorine ti ẹya chlorothiophene. Idinamọ jẹ iparọ (koff = 5x10-3s-1), iyara (kon = 1.7x107 mol / L-1 s-1), ati ni ọna igbẹkẹle ifọkansi (Ki = 0.4 nmol / L). Rivaroxaban lulú ti wa ni iwadii lọwọlọwọ fun itọju VTE, idena fun awọn iṣẹlẹ inu ọkan ati ẹjẹ ni awọn alaisan ti o ni iṣọn-alọ ọkan iṣọn-alọ ọkan, idena ti ikọlu ni awọn alaisan ti o ni fibrillation atrial.

Itọkasi

Elisabeth Perzborn, Susanne Roehrig, Alexander Straub, Dagmar Kubitza, Wolfgang Mueck, ati Volker Laux. Rivaroxaban lulú: ifosiwewe ẹnu tuntun Xa onidena. Arterioscler Thromb Vasc Biol 2010; 30 (3): 376-381

Apejuwe

Rivaroxaban lulú (BAY 59-7939) jẹ agbara ti o ga julọ,yiyan ati taara onidena Xa ifosiwewe Xa (FXa), iyọrisi ere to lagbara ni agbara anti-FXa (IC50 0.7 nM; Ki 0.4 nM).

 

Ni Vitro

Rivaroxaban lulú (BAY 59-7939) jẹ onidena, taara Factor Xa (FXa) onidena ni idagbasoke fun idena ati itọju ti iṣọn-ẹjẹ ati iṣọn-ẹjẹ iṣan. Rivaroxaban l’awon ifigagbaga dẹkun FXa eniyan (Ki 0.4 nM) pẹlu> 10 000-agbo yiyan pupọ ju fun awọn proteines serine miiran; o tun ṣe idiwọ iṣẹ prothrombinase (IC50 2.1 nM). Rivaroxaban lọna dẹkun FXa ti o ni agbara diẹ ninu pilasima eniyan ati ehoro (IC50 21 nM) ju pilasima eku (IC50 290 nM). O ṣe afihan awọn ipa ti egboogiagulant ninu pilasima eniyan, ilọpo meji akoko prothrombin (PT) ati mu akoko thromboplastin apa kan ṣiṣẹ ni 0.23 ati 0.69μM, lẹsẹsẹ.

 

Rivaroxaban lulú (BAY 59-7939) jẹ agbara ati yiyan, taara FXa onidena pẹlu iṣẹ inu vivo ati bioavailability ẹnu to dara. Rivaroxaban lulú (BAY 59-7939), ti a nṣakoso nipasẹ iv bolus ṣaaju ifunni thrombus, dinku ikẹkọ thrombus (ED50 0.1 mg / kg), dena FXa, ati pe gigun PT ni igbẹkẹle. PT ati FXa ni ipa diẹ ni ED50 (ilosoke 1.8 ati idena 32%, lẹsẹsẹ). Ni 0.3 iwon miligiramu / kg (iwọn lilo ti o fẹrẹ fẹrẹ dopin idiwọ ti iṣelọpọ thrombus), Rivaroxaban lọna ti o dara pẹ PT (3.2)±0,5-agbo) ati idilọwọ iṣẹ FXa (65±3%).

 

Ibi ipamọ

Powder

-20 ° C

3 ọdun
 

4 ° C

ọdun meji 2
Ni epo

-80 ° C

Oṣu mẹfa
 

-20 ° C

Oṣu 1

Ilana kemikali

Rivaroxaban

Iwe-ẹri

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

Isakoso didara

Quality management1

Imọran 18 Awọn iṣẹ Iṣiro Didara Didara eyiti o ti fọwọsi 4, ati 6 awọn iṣẹ akanṣe wa labẹ ifọwọsi.

Quality management2

Eto iṣakoso didara agbaye ti ni ilọsiwaju ti fi ipilẹ ipilẹ mulẹ fun awọn tita.

Quality management3

Abojuto didara nṣakoso nipasẹ gbogbo igbesi aye ti ọja lati rii daju didara ati ipa itọju. 

Quality management4

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