Rivaroxaban

Sharax Gaaban:

Magaca API Tilmaam Faahfaahinta US DMF  EU DMF  CEP
Rivaroxaban Anticoagulant Guriga Gudihiisa TDP    

Faahfaahinta alaabta

Calaamadaha alaabta

FAAHFAAHINTA SOO SAARKA

Gundhig

Rivaroxaban budada, 5-chloro-N - [[(5S) -2-oxo-3- [4- (3-oxomorpholin-4-yl) phenyl] -1,3-oxazolidin-5-yl] methyl] thiophene-2 -carboxamide, waa xoog-yare yar-yar oo xakameynaya cunsuriyada Xa taas oo ah cuncunka cuncunka marxalad xasaasi ah oo ku jirta marinka dhiig xinjirowga taasoo dhalisay jiilka thrombin iyo sameynta xinjirowga. Rivaroxaban wuxuu kuxiran yahay Tyr288 oo kujira jeebka S1 ee cunsuriyada Xa iyada oo loo marayo isdhexgalka Tyr288 iyo bedelka koloriin ee molosha chlorothiophene. Xakamaynta waa la beddeli karaa (koff = 5x10-3s-1), deg deg ah (kon = 1.7x107 mol / L-1 s-1), iyo qaab feejignaan ku tiirsan (Ki = 0.4 nmol / L). Rivaroxaban ayaa hadda loo baranayaa daaweynta VTE, ka hortagga dhacdooyinka wadnaha iyo xididdada ee bukaannada qaba cudurrada halista ah ee wadnaha, ka hortagga istaroogga ee bukaannada qaba cilladda wadnaha.

Tixraac

Elisabeth Perzborn, Susanne Roehrig, Alexander Straub, Dagmar Kubitza, Wolfgang Mueck, iyo Volker Laux. Rivaroxaban budada: waa cunsur cusub oo afka laga qaato Xa inhibitor. Arterioscler Thromb Vasc Biol 2010; 30 (3): 376-381

Sharaxaad

Rivaroxaban (BAY 59-7939) waa mid aad u awood badan,xulasho oo toos ah Factor Xa (FXa) xakamaynta, ku guuleysiga faa'iido xoog leh awoodda anti-FXa (IC50 0.7 nM; Ki 0.4 nM).

 

In Vitro

Rivaroxaban budada (BAY 59-7939) waa hadal afka ah, toos ah Factor Xa (FXa) xakameynaha horumarinta ee kahortaga iyo daaweynta xididdada dhiigga ee xididdada dhiigga. Rivaroxaban wuxuu si tartiib tartiib ah u xakameynayaa aadanaha FXa (Ki 0.4 nM) oo leh> 10 000-laab xulasho ka weyn kuwa kale ee difaaca jirka; waxay kaloo joojisaa waxqabadka prothrombinase (IC50 2.1 nM). Rivaroxaban wuxuu xakameynayaa FXa-yada dabiiciga ah ee aadka u xoogan ee plasma bini-aadamka iyo bakaylaha (IC50 21 nM) marka loo eego plasma rat (IC50 290 nM). Waxay muujineysaa saameynta xinjirowga lidka ku ah plasma-ka bini'aadamka, labalaabista waqtiga prothrombin (PT) waxayna kicineysaa waqtiga qayb ahaan thromboplastin ee 0.23 iyo 0.69μM, siday u kala horreeyaan.

 

Rivaroxaban budada (BAY 59-7939) waa mid awood leh oo xulasho leh, toos ah FXa inhibitor leh firfircoonida firfircoonaanta iyo bioavailability afka. Rivaroxaban budada (BAY 59-7939), oo ay maamusho iv bolus kahor soosaarka thrombus, wuxuu yareeyaa samaynta xididdada (ED50 0.1 mg / kg), wuxuu joojiyaa FXa, wuxuuna kordhiyaa qiyaasta PT si ku tiirsan. PT iyo FXa waxyar ayey kudhacayaan ED50 (1.8 laab laab ah iyo 32% xakameyn, siday u kala horreeyaan). At 0.3 mg / kg (qiyaasta u horseedda ku dhowaad dhammaystirka joojinta samaynta xididdada dhiigga), Rivaroxaban wuxuu si dhexdhexaad ah u dheereeyaa PT (3.2±0.5-laab) oo xakameynaya waxqabadka FXa (65±3%).

 

Kaydinta

Budada

-20 ° C

3 sano
 

4 ° C

2 sano
Kala dareeraha

-80 ° C

6 bilood
 

-20 ° C

1 bil

Qaab dhismeedka kiimikada

Rivaroxaban

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

MAAMULKA TAYO

Quality management1

Soo jeedin 18 Mashaariicda Qiimaynta Joogtada Tayo ee la ansixiyay 4, iyo 6 mashaariicdii waa la ansixinayaa.

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Nidaamka maaraynta tayada caalamiga ah ee horumarsan ayaa aasaas adag u dhigay iibka.

Quality management3

Kormeerka tayada ayaa maraya wareegga nolosha oo dhan ee badeecada si loo hubiyo tayada iyo saameynta daaweynta. 

Quality management4

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