Rivaroxaban powder

Tsananguro Pfupi:

Zita re API Chiratidzo Tsanangudzo US DMF  EU DMF  CEP
Rivaroxaban powder Anticoagulant Mumba TDP    

Chigadzirwa Chigadzirwa

Chigadzirwa Mateki

CHIDZIDZO CHIDZIDZO

Mhemberero

Rivaroxaban powder, 5-chloro-N - [[((5S) -2-oxo-3- [4- (3-oxomorpholin-4-yl) phenyl] -1,3-oxazolidin-5-yl] methyl] thiophene-2 -carboxamide, ine simba-diki mamorekuru inhibitor ye factor Xa inova iyo coagulation chinhu panguva yakakosha muropa coagulation nzira inokonzeresa mukugadzirwa kwetrombin uye kuumbwa kweganda. Rivaroxaban powder inosunga kune iyo Tyr288 muhomwe yeS1 ye factor Xa kuburikidza nekudyidzana kweTyr288 uye iyo kiriniki chinotsiva chechlorothiophene moiety. Iyo inhibition inodzoserwa (koff = 5x10-3s-1), inokurumidza (kon = 1.7x107 mol / L-1 s-1), uye nenzira yakasendamira-mukutenderera (Ki = 0.4 nmol / L). Rivaroxaban powder parizvino iri kuongororwa kurapwa kweVTE, kudzivirira zviitiko zvemoyo muvarwere vane acon coronary syndrome, kudzivirira sitiroko kune varwere vane atrial fibrillation.

Refer

Elisabeth Perzborn, Susanne Roehrig, Alexander Straub, Dagmar Kubitza, Wolfgang Mueck, naVolker Laux. Rivaroxabanxaban: chinhu chitsva chemumuromo Xa inhibitor. Arterioscler Thromb Vasc Biol 2010; 30 (3): 376-381

Tsananguro

Rivaroxaban powder (BAY 59-7939) ine simba kwazvoinosarudza uye yakanangana neFactor Xa (FXa) inhibitor, ichiwana pfuma yakasimba muanti-FXa potency (IC50 0.7 nM; Ki 0.4 nM).

 

MuVitro

Rivaroxaban powder (BAY 59-7939) ndeyemuromo, yakanangana neFactor Xa (FXa) inhibitor mukuvandudza kwekudzivirira uye kurapwa kweanopa uye venous thrombosis. Rivaroxaban makwikwi anokwenenzvera anodzivisa vanhu FXa (Ki 0.4 nM) ne> 10 000-kakapetwa akasarudzika kupfuura mamwe maserote proteases; iyo zvakare inodzivirira prothrombinase chiitiko (IC50 2.1 nM). Rivaroxaban powder inhibits endo native FXa zvakanyanya muhunhu uye tsuro plasma (IC50 21 nM) pane rat plasma (IC50 290 nM). Iyo inoratidza anticoagulant mhedzisiro muplasma yemunhu, inopetana kaviri prothrombin nguva (PT) uye inomutsa chikamu chepromboplastin nguva pa0.23 uye 0.69.μM, zvichiteerana.

 

Rivaroxaban powder (BAY 59-7939) ine simba uye inosarudza, yakananga FXa inhibitor ine yakanakisa mune vivo chiitiko uye yakanaka yemuromo bioavailability. Rivaroxaban powder (BAY 59-7939), inotungamirwa ne iv bolus pamberi pechiropa, inodzora kuumbwa (ED50 0.1 mg / kg), inodzivirira FXa, uye inowedzera PT dhizaini zvichienderana. PT neFXa zvinokanganiswa zvishoma pane iyo ED50 (1.8-fold kuwedzera uye 32% inhibition, zvichiteerana). Pa 0.3 mg / kg (dhizaini inotungamira kune ingangoita yakakwana yekudzivirira kweiyo thrombus kuumbwa), Rivaroxaban powder zvine mwero inowedzera PT (3.2±0.5-fold) uye inhibits chiitiko cheFXa (65±3%).

 

Kuchengetedza

Upfu

-20 ° C

3 makore
 

4 ° C

2 makore
Mune solvent

-80 ° C

6 mwedzi
 

-20 ° C

1 mwedzi

Chimiro chemakemikari

Rivaroxaban

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

UNHU HWEMAHARA

Quality management1

Chirevo 18 Hunhu Consistency Kuongorora mapurojekiti akabvumidza 4, uye 6 mapurojekiti ari kubvumidzwa.

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Yepamberi epasi rose mhando manejimendi manejimendi yakaisa hwaro hwakasimba hwekutengesa.

Quality management3

Kutarisirwa kwemhando yepamusoro kunoenderera kuburikidza nehupenyu hwese hwechigadzirwa kuti uve nechokwadi chehunhu uye hwekurapa mhedzisiro. 

Quality management4

Professional Regulatory Affairs timu inotsigira izvo zvemhando yepamusoro panguva yekushandisa uye kunyoreswa.

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