Rivaroxaban foda

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Sunan API Nuni Musammantawa US DMF  EU DMF  CEP
Rivaroxaban foda Anticoagulant Cikin-Gida TDP    

Bayanin Samfura

Alamar samfur

CIKAKKEN BAYANI

Bayan Fage

Rivaroxaban foda, 5-chloro-N - [((5S) -2-oxo-3- [4- (3-oxomorpholin-4-yl) phenyl] -1,3-oxazolidin-5-yl] methyl] maganin-2 -carboxamide, babban mai hana karamin kwayar cuta ne na factor Xa wanda ke haifar da daskarewa a mawuyacin lokaci a cikin hanyar tarawar jini wanda ya haifar da karuwar thrombin da samuwar gudan jini. Rivaroxaban foda yana ɗaure da Tyr288 a cikin aljihun S1 na factor Xa ta hanyar hulɗar Tyr288 da maye gurbin chlorine na molo ɗin chlorothiophene. Abun hanawa yana iya juyawa (koff = 5x10-3s-1), mai sauri (kon = 1.7x107 mol / L-1 s-1), kuma a cikin yanayin dogaro mai ɗorewa (Ki = 0.4 nmol / L). Rivaroxaban foda a halin yanzu ana nazarinsa don maganin VTE, rigakafin abubuwan da suka shafi zuciya da jijiyoyin jini a cikin marasa lafiya masu fama da cututtukan zuciya, rigakafin bugun jini a cikin marasa lafiya da ke fama da cutar atr.

Magana

Elisabeth Perzborn, Susanne Roehrig, Alexander Straub, Dagmar Kubitza, Wolfgang Mueck, da Volker Laux. Rivaroxaban foda: sabon nau'in maganganu Xa mai hanawa. Arterioscler Thromb Vasc Biol 2010; 30 (3): 376-381

Bayani

Rivaroxaban foda (BAY 59-7939) yana da ƙarfi sosai,zaɓaɓɓe kuma kai tsaye Factor Xa (FXa) mai hanawa, cimma riba mai ƙarfi a cikin ikon FXa (IC50 0.7 nM; Ki 0.4 nM).

 

A cikin Vitro

Rivaroxaban foda (BAY 59-7939) mai magana ne, kai tsaye Factor Xa (FXa) mai hanawa a ci gaba don rigakafi da maganin arterial da verom thrombosis. Rivaroxaban foda yana hana mutum FXa (Ki 0.4 nM) tare da> 10 000-ninki mafi girma fiye da na sauran sinadarin protease; Hakanan yana hana aikin prothrombinase (IC50 2.1 nM). Rivaroxaban foda yana hana FXa mai ƙoshin lafiya a cikin mutum da plasma zomo (IC50 21 nM) fiye da plasma bera (IC50 290 nM). Yana nuna tasirin kwayoyi a cikin plasma ta mutum, ninka lokacin prothrombin (PT) kuma yana kunna lokaci na thromboplastin mara kyau a 0.23 da 0.69μM, bi da bi.

 

Rivaroxaban foda (BAY 59-7939) mai ƙarfi ne kuma mai zaɓaɓɓe, kai tsaye mai hana FXa tare da kyakkyawa a cikin aikin vivo da kyakkyawan bioavailability na baki. Rivaroxaban foda (BAY 59-7939), wanda aka gudanar ta iv bolus kafin shigarwar thrombus, rage haɓakar thrombus (ED50 0.1 mg / kg), ya hana FXa, kuma ya tsawanta matakin PT mai dogaro. PT da FXa suna da tasiri kaɗan a ED50 (ƙaruwa 1.8 da hana 32%, bi da bi). A 0.3 mg / kg (kashi wanda ke haifar da kusan cikakkiyar hana haɓakar thrombus), Rivaroxaban foda yana ƙara tsawan PT (3.2±0.5-ninka) kuma yana hana aikin FXa (65±3%).

 

Ma'aji

Foda

-20 ° C

3 shekaru
 

4 ° C

2 shekaru
A sauran ƙarfi

-80 ° C

Wata 6
 

-20 ° C

Wata 1

Tsarin sunadarai

Rivaroxaban

TABBATARWA

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

KYAUTA MANAGEMENT

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