ʻO Rivaroxaban

Hōʻike Pōkole:

Ka inoa o API Hōʻike Hoakaka US DMF  EU DMF  CEP
ʻO Rivaroxaban Anticoagulant Ma-Hale TDP    

ʻIke kikoʻī

Nā huahana huahana

ʻIkepili Huahana

Papa kāʻei kua

Rivaroxaban, 5-chloro-N - [[(5S) -2-oxo-3- [4- (3-oxomorpholin-4-yl) phenyl] -1,3-oxazolidin-5-yl] methyl] thiophene-2 -carboxamide, kahi mea pāpā liʻiliʻi liʻiliʻi liʻiliʻi o ka mea Xa kahi kumu coagulation ma kahi manawa koʻikoʻi i ke ala coagulation koko e hopena ana i ka hanauna o ka thrombin a me ka hoʻokumu ʻana o ka ʻōpala. Hoʻopili ʻo Rivaroxaban i ka Tyr288 ma ka ʻeke S1 o ka mea Xa ma o ka launa pū ʻana o Tyr288 a me ka chlorine substituent o ka naʻau o chlorothiophene. Hoʻohuli ʻia ka pāpā (koff = 5x10-3s-1), wikiwiki (kon = 1.7x107 mol / L-1 s-1), a ma ke ʻano hilinaʻi nui (Ki = 0.4 nmol / L). Ke aʻo ʻia nei ʻo Rivaroxaban i kēia manawa no ka mālama ʻana iā VTE, ka pale ʻana i nā hanana cardiovascular i nā mea maʻi me ka maʻi coronary syndrome, ka pale ʻana i ka hahau ʻana i nā maʻi me ka fibrillation atrial.

Kākauʻōlelo

ʻO Elisabeth Perzborn, ʻo Susanne Roehrig, ʻo Alexander Straub, ʻo Dagmar Kubitza, ʻo Wolfgang Mueck, a ʻo Volker Laux. Rivaroxaban: kahi mea hoʻopuka Xa mea hoʻopuka hou. ʻO Arterioscler Thromb Vasc Biol 2010; 30 (3): 376-381

Wehewehe

ʻO Rivaroxaban (BAY 59-7939) kahi mana nui,koho a kuhikuhi pololei ʻo Factor Xa (FXa) mea kāohi, loaʻa i kahi loaʻa ikaika i ka anti-FXa ikaika (IC50 0.7 nM; Ki 0.4 nM).

 

I Vitro

ʻO Rivaroxaban (BAY 59-7939) kahi mea hoʻopuka waha, pololei Factor Xa (FXa) i ka hoʻomohala ʻana no ka pale a me ka mālama ʻana i ka thrombosis arterial a me venous. Hoʻoikaika ʻo Rivaroxaban i ka hoʻokūkū i ka FXa kanaka (Ki 0.4 nM) me> 10 000-pā koho i ʻoi aku ma mua o nā proteine ​​serine ʻē aʻe; kāohi ia i ka hana prothrombinase (IC50 2.1 nM). Hoʻopau ʻo Rivaroxaban i ka FXa endogenous ʻoi aku ka ikaika ma ka plasma kanaka a me ka rabbit (IC50 21 nM) ma mua o ka plasma rat (IC50 290 nM). Hōʻike ia i nā hopena anticoagulant i ka plasma kanaka, pālua i ka manawa prothrombin (PT) a hoʻoulu i ka manawa thromboplastin hapa ma 0.23 a me 0.69μM, pakahi.

 

ʻO Rivaroxaban (BAY 59-7939) kahi mea ikaika a koho, kuhikuhi i ka mea hoʻopukapuka FXa me ka hana vivo maikaʻi a me ka bioavailability waha maikaʻi. ʻO Rivaroxaban (BAY 59-7939), lawelawe ʻia e iv bolus ma mua o ka hoʻokomo ʻana o ka thrombus, hoʻemi i ka thrombus hoʻokumu (ED50 0.1 mg / kg), kāohi iā FXa, a hoʻolōʻihi i ka lāʻau PT me ka hilinaʻi. Hoʻopili iki ʻia ʻo PT a me FXa ma ka ED50 (hoʻonui 1.8-pā a me ka hōʻemi ʻana he 32%). Ma 0.3 mg / kg (lāʻau e alakaʻi ai i ka aneane piha ka pāpā o ka thrombus hoʻokumu), hoʻolōʻihi ʻo Rivaroxaban iā PT (3.2±0.5-pā) a kāohi i ka hana FXa (65±3%).

 

Waihona

Pauka

-20 ° C

3 makahiki
 

4 ° C

2 makahiki
I ka hoʻoheheʻe

-80 ° C

6 mahina
 

-20 ° C

1 mahina

ʻAno kemika

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

KA MANAWAI ANA

Quality management1

Palapala Noi 18 Nā papahana loiloi e like me ka Consistency i ʻae ʻia 4, a 6 ke ʻae ʻia nei nā papahana.

Quality management2

Ua hoʻokumu ʻia ka ʻōnaehana hoʻokele kūlana kiʻekiʻe kiʻekiʻe loa no ke kūʻai aku.

Quality management3

Holo ka nānā ʻana i ka maikaʻi ma waena o ke ola holoʻokoʻa o ka huahana e hōʻoia i ka maikaʻi a me ka hopena therapeutic. 

Quality management4

Kākoʻo ka ʻoihana Hoʻokele ʻoihana ʻoihana i nā koi maikaʻi i ka wā o ka noi a me ke kau inoa.

MANAGEMENT HUA

cpf5
cpf6

Kōleka Packaging ʻōmole Korea

cpf7
cpf8

ʻO ka laina Packaging ʻōmole ʻo Taiwan CVC

cpf9
cpf10

ʻO ka laina Packaging Papa CAM Italia

cpf11

Mīkini Pīkī Fette Kelemania

cpf12

ʻO Iapana Viswill Tablet Detector

cpf14-1

Rumi Nahenahe DCS

HOA HOA

ʻO ke alu like ʻana me ka honua
International cooperation
Hana kūloko
Domestic cooperation

  • Kekahi:
  • Aʻe:

  • Kākau i kāu leka ma aneʻi a hoʻouna iā mākou