LCZ696 (Sacubitril + Valsartan)

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Magaca API Tilmaam Faahfaahinta US DMF  EU DMF  CEP
LCZ696 (Sacubitril + Valsartan) Wadne istaag Guriga Gudihiisa    

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Sharaxaad

LCZ696 (Sacubitril / Valsartan), oo ka kooban Valsartan (ARB) iyo Sacubitril (AHU377) oo kujirta saamiga 1: 1, waa fasal-koowaad, hadal ahaan bioavailable, iyo laba-fal-qabade angiotensin receptor-neprilysin (ARN) xakamaynta dhiig-karka iyo wadnaha oo istaaga [1] [2] [3]. LCZ696 wuxuu hagaajiyaa kaadionyopathy-ka kaadi sonkorowga isagoo xakameynaya bararka, cadaadiska oksida iyo apoptosis.

 

Gundhig

LCZ696 waa fasalka koowaad ee ARNi (angiotensin receptor neprilysin inhibitor) oo ka kooban moiitiyada anionic-ka ee AR valsartan iyo neprilysin inhibitor prodrug AHU377 (1: 1 ratio) wadnaha oo istaaga iyo dhiig kar.

Daawooyinka loo yaqaan 'angiotensin receptors' waa kuwa soo dhaweeya G-protein-coupled. Waxay dhexdhexaadiyaan wadnaha iyo xididdada dhiigga iyo saameynta kale ee angiotensin II oo ah peptide bioactive ee nidaamka renin-angiotensin. Neprilysin waa endopeptidase dhexdhexaad ah oo hoos u dhigta peptides vasoactive endogenous sida peptides natriuretic. Xakamaynta neprilysin waxay kordhisaa uruurinta peptides-ka dabiiciga ah ee ka qayb qaatay ilaalinta wadnaha, xididdada iyo kalyaha. [1]

Jiirka Sprague-Dawley, maamulka afka ee LCZ696 wuxuu u horseeday kor u kac ku tiirsan qiyaasta jirka ee difaaca jirka ee peptide atrial natriuretic peptide taasoo ka dhalatay joojinta neprilysin. Jiirka dhiig-karka laba-labka ah ee dhiig-karka, LCZ696 wuxuu sababay qaadasho ku tiirsan iyo joogtaynta celceliska cadaadiska halbowlaha. Kaqeybgalayaal caafimaad qaba, oo la kala soocay, laba-indhoole ah, daraasad lagu xakameynayo xakamaynta ayaa xaqiijisay in LCZ696 ay bixisay xakameyn neprilysin ah iyo xannibaadda AT1. LCZ696 wuxuu ahaa mid nabdoon oo si wanaagsan loogu dulqaatay aadanaha. [2] [3]

Tixraacyo:
McMurray JJ, Packer M, Desai AS et al. Angiotensin-neprilysin xakameynta iyo enalapril ee wadnaha oo shaqeynaya. N Engl J Med. 2014 Sebtember 11; 371 (11): 993-1004.
Gu J, Noe A, Chandra P, Al-Fayoumi S et al. Farmashiistaha iyo farmasiga firfircoonida ee LCZ696, oo ah sheeko-falanqeeye laba-qabad leh oo loo yaqaan 'angiotensin receptor-neprilysin inhibitor' (ARNi). J Clin Pharmacol. Abriil 2010; 50 (4): 401-14.
Langenickel TH, Dole WP. Angiotensin receptor-neprilysin inhibition with LCZ696: hab cusub oo loogu talagalay daaweynta wadnaha oo shaqeynaya, Discov Drug maanta: Xeeladaha Ther (2014),

 

Kaydinta

Budada

-20 ° C

3 sano
 

4 ° C

2 sano
Kala dareeraha

-80 ° C

6 bilood
 

-20 ° C

1 bil

Qaab dhismeedka kiimikada

LCZ696(Sacubitril + Valsartan)

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

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

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