Etelcalcetide Hydrochloride

API ɗin Etelcalcetide Hydrochloride
Etelcalcetide Hydrochloride wani labari ne na roba peptide calcimimetic wanda aka ƙera don maganin hyperparathyroidism na biyu (SHPT) a cikin marasa lafiya da ke fama da cututtukan koda na yau da kullun (CKD) waɗanda ke jurewa aikin haemodialysis. SHPT wani abu ne na kowa kuma mai tsanani a cikin marasa lafiya na CKD, wanda ke da haɓaka matakan hormone parathyroid (PTH), rushewar calcium-phosphate metabolism, da kuma ƙara haɗarin kashi da cututtukan zuciya.

Etelcalcetide yana wakiltar calcimimetic na ƙarni na biyu, ana gudanar da shi ta hanyar jijiya, kuma yana ba da fa'idodi akan hanyoyin maganin baka na baya kamar cinacalcet ta inganta bin doka da rage tasirin gastrointestinal.

Tsarin Aiki
Etelcalcetide yana aiki ta hanyar ɗaure zuwa da kunna mai karɓar calcium-sensing (CaSR) wanda ke kan ƙwayoyin glandon parathyroid. Wannan yana kwaikwayi tasirin physiological na calcium extracellular, yana haifar da:

Ƙunƙarar ɓoyewar PTH

Rage yawan sinadarin calcium da matakan phosphate

Ingantattun ma'auni na ma'adinai da ƙasusuwan kashi

A matsayin mai kunnawa na tushen peptide na CaSR, Etelcalcetide yana nuna ƙayyadaddun ƙayyadaddun ƙayyadaddun ayyuka da dorewar aiki biyo bayan gudanarwar jijiya bayan dialysis.

Binciken Clinical da Tasirin warkewa
An kimanta Etelcalcetide da yawa a cikin gwaji na asibiti na lokaci 3, gami da EVOLVE, AMPLIFY, da nazarin EQUIP. Abubuwan da aka gano sun haɗa da:

Mahimmanci da ci gaba da raguwa a matakan PTH a cikin marasa lafiya na CKD akan hemodialysis

Ingantacciyar kula da sinadarin calcium da phosphorus, yana ba da gudummawa ga ingantaccen homeostasis na kashi-ma'adinai

Ingantacciyar juriya idan aka kwatanta da na baka na baka (ƙananan tashin zuciya da amai)

Ingantacciyar riko da haƙuri saboda gudanarwa na IV na mako-mako sau uku yayin zaman dialysis

Waɗannan fa'idodin sun sa Etelcalcetide ya zama muhimmin zaɓi na warkewa don masu ilimin nephrologists da ke sarrafa SHPT a cikin yawan dialysis.

Quality da Manufacturing
API ɗin mu Etelcalcetide Hydrochloride:

Ana haɗa shi ta hanyar haɗakarwar peptide mai ƙarfi-lokaci (SPPS) tare da babban tsabta

Yayi daidai da ƙayyadaddun matakan magunguna, wanda ya dace da ƙirar allura

Yana nuna ƙananan matakan sauran kaushi, ƙazanta, da endotoxins

Yana da ma'auni don samar da babban tsari na GMP