Etelcalcetide Hydrochloride API
Etelcalcetide Hydrochloride yog ib qho tshiab hluavtaws peptide calcimimetic tsim rau kev kho mob ntawm theem nrab hyperparathyroidism (SHPT) hauv cov neeg mob uas muaj kab mob raum ntev (CKD) tab tom hemodialysis. SHPT yog ib qho teeb meem loj thiab muaj teeb meem loj hauv cov neeg mob CKD, tus cwj pwm los ntawm qib siab parathyroid hormone (PTH), cuam tshuam cov calcium-phosphate metabolism, thiab muaj kev pheej hmoo ntawm pob txha thiab kab mob plawv.
Etelcalcetide sawv cev rau lub thib ob tiam calcimimetic, muab intravenously, thiab muaj qhov zoo dua li kev kho qhov ncauj ua ntej xws li cinacalcet los ntawm kev txhim kho kev ua raws cai thiab txo cov kev mob tshwm sim ntawm plab hnyuv.
Mechanism ntawm Action
Etelcalcetide ua haujlwm los ntawm kev khi rau thiab ua kom cov calcium-sensing receptor (CaSR) nyob rau ntawm cov qog hlwb parathyroid. Qhov no ua rau cov nyhuv physiological ntawm extracellular calcium, ua rau:
Tiv thaiv PTH secretion
Kev txo qis hauv cov ntshav calcium thiab phosphate qib
Txhim kho cov ntxhia sib npaug thiab cov pob txha metabolism
Raws li peptide-raws li allosteric activator ntawm CaSR, Etelcalcetide qhia tau hais tias muaj kev tshwj xeeb thiab kev ua haujlwm ruaj khov tom qab kev tswj hwm hauv cov hlab ntsha tom qab lim ntshav.
Kev Tshawb Fawb Kev Tshawb Fawb thiab Kev Kho Mob
Etelcalcetide tau raug soj ntsuam ntau hauv theem 3 kev sim tshuaj, suav nrog EVOLVE, AMPLIFY, thiab EQUIP cov kev tshawb fawb. Cov txiaj ntsig tseem ceeb suav nrog:
Qhov tseem ceeb thiab kev txo qis hauv PTH qib hauv cov neeg mob CKD ntawm hemodialysis
Kev tswj tau zoo ntawm cov ntshav calcium thiab phosphorus, pab txhim kho pob txha-mineral homeostasis
Kev zam tau zoo dua piv rau qhov ncauj calcimimetics (tsawg xeev siab thiab ntuav)
Kev txhim kho tus neeg mob ua raws li kev tswj hwm peb lub lis piam IV thaum lub sijhawm lim ntshav
Cov txiaj ntsig no ua rau Etelcalcetide yog qhov kev xaiv kho mob tseem ceeb rau cov kws kho mob nephrologists tswj SHPT hauv cov neeg mob lim ntshav.
Quality thiab Manufacturing
Peb Etelcalcetide Hydrochloride API:
Nws yog synthesized los ntawm solid-phase peptide synthesis (SPPS) nrog siab purity
Raws li kws tshuaj-qib specifications, haum rau txhaj tshuaj formulations
Qhia tau qis qis ntawm cov kuab tshuaj residual, impurities, thiab endotoxins
Yog scalable rau GMP-raws li loj-batch ntau lawm