Etelcalcetide

Sharaxaad Gaaban:

Etelcalcetide waa calcimimetic peptide synthetic ah oo loo isticmaalo daaweynta hyperparathyroidism secondary (SHPT) ee bukaanada qaba cudurka kelyaha ee raaga (CKD) ee hemodialysis. Waxay ka shaqeysaa iyada oo kicinaysa soo-dhoweynta kalsiyum-dareenka (CaSR) ee unugyada parathyroid, taas oo hoos u dhigta heerarka hoormoonka parathyroid (PTH) iyo hagaajinta dheef-shiid kiimikaadka macdanta. Etelcalcetide API ee nadiifka ah ee nadiifka ah waxaa lagu soo saaray isku-dhafka peptide-waji adag (SPPS) iyadoo la raacayo shuruudaha GMP, oo ku habboon qaababka la isku duro.

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Etelcalcetide API

Etelcalcetidewaa sheeko cusub, syntheticpeptide calcimimeticloo ansixiyey daaweyntahyperparathyroidism labaad (SHPT)bukaanada qaangaarka ah ee qabaCudurka kelyaha ee joogtada ah (CKD)helidhemodialysis. SHPT waa dhibaato caadi ah oo halis ah oo ah xanuunka kelyaha ee heer-dhamaadka, oo ay sababto carqaladaynta kalsiyum, fosfooraska, iyo dheef-shiid kiimikaadka fitamiin D. Kor u kaca joogtada ah eehormoonka parathyroid (PTH)keeni kartaosteodystrophy kelyaha, Calcification vascular, cudurada wadnaha, iyo dhimashada kordhaysa.

Etelcalcetide waxay bixisaa ala beegsaday, doorasho aan qalliin ahaynsi loo xakameeyo heerarka PTH ee bukaanka sifaynta, taasoo ka dhigan jiilka labaad ee calcimimetic lehfaa'iidooyinka kala duwanDaawooyinka afka laga qaato sida cinacalcet.

Habka Waxqabadka

Etelcalcetide waa aagonist peptide syntheticee ahreceptor kaalshiyam-dareenka (CaSR), oo ku yaal dusha sare ee unugyada qanjidhada parathyroid. Waxay la jaan qaadaysaa ficilka kaalshiyamka ka baxsan unugga iyadoo si buuxda u hawlgelinaysa CaSR, sidaas awgeed:

Joojinta dheecaanka hormoonka parathyroid (PTH).
Hoos u dhigista kalsiyumka serum iyo fosfooraska
Hagaajinta kalsiyum-phosphate homeostasis
Hoos u dhigida khatarta is-beddelka lafaha iyo kala-soocidda xididdada dhiigga

Si ka duwan calcimimetics afka, Etelcalcetide waa la maamulaaxididkaka dib hemodialysis, kaas oo wanaajinaya u hoggaansanaanta daawaynta oo yaraynaysa dhibaatooyinka caloosha iyo mindhicirka.

Cilmi-baadhista Caafimaadka iyo Waxtarka

Etelcalcetide ayaa lagu qiimeeyay tijaabooyin badan oo waji 3 ah, oo ay ku jiraanlaba daraasadood oo muhim ah oo la kontoroololagu daabacayLancetiyoWargeyska Caafimaadka ee New England. Daraasadahani waxay ku lug lahaayeen in ka badan 1000 bukaan-socodka hemodialysis oo aan la xakameynin SHPT.

Natiijooyinka caafimaad ee muhiimka ah waxaa ka mid ah:

Tirakoob ahaan hoos u dhac weyn oo ku yimid heerarka PTH(> 30% inta badan bukaanada)
Xakamaynta sare eeSerum fosfooraska iyo alaabta kalsiyum-fosfate (Ca × P)
Heerarka jawaabta biochemical ee guud ahaan ka sii weynmarka la barbar dhigo cincalcet
U hoggaansanaanta bukaanka oo ka wanaagsaniyadoo ay ugu wacan tahay maamulka faleebbaha ee saddex-toddobaadle ah ka dib
Hoos u dhigista calaamadaha rogrogmada lafaha(tusaale, fosfatase alkaline ah oo laf-gaar ah)

Faa'iidooyinkani waxay taageeraan Etelcalcetide sida asafka kowaad ee calcimimetic la isku durosi loogu maareeyo SHPT bukaannada sifaynta.

Soo-saarka API iyo Tayada

OurEtelcalcetide APIwaxaa la soo saaray viaWajiga adag ee peptide synthesis (SPPS), hubinta dhalidda sare, nadiifnimada, iyo xasiloonida molecular. API:

U hoggaansama si adagHeerarka GMP iyo ICH Q7
Ku haboon in lagu isticmaalodaawooyinka la isku duro
Wuxuu maraa imtixaan gorfayn dhamaystiran, oo ay ku jiraan HPLC, dareerayaasha haraaga ah, biraha culus, iyo heerarka endotoxin
Waxaa laga heli karaa gudahatijaabada iyo miisaanka wax soo saarka ganacsiga

Faa'iidooyinka iyo Faa'iidooyinka Daawaynta

Daawaynta aan hormoonka ahaynloogu talagalay SHPT ee bukaannada CKD ee sifaynta
Dariiqa IV waxa ay hubisaa u hoggaansanaanta, gaar ahaan bukaanada qaba culeyska kiniinka ama dulqaad la'aanta GI
Waxaa laga yaabaa inay ku caawiso dhimistadhibaatooyinka muddada-dheerkhalkhalka macdanta iyo lafaha (CKD-MBD)
La jaanqaadi kara xirayaasha fosfatetada, fiitamiin D anagooyada, iyo daryeelka sifeynta caadiga ah