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Etelcalcetide

Takaitaccen Bayani:

Etelcalcetide shine calcimimetic peptide na roba wanda ake amfani dashi don maganin hyperparathyroidism na biyu (SHPT) a cikin marasa lafiya da cututtukan koda na yau da kullun (CKD) akan hemodialysis. Yana aiki ta hanyar kunna mai karɓar calcium-sensing (CaSR) akan ƙwayoyin parathyroid, ta haka rage matakan parathyroid hormone (PTH) da inganta ƙwayar ma'adinai. Babban tsaftar Etelcalcetide API ɗinmu an ƙera ta ta hanyar haɗakar peptide mai ƙarfi-lokaci (SPPS) ƙarƙashin yanayin da ya dace da GMP, wanda ya dace da ƙirar allura.


Cikakken Bayani

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API ɗin Etelcalcetide

Etelcalcetidelabari ne, robacalcimimetic peptideyarda domin lura dana biyu hyperparathyroidism (SHPT)a cikin manya marasa lafiya daCiwon koda na kullum (CKD)karbahemodialysis. SHPT cuta ce ta gama-gari kuma mai tsanani na cututtukan koda na ƙarshen zamani, wanda ke haifar da rushewar alli, phosphorus, da bitamin D metabolism. Tsayawa mai tsayi naparathyroid hormone (PTH)zai iya kaiwa garenal osteodystrophy, jijiyar jijiyoyi, cututtuka na zuciya, da karuwar mace-mace.

Etelcalcetide yana bayar da aniyya, zaɓin da ba na tiyata badon sarrafa matakan PTH a cikin marasa lafiya na dialysis, wakiltar ƙirar ƙira ta biyu tare dabambanta abũbuwan amfãniakan magungunan baka kamar cinacalcet.

Tsarin Aiki

Etelcalcetide shine aroba peptide agonistnaCalcium-sensing receptor (CaSR), wanda yake a saman sel parathyroid gland. Yana kwaikwayi aikin calcium na waje ta hanyar kunna CaSR, ta haka:

  • Yana hana parathyroid hormone (PTH).

  • Rage yawan adadin sinadarin calcium da phosphorus

  • Inganta calcium-phosphate homeostasis

  • Rage haɗarin ɓarna na jujjuya kashi da ƙididdiga na jijiyoyin jini

Ba kamar calcimimetics na baka ba, ana gudanar da Etelcalcetidea cikin jijiyabayan hemodialysis, wanda ke inganta riko da magani kuma yana rage tasirin gastrointestinal.

Bincike na asibiti da inganci

An kimanta Etelcalcetide a cikin gwaje-gwajen asibiti da yawa na Phase 3, gami dabiyu muhimmai bazuwar karatu karatuaka buga aLancetkumaNew England Journal of Medicine. Waɗannan karatun sun haɗa da marasa lafiya na hemodialysis sama da 1000 tare da SHPT marasa kulawa.

Mahimman sakamakon asibiti sun haɗa da:

  • Rage ƙididdiga mai mahimmanci a matakan PTH(> 30% a yawancin marasa lafiya)

  • Babban iko nasamfurin sinadarin phosphorus da calcium-phosphate (Ca × P)

  • Mafi girman ƙimar amsawar biochemical gabaɗayaidan aka kwatanta da cinacalcet

  • Kyakkyawan haƙurin rikosaboda gudanar da aikin wanzar da cutar ta IV na mako-mako sau uku

  • Rage alamun jujjuya kashi(misali, alkaline phosphatase na musamman na kashi)

Waɗannan fa'idodin suna tallafawa Etelcalcetide azaman aallurar calcimimetic na layin farkodon sarrafa SHPT a cikin marasa lafiya na dialysis.

API Manufacturing da Quality

MuAPI ɗin Etelcalcetideana kera ta ta hanyarTsarin peptide mai ƙarfi (SPPS), tabbatar da yawan amfanin ƙasa, tsabta, da kwanciyar hankali na kwayoyin halitta. API ɗin:

  • Yayi daidai da stringentMatsayin GMP da ICH Q7

  • Ya dace da amfani a cikialluran magunguna

  • Yana fuskantar cikakkiyar gwajin nazari, gami da HPLC, sauran kaushi, karafa masu nauyi, da matakan endotoxin

  • Akwai a cikimatukin jirgi da sikelin samar da kasuwanci

Yiwuwar warkewa da Fa'idodi

  • Maganin marasa maganidon SHPT a cikin marasa lafiya na CKD akan dialysis

  • Hanyar IV tana tabbatar da yarda, musamman a cikin marasa lafiya da nauyin kwaya ko rashin haƙuri na GI

  • Zai iya taimakawa ragewarikitarwa na dogon lokacina rashin lafiyan ma'adinai da kashi (CKD-MBD)

  • Mai jituwa tare da masu ɗaure phosphate, analogues na bitamin D, da daidaitaccen kulawar dialysis

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