Tesamorelin API
Tesamorelin bụ ọgwụ peptide sịntetik, aha zuru oke bụ ThGRF(1-44) NH₂, nke bụ homonụ na-ewepụta homonụ uto (GHRH). Ọ na-akpali pituitary anterior secrete ibu hormone (GH) site simulating omume nke endogenous GHRH, si otú na-apụtaghị ìhè na-amụba larịị nke insulin-dị ka ibu ihe 1 (IGF-1), na-eweta usoro nke uru na metabolism na anụ ahụ nrụzi.
Ka ọ dị ugbu a, FDA kwadoro Tesamorelin maka ọgwụgwọ nke lipodystrophy metụtara HIV, karịsịa maka ibelata mkpokọta abụba visceral abdominal (visceral adipose tissue, VAT). A na-amụkwa ya nke ọma maka ** mgbochi ịka nká, ọrịa metabolic syndrome, ọrịa imeju na-adịghị egbu egbu (NAFLD/NASH)** na mpaghara ndị ọzọ, na-egosi atụmanya ngwa ngwa.
Usoro nke ime ihe
Tesamorelin bụ peptide 44-amino acid nwere usoro yiri nke GHRH eke. Usoro ọrụ ya bụ:
Mee ka onye na-anabata GHRH rụọ ọrụ (GHRHR) iji kpalie pituitary dị n'ihu ịhapụ GH.
Mgbe GH buliri elu, ọ na-eme na imeju na anụ ahụ gbara ya gburugburu iji mee ka njikọ IGF-1 dịkwuo elu.
GH na IGF-1 jikọrọ aka na-ekere òkè na abụba abụba, protein njikọ, mmezi cell na njupụta ọkpụkpụ.
Ọ na-emekarị na ire abụba visceral (nchịkọta abụba) ma nwee mmetụta dị nta na abụba subcutaneous.
E jiri ya tụnyere injection exogenous kpọmkwem nke GH, Tesamorelin na-akwalite secretion GH site na usoro endogenous, nke dị nso na usoro physiological ma na-ezere mmeghachi omume ọjọọ nke GH gabigara ókè, dị ka njide mmiri na nkwụsị insulin.
Nnyocha na ụlọ ọgwụ dị irè
Achọpụtala ịdị irè nke Tesamorelin site n'ọtụtụ ule ụlọ ọgwụ, ọkachasị na mpaghara ndị a:
1. Lipodystrophy metụtara HIV (ihe ngosi FDA kwadoro)
Tesamorelin nwere ike ibelata VAT nke afọ (nkezi mbelata nke 15-20%);
Mmụba ọkwa IGF-1 ma melite ọnọdụ metabolic nke ahụ;
Meziwanye ọdịdị ahụ ma belata ibu nke uche nke jikọtara ya na nkesa abụba;
Ọ naghị emetụta oke abụba subcutaneous, njupụta ọkpụkpụ ma ọ bụ uru ahụ.
2. Steatohepatitis na-adịghị egbu egbu (NASH) na imeju fibrosis
Nnwale ụlọ ọgwụ egosila na Tesamorelin nwere ike ibelata ọdịnaya abụba imeju (MRI-PDFF imaging);
A na-atụ anya na ọ ga-emeziwanye mmetụta insulin hepatocyte;
Ọ na-adị irè karịsịa maka ndị ọrịa nwere nje HIV na NAFLD, ma nwee ikike nchebe metabolic sara mbara.
3. Metabolic syndrome na insulin iguzogide
Tesamorelin na-ebelata oke triglyceride na oke ibu nke afọ;
Na-eme ka ndeksi HOMA-IR dịkwuo mma ma na-enyere aka imeziwanye nguzogide insulin;
Nnyocha e mere egosiwo na ọ nwere ike ịkwalite ikike protein protein muscle, nke bara uru nye ndị agadi ma ọ bụ ọrịa na-adịghị ala ala.
API mmepụta na njikwa mma
Tesamorelin API nke Gentolex Group nyere na-anabata teknụzụ siri ike nke peptide synthesis (SPPS) ma na-emepụta ya n'okpuru GMP gburugburu. O nwere njirimara ndị a:
Ịdị ọcha ≥99% (HPLC)
Enweghị endotoxin, metal dị arọ, nchọpụta ihe mgbaze fọdụrụnụ tozuru oke
Usoro Amino acid na nkwenye nhazi site na LC-MS/NMR
Nye mmepụta ahaziri n'ọkwa gram ruo kilogram