Mankhwala a peptide nthawi zambiri amatanthauzidwa ngati ma polima opangidwa ndi ma amide bond okhala ndi zotsalira za amino acid zosakwana 40.Chifukwa cha kuchuluka kwa ma receptor komanso kusankha kwa mankhwala a peptide omwe ali ndi chiopsezo chochepa cha zotsatirapo zake, pakhala chidwi chachikulu cha peptides kuchokera kumakampani opanga mankhwala.Panthawiyi, panalinso mankhwala ambiri anyenyezi, omwe adakhazikika kwambiri m'makampani a metabolic matenda, monga GLP-1 analogue somalitide, gastric inhibitory peptide (GIP) glucagon-like peptide-1 (GLP-1) tesiparatide ndi ena apawiri. - receptor agonists.Kuphatikiza apo, ndi kukwera kwa mankhwala a PDC ndi RDC.Pakali pano, pokonzekera njira za mankhwala polypeptide makamaka monga mankhwala synthesis ndi kwachilengedwenso nayonso mphamvu.Biofermentation imagwiritsidwa ntchito makamaka popanga ma peptides aatali.Ubwino wake ndi wotsika mtengo wopangira, koma kulephera kuyambitsa ma amino acid osakhala achilengedwe mumayendedwe a peptide komanso kulephera kupanga zokongoletsa zosiyanasiyana pa unyolo wa peptide.Choncho, ntchito yake ndi yochepa kwambiri.Njira zophatikizira mankhwala zimaphatikizapo kaphatikizidwe kagawo kolimba komanso kaphatikizidwe kamadzimadzi.Kuphatikizika kwa gawo lolimba kumakhala ndi mwayi waukulu kuposa kaphatikizidwe kamadzimadzi: zinthu zambiri zitha kugwiritsidwa ntchito pochita kuonetsetsa kulumikizana kwathunthu.Ma amino acid ochulukirapo, ma shrinkage agents, ndi zinthu zopangidwa ndi zinthu zimatha kuchotsedwa ndi ntchito zosavuta zotsuka, kupewa zovuta pambuyo pokonza ndi kuyeretsa komanso kukonza magwiridwe antchito, motero njira yolumikizira gawo lolimba yakhala ikugwiritsidwa ntchito kwambiri."Zida zopangira makemikolo zopangira ma peptides zimaphatikizapo zida zoyambira, zopangira, ndi zosungunulira."Ubwino wawo, makamaka ubwino wa zinthu zoyamba, ukhoza kukhala ndi zotsatira zosiyana pa khalidwe la API.Zinthu zoyambira makamaka zimatanthawuza zotengera zotsimikizika za amino acid za peptide unyolo kusinthidwa mafuta zidulo, polyethylene glycol, etc. Monga zidutswa structural zofunika, iwo m'gulu monga zipangizo mu dongosolo API, amene mwachindunji zogwirizana ndi khalidwe la API.Choncho, tiyenera kuyang'ana pa ulamuliro wa zinthu zoyambira.
I. Kulinganiza kusankha zinthu koyambirira
ICHQ11 ikuwonetsa momveka bwino kuti ngati mankhwala omwe amagulitsidwa pamsika agwiritsidwa ntchito ngati zopangira zoyambira, wopemphayo nthawi zambiri safunikira kukambirana zomveka.Mankhwala ogulitsidwa pamsika nthawi zambiri amatha kugwiritsidwa ntchito osati kungoyambira mankhwala, komanso amatha kugulitsidwa m'misika yopanda mankhwala.Mankhwala opangidwa mwamakonda komanso opangidwa sizinthu zomwe zimagulitsidwa pamsika.Ngakhale kulibe msika wosakhala wamankhwala woteteza ma amino acid kuti akwaniritse tanthauzo la ICHQ11 la mankhwala omwe amagulitsidwa pamsika, ndi ophatikizika, osiyana ndi mankhwala komanso omveka bwino, osavuta kudzipatula ndikuyeretsa, ndipo amatha kudziwika ndikuyesedwa ndi njira zowunikira wamba. .Ali ndi zinthu zokhazikika zamakemikolo ndipo ndi zosavuta kusunga, kunyamula, ndi kupanga
Ii.Kuwongolera zinthu zofunikira muzinthu zoyambira
Zomwe tatchulazi zoteteza amino acid zikuphatikizidwa mu dongosolo la API monga gawo lofunikira lachipangidwe, lomwe limagwirizana mwachindunji ndi khalidwe la API.Choncho, tiyenera kulamulira mosamalitsa zonyansa zomwe zili m'zinthu zoyamba, kumvetsetsa kusintha ndi kuchotsedwa kwa zonyansazi mu ndondomeko yokhazikitsidwa, ndipo potsirizira pake timveketse mgwirizano pakati pawo ndi zonyansa mu API.
Kumvetsetsa kwa mankhwala a polypeptide poyambira zida
Chachitatu, zotsalira zosungunulira m'zinthu zoyambirira
Nthawi zambiri, kutengera kukhazikika kwa gawo lolimba la ma peptides, zosungunulira zambiri zidzagwiritsidwa ntchito kuyeretsa utomoni wa peptide mukamaliza gawo lililonse la kulumikizana kwa amino acid ndikuchotsa chitetezo.Ma peptide osakhwima omwe amapezeka pophwanya utomoni wa peptide amapangidwanso ndi HPLC ndikuwumitsidwa.Choncho, pali chiopsezo chochepa kuti chosungunulira chochepa chophatikizidwa ndi ma amino acid otetezera chidzaperekedwa ku API yomaliza.Komabe, chidwi chapadera chiyenera kuperekedwa kwa zotsalira za acetate, butyl acetate, ndi zosungunulira za mowa, chifukwa zosungunulirazi zingayambitse mavuto ndi ma amino acid kapena ma peptide unyolo panthawi yogwirizanitsa ma amino acid.Mwachitsanzo, pakulumikizana kwa amino acid, asidi wotsalira wa acetic adzachitapo kanthu ndi gulu la amino lowonekera pa unyolo wa peptide, zomwe zimapangitsa kuti unyolo wa peptide ukhale wotsekedwa;Pa ntchito ya amino acid, zosungunulira zotsalira za mowa zimatha kuchitapo kanthu ndi gulu logwira ntchito la carboxyl, zomwe zimapangitsa kuti amino acid azitha kusintha, kuchepetsa ofanana ndi amino acid, ndipo pamapeto pake kumabweretsa kusakwanira kwa amino acid komanso kusowa kwa zonyansa za peptide.Kampaniyo imayendetsa butyl acetate, mowa, methanol, ndi asidi acetic ku COA, kutenga amino acid kuchokera ku Zheng Yuan Biochemical monga chitsanzo.Muyezo wa butyl acetate unali ≤0.5% butyl acetate, womwe unapezeka kuti ndi 0.10%.Malinga ndi ICHQ3C, butyl acetate ya mitundu itatu ya zosungunulira, ikani muyezo wa 0.5% kapena kuchepera mogwirizana ndi zofunikira za ICHQ3C, koma kuganizira za butyl acetate amino acetylation kungayambitse chiopsezo, komanso kuthana ndi butyl acetate kuti muyimitse kafukufuku. , kudziwa miyezo yoyenera kwambiri.
Nthawi yotumiza: Aug-29-2023