Liraglutide 2mg / vial Zoo tswj cov ntshav qab zib, txo qhov hnyav, thiab tiv thaiv kab mob plawv

Liraglutide 2mg / vial core qhia

Ntev- ua haujlwm GLP-1 receptor agonist|Fatty acid hloov cov piam thaj- txo qis thiab poob phaus peptides 2mg / lub raj mis

Lub npe: liraglutide

Ib ntus: Raws li cov qauv ntawm tib neeg GLP-1 (7-37), hloov kho los ntawm amino acid hloov thiab fatty acid sab saw hloov.

Molecular hnyav: kwv yees 3751.2 Da

Purity: Ntau dua lossis sib npaug li 99.0% (HPLC)

Qhov tshwm sim: Dawb rau tawm -dawb lyophilized hmoov

Cia: khov ntawm -20 degree, tiv thaiv lub teeb, thiab khaws cia rau hauv qhov chaw qhuav.

Daim ntawv qhia kev siv thiab cia

Liraglutide:

Liraglutide yog ib qho kev tsim kho, ntev - ua glucagon-zoo li peptide-1 (GLP-1) analogue uas thim rov qab khi rau albumin los ntawm nws cov fatty acid sab saw, ua rau nws ntev dua ib nrab -lub neej thiab ua kom ruaj khov ntawm cov ntshav qabzib thiab qhov hnyav. nrog kev noj ib zaug ib hnub. Piv rau ntuj GLP-1, nws ruaj khov dua thiab muaj lub sijhawm ntev ntawm kev ua hauv vivo. Nws lub zog GLP-1 receptor agonist kev ua haujlwm tsis yog tsuas yog txhawb nqa cov tshuaj insulin secretion thiab inhibits glucagon nyob rau hauv cov piam thaj-dependant, tab sis kuj ua rau lub plab khoob thiab ua rau lub hauv nruab nrab lub paj hlwb kom txo qis qab los noj mov. Nws qhov kev ua tau zoo ua pov thawj ua rau nws yog ib qho kev tshawb fawb tseem ceeb hauv kev kawm txog cov txheej txheem pathophysiological thiab cov tswv yim kho mob ntawm hom 2 mob ntshav qab zib, rog rog, thiab lawv cov teeb meem.

Liraglutide feem ntau xaiv los ntawm cov kws tshawb fawb ntawm cov kab mob metabolic vim nws cov ntshav qabzib dav siv tau ntau yam - txo qis thiab qhov hnyav - cov teebmeem poob, nrog rau qhov yooj yim uas nws ib zaug - noj txhua hnub ua rau kev soj ntsuam ntawm lub cev kev hloov pauv hauv cov tsiaj sim. Nws ua haujlwm los ntawm kev ua kom muaj tseeb ntawm GLP-1 receptor, zam cov kev mob tshwm sim nyuaj cuam tshuam nrog kev sib deev cov tshuaj hormones. Nws lub luag haujlwm tseem ceeb hauv kev tswj hwm glycemic homeostasis, lub zog metabolism, thiab kev noj zaub mov zoo ua rau nws yog ib qho cuab yeej siv tau zoo nrog -txoj kev txiav txim siab thiab txhim khu kev qha hauv cov qauv ua ntej ntawm metabolic syndrome, insulin tsis kam, thiab cov kab mob rog rog.

Kev siv liraglutide:

Nws ua rau GLP-1 receptors, txhawb nqa cov tshuaj insulin secretion thiab inhibiting glucagon tso tawm hauv cov piam thaj-raws li, ua kom lub plab zom mov zoo thiab ua rau lub hauv paus ntawm satiety. Liraglutide yog qhov ntev - ua haujlwm hypoglycemic thiab tswj qhov hnyav peptide tsim los ntawm fatty acid side-chain modification technology, thiab yog ib qho tseem ceeb siv molecule hauv kev tshawb fawb metabolic.

Liraglutide yog dav siv nyob rau hauv txoj kev tshawb no ntawm pathological mechanisms thiab pharmacodynamics ntawm hom 2 mob ntshav qab zib, rog rog, thiab lwm yam kab mob metabolic. Nws zoo -txhais cov tshuaj pharmacokinetic thiab pharmacodynamic cov yam ntxwv muab qhov zoo tshaj - qauv kev sim zoo rau kev ntsuas GLP tshiab-1 cov tshuaj, tshawb nrhiav kev kho ua ke, thiab tshawb nrhiav cov tswv yim cuam tshuam txog kev cuam tshuam metabolic mus ntev. Nws kuj tseem ua lub luag haujlwm tseem ceeb hauv cov kev tshawb fawb tseem ceeb xws li kev tswj hwm kev noj zaub mov, kev siv hluav taws xob, thiab lipid metabolism.

Txoj kev siv thiab khaws cia

1. Kev kho dua tshiab thiab kev npaj:

Cov kuab tshuaj pom zoo:

Nyiam cov kuab tshuaj: Cov tshuaj muaj sterile diluentlos yogib qho kev daws teeb meem tsis haum nrog pH 8.0-8.5.

Lus Cim Tseem Ceeb: Tsis txhob siv cov ntsev zoo tib yam, cov dej tsis muaj menyuam rau kev txhaj tshuaj, lossis lwm yam kuab tshuaj uas tsis tau lees paub. Cov kuab tshuaj tsis raug yuav ua rau nag lossis daus thiab tsis ua haujlwm.

Rau kev sim dilution: Tom qab dissolving nyob rau hauv cov saum toj no -hais tshwj xeeb hnyav hnyav, nws yuav tsum diluted zaum ob nrogphysiological saline muaj 0.1% bovine serum albumin (BSA).

Tus txheej txheem npaj:

Solvent npaj:

Siv cov kuab tshuaj uas tau ua kom tsis muaj menyuam los ntawm 0.22μm lim membrane.

Qhov ntsuas kub hnyav tau rov qab los rau hauv chav sov (20-25 degree).

Reconstitution txheej txheem:

Ntxiv 1.0 mL ntawm cov kuab tshuaj tshwj xeeb rau 2 mg vial.

Ncuav maj mam raws lub raj mis phab ntsa kom tsis txhob muaj kev cuam tshuam ncaj qha rau lub khov - ncuav mog qab zib qhuav.

Maj mam tiglub vial horizontally nyob rau hauv xib-teg ntawm koj txhais tes rau yam tsawg kawg yog 2-3 feeb kom txog rau thaum ib tug ntshiab los yog me ntsis opalescent cov ntaub ntawv.Kev tshee tshee, tshee, lossis vortexing yog txwv tsis pub.

Qhov kawg concentration: 2 mg / mL (kwv yees li 0.53 mM).

Dispensing thiab dilution:

Yog tias tsis siv tam sim ntawd, nws yuav tsum tau muab xa mus rau hauv ib qho - kev sim kom muaj nuj nqis uas siv qis - cov raj xa dej cryopreservation kom sai li sai tau.

Rau qis concentration, sivphysiological saline muaj 0.1% BSArau gradient dilution thiab maj mam invert mus sib tov.

Ua hauj lwm concentration/dosage reference:

Kev sim hauv vitro cell: Feem ntau siv cov concentration ntau yog 0.1 nM txog 100 nM

Tsiaj hauv vivo kev tshawb fawb: Qhov ntau npaum li cas yog 0.1 txog 0.6 mg / kg (ib zaug ib hnub, txhaj tshuaj subcutaneous).

Piv txwv ntawm kev npaj xam: Yog tias yuav tsum muaj 10 nM kev daws teeb meem, noj 18.9 μL ntawm cov tshuaj hauv Tshuag thiab ntxiv rau 1 mL ntawm kab lis kev cai nruab nrab.

Cov ntsiab lus tseem ceeb kom nco ntsoov:

Solvent specification: Cov kuab tshuaj tshwj xeeb yuav tsum tau siv, uas yog ib qho tseem ceeb los xyuas kom meej nws solubility thiab ntev - cov khoom kav ntev.

Cov txheej txheem dissolving: Dissolve tsuas yog maj mam tig kab rov tav. Ib qho kev tuav nruj heev tuaj yeem ua rau cov protein denaturation lossis sib sau ua ke.

Aseptic thiab lub teeb -cov txheej txheem tiv thaiv: Kev ua haujlwm nruj aseptic thiab ua tiav kev tiv thaiv los ntawm lub teeb thoob plaws hauv cov txheej txheem.

Saib xyuas qhov kev daws teeb meem: Cov tshuaj yuav tsum tau meej los yog me ntsis opalescent tom qab reconstitution. Yog hais tias nag lossis daus, fibers lossis discoloration tshwm sim, cov tshuaj yuav tsum muab pov tseg.

Npaj -rau- siv: Tom qab kev kho dua tshiab, nws yuav tsum tau sivhauv 1 teev, los yog khaws cia luv luv raws li tau teev tseg.

2. Cia tej yam kev mob:

Unreconstituted lyophilized hmoov:

Ntev - lub sij hawm cia: Khaws khov ntawm -20 degree, txee lub neej 24 lub hlis.

Kev cia zoo: Khaws khov ntawm -80 degree, txee lub neej 36 lub hlis.

Kev tiv thaiv nruj ntawm lub teeb: Yuav tsum muab khaws cia rau hauv lub teeb qub- pov thawj aluminium foil hnab.

Kev tiv thaiv noo noo: Khaws qhuav; muaj desiccant.

Reconstituted daws:

Siv tam sim ntawd: Rau kev ua haujlwm zoo tshaj plaws, siv tam sim tom qab hloov kho.

Short - lub sij hawm cia: Khaws ntawm 2-8℃deb ntawm lub teeb tsis pub ntau tshaj 24 teev.

Kev khov yog txwv nruj heev: Cov kev daws teeb meem uas tau muab kho dua yuav tsum tsis txhob khov dua.

Kev thauj mus los:

Txias- cov hmoov qhuav: thauj los ntawm cov dej khov qhuav (-78 degree).

Ntim: Lub teeb- pov thawj aluminium foil hnab + lub tshuab nqus tsev foob + ua npuas ncauj insulated lub thawv.

3. Kev ruaj ntseg thiab cov qauv ua tiav:

Physicochemical stability:

Nws yog qhov ruaj khov tshaj plaws nyob rau hauv pH tej yam kev mob ntawm ib qho hnyav hnyav.

Nws yog rhiab heev rau cov kev hloov pauv hauv pH thiab ionic zog ntawm cov uas tsis yog- cov kuab tshuaj tshwj xeeb thiab muaj kev sib sau ua ke.

rhiab heev rau txhua yam kev ntxhov siab (xws li kev vibration hnyav).

Cov ntsiab lus tseem ceeb rau khaws cia cov khoom xyaw nquag:

Kev ua raws cai nruj rau cov txheej txheem kev sib cais thiab cov txheej txheem dilution yog qhov tseem ceeb rau kev tswj hwm nws cov kev ua haujlwm lom neeg thiab ntev ntev - cov tshuaj pharmacokinetic kav ntev.

Xav taudab tsi, thov hu raupeb

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