Shaanxi BLOOM Tech Co., Ltd. yog ib tug ntawm cov uas paub txog manufacturers thiab lwm tus neeg ntawm teduglutide txhaj nyob rau hauv Suav teb. Txais tos rau kev lag luam wholesale bulk zoo teduglutide txhaj rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Teduglutide txhaj tshuajyog glucagon-zoo li peptide 2 (GLP-2) analogue ua los ntawm recombinant DNA technology siv hloov kho Escherichia coli hom. Tam sim no, cov tshuaj feem ntau yog qhia rau kev kho mob ntawm plab plob tsis so tswj syndrome, hais txog cov kev xav tau tseem ceeb xws li kev kho mob tom qab hloov kho hauv cov neeg mob uas muaj plab plob tsis so tswj, kev ua kom zoo ntawm parenteral noj zaub mov dependence, thiab rov qab ua haujlwm enteric.
Peb Cov Khoom Muag Khoom
Teduglutide COA
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| Certificate of Analysis | ||
| Compound npe | Teduglutide | |
| Qib | Pharmaceutical qib | |
| CAS Nr. | 197922-42-2 | |
| Ntau | 62g | |
| Ntim txheem | PE hnab + Al foil hnab | |
| Chaw tsim tshuaj paus | Shaanxi BLOOM TECH Co., Ltd | |
| Ntau No. | 202601090088 | |
| MFG | Peb 9, 2026 | |
| EXP | Peb 8, 2029 | |
| Qauv |
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| Yam khoom | Enterprise txheem | Kev txheeb xyuas qhov tshwm sim |
| Qhov tshwm sim | Dawb los yog yuav luag dawb hmoov | Ua raws |
| Cov ntsiab lus dej | Tsawg dua lossis sib npaug li 5.0% | 0.36% |
| Poob rau ziab | Tsawg dua lossis sib npaug li 1.0% | 0.41% |
| Hnyav Hlau | Pb Tsawg dua lossis sib npaug li 0.5ppm | N.D. |
| Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Hg Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Cd Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Purity (HPLC) | Ntau dua lossis sib npaug li 99.0% | 99.80% |
| Ib leeg impurity | <0.8% | 0.27% |
| Tag nrho microbial suav | Tsawg dua lossis sib npaug li 750cfu / g | 250 |
| E. Coli | Tsawg dua lossis sib npaug li 2MPN / g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (los ntawm GC) | Tsawg dua lossis sib npaug li 5000ppm | 5 10 ppm |
| Cia | Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab 2-8 degree | |
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Routine Therapy Tom qab plab hnyuv hloov nyob rau hauv cov neeg mob nrog lub plab plob tsis so tswj syndrome
Short bowel Syndrome (SBS) yog ib qho kev kho mob uas tshwm sim los ntawm kev mob plab me me vim muaj ntau yam ua rau, ua rau muaj kev txo qis hauv cov plab hnyuv siab raum, tsis haum cov as-ham, dej thiab electrolytes, thiab tom qab kev kho mob tshwm sim suav nrog raws plab, lub cev qhuav dej, tsis muaj zaub mov noj thiab poob phaus. Nws qhov teeb meem tseem ceeb yog mob plab hnyuv tsis ua hauj lwm, thiab cov neeg mob feem ntau xav tau ntev - lub sij hawm dependence rau parenteral noj zaub mov (PN) thiab intravenous fluid hloov mus rau lub neej.
Raws li GLP-2 analogue,txhaj tshuaj teduglutidemimics cov teebmeem physiological ntawm endogenous GLP-2, txhawb kev loj hlob thiab kev sib txawv ntawm cov me me enteric mucosal hlwb, ua rau plab hnyuv villus qhov siab thiab crypt qhov tob kom nthuav dav qhov chaw nqus dej, thiab txhim kho enteric motility thiab barrier muaj nuj nqi. Nws yog ib qho tseem ceeb uas yuav tsum tau kho tus neeg sawv cev rau cov neeg mob uas muaj plab plob tsis so tswj tom qab enteric adaptation.
Lub sij hawm "tom qab enteric adaptation" yog hais txog theem thaum cov neeg mob, tom qab lub plab zom mov me me thiab lub sij hawm ntawm kev kho mob, ua tiav kev ua haujlwm ruaj khov thiab ua siab ntev rau cov khoom noj khoom haus yooj yim. Kev pib ntawm cov khoom nyob rau theem no ntxiv txhawb kev ua kom lub plab zom mov thiab pab cov neeg mob maj mam rov qab los ntawm kev nqus nkag mus rau hauv lub cev. Lub hom phiaj tseem ceeb ntawm qhov chaw kho mob no yog txhawm rau txhim kho kev nqus cov khoom noj kom zoo, txo qhov zaus thiab qhov hnyav ntawm cov tsos mob xws li raws plab thiab lub cev qhuav dej, thiab tsim lub hauv paus rau kev txo qis ntawm cov khoom noj khoom haus parenteral dependence.
Cov ntaub ntawv qhov chaw: Tuam Tshoj Pharmaceutical Information Query Platform, Pob Ntxig rau Teduglutide rau Txhaj Tshuaj; Takeda US, Pob Ntxig rau Teduglutide rau Txhaj.
Optimization ntawm Parenteral Nutrition Dependence nyob rau hauv cov neeg mob nrog lub plab plob tsis so tswj
Ntev - lub sij hawm dependence rau parenteral khoom noj khoom haus yog ib qho ntawm cov yam ntxwv tseem ceeb ntawm kev kho mob ntawm cov neeg mob uas muaj plab plob tsis so tswj syndrome. Txawm li cas los xij, kev noj zaub mov tsis zoo yog cuam tshuam nrog ntau yam teeb meem, suav nrog hauv nruab nrab venous catheter- cuam tshuam txog kab mob, cholestasis, mob siab thiab cov kab mob metabolic, uas cuam tshuam rau cov neeg mob lub neej zoo thiab ntev - ciaj sia taus. Ib qho ntawm cov ntsiab lus tseem ceeb ntawm cov khoom lag luam yog txhawm rau txhim kho cov khoom noj khoom haus parenteral nyob rau hauv cov neeg mob no. Los ntawm kev txhim kho enteric absorption, nws maj mam txo qhov yuav tsum tau rau parenteral khoom noj khoom haus thiab tej zaum kuj yuav pab tau qee cov neeg mob ua tiav kev tshem tawm los ntawm parenteral khoom noj khoom haus.
Cov ntaub ntawv qhov chaw: PMC, Kev Ua Tau Zoo thiab Kev Nyab Xeeb ntawm Teduglutide Kev Kho Mob hauv Cov Neeg Laus Nrog Cov Kab Mob Hlwb luv luv: Cov Ntaub Ntawv Txheej Txheem thiab Kev Ntsuam Xyuas Cov Ntaub Ntawv Tam Sim No.
Adjunctive Therapy rau plab hnyuv muaj nuj nqi rov qab rau cov neeg mob nrog lub plab plob tsis so tswj
Cov neeg mob uas muaj lub plab plob tsis so tswj, vim qhov loj me me ntawm lub plab zom mov, tsis yog tsuas yog raug kev txom nyem los ntawm qhov tsis txaus ntawm qhov chaw nqus, tab sis kuj nquag nquag nrog enteric dysmotility thiab cov plab hnyuv ua haujlwm tsis zoo, tshwm sim raws li mob raws plab, enteric dysbacteriosis thiab malnutrition, uas cuam tshuam rau enteric functional zoo. Raws li cov hnyuv trophic,txhaj tshuaj teduglutidepab txoj hnyuv rov qab los ntawm ntau txoj hauv kev thiab ua ib qho tshuaj tseem ceeb hauv kev kho plab hnyuv.
Ntawm qhov tod tes, cov khoom txhawb nqa enteric mucosal kho thiab rov tsim dua tshiab, nce villus qhov siab thiab crypt qhov tob, txhim kho mucosal kev ncaj ncees, ntxiv dag zog rau enteric barrier, txo cov endotoxin nqus thiab txo qhov kev pheej hmoo ntawm plab hnyuv, yog li alleviating mob raws plab thiab mob plab. Txhim kho kev ua haujlwm tsis zoo kuj tseem txo cov plab hnyuv dysbacteriosis, tswj lub plab microecological tshuav nyiaj li cas, thiab txhawb ntxiv enteric rov qab. Ntawm qhov tod tes, cov tshuaj modulates enteric motility thiab lub sij hawm thauj mus los, tiv thaiv overly passage ntawm cov as-ham uas impairs absorption, thaum txo cov zaus thiab mob raws plab thiab pab kho cov hnyuv ib txwm tshem tawm cov qauv.
Hauv qhov chaw no, cov khoom lag luam feem ntau ua ke nrog kev kho mob enteric rehabilitation, nrog rau kev tswj kev noj zaub mov, kev kho mob plab hnyuv thiab kev ua kom rov zoo, tsim kom muaj kev kho mob dav dav. Kev tswj kev noj zaub mov yuav maj mam nce ntxiv hauv qhov ncauj qhov ntim thiab ntau yam raws li qhov seem ntawm enteric muaj nuj nqi, nrog rau kev zom tau yooj yim, siab - khoom noj khoom haus thiab siab - cov khoom noj muaj zog los txhim kho qhov nqus ntawm cov tshuaj. Txoj hnyuv flora modulation siv probiotics los txhim kho lub plab microenvironment thiab txhim kho plab zom mov thiab nqus tau. Qhov kev sib koom ua ke no ua tau zoo dua txhawb kev rov qab los, txo cov khoom noj khoom haus parenteral, thiab ua rau cov neeg mob rov qab mus rau kev noj zaub mov zoo thiab lub neej txhua hnub.
Cov ntaub ntawv qhov chaw: PMC, Kev Ua Tau Zoo thiab Kev Nyab Xeeb ntawm Teduglutide Kev Kho Mob hauv Cov Neeg Laus Nrog Cov Kab Mob Hlwb luv luv: Cov Ntaub Ntawv Txheej Txheem thiab Kev Ntsuam Xyuas Cov Ntaub Ntawv Tam Sim No.
Symptomatic Treatment of Chronic Intestinal Failure Associated with Short bowel Syndrome
Qhov teeb meem loj tshaj plaws ntawm lub plab plob tsis so tswj yog mob enteric tsis ua hauj lwm, txhais tau tias yog qhov tsis muaj peev xwm ntawm txoj hnyuv kom nqus tau cov as-ham thiab dej kom tau raws li qhov xav tau ntawm lub cev, yuav tsum muaj kev cia siab rau lub neej ntawm cov khoom noj khoom haus parenteral thiab cov kua dej hauv lub cev. Lub plab hnyuv tsis ua haujlwm ntev ua rau muaj kev noj zaub mov tsis zoo, lub cev qhuav dej, kev cuam tshuam ntawm electrolyte, thiab muaj kev pheej hmoo ntawm kev kis kab mob thiab mob siab rau lub siab, ua rau muaj kev hem thawj loj rau kev ciaj sia. Raws li kev kho mob rau lub plab zom mov luv luv, cov khoom lag luam yog ib qho tseem ceeb rau kev kho mob ntawm cov hnyuv tsis ua haujlwm.
Tsis tas li ntawd, ntev -kev kho mob nrogtxhaj tshuaj teduglutidepab tswj kev ua haujlwm ruaj khov enteric thiab tiv thaiv kev ua kom tsis zoo ntxiv rau cov neeg mob uas mob plab hnyuv tsis ua haujlwm, muab cov hauv kev kho mob ntxiv. Txawm hais tias cov pov thawj ntawm qhov sib piv ntev - lub sij hawm ua tau zoo ntawm cov tshuaj tseem hloov zuj zus mus, cov ntaub ntawv kho mob uas twb muaj lawm tau txheeb xyuas nws cov kev ua tau zoo thiab kev nyab xeeb hauv kev kho cov tsos mob ntawm cov hnyuv tsis ua hauj lwm, muab cov kev kho mob tseem ceeb rau cov neeg mob uas muaj lub plab zom mov luv luv - ntsig txog kev mob plab tsis ua hauj lwm.
Cov ntaub ntawv qhov chaw: PMC, Kev Ua Tau Zoo thiab Kev Nyab Xeeb ntawm Teduglutide Kev Kho Mob hauv Cov Neeg Laus Nrog Cov Kab Mob Hlwb luv luv: Cov Ntaub Ntawv Txheej Txheem thiab Kev Ntsuam Xyuas Cov Ntaub Ntawv Tam Sim No.
I. Discovery Background
Txij xyoo 1980 mus txog rau xyoo 1990, kev nce qib hauv plab hnyuv physiology kev tshawb fawb tau qhia txog kev ua haujlwm ntawm lub cev ntawm endogenous GLP-2, ib qho tshuaj hormone secreted los ntawm plab hnyuv L hlwb uas txhawb nqa me me plab hnyuv mucosal proliferation thiab txhim kho txoj hnyuv nqus. Thaum lub sij hawm ntawd, cov neeg mob uas muaj lub plab plob tsis so tswj, tom qab kev phais me me, tau ntsib qhov txo qis hauv qhov chaw nqus dej thiab xav tau cov khoom noj khoom haus mus sij hawm ntev, uas ua rau muaj teeb meem loj xws li kev kis kab mob thiab mob siab, tsis muaj tshuaj kho mob rau txoj hnyuv ua haujlwm rov qab los. Qhov kev xav tau kev kho mob tsis txaus ntseeg no tau tsav txoj kev loj hlob ntawm GLP-2 analogues los ua cov tshuaj endogenous GLP-2, rov ua kom lub plab zom mov tsis zoo, thiab txo cov khoom noj khoom haus parenteral, pib kev tshawb fawb thiab kev loj hlob ntawm teduglutide.
II. Kev tshawb fawb thiab kev loj hlob
Lub hauv paus ntawm teduglutide txoj kev loj hlob yog molecular hloov kho ntawm haiv neeg GLP-2 kom kov yeej nws luv luv ib nrab-lub neej thiab raug rau degradation. Siv cov thev naus laus zis DNA recombinant, cov kws tshawb fawb tau ua kom zoo dua cov amino acid ib ntus ntawm haiv neeg GLP-2 txhawm rau txhim kho kev tiv thaiv rau dipeptidyl peptidase 4 (DPP-4), ua kom nws ntev hauv vivo ib nrab-lub neej, thaum khaws nws cov haujlwm tseem ceeb hauv kev txhawb nqa kev loj hlob ntawm cov mucosal. Cov khoom loj loj tau ua tiav tom qab sivEscherichia colihom kab mob los xyuas kom meej cov tshuaj purity thiab lom lom.
Hauv kev txhim kho kho mob, multicenter, ntau- kev sim sib koom ua ke tau ua los txhim kho kev txhim kho kev ua tau zoo thiab kev nyab xeeb ntawm teduglutide. Cov kev sim thaum ntxov tau tsom mus rau kev txhim kho kev ua haujlwm zoo hauv plab hnyuv luv, thaum tom qab ntev - lub sijhawm ua raws- cov kev tshawb fawb tau lees paub nws qhov ua tau zoo hauv kev txo cov kev xav tau ntawm cov khoom noj khoom haus parenteral thiab teeb meem kev pheej hmoo, nteg lub hauv paus ruaj khov rau kev pom zoo. Zoo ib yam li txoj kev loj hlob ntawm concurrent GLP-1 analogues (xws li, exenatide), teduglutide ua los ntawm kev siv cov tshuaj endogenous incretin ua ke nrog molecular optimization ntawm cov khoom siv tshuaj.
III. Kev lag luam thiab kev kho mob
Hauv xyoo 2012, teduglutide tau pom zoo thawj zaug los ntawm FDA hauv Tebchaws Meskas thiab Tebchaws Europe, dhau los ua lub ntiaj teb thawj GLP-2 analogue qhia rau lub plab zom mov luv, ua kom muaj qhov sib txawv ntawm kev kho mob hauv enteric rehabilitation. Tom qab ntawd nws tau pom zoo hauv lwm thaj chaw suav nrog Nyij Pooj, nrog qhov qhia tau nthuav dav rau cov neeg mob menyuam yaus hnub nyoog 1 xyoos thiab siab dua. Xyoo 2024, teduglutide tau pom zoo nyob rau hauv Suav teb, thiab xyoo 2025 nws tau suav nrog hauv Cov Ntawv Pov Hwm Kev Noj Qab Haus Huv Kev Lag Luam Kev Lag Luam Tshiab, maj mam txhim kho kev nkag mus thiab pab ntau tus neeg mob uas muaj lub plab plob tsis so tswj txo qis parenteral noj zaub mov dependence thiab rov pib lub neej qub. Nws qhov kev tshawb pom thiab kev loj hlob, nyob rau hauv cov kev xav tau ntawm kev kho mob, ua tiav kev txhais lus zoo los ntawm kev tshawb fawb ntawm lub cev mus rau tus neeg sawv cev kho mob.
Cov ntaub ntawv qhov chaw: Tuam Tshoj Txhua Hnub, Shanghai tsev kho mob teeb meem Tuam Tshoj thawj tus neeg laus tshuaj rau Teduglutide; Qilu Yidian, Kev xaiv kho tshiab rau lub plab zom mov luv! Teduglutide rau Kev Txhaj Tshuaj muaj nyob rau hauv kev tuav pov hwm kev lag luam cov npe tshuaj tshiab.
Hypersensitivity Reactions
Contraindicated nyob rau hauv cov neeg mob hypersensitivity rau teduglutide los yog excipients (histidine, mannitol, phosphates). Tsis txhob kho tam sim ntawd thiab pib kev kho mob thaum muaj pob khaus, pruritus, dyspnea los yog lub ntsej muag o.
Cov ntaub ntawv qhov chaw: Suav pob ntxig; FDA pob ntxig.
FAQ
Puas yog teduglutide yog GLP-1?
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Teduglutide yog glucagon -zoo li peptide-2 (GLP-2) analoguas tau pom zoo rau kev kho mob ntawm cov neeg mob siab dua lossis sib npaug li 1 xyoos nrog lub plab plob tsis so tswj (SBS) uas yog nyob ntawm kev txhawb nqa niam txiv.
Cov tshuaj teduglutide siv rau dab tsi?
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Teduglutide (lub npe npe Gatex) yog cov tshuaj siv los kho cov mob plab hnyuv (SBS) rau cov neeg laus thiab menyuam yaus (1 xyoos thiab laus dua) uas tso siab rau kev noj zaub mov hauv cov hlab ntsha (IV). Nws yog GLP-2 analog uas txhim kho plab hnyuv nqus ntawm cov kua thiab cov as-ham, txo qhov kev xav tau ntawm kev txhawb nqa parenteral (TPN).
Cim npe nrov: Teduglutide txhaj tshuaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom