Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm teduglutide peptide hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo teduglutide peptide muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Teduglutide peptide(Gattex) yog glucagon hluavtaws-zoo li peptide-2 (GLP-2) analogue. Nws lub luag haujlwm tseem ceeb yog ua raws li kev ua haujlwm ntawm lub cev ntawm endogenous GLP-2, txhawb kev kho cov hnyuv mucosal thiab kev loj hlob, txhawb kev nkag mus rau hauv lub cev, thiab pab cov neeg mob txo lawv txoj kev vam khom ntawm cov khoom noj khoom haus parenteral. Raws li cov tshuaj polypeptide uas muaj 33 amino acids, nws kov yeej qhov kev txwv ib nrab-lub neej luv ntawm endogenous GLP-2 los ntawm kev hloov kho cov qauv ntawm haiv neeg GLP-2, yog li ua tiav cov txiaj ntsig kho mob ntev dua.
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 qho 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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Core Mechanism of Action
Lub ntsiab mechanism ntawm kev ua ntawmteduglutide peptideyog txhawm rau khi tshwj xeeb rau GLP-2 receptors hauv cov ntaub so ntswg enteral, qhib cov kab ke ntawm cov kev taw qhia hauv qab, thiab thaum kawg txhawb kev loj hlob thiab kho cov hnyuv mucosa thiab txhim kho nws txoj haujlwm nqus. Cov txheej txheem no nruj me ntsis raws li cov lus qhia ntawm "receptor binding - teeb liab ua kom - effector teb" thiab ua tshwj xeeb hauv cov hnyuv, ua kom pom tseeb lub hom phiaj xaiv.
Ua ntej, lub hom phiaj khi ntawm nws yog qhov tshwj xeeb heev. GLP-2 receptors feem ntau yog faib rau hauv cov hlwb enteroendocrine, subepithelial myofibroblasts, thiab enteric neurons hauv submucosal thiab myenteric plexuses.
Cov qauv kev faib tawm no txwv qhov kev txiav txim ntawm cov khoom feem ntau rau cov kab mob nkag mus thiab cov ntaub so ntswg, txo qhov cuam tshuam loj rau lwm yam kabmob. Gatex peptide nthuav tawm kev sib koom ua ke rau GLP-2 receptors piv rau cov endogenous GLP-2 thiab tuaj yeem sib tw tuav cov receptors no. Ua tsaug rau nws lub neej ntev dua ib nrab-, nws txhawb nqa cov neeg nyob hauv lub cev thiab ua kom muaj teeb meem, muab cov teebmeem ua haujlwm ntev-ib qho ntawm nws cov txiaj ntsig kho tseem ceeb tshaj li haiv neeg GLP-2.
Qhov thib ob, cov teeb liab downstream transduction tom qab receptor activation yog qhov tseem ceeb rau cov tshuaj pharmacological ntawm gatex peptide.
Thaum khi rau GLP-2 receptors, nws ua kom cov receptor-coupled G proteins (feem ntau G s proteins), uas tig mus ua kom adenylate cyclase (AC), ua rau kom siab intracellular cyclic adenosine monophosphate (cAMP) qib. Raws li tus xa xov thib ob, cAMP txuas ntxiv ua kom muaj protein ntau kinase A (PKA), pib ua ib qho kev cuam tshuam ntawm cov xwm txheej hauv qab. Kev ua kom txoj hauv kev no ncaj qha tswj kev loj hlob, kev loj hlob, thiab kev sib txawv ntawm cov hnyuv epithelial hlwb, thaum txhawb kev tso tawm ntawm ntau yam kev loj hlob los txhawb txoj hnyuv mucosal kho thiab kev loj hlob.
Thaum lub sijhawm hloov cov teeb liab, gattex txhawb kev tso tawm hauv zos ntawm cov neeg nruab nrab suav nrog insulin-zoo li kev loj hlob-1 (IGF-1), keratinocyte kev loj hlob zoo (KGF), thiab nitric oxide (NO) los ntawm kev ua haujlwm PKA signaling.
Ntawm cov no, IGF-1 thiab KGF yog qhov tseem ceeb ntawm kev loj hlob ntawm enteral mucosal kev loj hlob: IGF-1 stimulates plab hnyuv epithelial cell proliferation, inhibits apoptosis, thiab accelerates kho ntawm mucosal raug mob; KGF ua feem ntau ntawm cov kab mob hauv plab hnyuv epithelial los txhawb lawv txoj kev loj hlob thiab kev sib txawv, nce mucosal thickness. TSIS MUAJ feem ntau koom nrog hauv kev tswj cov kab mob hauv plab hnyuv, txhim kho cov ntshav rau cov plab hnyuv siab raum kom muab cov as-ham txaus thiab oxygen rau kev loj hlob ntawm cov mucosal, thaum inhibiting plab hnyuv du nqaij contraction, qeeb txoj hnyuv, ncua kev khaws cov as-ham hauv txoj hnyuv, thiab txhim kho kev nqus tau zoo.
Cov ntaub ntawv qhov chaw: CPC Scientific, Gatex; PMC, Kev Ua Tau Zoo thiab Kev Nyab Xeeb ntawm Kev Kho Mob Gatex hauv cov neeg laus cov neeg mob uas muaj lub plab zom mov luv: Cov Ntaub Ntawv Txheej Txheem thiab Kev Ntsuam Xyuas Cov Ntaub Ntawv Tam Sim No; benchchem.com, Ib qho Hauv -Kev qhia tob tob rau Kev Tshawb Fawb thiab Kev Txhim Kho ntawm Gatex.
Cov teebmeem loj Physiological thiab Extended Actions
Los ntawm GLP-2 receptor activation thiab downstream signaling,teduglutide peptideexerts peb physiological teebmeem: txhawb enteral mucosal kev loj hlob, txhim kho plab hnyuv nutrient thiab dej nqus, thiab regulating gastrointestinal muaj nuj nqi. Cov teebmeem no ua haujlwm sib koom ua ke los txhim kho txoj hnyuv ua haujlwm, ua rau nws tshwj xeeb tshaj yog haum rau kev kho mob ntawm plab plob tsis so tswj. Nws cov haujlwm physiological tseem txuas ntxiv mus rau immunomodulation thiab tswj kev mob, ntxiv dag zog rau cov hnyuv.
Thawj cov nyhuv physiological yog kev txhawb nqa ntawm enteral mucosal kev loj hlob thiab kho, qhov tseem ceeb tshaj plaws ntawm cov khoom. Los ntawm activating downstream signaling pathways thiab tso cov kev loj hlob yam tseem ceeb, nws ho tsub kom txoj hnyuv villus qhov siab thiab crypt qhov tob, expanding qhov chaw ntawm lub plab hnyuv mucosa. Ob qhov kev tshawb fawb hauv tsev kho mob thiab kev kho mob tau lees paub tias tom qab kev kho mob gattex, cov neeg mob pom tau tias muaj qhov siab ntawm villus qhov siab, qhov tob crypts, thiab txhim kho mucosal tuab, uas ncaj qha nthuav dav qhov nqus dej rau cov as-ham thiab txhim kho txoj hnyuv nqus.
Qhov thib ob tseem ceeb physiological nyhuv yog txhim kho plab hnyuv nqus ntawm cov as-ham thiab dej. Nws ua tiav qhov no los ntawm ntau txoj hauv kev: ntawm ib sab, nthuav cov plab hnyuv mucosal ncaj qha nce qhov chaw nqus rau cov as-ham, txhim kho kev nqus ntawm carbohydrates, rog, proteins, thiab lwm yam khoom noj; Ntawm qhov tod tes, nws tswj cov kev qhia ntawm cov zaub mov thauj mus rau hauv cov hnyuv epithelial hlwb, txhawb cov synthesis thiab activation ntawm transporters rau qabzib, amino acids, fatty acids, thiab lwm yam, accelerating lub translocation ntawm as-ham los ntawm txoj hnyuv lumen mus rau hauv enterocytes thiab ntxiv boosting absorption efficiency. Tsis tas li ntawd, nws txhim kho kev nqus dej nkag mus, txo cov kua dej thiab tshem tawm raws plab, ib qho kev mob tshwm sim hauv cov neeg mob plab plab luv.
Qhov thib peb tseem ceeb physiological nyhuv yog kev tswj ntawm plab hnyuv muaj nuj nqi thiab txo cov plab hnyuv voos, tsim kom muaj ib qho chaw zoo rau kev nqus cov as-ham. Cov khoom no inhibits gastric acid secretion, txo cov kua qaub-induced irritation rau lub plab hnyuv mucosa, thaum tiv thaiv lub plab hnyuv mucosal barrier, txo qhov nqus ntawm plab hnyuv co toxins, thiab txo txoj kev pheej hmoo ntawm plab hnyuv. Endogenous GLP-2 lawm inhibits gastric acid secretion thiab tsub kom cov hnyuv thiab portal cov ntshav txaus, muaj nuj nqi tau txais txiaj ntsig thiab ntev los ntawm gatex raws li nws cov analogue. Tsis tas li ntawd, gattex slows plab hnyuv motility, ncua lub sij hawm nyob rau hauv cov hnyuv kom tso cai rau kom tiav kev nqus.
Tsis tas li ntawd, cov teebmeem physiological ntawm gatex peptide txuas mus rau immunomodulation thiab tswj kev mob. Cov hnyuv yog lub cev loj tshaj plaws ntawm lub cev tiv thaiv kab mob, thiab txoj hnyuv mucosal kev ncaj ncees yog ze rau kev tiv thaiv kab mob. Los ntawm kev txhawb nqa mucosal kho thiab tswj kev ruaj ntseg barrier,teduglutide peptidetxo qhov ntxeem tau ntawm cov kab mob thiab cov co toxins, txo qis kev pheej hmoo ntawm enteral o. Nws kuj modulates lub plab hnyuv mucosal tiv thaiv kab mob, txhawb kev tso tawm ntawm cov tshuaj tiv thaiv -inflammatory yam thiab inhibiting pro-inflammatory cytokine qhia, alleviating plab hnyuv teb.
Cov kev tshawb fawb soj ntsuam pom tau hais tias txawm hais tias C-reactive protein ntau ntau tuaj yeem nce ntxiv thiab nruab nrab thaum kho gattex, kev kho lub sij hawm ntev - tsis muaj qhov cuam tshuam los ntawm cov kab hauv qab, tsis muaj qhov txawv txav los yog cov tsos mob hauv chaw kho mob, qhia tau tias muaj kev nyab xeeb zoo thiab kev tswj xyuas cov kab mob hauv plab hnyuv.
Cov ntaub ntawv qhov chaw: CPC Scientific, Gatex; PMC, Kev Ua Tau Zoo thiab Kev Nyab Xeeb ntawm Kev Kho Mob Gatex hauv cov neeg laus cov neeg mob uas muaj lub plab zom mov luv: Cov Ntaub Ntawv Txheej Txheem thiab Kev Ntsuam Xyuas Cov Ntaub Ntawv Tam Sim No; benchchem.com, Ib qho Hauv -Kev qhia tob tob rau Kev Tshawb Fawb thiab Kev Txhim Kho ntawm Gatex.
I. Recombinant DNA Biosynthetic Route
Gatex yog 33-amino-acid polypeptide tshuaj. Txoj kev tsim khoom tseem ceeb hauv kev lag luam siv cov txheej txheem DNA microbial recombinant siv kev tsim kho caj cesEscherichia coliraws li tus tswv tsev qhia. Ua ntej, lub hom phiaj gene encoding gatex yog synthesized artificially, muab tso rau hauv ib qho kev qhia vector, thiab hloov mus rau hauv kev muaj peev xwm.E. colihlwb los tsim kom muaj kev ruaj ntseg engineering strain. Los ntawm fermentation, cov kab mob qhia ntau ntau ntawm fusion gatex precursor protein. Tom qab fermentation, cov kab mob hlwb raug sau thiab lysed kom tso cov protein intracellular hom phiaj. Lub fusion tag ces muab tshem tawm ntawm enzymatic los yog tshuaj cleavage kom tau crude polypeptide. Txoj kev no muaj cov txiaj ntsig zoo thiab cov nqi tswj tau, tsim nyog rau kev tsim khoom loj -.
II. Khoom -Phase Peptide Synthesis (SPPS) Txoj Kev
Fmoc-raws li khoom-theem peptide synthesis feem ntau yog siv rau hauv chav kuaj thiab me me - nplai npaj. Siv cov resin ua ib qho khoom txhawb nqa, cov amino acid monomers yog sib txuas los ntawm C-terminus mus rau N-terminus, nrog peptide bond tsim kho los ntawm condensation reagents. Lub voj voog ntawm kev tiv thaiv - kev sib txuas - kev ntxuav yog rov ua dua kom txog thaum tag nrho cov txheej txheem sib sau ua ke. Thaum ua tiav, cleavage reagents yog siv los tshem tawm cov polypeptide los ntawm cov resin thiab tshem tawm sab -chain tiv thaiv pawg, yielding crude peptide. Txoj kev no ua rau muaj kev tswj xyuas qhov tseeb thiab hloov pauv tau N-terminal glycine hloov pauv thiab hloov kho, ua tau raws li qhov xav tau ntawm kev tshawb fawb thiab kev txhim kho theem.
III. Purification thiab tiav cov khoom npaj
Crude gattex raug rau ntau-theem purification los ntawm thim rov qab-theem siab- ua kua chromatography (RP-HPLC) kom tshem tawm cov impurities xws li truncated thiab misfolded peptides, ua raws li kev ua kom zoo ntxiv siv ion-chromatography. Cov khoom purified yog lyophilized kom tau ib tug siab -purity dawb hmoov, feem ntau nrog ib tug purity ntawm Greater los yog sib npaug rau 98%. Cov khoom kawg yog tsim, tsis muaj menyuam- lim, thiab xa tawm raws li kev xav tau tshuaj los tsim gatex rau kev txhaj tshuaj. Cov yam ntxwv zoo tseem ceeb suav nrog cov tshuaj muaj feem cuam tshuam, kev soj ntsuam, thiab kev txwv microbial raug tswj nruj me ntsis thoob plaws hauv cov txheej txheem kom ua raws li cov qauv tshuaj pharmacopoeial.
Cov ntaub ntawv qhov chaw: European Medicines Agency (EMA) kev soj ntsuam daim ntawv qhia rau Revestive (gattex); Takeda US Prescribing Information rau gatex.
Cov kev ceev faj
Tej zaum yuav ua rau cholestasis, cholelithiasis, cholecystitis, thiab cholangitis.
Ntsuas bilirubin thiab alkaline phosphatase qib 6 lub hlis ua ntej pib kho.
Saib xyuas daim siab ua haujlwm txhua 6 lub hlis thaum kho. Rau qhov tshwm sim txawv txav, ua lub gallbladder / biliary tract imaging; xav txog kev txiav kev kho mob rau kev ntsuam xyuas yog tias tsim nyog.
Nrhiav kev kho mob tam sim ntawd rau qhov mob plab sab xis, jaundice, ua npaws, xeev siab, lossis ntuav.
Cov ntaub ntawv qhov chaw: FDA Cov Lus Qhia; Tuam Tshoj Cov Ntaub Ntawv Kho Mob Query Platform
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