Shaanxi BLOOM Tech Co., Ltd. yog ib tug ntawm cov uas paub txog manufacturers thiab lwm tus neeg ntawm lixisenatide txhaj nyob rau hauv Suav teb. Txais tos rau kev lag luam wholesale bulk zoo lixisenatide txhaj rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Kev txhaj tshuaj lixisenatideyog ib qho tshuaj tshiab rau kev kho mob ntshav qab zib hom 2, koom nrog glucagon zoo li peptide-1 (GLP-1) receptor agonists. Nws simulates lub ntuj tso tawm ntawm GLP-1 cov tshuaj hormones los ntawm tib neeg lub cev, ua kom cov receptors sib xws, thiab yog li ua rau muaj ntau yam teebmeem hypoglycemic.
Pom zoo rau cov npe hauv Tebchaws Europe hauv xyoo 2013 raws li lub npe Lyxumia ®, Nws tuaj yeem siv ib leeg lossis ua ke nrog cov tshuaj hypoglycemic ntawm qhov ncauj thiab insulin los kho mob ntshav qab zib hom 2. Nws cov yam ntxwv pharmacokinetic tshwj xeeb thiab kev nyab xeeb zoo ua rau nws yog ib qho kev xaiv tseem ceeb rau kev tswj hwm cov ntshav qab zib.
Peb Cov Khoom Muag Khoom
Lixisenatide COA
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| Certificate of Analysis | ||
| Compound npe | Lixisenatide | |
| Qib | Pharmaceutical qib | |
| CAS Nr. | 320367-13-3 | |
| Ntau | 40g | |
| Ntim txheem | PE hnab + Al foil hnab | |
| Chaw tsim tshuaj paus | Shaanxi BLOOM TECH Co., Ltd | |
| Ntau No. | 202601090057 | |
| 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% | 0.47% |
| Poob rau ziab | Tsawg dua lossis sib npaug li 1.0% | 0.35% |
| 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% | 99.90% |
| Ib qho impurity | <0.8% | 0.56% |
| Tag nrho microbial suav | Tsawg dua lossis sib npaug li 750cfu / g | 170 |
| 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 | 400ppm ua |
| Cia | Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab -20 degree | |
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Nyob rau hauv xyoo tas los no, kev nthuav dav ntawm ntau yam kabmob thoob plaws hauv lub cev, tshwj xeeb tshaj yog cov paj hlwb hauv nruab nrab, tau nyiam cov kws tshawb fawb. Kev tshawb fawb ntawmKev txhaj tshuaj lixisenatidetau dhau mus dhau qhov kev ua haujlwm ntawm endocrinology thiab nkag mus rau cov kab mob neurodegenerative.
Theoretical hauv paus ntawm neuroprotective mechanisms
Kev tshawb fawb tau pom tias cov kab mob neurodegenerative xws li Parkinson's Disease (PD) thiab Alzheimer's Disease (AD) muaj feem cuam tshuam nrog cov tshuaj insulin tsis kam, mob neuroinflammation, oxidative stress, thiab mitochondrial dysfunction hauv lub hlwb. Nws tuaj yeem nkag mus rau hauv cov ntshav- lub hlwb teeb meem, qhib GLP-1 receptors ntawm cov neurons, thiab los ntawm cAMP mediated signaling pathway:
Inhibit qhov kev ua kom ntau dhau ntawm microglia, yog li txo qis cov tshuaj tiv thaiv cascade hauv nruab nrab paj hlwb.
Txhim kho qhov kev qhia ntawm cov tshuaj tiv thaiv apoptotic (xws li Bcl-2), inhibiting apoptosis, thiab ncaj qha tiv thaiv dopaminergic neurons los ntawm kev puas tsuaj lom.
Txhim kho cellular zog metabolism thiab mitochondrial muaj nuj nqi.
Cov ntaub ntawv Source:
Nature Reviews Neuroscience, Mechanism of GLP-1 in Neurodegenerative Diseases, 2020;
MCE Scientific Product Data Platform, Lixisenatide Pharmacological Applications, 2023
Milestone kuaj sim rau Parkinson's disease (PD) (LIXIPARK)
Hauv kev kho mob Parkinson tus kab mob, kev tshawb fawb tsis ntev los no ntawm cov tshuaj no tau ua rau muaj kev poob siab thoob ntiaj teb hauv zej zog kev kho mob vim tias tsis muaj "kev hloov kho kab mob" cov tshuaj uas tuaj yeem thim rov qab lossis qeeb cov txheej txheem kab mob.
Thaum lub Plaub Hlis 2024, cov ntawv xov xwm kho mob thoob ntiaj teb sab saum toj, New England Journal of Medicine (NEJM), tau luam tawm cov txiaj ntsig ntawm ntau qhov chaw, randomized, ob npaug - dig muag, placebo- tswj theem II kev sim tshuaj hu ua LIXIPARK.
Kev sim tsim: Txoj kev tshawb no tau coj los ntawm pab pawg los ntawm Fab Kis Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Kev Tshawb Fawb Kev Kho Mob (Inserm). Txoj kev tshawb no suav nrog 156 tus neeg mob kuaj pom tsawg dua peb xyoos dhau los uas tau txais kev kho tus qauv rau thaum ntxov -stage Parkinson's disease. Cov neeg mob tau raug muab tso tseg kom tau txais kev txhaj tshuaj subcutaneous ntawm levocetirizine ib hnub ib zaug lossis placebo rau 12 lub hlis.
Cov txiaj ntsig xav tsis thoob: Thaum kawg ntawm 12- lub hlis kho mob, cov kws tshawb fawb tau soj ntsuam cov neeg mob uas siv MDS-UPDRS Ntu III (Motor Function Score). Cov txiaj ntsig tau pom tias cov neeg mob hauv pab pawg placebo muaj 3.04 point deterioration hauv lawv cov qhab nia ntawm lub cev muaj zog (raws li kev loj hlob ntawm tus kab mob), thaum cov neeg mob hauv pab pawg tau kho nrog liraglutide tsis yog lawv cov qhab nia lub cev muaj zog tsis zoo, tab sis kuj txhim kho los ntawm 0.04 cov ntsiab lus.
Qhov tseem ceeb ntawm kev kho mob: Cov txiaj ntsig no muaj lub sijhawm- ua qhov tseem ceeb. Thawj zaug hauv kev sim tshuaj nruj nruj, nws tau pom tias cov tshuaj hypoglycemic, liraglutide, tuaj yeem ua rau qeeb qeeb ntawm cov tsos mob ntawm lub cev muaj zog hauv Parkinson tus kab mob, qhia tias nws muaj kev tiv thaiv tiag tiag ntawm dopaminergic neurons hauv lub hlwb. Txawm hais tias kwv yees li 46% ntawm cov neeg mob hauv pawg sim tau ntsib kev xeev siab raws li kev mob plab hnyuv, lub peev xwm ntawm cov tshuaj no yog qhov tsis txaus ntseeg piv rau cov txiaj ntsig loj ntawm kev ncua cov kab mob neurodegenerative.
Cov ntaub ntawv qhov chaw: The New England Journal of Medicine, Clinical trial LIXIPARK on the treatment of Early Parkinson's disease with Lisilar, Plaub Hlis Ntuj 2024
Lwm cov kev tshawb fawb muaj peev xwm
Ntxiv nrog rau cov kab mob hauv lub paj hlwb, kev tshawb fawb tseem ceeb tseem tab tom tshawb fawb txog qhov muaj peev xwm kho tau ntawm liraglutide hauv rheumatoid mob caj dab (vim nws cov tshuaj tiv thaiv- mob) thiab tsis yog- dej cawv steatohepatitis (NASH) / metabolic fatty siab kab mob (MASLD). Nws tau pom tias yuav txo tau daim siab steatosis hauv cov qauv tsiaj los ntawm kev txo cov synthesis ntawm fatty acids nyob rau hauv daim siab thiab txhawb oxidation ntawm dawb fatty acids.
Cov ntaub ntawv qhov chaw: Hepatology, Lub Hom Phiaj Kawm ntawm GLP-1 Analogs hauv NASH Kev Kho Mob, 2022
Kev ua tau zoo thiab kev sim tshuaj tseem ceeb (GetGoal series kev tshawb fawb)
Kev txhaj tshuaj lixisenatideKev ua tau zoo thiab kev nyab xeeb feem ntau tau lees paub los ntawm lub ntiaj teb loj theem III qhov kev sim tshuaj ntsuam xyuas - GetGoal series ntawm kev tshawb fawb. Txoj kev npaj them rau ntau dua 5000 tus neeg mob uas muaj hom 2 mob ntshav qab zib mellitus, thiab ntsuas nws cov txiaj ntsig zoo li ib qho tshuaj, ua ke nrog cov tshuaj hypoglycemic ntawm qhov ncauj (xws li metformin thiab sulfonylurea), thiab ua ke nrog cov tshuaj insulin.
Cov ntaub ntawv hauv qab no: Kev tshuaj xyuas dav dav ntawm ntshav qab zib, Kev rog thiab Metabolism, GetGoal series kuaj, 2015
Hauv kev sim GetGoal Mono, rau cov neeg mob uas tswj tsis tau tsuas yog los ntawm kev noj zaub mov thiab kev tawm dag zog, ib zaug kev kho mob txhua hnub nrog liraglutide rau 12 lub lis piam ua rau muaj qhov txo qis ntawm kwv yees li 0.7% mus rau 0.9% hauv glycated hemoglobin (HbA) qib piv rau cov hauv paus, nrog rau kev poob phaus. Hauv GetGoal-M mus sib hais, nws ntxiv rau metformin tom qab kev kho mob pom tau tias muaj txiaj ntsig zoo rau cov ntshav qab zib thiab poob phaus piv rau cov placebo.
GetGoal-X yog qhov qhib daim ntawv lo uas tsis yog qhov kev sim siab uas sib piv ib zaug kev tswj hwm ib hnub nrog ob zaug kev tswj hwm txhua hnub ntawm Exenatide. Cov txiaj ntsig kev tshawb fawb tau pom tias liraglutide tsis yog qis dua rau exenatide hauv kev txo HbA, thiab pab pawg liraglutide muaj kev ua haujlwm zoo dua ntawm plab hnyuv siab raum (tshwj xeeb tshaj yog txo qis ntawm xeev siab) thiab txo qis kev pheej hmoo ntawm hypoglycemia.
Cov ntaub ntawv qhov chaw: Diabetes Care, GetGoal-X, 2012
Kev ntsuam xyuas plawv thiab lub raum kev nyab xeeb (ELIXA Trial)
Rau tag nrho cov tshuaj hypoglycemic tshiab, US FDA xav kom muaj kev kuaj mob plawv (CVOT) los ua pov thawj tias cov tshuaj tsis ua rau muaj kev pheej hmoo ntawm cov kab mob plawv. Nws cov txiaj ntsig ntawm kev mob plawv yog hu ua ELIXA (Kev Ntsuas ntawm Lixsenatide hauv Acute Coronary Syndrome).
Cov ntaub ntawv qhov chaw: The New England Journal of Medicine, ELIXA trial tiav, 2015
ELIXA yog ib qho kev tshawb fawb tseem ceeb, vim tias nws tshwj xeeb nrhiav cov neeg mob uas muaj kev pheej hmoo siab plawv: 6068 cov neeg mob uas muaj ntshav qab zib hom 2 uas nyuam qhuav dhau los (hauv 180 hnub) tau tsim cov kab mob plawv (ACS, suav nrog myocardial infarction lossis tsis ruaj khov angina pectoris).
Cov ntsiab lus tseem ceeb: Plaub yam ntawm cov xwm txheej tseem ceeb hauv plawv plawv (MACE-4), suav nrog kev tuag ntawm cov hlab plawv, tsis tuag myocardial infarction, tsis mob stroke, lossis pw hauv tsev kho mob rau qhov tsis ruaj khov angina.
Cov txiaj ntsig tshawb fawb: Qhov nruab nrab ua raws- lub sijhawm nce yog 25 lub hlis. Qhov kev faib ua feem ntawm thawj qhov kawg tshwm sim tshwm sim hauv pawg no yog 13.4%, piv rau 13.2% hauv pawg placebo. Qhov phom sij txaus ntshai (HR) yog 1.02 (95% kev ntseeg siab lub sijhawm 0.89-1.17). Qhov no ua rau pom qhov kev nyab xeeb ntawm lub plawv zoo heev ntawm liraglutide hauv qhov no siab heev - cov neeg muaj kev pheej hmoo (ua tau raws li cov txheej txheem tsis zoo), txawm hais tias nws tsis tau qhia tib cov txiaj ntsig ntawm cov hlab plawv raws li qee qhov ua haujlwm ntev GLP-1 (xws li LEADER sim ntawm liraglutide) (piv txwv li, kev ua tau zoo).
Ntxiv tom qab hoc tsom xam ntawm ELIXA cov ntaub ntawv thiab cov kev tshawb fawb txog microvascular teeb meem tau pom tias nws muaj peev xwm tiv thaiv lub raum. Cov ntaub ntawv qhia tau hais tias liraglutide tuaj yeem txo qhov tshwm sim ntawm albuminuria loj heev thiab txo qhov kev loj hlob ntawm cov zis albumin / creatinine piv (UACR). Cov txiaj ntsig ntawm lub raum no tsis muaj kev ywj pheej ntawm nws cov nyhuv hypoglycemic thiab tej zaum yuav cuam tshuam rau nws cov kev tiv thaiv ncaj qha - mob, kev nyuaj siab antioxidant, thiab txhim kho lub raum hemodynamics mechanisms.
Cov ntaub ntawv qhov chaw: CJASN, Clinical Journal of the American Society of Nephrology, Riseratide tuaj yeem tiv thaiv lub raum puas hauv cov neeg mob ntshav qab zib hom 2, kev soj ntsuam thib ob raws li ELIXA cov ntaub ntawv, 2017
Hauv kev xaus, raws li luv luv -lub sij hawm GLP-1 receptor agonist thaum noj mov,Kev txhaj tshuaj lixisenatidetau ua pov thawj nws qhov muaj txiaj ntsig zoo hauv kev tswj hwm cov ntshav qabzib hloov pauv hauv cov ntshav qabzib, txo qhov hnyav, thiab tswj hwm kev nyab xeeb ntawm cov hlab plawv hauv cov neeg mob ntshav qab zib hom 2 hauv nws daim ntawv thov kho mob rau ntau tshaj 10 xyoo. Tshwj xeeb tshaj yog nws ua ke nrog insulin glargine, cov tshuaj sib xyaw ua ke Soliqua, muab cov txiaj ntsig zoo, ua raws, thiab cov kev mob tshwm sim hedging txoj kev kho mob tshiab rau cov neeg mob uas tsis muaj kev tswj hwm monotherapy.
Cov tshuaj pharmacokinetic ntsuas qhov zaus ntawm kev tswj hwm ib hnub.
Absorption: nqus sai sai tom qab txhaj tshuaj subcutaneous (feem ntau hauv plab, ncej puab, lossis sab caj npab). Lub sijhawm kom ncav cuag qhov siab tshaj plaws plasma concentration yog kwv yees li ntawm 1 thiab 3.5 teev tom qab kev tswj hwm.
Kev faib tawm: Qhov pom meej ntim ntawm kev faib tawm hauv lub cev yog kwv yees li 100 litres. Nws feem ntau muaj nyob rau hauv daim ntawv dawb hauv cov ntshav, nrog rau cov ntshav plasma protein khi tus nqi (kwv yees li 55%).
Metabolism: Raws li peptide,Kev txhaj tshuaj lixisenatideNws tsis yog metabolized los ntawm cytochrome P450 (CYP) enzyme system hauv lub siab. Nws yog tsuas yog lim hauv ob lub raum thiab feem ntau degraded los ntawm proteolytic enzymes rau hauv me me peptide ntu thiab monomeric amino acids.
Kev tshem tawm & Ib nrab lub neej: Cov khoom degradation feem ntau yog tawm los ntawm ob lub raum. Nws lub davhlau ya nyob twg tshem tawm ib nrab - lub neej luv luv, txog 3 teev. Qhov luv luv no ib nrab-lub neej ua rau nws tshwj xeeb tshaj yog haum rau kev txhaj tshuaj ua ntej noj mov tseem ceeb ntawm hnub (feem ntau yog pluas tshais lossis noj hmo) txhawm rau txhawm rau txhawm rau txhawm rau txo qis ntshav qab zib tom qab noj mov.
Cov neeg tshwj xeeb: Cov neeg mob uas mob me mus rau nruab nrab lub raum tsis txaus feem ntau tsis tas yuav hloov tshuaj, tab sis hauv cov neeg mob uas lub raum tsis txaus (creatinine tshem tawm qis dua 30 mL / min) thiab kawg - kab mob raum, kev siv levocetirizine tsis pom zoo vim txo cov tshuaj tshem tawm.
Cov ntaub ntawv qhov chaw: EMA Lyxumia pharmacokinetic evaluation report, 2013
Cov ntaub ntawv qhov chaw: FDA Adlyxin cov ntaub ntawv tshuaj, 2016
Cov hauv qab no yog cov ntaub ntawv tseem ceeb thiab cov ntaub ntawv tseeb uas tau hais thaum lub sijhawm sau ntawv ntawm tsab xov xwm no:
1. Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Ntiaj Teb (WHO): Cov ntaub ntawv sau npe ntawm Lixisenatide hauv Daim Ntawv Teev Npe Thoob Ntiaj Teb ntawm Cov Tshuaj Tsis Muaj Cai (INN).
2. European Medicines Agency (EMA): 2013 Public Evaluation Report (EPAR) - Lyxumia, npog cov kev tshawb fawb thiab kev loj hlob keeb kwm, pharmacokinetics, siv nyob rau hauv cov neeg tshwj xeeb, thiab cov ntaub ntawv ntawm kev loj hlob toxicity ntawm Lysimab.
3. US Food and Drug Administration (FDA): 2016 Adlyxin cov lus qhia tshuaj thiab cov ntaub ntawv sau tshuaj, suav nrog kev siv thiab ntau npaum li cas, qhov tshwm sim ntawm kev phiv tshuaj (xws li xeev siab), contraindications, thiab cov ntaub ntawv ceeb toom kev nyab xeeb tom qab kev lag luam.
4. National Medical Products Administration (NMPA): Suav cov lus qhia tshuaj thiab cov lus qhia kev kho mob rau Soliqua (insulin glargine txhaj).
5. PubChem: Compound Database (CID: 56841944/CAS: 320367-13-3) muab cov tshuaj formula meej, amino acid sequence, thiab cov ntaub ntawv txheeb ze molecular hnyav rau Liragliflozin.
6. Phau ntawv Journal of Medicinal Chemistry: Ib txoj kev tshawb fawb luam tawm xyoo 2014 ntawm kev hloov kho cov qauv ntawm GLP-1 analogs tau muab cov tshuaj siv tshuaj los ntawm poly-Lysine tail resists DPP-4 degradation.
7. Molecular Endocrinology: Cov ntaub ntawv luam tawm xyoo 2012 uas muab cov ncauj lus kom ntxaws txog cov piam thaj hauv cov tshuaj insulin secretion uas ua rau muaj kev nce qib ntawm cAMP thiab intracellular calcium tso tawm tom qab GLP-1 khi rau receptors.
8. Lancet diabetes&Endocrinology: Ib txoj kev tshawb fawb sib piv luam tawm xyoo 2015 tau lees paub qhov tseem ceeb ntawm cov tshuaj pharmacodynamic sib txawv ntawm luv-lub sij hawm thiab ntev-lub sij hawm GLP-1 RA hauv plab hnyuv plab thiab kev tswj ntshav qab zib tom qab.
FAQ
Cov tshuaj lixisenatide siv rau dab tsi?
Kev txhaj tshuaj lixisenatide yog siv los kho mob ntshav qab zib hom 2. Lixisenatide yog siv ua ke nrog kev noj haus thiab kev tawm dag zog los pab tswj koj cov ntshav qab zib. Cov tshuaj no yog glucagon-zoo li peptide-1 (GLP-1) receptor agonist. Cov tshuaj no tsuas muaj nyob nrog koj tus kws kho mob cov tshuaj.
Puas yog lixisenatide raug txiav tawm?
Lixisenatide (Lyxumia®) 10 microgram thiab lixisenatide pib kho pob khoom (10 microgram thiab 20 microgram) tau txiav tawm. Qhov no txhais tau tias tsis muaj cov neeg mob tshiab tuaj yeem pib ntawm lixisenatide.
Cim npe nrov: Lixisenatide txhaj tshuaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom