Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm alarelin peptide hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo aarelin peptide muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Alarelin peptideyog ib qho hluavtaws nonapeptide gonadotropin- tso cov tshuaj hormone agonist (GnRH-a) nrog cov mis molecular C₅₆H₇₈N₁₆O₁₂ thiab molecular hnyav ntawm 1167.3. Nws tau raug tsim los ntawm cov khoom siv -theem peptide synthesis, nthuav tawm siab receptor-binding affinity thiab metabolic stability. Nws pom tau tias muaj txiaj ntsig zoo hauv kev kho mob endometriosis thiab uterine fibroids. Tsis tas li ntawd, nws inhibits kev loj hlob ntawm cov qog nqaij hlav endometrial los ntawm kev tswj cov TGF- /Smad signaling pathway, uas qhia ntau - phiaj antitumor muaj peev xwm.
Peb Cov Khoom Muag Khoom
Alarelin COA
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| Certificate of Analysis | ||
| Compound npe | Alarelin | |
| Qib | Pharmaceutical qib | |
| CAS Nr. | 79561-22-1 | |
| Ntau | 42g | |
| Ntim txheem | PE hnab + Al foil hnab | |
| Chaw tsim tshuaj paus | Shaanxi BLOOM TECH Co., Ltd | |
| Ntau No. | 202601090056 | |
| 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% | 1.11% |
| Poob rau ziab | Tsawg dua lossis sib npaug li 1.0% | 0.51% |
| 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% | 0.47% |
| Tag nrho microbial suav | Tsawg dua lossis sib npaug li 750cfu / g | 547 |
| 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 | 712 pwm |
| Cia | Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab -20 degree | |
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Daim ntawv thov hauv Central Precocious Puberty (CPP)
Central precocious puberty (CPP) tshwm sim los ntawm kev ua kom ntxov ntxov ntawm hypothalamic-pituitary-gonadal (HPG) axis, ua rau kev loj hlob ntawm cov yam ntxwv ntawm kev sib deev ua ntej hnub nyoog 8 xyoo hauv cov ntxhais thiab 9 xyoo hauv cov tub hluas, nrog rau cov pob txha laus thiab cov epiphyseal kaw ntxov ntxov, thaum kawg ua rau cov neeg laus muaj kev ntxhov siab. Raws li tus neeg sawv cev hauv tsev GnRH-a,alarelin peptide tshuajyog thawj - kab kev kho rau CPP, tsom rau cov txheej txheem tseem ceeb ntawm tus kab mob.
(1) Core Clinical Scenarios
Ua ntej - kab kev kho mob rau idiopathic CPP: Tom qab tsis suav nrog lwm yam ua rau xws li qog nqaij hlav hauv nruab nrog cev thiab cov qog adrenal hyperplasia, idiopathic CPP suav rau feem ntau ntawm cov menyuam yaus hnub nyoog laus dua. Nws tsis tu ncua suppresses pituitary LH thiab FSH secretion, sai txo estradiol thiab testosterone kom ua ntej - qib pubertal thiab halting qhov kev loj hlob ntawm kev sib deev yam ntxwv theem nrab.
Kev cuam tshuam ntawm pob txha hnub nyoog thiab kev tiv thaiv rau cov neeg laus qhov siab: Rau cov menyuam yaus uas muaj qhov qhib epiphyses thiab qhov muaj peev xwm loj hlob ntxiv, nws ua rau cov pob txha loj hlob qeeb thiab qeeb epiphyseal kaw, ncua lub qhov rais loj hlob. Cov ntaub ntawv kho mob qhia tau tias tus qauv kev kho mob 1 xyoo txwv cov pob txha muaj hnub nyoog nce mus txog kwv yees li 6 lub hlis, txhim kho cov neeg laus qhov siab.
Cov Ntaub Ntawv Keeb Kwm: Hunan Pharmaceutical Affairs Service Network, Alarelin Injection Package Insert; Suav Phau ntawv Journal ntawm Pediatrics, Cov Lus Qhia rau Kev Ntsuas thiab Kev Tswj ntawm Central Precocious Puberty (2015 Edition); Biotechnology Bulletin, Advances in GnRH-ib daim ntawv thov hauv Central Precocious Puberty
Daim ntawv thov hauv Assisted Reproductive Technology (ART)
Lub hauv paus ntawm ART (suav nrog hauv vitro fertilization-embryo hloov [IVF-ET] thiab intracytoplasmic phev txhaj [ICSI]) yog tswj zes qe menyuam hyperstimulation (COH). Los ntawm pituitary downregulation, nws tiv thaiv ntxov ntxov endogenous LH surges, ua kom synchronous follicular txoj kev loj hlob, thiab yields txaus siab - zoo oocytes. Nws yog ib qho tseem ceeb ntawm kev tswj hwm tus neeg sawv cev hauv ART, muaj feem xyuam rau cov txheej txheem kev txhawb nqa loj thiab ntau yam kev xeeb tub.
(1) Downregulation hauv Tswj Ovarian Hyperstimulation
Kev txo qis hauv cov txheej txheem ntev (cov ntawv thov tseem ceeb): Cov txheej txheem ntev yog IVF classic-ET kev tswj hwm. Nws feem ntau yog siv rau hnub 21 ntawm kev coj khaub ncaws (nruab nrab- luteal theem) kom ua tiav pituitary downregulation. Nws lub luag haujlwm tseem ceeb suav nrog: txo qis LH qhov zais cia kom tsis txhob muaj luteinization ntxov ntxov thiab lub voj voog tshem tawm los ntawm LH ntxov ntxov; synchronizing follicular kev loj hlob los txhim kho follicular uniformity tom qab FSH / HMG stimulation thiab nce oocyte tawm los. Cov ntaub ntawv kho mob qhia tau hais tias oocyte suav thiab siab -zoo embryo tus nqi yog sib piv ntawm cov khoom ntev raws tu qauv thiab imported triptorelin, thaum tus nqi kho mob txo los ntawm 30%–40%.
Ovulation induction rau folliculogenesis thiab ovulatory dysfunction: Rau infertility vim me me - follicle ovulation, polycystic ovary syndrome (PCOS), thiab lwm yam ovulatory ntshawv siab, cov khoom ua ke nrog HMG ho txhim kho follicle zoo. Cov kev tshawb fawb pom tau hais tias cov pab pawg ua ke muaj qhov loj tshaj plaws follicle txoj kab uas hla ntawm HCG hnub, ntau cov follicles Ntau dua lossis sib npaug li 14 hli, siab dua qhov kev kuaj mob cev xeeb tub (nce ntawm 9.6% mus rau 22.4%), 60% qis dua LH surge tus nqi, thiab txo qis lub voj voog tshem tawm, nchuav menyuam, thiab OMG hyperstimulation.
(2) Cov xwm txheej hloov kho tshwj xeeb hauv Kev Pab Txhawb Kev Tsim Kho
Optimized tiv thaiv ntawm OHSS: OHSS yog ib qho teeb meem loj ntawm zes qe menyuam stimulation. Los ntawm kev inhibiting LH secretion, txo cov neeg ua haujlwm hauv follicle ntau dhau thiab tso tawm vasoactive, nws ua ke nrog qis - koob tshuaj FSH txwv qis nruab nrab - mus rau - OHSS hnyav rau qis dua 1%. Rau siab- cov neeg mob uas muaj kev pheej hmoo (PCOS, cov poj niam cev xeeb tub), cov txheej txheem "coasting" (txiav FSH thaum txuas ntxiv alarelin) tom qab kev tswj xyuas kom tsis txhob muaj tus lej follicle thiab txo OHSS kev pheej hmoo.
Kev tswj hwm ntawm kev cog qoob loo rov qab tsis ua haujlwm: Hauv cov neeg mob uas rov ua lub embryo implantation tsis ua haujlwm, cov khoom lag luam txo qis cov tshuaj estrogen hauv cov txheej txheem los txhim kho endometrial receptivity (modulating thickness, morphology, thiab implantation- ntsig txog qhov qhia). Nws kuj tseem txwv tsis pub cov tshuaj tiv thaiv kab mob tsis zoo thiab txo qis hauv zos endometrial inflammatory cytokines, tsim kom muaj qhov chaw ruaj khov rau embryo implantation thiab nce kev kuaj mob cev xeeb tub.
Kev npaj endometrial rau khov -thawed embryo hloov chaw (FET): Hauv kev tsim khoom- voj voog FET,Alarelin peptideinduces pituitary downregulation los suppress endogenous follicle txoj kev loj hlob, ua endometrial kev loj hlob tag nrho nyob ntawm exogenous estrogen thiab progesterone. Qhov no synchronizes endometrial thiab embryonic txoj kev loj hlob, haum rau FET cycles nyob rau hauv cov neeg mob endometriosis thiab adenomyosis.
Cov ntaub ntawv pov thawj: ChemicalBook, Clinical Application and Pharmacological Research of Alarelin Acetate; VIP Journals, Daim Ntawv Thov Hloov Kho Alarelin Ntev raws tu qauv hauv IVF-ET; Phau ntawv Journal ntawm Xuzhou Medical University, Sib piv ntawm Alarelin thiab Triptorelin hauv Cov Txheej Txheem luv rau Kev Tswj Ovarian Hyperstimulation
Muaj peev xwm thov hauv Gastric Acid Secretion Inhibition
Cov nyhuv inhibitory ntawm cov khoom ntawm gastric acid secretion yog ib qho chaw tshawb fawb tshiab hauv peptide kho. Nws tswj cov kua qaub tso tawm los ntawm lub hauv nruab nrab thiab sab hauv ob lub tshuab, uas qhia txog qhov muaj txiaj ntsig ntawm cov kua qaub- cuam tshuam nrog cov kab mob gastroesophageal reflux (GERD), peptic ulcer, thiab Zollinger-Ellison syndrome. Kev tshawb fawb tam sim no nyob rau theem preclinical thiab thaum ntxov.
(1) Mechanisms ntawm Gastric Acid Inhibition
Central neural regulation: Cov khoom hla cov ntshav-hlwb thaiv kev ua haujlwm ntawm hypothalamus, inhibiting vagal efferent impulses thiab txo acetylcholine (ACh) tso tawm - ib qho tseem ceeb neurotransmitter stimulating parietal cell acid secretion. Los ntawm thaiv vagovagal reflexes, nws txo qis basal thiab postprandial peak acid tso zis, tshwj xeeb tshaj yog haum rau hypersecretion tshwm sim los ntawm kev nce neural excitability (xws li, kev ntxhov siab rwj, ntxhov siab vim-txog reflux).
Peripheral direct inhibition: Cov khoom lag luam ua ncaj qha rau ntawm lub plab parietal hlwb los ntawm kev sib tw rau kev ua haujlwm ntawm GnRH receptors qhia rau ntawm lawv qhov chaw, inhibiting H⁺/K⁺-ATPase (proton twj tso kua mis) kev ua thiab thaiv cov kauj ruam kawg ntawm cov kua qaub secretion. Nws kuj tseem txo qis kev tso tawm ntawm cov kua qaub- txhawb nqa yam xws li gastrin thiab histamine, txo cov tshuaj histamine tso tawm los ntawm enterochromaffin-zoo li (ECL) hlwb thiab gastrin los ntawm G hlwb, ua tiav ntau- lub hom phiaj acid suppression.
(2) Muaj peev xwm kho mob daim ntawv thov
Gastroesophageal Reflux Disease (GERD): GERD yog tus cwj pwm los ntawm kev raug mob ntawm esophageal mucosal los ntawm acid reflux. Nws txo qhov ntim ntawm gastric acid thiab elevates intragastric pH, txo acidic irritation ntawm refluxate. Nws qhov mob me me thiab muaj zog acid inhibition tsis muaj qhov ua siab ntev cuam tshuam nrog proton twj tso kua mis inhibitors (PPIs), ua rau nws tsim nyog rau lub sijhawm ntev - kho mob me me - mus rau -mob GERD lossis PPI - cov neeg mob tsis haum.
Peptic Ulcer (Gastric thiab Duodenal Ulcer): Rau mucosal raug mob los ntawm gastric hypersecretion, cov khoom inhibits basal thiab maximal acid tso zis los txhawb ulcer kho. Tsiaj cov kev tshawb fawb pom tau hais tias cov hlab ntsha los yog intragastric alarelin (2 ug / kg) txo cov kua qaub hauv plab los ntawm 60% -70% thiab ua rau cov kab mob rhiab heev ntawm 50% hauv cov nas, tsis muaj qhov cuam tshuam loj ntawm plab hnyuv.
Zollinger-Ellison Syndrome: Cov tsos mob no cuam tshuam nrog kev ua kom tsis muaj zog vim yog gastrin ntau dhau los ntawm gastrinomas, feem ntau xav tau siab - koob tshuaj PPI nrog kev ua siab ntev.
Nws tswj intractable hypersecretion ntawm dual central thiab peripheral inhibition ntawm gastrin secretion thiab parietal cell kev ua, ua hauj lwm raws li ib tug ua ke kev kho mob los txhim kho kev ua tau zoo.
Kev Tiv Thaiv Kab Mob Kev Nyuaj Siab: Rau cov neeg mob hnyav (kev raug mob craniocerebral, kub hnyiab, kev phais loj) nrog kev ntxhov siab- ua rau lub plab zom mov, nws ua kom muaj zog neuroendocrine thiab inhibits vagal hyperactivity los tiv thaiv kev ntxhov siab los ntshav. Nws cov qauv peptide muab kev nyab xeeb siab yam tsis muaj lub siab lossis lub raum toxicity, haum rau lub cev tsis muaj zog ntawm cov neeg mob hnyav.
Cov Ntaub Ntawv Keeb Kwm: GDE Chem, Kev Ua Txhaum Cai thiab Kev Nyuaj Siab Gastric Acid Inhibition ntawm Alarelin Acetate; PubMed, Kev Tshawb Fawb Sib piv ntawm Kev Tiv Thaiv Acid los ntawm Alrestatin thiab GnRH-Agents
Cov kua qaub-suppressive nyhuv ntawmalarelin peptide tshuajtau raug lees paub hauv cov qauv nas: kev tswj hwm intragastric siv sijhawm li 15 feeb, nce siab ntawm 60 feeb, thiab kav 4-6 teev. Intravenous tswj yields 100% bioavailability, nrog kev ua tau zoo piv rau cimetidine tab sis tsis muaj anti-androgenic thiab hepatic enzyme inhibitory los ntawm H2-receptor antagonists. Cov kev tshawb fawb preclinical qhia tias tsis muaj kev puas tsuaj rau plab hnyuv thiab txhim kho cov ntshav ntws mus rau hauv lub cev, sib txuas cov kua qaub nrog kev tiv thaiv mucosal.
Cov lus qhia txog kev txhim kho yav tom ntej muaj xws li: ntev- ua kom ruaj khov- tso tawm cov qauv (microspheres, liposomes) kom ntev mus rau 12-24 teev ib zaug- noj txhua hnub; Qhov ncauj peptide xa khoom thev naus laus zis los txhim kho plab hnyuv ruaj khov thiab hloov cov tshuaj kom ua raws li kev ua tau zoo dua; thiab kev tshawb fawb kev sib xyaw ua ke nrog PPIs thiab cov tshuaj tiv thaiv mucosal txhawm rau nthuav dav cov txheej txheem rau cov kua qaub refractory- ntsig txog kab mob.
Cov Ntaub Ntawv Keeb Kwm: Suav Pharmacological Bulletin: Kev Ua Ntej Hauv Kev Siv Tshuaj Peptide Hauv Cov Kabmob Kabmob Cov Kabmob Hauv Cov Kabmob Endocrinology: Gastrointestinal Hormones thiab Regulatory Mechanisms of Gastric Acid Secretion
Contraindications
Cov poj niam cev xeeb tub (yuav ua rau kom rho menyuam)
Cov poj niam cev xeeb tub (cov tshuaj tau tawm hauv cov kua mis thiab tuaj yeem ua mob rau cov menyuam mos)
Cov neeg mob uas tsis tau piav qhia qhov chaw mos los ntshav
Cov neeg mob hypersensitive rau GnRH lossis nws cov analogues
Cov ntaub ntawv Sources: Suav Pharmocopoeia Commission,Clinical Medicine Guidelines; Yaoyuan.com
Tshawb nrhiav keeb kwm thiab keeb kwm
Kev tshawb fawb thiab kev loj hlob ntawm Alarelin pib thaum xyoo 1970s, txhawb nqa los ntawm kev nce qib thoob ntiaj teb hauv kev tshawb fawb ntawm GnRH (Gonadotropin-Tshuaj Hormone). Xyoo 1971, Asmeskas cov kws tshawb fawb Andrew Schally thiab Roger Guillemin tau ua tiav cais thiab txheeb xyuas cov qauv ntawm ntuj GnRH, tso lub hauv paus rau kev txhim kho GnRH analogs. Kev tshoov siab los ntawm qhov kev ua tiav no, pab pawg tshawb fawb Suav tau pib ua cov kev tshawb fawb pioneering ntawm kev sib txuas ntawm GnRH analogs hauv xyoo 1973-1974, qeb duas ntawm cov pab pawg tshawb fawb ntxov tshaj plaws thoob ntiaj teb los tshawb txog daim teb no.
Kev hloov kho cov qauv thiab cov khoom sib xyaw ua ke
Nyob rau hauv nruab nrab -1970s, los daws qhov tsis txaus ntawm ntuj GnRH- luv ib nrab- lub neej thiab muaj kev pheej hmoo siab rau enzymatic degradation- pab pawg tshawb fawb tau ua cov kev hloov pauv tseem ceeb raws li nws cov qauv nonapeptide: glycine ntawm txoj hauj lwm 6}} thiab C {8} terminal {8}, Ethylaminated rau optimization. Cov kev hloov pauv no ua rau muaj txiaj ntsig zoo rau kev sib txuas ntawm receptor-binding affinity thiab nyob rau hauv vivo stability, boost nws biological kev ua si rau ntau tshaj 15 npaug ntawm natural GnRH. Xyoo 1974, thawj tag nrho cov tshuaj synthesis ntawm cov khoom tau ua tiav raws li kev coj noj coj ua ntawm Shanghai Institute of Biochemistry, Suav Academy ntawm Sciences. Cov tshuaj tau hu ua "Bing'anruilin" hauv Suav, nrog rau lub npe thoob ntiaj teb uas tsis yog tswv cuab Alarelin.
Clinical Translation thiab Marketing History
Thaum xyoo 1980s thiab 1990s, kev tshawb fawb hauv tsev tau ua tiav cov tshuaj pharmacological, tshuaj lom neeg, thiab kev soj ntsuam kev soj ntsuam ntawm cov khoom, tshawb xyuas nws txoj kev nyab xeeb thiab kev ua tau zoo hauv kev kho mob ntawm precocious puberty, pab kev ua me nyuam, thiab lwm yam kev qhia. Xyoo 1998, Alarelin API thiab nws cov kev npaj txhaj tshuaj tau pom zoo los ntawm Ministry of Health ntawm Tuam Tshoj (Kev Pom Zoo Nos. (98) WSYSZ X-38 thiab X-39). Kev tsim khoom lag luam tau paub los ntawm Shanghai Livzon Dongfeng Biotechnology Co., Ltd., ua Alarelin thawj lub tsev tsim thiab muag GnRH-peptide tshuaj hauv Suav teb.
Cov Ntaub Ntawv Keeb Kwm: Anhui Kev Kho Mob thiab Pharmaceutical Journal, Qhov Teeb Meem 3, 1999, Kev Txhim Kho thiab Kev Siv Gonadotropin-Tshuaj Hormone thiab Nws Cov Analogs; Daim ntawv ceeb toom rau pej xeem txog kev pom zoo tshuaj tshiab los ntawm Ministry of Health, 1998 (Baimu Medical Network)
FAQ
Dab tsi yog qhov txiaj ntsig ntawm alarelin acetate?
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Alarelin acetate (AA), ib qho hluavtaws nonapeptide gonadotropin - tso cov tshuaj hormone (GnRH) analogue,induces reversible hypogonadism los ntawm pituitary desensitization, ua rau nws zoo rau endometriosis thiab cov tshuaj hormones -nyob ntawm cov qog nqaij hlav .
Cim npe nrov: alarelin peptide, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom