Cov khoom
Kev txhaj tshuaj Ziconotide
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Kev txhaj tshuaj Ziconotide

Kev txhaj tshuaj Ziconotide

1. General Specification (hauv Tshuag)
(1) API (Ntshiab hmoov)
(2) Txhaj tshuaj
(3) Tablet
2.Customization:
Peb yuav sib tham tus kheej, OEM / ODM, Tsis muaj hom, rau kev tshawb nrhiav kev ruaj ntseg nkaus xwb.
PIB: BM-3-145
Ziconotide CAS 107452-89-1
Chaw tsim tshuaj paus: BLOOM TECH Wuxi Hoobkas
Kev tshuaj xyuas: HPLC, LC-MS, HNMR
Lub khw tseem ceeb: Tebchaws Asmeskas, Australia, Brazil, Nyiv, Lub Tebchaws Yelemees, Indonesia, UK, New Zealand, Canada thiab lwm yam.
Kev them nyiaj yug Technology: R&D Dept.-4

Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm ziconotide txhaj tshuaj hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo ziconotide txhaj rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.

 

Cov khoom xyaw nquag ntawmkev txhaj tshuaj ziconotideyog ziconotide, ib tug hluavtaws ω-conotoxin Ameslikas cais thiab muab rho tawm los ntawm cov venom ntawm marine cone snails thiab chemically hloov los tsim ib tug txhaj tshuaj formulation. Nws muaj qhov hnyav molecular ntawm 2639.15 thiab CAS tus lej ntawm 107452-89-1. Cov txheej txheem ntawm kev ua ntawm ziconotide yog txawv kiag li ntawm cov tshuaj opioids: es tsis txhob ua rau opioid receptors, nws exerts analgesic nyhuv los ntawm kev xaiv thaiv N-hom calcium channels nyob rau hauv lub hauv paus paj hlwb.

Peb Cov Khoom Muag Khoom

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Method of Analysis

Ziconotide Polyacetate COA

Shaanxi BLOOM Tech Co., Ltd
Certificate of Analysis
Compound npe Ziconotide Polyacetate
Qib Pharmaceutical qib
CAS Nr. 107452-89-1
Ntau 30g
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

Ziconotide structure | Shaanxi BLOOM Tech Co., Ltd

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% 0.54%
Poob rau ziab Tsawg dua lossis sib npaug li 1.0% 0.42%
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% 99.98%
Ib leeg impurity <0.8% 0.52%
Tag nrho microbial suav Tsawg dua lossis sib npaug li 750cfu / g 95
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 500ppm ua
Cia Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab -20 degree

Ziconotide NMR | Shaanxi BLOOM Tech Co., Ltd

Shaanxi BLOOM Tech Co., Ltd

Chemical Formula: C97H170N34O30S5
Exact Mass: 2511
Molecular Luj: 2513
m/z: 2511 (100.0%), 2513 (95.3%), 2511 (40.8%), 2513 (22.6%),2511 (21.5%), 2454 (17.2%), 2453 (12.6%), 2452 (12.0%), 2455 (11.7%), 2453 (11.2%), 2454 (6.5%), 2454 (6.2%), 2453 (5.9%), 2455 (4.5%), 2453 (4.0%), 2456 (3.9%), 2452 (3.8%), 2455 (2.8%), 2454 (2.7%), 2455 (2.5%), 2456 (2.0%), 2453 (2.0%), 2455 (1.9%), 2452 (1.9%), 2454 (1.6%), 2456 (1.5%), 2455 (1.4%), 2456 (1.4%), 2455 (1.3%), 2453 (1.1%), 2452 (1.1%), 2456 (1.1%), 2457 (1.0%)
Elemental Analysis: C, 47.50; H, 6.99; N, 19.42; O, 19.57; S, 6.54

Applications-

 

Mob qog noj ntshav yog ib qho ntawm cov tsos mob tshwm sim hauv cov neeg mob uas mob qog noj ntshav siab, ua rau cov neeg mob lub neej tsis zoo, kev kho mob, thiab kev ciaj sia. Raws li tus tshiab non-opioid analgesic,Kev txhaj tshuaj Ziconotideqhia tau hais tias muaj txiaj ntsig zoo hauv kev kho mob qog noj ntshav refractory vim nws cov txheej txheem tshwj xeeb ntawm kev ua haujlwm, kev ua kom lub cev muaj zog, thiab tsis muaj peev xwm tsim txom, ua ib qho tseem ceeb ntxiv rau kev kho mob analgesic.

Daim ntawv thov tus nqi hauv Refractory Cancer Mob

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(I) Lub Hom Phiaj Muaj Peev Xwm Muaj Peev Xwm Muaj Peev Xwm thiab Cov Lus Qhia Siab

Cov khoom no tau qhia rau cov neeg mob uas mob cancer refractory uas nws qhov mob tsis txaus tswj tau (Visual Analogue Scale, VAS Ntau dua lossis sib npaug li 5) txawm tias tus qauv kho opioid, lossis leej twg tsis tuaj yeem tiv taus cov tshuaj tiv thaiv opioid (piv txwv li, kev nyuaj siab ua pa hnyav, cem quav, xeev siab thiab ntuav). Nws yog tshwj xeeb tshaj yog haum rau cov neeg mob uas muaj concomitant neuropathic mob cancer, uas suav rau ntau tshaj 50% ntawm refractory mob cancer mob.Neuropathic mob cancer muaj ib tug complex pathogenesis, feem ntau yog tshwm sim los ntawm qog invasion ntawm qab haus huv, chemotherapy-los yog radiotherapy-induced paj raug mob, thiab manifests li kub hnyiab, zoo li hluav taws xob stabbing-stabbing. tshuaj opioids.

Cov khoom lag luam muab cov cim ua rau mob rau hom mob no.Cov kev tshawb fawb pom tau tias intrathecal infusion ntawm nws zoo txo cov qhab nia ntawm qhov mob thiab txhim kho kev pw tsaug zog thiab kev ua neej zoo nyob rau hauv cov neeg mob uas mob cancer refractory uas yog opioid-tolerant los yog tsis teb rau opioids.A case series ntawm 8 cov neeg mob uas muaj refractory mob cancer (5 nrog concomitant) qhov mob tseem ceeb hauv cov neeg mob 5 hnub. Tom qab kev tswj hwm intrathecal ntawm ziconotide ua ke nrog morphine. Ib tus neeg mob uas tsis tuaj yeem teb rau fentanyl tseem ua tiav kev tswj xyuas qhov mob zoo tom qab rov pib kho ziconotide, lees paub nws tus nqi hauv cov neeg mob tsis teb rau opioids.

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(II) Cov txiaj ntsig tseem ceeb ntawm cov tshuaj loog thiab cov khoom tsis muaj yees

Lub zog muaj zog ntawm nws yog piv rau cov tshuaj morphine thiab txawm tias zoo dua hauv qee cov neeg mob, nrog rau kev noj tshuaj raws li kev noj tshuaj analgesic; Qhov zoo tshaj plaws analgesia tuaj yeem ua tiav los ntawm kev siv tshuaj titration qeeb. Ntau cov kev tshawb fawb soj ntsuam tau lees paub tias qhov intrathecal infusion ntawm nws txo cov qhab nia ntawm qhov mob ntau dua 30% hauv cov neeg mob uas muaj mob qog noj ntshav, nrog rau qhov mob ntau dua 70% hauv qee tus neeg. Nyob rau hauv ib qho randomized, ob-dig muag, tshuaj placebo-tshuaj ntsuam xyuas nrog rau 169 tus neeg mob uas mob hnyav heev (xws li cov neeg mob cancer refractory), kev kho mob ziconotide txo qhov qhab nia VAS los ntawm 31.2%, piv nrog tsuas yog 6.0% hauv pawg placebo, sawv cev rau qhov sib txawv tseem ceeb tshaj li 010).

Piv nrog rau opioids, qhov tseem ceeb tshaj plaws kom zoo dua ntawmkev txhaj tshuaj ziconotideyog nws tsis muaj peev xwm tiv thaiv tau. Nws tsis ua rau opioid receptors, tsis ua rau lub cev lossis kev puas siab puas ntsws dependence, thiab tsis ua rau tshem tawm cov tsos mob, tso cai rau kev siv mus sij hawm ntev. Qhov no tshwj xeeb tshaj yog tseem ceeb heev rau cov neeg mob qog noj ntshav uas xav tau kev tso tshuaj ntev ntev, vim nws zam kev txom nyem ntxiv thiab kev kho mob cuam tshuam nrog kev quav yeeb tshuaj. Tsis tas li ntawd, cov tshuaj tsis ua rau kev nyuaj siab ua pa, muab kev nyab xeeb dua rau cov neeg mob uas muaj mob qog noj ntshav refractory thiab ua pa tsis txaus, tsis muaj kev pheej hmoo ntawm kev ua pa ua pa tsis ua haujlwm.

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(III) Kev sib xyaw ua ke nrog lwm cov tshuaj loog txhawm rau txhim kho cov txiaj ntsig kho mob

Hauv kev tswj hwm ntawm qhov mob qog noj ntshav refractory, monotherapy feem ntau tsis ua tiav qhov kev ua kom zoo tshaj plaws, ua kev sib xyaw ua ke yog ib lub tswv yim zoo. Cov khoom siv tuaj yeem siv ua ke nrog opioids, tshuaj loog hauv zos (piv txwv li, bupivacaine), thiab lwm yam tshuaj tua kab mob los tsim cov tshuaj analgesia, txo cov tshuaj noj ib tus neeg, thiab txo qis qhov tshwm sim ntawm qhov tshwm sim tsis zoo.

Cov kev tshawb fawb soj ntsuam pom tau tias cov tshuaj ziconotide qis ua ke nrog intrathecal morphine sai tswj cov mob qog noj ntshav opioid-refractory thaum txo cov tshuaj morphine thiab nws cov kev cuam tshuam tsis zoo xws li cem quav thiab ua pa nyuaj siab. Ib rooj plaub ntawm 8 tus neeg mob uas mob qog noj ntshav tau qhia tias txhua tus neeg mob tau ua tsis tiav ua ntej intrathecal morphine ntxiv rau bupivacaine txoj kev kho, tab sis ua tiav qhov mob zoo tom qab kev kho mob ntxiv ntawm ziconotide pib ntawm 0.5-1.0 ug / hnub thiab titrated nce siab los ntawm 0.5 ug txhua 4-7 hnub (ntau tshaj li 0. Morphine ntau npaum li cas kuj raug txo, lees paub qhov ua tau zoo thiab kev nyab xeeb ntawm kev sib xyaw ua ke.

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Cov ntaub ntawv qhov chaw: Intrathecal Ziconotide thiab Morphine rau Kev Kho Mob: Ib Kab Mob ntawm yim tus neeg mob uas mob qog noj ntshav, suav nrog tsib kis mob neuropathic; Intrathecal ziconotide nyob rau hauv kev kho mob ntawm cov mob uas tsis yog-malignant: ib qho randomized, ob-dig muag, placebo-controlled soj ntsuam kuaj.

 

Development prospects

Kev Tshawb Fawb Kev Tshawb Fawb Kev Tshawb Fawb thiab Daim Ntawv Thov Kev Pom Zoo

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(I) Kev Tshawb Fawb Txog Kev Tshawb Fawb

Hauv xyoo tas los no, ntau qhov kev tshawb fawb hauv tsev thiab thoob ntiaj teb tau tshawb xyuaskev txhaj tshuaj ziconotiderau refractory mob cancer, ntxiv validating nws analgesic efficiency thiab kev nyab xeeb. Ib txoj kev tshawb fawb multicenter, randomized, ob-dig muag, placebo-tswj txoj kev kawm sau npe 457 cov neeg mob uas mob hnyav heev (xws li mob qog noj ntshav refractory), randomized rau ziconotide (268 tus neeg mob) lossis placebo (189 tus neeg mob) nrog qeeb koob tshuaj titration rau 21 hnub.

Cov pab pawg ziconotide tau pom tias qhov mob tau txo qis ntawm 12%, piv nrog 5% hauv cov placebo pab pawg (cov ntaub ntawv tseem ceeb), nrog rau qhov tshwm sim tsis zoo tshwm sim ntau dua li kev titration sai.Cov pov thawj hauv ntiaj teb kuj txhawb nws txoj kev siv tshuaj kho mob. Ib qho 18-hli lub neej yav tom ntej, kev tshawb nrhiav ntau qhov chaw (PRIZM Registry) suav nrog 93 tus neeg mob uas muaj mob hnyav kho nrog intrathecal ziconotide. Kev ntsuam xyuas los ntawm Numeric Pain Rating Scale (NPRS) tau qhia txog kev txo qhov mob tseem ceeb ntawm 12 lub lis piam thiab muaj txiaj ntsig zoo rau kev nyab xeeb mus sij hawm ntev, lees paub nws tus nqi hauv kev mob ntev ntev.

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Tsis tas li ntawd, kev tshawb fawb txog kev mob qog noj ntshav neuropathic qhia ziconotide muab kev pab zoo dua piv nrog cov tshuaj opioids, muab kev xaiv zoo dua rau cov neeg mob no.

Kev tshawb fawb tsis tu ncua yog tshawb nrhiav kev kho kom zoo dua qub, suav nrog cov tswv yim sib xyaw ua ke thiab ib tus neeg siv tshuaj titration, txhawm rau txhim kho kev mob analgesia thiab txo qis qhov tsis zoo. Kev tshawb fawb hauv cov neeg tshwj xeeb (xws li, cov neeg mob laus, cov neeg mob siab lossis lub raum tsis zoo) tseem tab tom ua los txhawb kev kho tus kheej.

(II) Daim Ntawv Thov Kev Pom Zoo

Nrog kev thov nce ntxiv rau kev tswj kev mob qog noj ntshav, cov khoom lag luam, raws li cov tshuaj tsis muaj tshuaj opioid tshiab, muaj kev cia siab dav dav. Ntawm qhov tod tes, nws cov txheej txheem tshwj xeeb ua rau nws yog qhov tseem ceeb hauv kev xaiv kho mob rau cov neeg mob uas muaj opioid kam rau ua lossis tsis teb, ua rau qhov sib txawv ntawm qhov chaw kho mob thiab txhim kho lub neej zoo. Ntawm qhov tod tes, nws cov khoom tsis muaj tshuaj lom thiab tsis ua pa-kev nyuaj siab txo qis cov xwm txheej tsis zoo thiab kev pheej hmoo kho mob, tshwj xeeb tshaj yog rau cov neeg mob ua pa tsis txaus lossis muaj kev pheej hmoo ntxiv rau kev quav yeeb quav tshuaj.Raws li kev tshawb fawb soj ntsuam, nws yuav muaj peev xwm ua tau ntxiv rau cov kab mob qog noj ntshav tshwj xeeb, nrog rau kev kho kom zoo thiab nthuav dav.

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Lub caij no, kev txais yuav dav dua thiab kev ua qauv ntawm kev xa tshuaj intrathecal yuav ua rau nws cov kev siv tshuaj kho mob ntau dua, muaj txiaj ntsig ntau rau cov neeg mob. Kev txhim kho ntawm cov qauv ua haujlwm ntev kuj tseem yuav yog qhov kev tshawb fawb yav tom ntej, txhawm rau txo kev siv tshuaj ntau zaus thiab txhim kho cov neeg mob yooj yim thiab ua raws li.

Qhov tseem ceeb, nws muaj cov kev txwv tam sim no, suav nrog txoj kev tswj hwm nyuaj (yuav tsum tau intrathecal infusion), qhov tshwm sim ntawm qhov tsis zoo, thiab tus nqi siab, uas txwv tsis pub siv dav. Kev tsim kho tshiab yav tom ntej hauv kev siv thev naus laus zis thiab kev tswj hwm tus nqi yuav daws cov teeb meem no, txhim kho kev nkag mus tau yooj yim hauv tsev kho mob, thiab tau txais txiaj ntsig ntau dua rau cov neeg mob uas mob qog noj ntshav refractory.

Cov ntaub ntawv qhov chaw: Intrathecal Ziconotide thiab Morphine rau Kev Kho Mob: Ib Kab Mob ntawm yim tus neeg mob uas mob qog noj ntshav, suav nrog tsib kis mob neuropathic; Intrathecal ziconotide nyob rau hauv kev kho mob ntawm cov mob uas tsis yog-malignant: ib qho randomized, ob-dig muag, placebo-controlled soj ntsuam kuaj.

Ntxiv Hypersensitivity thiab contraindications
 

Hypersensitivity Contraindication: Contraindicated nyob rau hauv cov neeg mob uas paub hypersensitivity rau ziconotide los yog tej excipients (acetic acid, sterile dej rau txhaj, thiab lwm yam).

 

Contraindications rau Intrathecal Administration: Contraindicated nyob rau hauv cov neeg mob uas muaj kab mob ntawm qhov chaw infusion, coagulopathy, spinal kwj dej obstruction, los yog lwm yam teeb meem impairing cerebrospinal kua ncig.

Cov ntaub ntawv qhov chaw: FDA Prescribing Information, DailyMed Database

FAQ
 
 

Puas yog ziconotide muaj zog dua morphine?

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Kev tshawb fawb Pharmacodynamic hauv tib neeg. Hauv ntau hom tsiaj mob, intrathecal ziconotide ua rau muaj zog tiv thaiv kab mob, uas yogtsawg kawg yog kaum lub sij hawm muaj zog tshaj li cov intrathecal morphine.

Dab tsi yog ziconotide siv los kho?

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Ziconotide yog ib qho tshuaj intrathecal analgesic siv rau kev kho mobmob mob. Intrathecal therapy tau qhia nyob rau hauv 1980s raws li ib tug txhais tau tias los kho mob refractory mob. Cov tshuaj siv niaj hnub no feem ntau suav nrog opioid analgesics xws li morphine thiab tshuaj loog hauv zos xws li bupivacaine.

Puas yog ziconotide yog peptide?

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Ziconotide yog peptidenrog rau cov amino acid sequence H-Cys-Lys-Gly-Lys-Gly-Ala-Lys-Cys-Ser-Arg-Leu-Met-Tyr-Tyr }}Asp-Cys-Cys-Thr-Gly-Ser-Cys-Arg-Ser-Gly-Lys-Cys{25}2(CKGKGAKCSRLMYDCCTGSCRSGKC-NH2) thiab muaj 3 daim ntawv cog lus disulfide (Cys1-Cys16, Cys8-Cys20, thiab Cys15-Cys25).

 

Cim npe nrov: Ziconotide txhaj tshuaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom

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