Hwm siab -purity Peptides Triptorelin/GnRH 2mg

1. Product Classification System

Raws li cov ntaub ntawv raw thiab daim ntawv thov lub hom phiaj, Triptorelin / GnRH peptides feem ntau tuaj yeem muab faib ua peb pawg loj:

1. Pharmaceutical Qib

Pharmaceutical grade Triptorelin yog siv los npaj cov tshuaj txhaj tshuaj, xws li lyophilized hmoov los yog sustained -tso tawm npaj (piv txwv li, 1-hli, 3-hli, 6-hli ntev-cov qauv ua yeeb yam). Cov khoom no yuav tsum nruj me ntsis ua raws li pharmacopoeia-qib cov qauv zoo, nrog purity feem ntau siab dua 98% -99.5%, thiab cov kev cai meej rau cov kuab tshuaj residual, hnyav hlau, thiab microbial txwv. Kev tsim khoom yuav tsum ua raws li GMP cov xwm txheej, nrog nruj batch-rau-batch sib xws.

2. Qib tshawb fawb

Kev tshawb fawb qib feem ntau yog siv rau kev tshawb fawb tshawb fawb, xws li kev sim ntawm tes, kev sim tsiaj, thiab receptor mechanism ntawm kev tshawb fawb. Purity feem ntau yog nyob nruab nrab ntawm 95% thiab 98%, nrog rau me ntsis siab dua impurity ntau dua li qib tshuaj, tab sis tseem xav tau kev ruaj ntseg thiab kev ua haujlwm.

3. Engineering lossis Industrial Qib

Siv rau kev siv tsis yog-cov ntaub ntawv kho mob xws li kev qhia qhia, kev txhim kho txoj kev, thiab kev tshawb fawb txog cov khoom siv raw. Nrog lub purity ntawm kwv yees li 90-95%, thiab tus nqi qis, nws feem ntau tsis siv hauv cov tshuaj formulations lossis hauv vivo thwmsim.

2. Chemical Structure thiab Composition yam ntxwv

Triptorelin belongs rau cov qauv decapeptide ntawm GnRH, tab sis los ntawm kev hloov tshuaj lom neeg ntawm 6th amino acid, nws cov receptor affinity thiab tsis kam mus rau enzymatic degradation yog txhim kho, ua kom nws lub sijhawm ua haujlwm.

1. Molecular Formula thiab Molecular Luj

Cov mis mos molecular: C64H82N18O13

Molecular Luj: Kwv yees li ntawm 1311.5 Da Raws li polypeptide, nws cov qauv muaj kaum amino acid residues, qee qhov hloov kho los txhim kho kev lom zem.

2. Amino Acid Sequence Yam ntxwv

Piv rau GnRH ntuj, Triptorelin hloov Gly nrog D-Trp ntawm 6 txoj hauj lwm, uas ua rau muaj kev cuam tshuam thiab muaj zog agonistic ntawm cov receptor. Txawm li cas los xij, tom qab ua haujlwm ntev, nws ua rau "desensitization" cuam tshuam rau ntawm lub caj pas pituitary, yog li ua tiav lub hom phiaj ntawm inhibiting gonadotropins.

3. Cov yam ntxwv zoo

Nws belongs rau tsev neeg linear polypeptide.

Nws muaj ntau pawg ua haujlwm uas tuaj yeem tsim cov ntawv cog lus hydrogen thiab cuam tshuam nrog cov dej molecules.

Nws muaj kev cuam tshuam rau enzymatic hydrolysis, tab sis tseem muaj kev ruaj ntseg ntau dua piv rau ntuj peptides.

3. Physicochemical Properties

1. Cov tsos thiab xim

High -purity Triptorelin raw khoom hmoov feem ntau tshwm li:

Dawb los yog tawm -dawb hmoov

Muaj tsawg zaus, nws tuaj yeem tshwm daj daj (feem ntau yog vim qhov seem ntawm cov dej noo lossis cov kab tsis huv).

Yog tias cov xim daj lossis grey tshwm sim, nws feem ntau yog qhov qhia txog kev degradation lossis siab impurity.

2. Solubility

Triptorelin yog yooj yim soluble nyob rau hauv feem ntau aqueous systems, xws li:

Dej

Physiological ntsev

Buffer daws nrog pH 4-7

Nws yog insoluble lossis tsuas yog me ntsis soluble hauv cov kuab tshuaj organic xws li ethanol, acetone, thiab hexane.

Nws cov dej solubility yog los ntawm ntau pawg hydrophilic ntawm cov saw tseem ceeb thiab sab chains, xws li cov amino thiab carboxyl pawg.

3. Kev ruaj ntseg

Triptorelin yog rhiab heev rau qhov kub thiab txias, pH, thiab lub teeb:

Khaws kom deb ntawm lub teeb kom tiv thaiv peptide chain breakage los ntawm ultraviolet hluav taws xob.

Qhov pH ntau ntawm 2-6 yog qhov ruaj khov tshaj plaws.

Kev kub siab tuaj yeem ua rau hydrolysis; Yog li ntawd, cov hmoov nyoos yuav tsum tau khaws cia khov ntawm qhov kub thiab txias.

4. Kev cia khoom

Nws feem ntau pom zoo kom khaws cia ntawm -20℃lossis qis dua rau lub sijhawm ntev, thiab tuav lub tshuab nqus tsev lossis cov ntim ntim nitrogen kom txo qis oxidative degradation.

4. Qhov zoo thiab yam ntxwv

Triptorelin tau dhau los ua ib qho ntawm feem ntau siv GnRH analogs feem ntau vim nws ob peb yam zoo:

1. Siab Receptor Affinity

Nws txoj kev sib raug zoo rau GnRH receptors yog qhov siab dua li ntawm GnRH ntuj, ua rau muaj zog agonistic nyhuv thiab ua rau lub caj pas pituitary tso tawm sai sai LH / FSH hauv lub sijhawm luv.

2. Ntau ruaj khov desensitization nyhuv

Kev ua tsis tu ncua tuaj yeem ua rau receptor downregulation, txo LH thiab FSH secretion, yog li inhibiting gonadal muaj nuj nqi. Cov nyhuv inhibitory no yog qhov tseem ceeb tshwj xeeb hauv kev ua yeeb yam ntev -.

3. Ntev Ib nrab -Lub neej

Ntuj GnRH muaj ib nrab ntawm - lub neej tsuas yog 2-4 feeb hauv vivo, thaum hloov kho Triptorelin tuaj yeem muaj ib nrab ntawm - lub neej ntawm ob peb teev lossis ntev dua (nyob ntawm kev tsim qauv), ua rau nws yooj yim dua rau kev siv tshuaj kho mob.

4. Kev nyab xeeb siab dua

Raws li peptide, nws cov khoom degradation yog cov amino acids thiab peptides luv luv, uas feem ntau tsis ua rau muaj tshuaj lom, yog li tswj kom muaj kev tiv thaiv zoo txawm tias siv sijhawm ntev -.

5. Yooj yim tsim cov khoom siv raw hmoov

Nws cov hmoov hmoov yog ruaj khov, ua rau nws haum rau:

Lyophilized hmoov rau kev txhaj tshuaj

Microsphere txhawb nqa - tso tawm cov qauv

Thaum ntxov- kev tshawb fawb cov txheej txheem rau roj- raws li kev txhaj tshuaj

5. Kev tsim khoom thiab kev tswj xyuas zoo

1. Txoj kev sib xyaw ua ke

Triptorelin feem ntau yog tsim los siv cov khoom siv -theem peptide synthesis (SPPS) thev naus laus zis, siv Fmoc lossis Boc tiv thaiv pab pawg cov tswv yim kom ua tiav cov kauj ruam elongation. Txoj kev no ua kom lub siab purity, meej ib theem zuj zus, thiab zoo reproducibility.

2. Kev ua kom huv huv

Cov txheej txheem siv feem ntau suav nrog:

Rov qab-theem siab-kev ua haujlwm ua kua chromatography (RP-HPLC)

Npaj LPLC lossis HPLC

Lyophilization los xyuas kom meej cov qauv stability

3. Cov khoom tswj tau zoo

Txhawm rau kom ntseeg tau tias cov tshuaj - qib zoo, yuav tsum muaj ntau yam kev xeem, suav nrog:

Kev tshuaj xyuas qhov tshwm sim

Cov dej noo

HPLC purity

Amino acid tsom xam lossis kev txheeb xyuas cov kab ke

Kev txiav txim siab molecular hnyav (MS)

Residual solvent detection (GC method)

Kev txwv microbial thiab kuaj endotoxin

6. Cov cheeb tsam thov

Triptorelin muaj cov ntawv thov dav heev, npog ntau yam xws li tshuaj, kev tshawb fawb tshawb fawb, thiab biopharmaceuticals.

1. Kev siv kho mob

Raws li GnRH agonist, nws tuaj yeem siv los kho ntau yam kab mob, suav nrog:

Prostate-cov kab mob ntsig txog

Endometrial-cov kab mob ntsig txog

Adjunctive kho rau infertility

Kev tswj hwm Hormonal hauv lub mis -cov kab mob ntsig txog

Precocious puberty intervention

Nws cov khoom gonadotropic ua rau nws yog ib qho cuab yeej tseem ceeb rau kev tswj hwm endocrine.

2. Cov ntawv thov tshawb fawb

Hauv biomedical teb, nws yog siv rau:

Kawm txog hypothalamic{0}}pituitary-gonadal axis (HPG)

GnRH receptor mechanism tshawb fawb

Hormonal tswj thiab kev tawm tswv yim sim

Pharmacodynamic thiab pharmacokinetic qauv

3. Pharmaceutical Development

Triptorelin yog ib qho tseem ceeb raw khoom rau ntau yam kev txhawb nqa -tso tawm formulations thiab yog dav siv nyob rau hauv txoj kev loj hlob ntawm:

Microsphere ntev - kev txhaj tshuaj (1 hli, 3 hli, 6 hli)

Npaj-rau- siv lyophilized hmoov rau txhaj

Txhim kho kev tso tawm (nanoparticles, liposomes, thiab lwm yam)

7. Cov ntaub ntawv ntxiv txog qhov tshwm sim thiab cov qauv kuaj

Txhawm rau kom ntseeg tau qhov kev ntseeg siab ntawm Triptorelin hauv cov tshuaj thiab kev tshawb fawb, nws cov xim, cov qauv hmoov, thiab kev ua kom tiav yog feem ntau teev nyob rau hauv kom meej.

High -zoo Triptorelin yuav tsum muaj cov yam ntxwv zoo li hauv qab no:

Zoo, fluffy lyophilized hmoov qauv

Dawb los yog tawm -dawb, zoo ib yam, thiab tsis muaj impurities

Tsis pom tseeb agglomeration

Hauv kev daws teeb meem, nws yuav tsum yog pob tshab thiab meej, tsis muaj teeb meem tsis pom kev; qhov no kuj yog ib qho ntawm cov cim tseem ceeb rau kev kuaj zoo.

8. Cov lus xaus

Triptorelin, uas yog ib qho tseem ceeb ntawm GnRH analogue, nyob hauv txoj haujlwm tseem ceeb hauv kev kho mob endocrine niaj hnub thiab biopharmaceutical technology. Nws muaj kev ruaj ntseg siab, kev ua haujlwm siab, thiab cov khoom tsim muaj txiaj ntsig ua rau nws tsis yog tsuas yog ua lub luag haujlwm tseem ceeb hauv kev kho mob tab sis kuj tseem ua cov khoom tseem ceeb rau kev tshawb fawb thiab kev loj hlob. Los ntawm kev faib cov khoom raw, physicochemical zog, thiab cov yam ntxwv ntawm cov qauv rau daim ntawv thov thiab kev tswj kom zoo, txhua yam sib sau ua ke tsim nws tus nqi tseem ceeb hauv kev lag luam kws tshuaj.

Txhawb txoj kev them nyiaj

 

 

Peb txhawb ntau txoj kev them nyiaj

 

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