1. Taw qhia
Alarelin Acetate yog dawb los yog yuav luag dawb hmoov; Tsis muaj ntxhiab, nrog cov av noo. Cov khoom yog yaj hauv dej, me ntsis hauv methanol thiab 1% acetic acid. Kev sib hloov tshwj xeeb: nqa cov khoom no, ntsuas nws qhov tseeb, ntxiv 1 feem pua acetic acid kom yaj nws thiab dilute nws kom muaj nuj nqis rau cov tshuaj uas muaj txog 5mg ib 1ml. Txiav txim siab raws li txoj cai (Appendix VI e, Volume II, Chinese Pharmacopoeia, 2000 EDITION). Kev sib hloov tshwj xeeb yog - 46 degree rau - 56 degree raws li cov khoom tsis muaj dej thiab acetic acid. Lub absorbance ntawm cov khoom yog txiav txim los ntawm spectrophotometerry (Appendix IV A, Volume II, Suav Pharmacopoeia, 2000 EDITION). Lub absorbance ntawm 279nm yuav tsum yog 0.50-0.57 raws li anhydrous thiab acetic acid dawb tshuaj.
2.Main Function
Pharmacology thiab toxicology: Alarelin Acetate yog ib qho hluavtaws cuaj peptide analogue ntawm gonadotropin tso cov tshuaj hormone (GnRH), uas tuaj yeem ua rau lub pituitary tso tawm luteinizing hormone (LH) thiab follicle stimulating hormone (FSH) thaum pib ntawm cov tshuaj, ua rau muaj kev nce ntxiv. ntawm zes qe menyuam derived steroids; Kev tswj hwm rov qab tuaj yeem cuam tshuam kev tso tawm LH thiab FSH los ntawm cov qog pituitary, txo cov qib estradiol hauv cov ntshav, thiab ua tiav cov nyhuv ntawm cov tshuaj ovariectomy. Qhov kev tiv thaiv no tuaj yeem siv los kho cov kab mob ntawm cov tshuaj hormones xws li endometriosis.
3. Daim ntawv thov
Pharmacokinetics: Alarelin Acetate kev sim tsiaj tau pom tias cov tshuaj tau nqus sai sai tom qab txhaj tshuaj intramuscular hauv cov nas, thiab cov ntshav siab nce mus txog qhov siab tshaj plaws ntawm li 20 feeb, thiab qhov txo qis ntawm cov ntshav concentration yog nyob rau hauv txoj kab nrog ob chav qauv 2 h, T1 / 2 Txog 1.8 H. T1 / 2 nyob rau hauv cov hlab ntsha 08 h, T1 / 2 2 h. Nws bioavailability yog li 80 feem pua. Kev sib txuas nrog cov plasma protein yog 27 feem pua - 35 feem pua. Hauv cov ntaub so ntswg faib, lub raum yog qhov siab tshaj plaws, ua raws li daim siab, gonad thiab pituitary. Cov tshuaj tuaj yeem tso tawm los ntawm cov kua tsib, metabolized thiab decomposed tag nrho hauv 24 teev, thiab tawm los ntawm cov zis thiab quav, ntawm 80 feem pua ntawm cov zis tawm.

4.Quality Standard
TEST | SPECIFICATION | TSEEM CEEB |
Qhov tshwm sim | Dawb los yog dawb hmoov hmoov | Ua raws |
Solubility | Soluble hauv DMSO | Confon |
Cov ntsiab lus dej (Karl Fischer) | Tsawg dua lossis sib npaug rau 8.0 feem pua |
7.8 feem pua |
Acetic Acid (ByHPLC) | Tsawg dua lossis sib npaug li 15 .0 feem pua |
1.6 feem pua |
Peptide Purity (ByHPLC) |
Ntau dua lossis sib npaug rau 98.0 feem pua |
98.50 :ua |
Yam khoom (los ntawm HPLC) | Tag nrho impurities(%) : Tsawg dua los yog sib npaug rau 2.0 feem pua | 0.2 feem pua |
Xaus: cov khoom ua raws li kev lag luam tus qauv thiab tsim nyog |
5.Txoj kev tsom xam
O
Clarity thiab xim ntawm cov tshuaj: noj 20mg ntawm cov khoom no thiab yaj nws nrog 2ml dej. Cov
kev daws yuav tsum yog ntshiab thiab tsis muaj xim; Yog tias cov xim yog tsim, nws yuav tsum tsis txhob tob tshaj qhov
Yellow No.2 standard colorimetric tov (thawj txoj kev nyob rau hauv Appendix IX a, Part II, Suav
Pharmacopoeia, 2000 EDITION). Acetic acid noj txog 50mg ntawm glacial acetic acid, kom raug
hnyav nws, muab tso rau hauv 50ml ntsuas lub raj mis, thiab ntxiv 0. 1 feem pua dioxane (tus qauv sab hauv) tov rau
dilute nws mus rau qhov ntsuas. Co zoo raws li kev tswj kev daws teeb meem; Tsis tas li ntawd, noj txog 100mg ntawm qhov no
cov khoom, raug ntsuas nws, muab tso rau hauv 5ml ntsuas lub raj mis, ntxiv 0. 1 feem pua dioxane (intemal
standard) tov kom yaj nws, dilute nws mus rau lub teev, co nws zoo, thiab siv raws li qhov kev ntsuam xyuas.
Kos raws li txoj cai (Appendix VlI P, Volume II, Suav Phamacopoeia, 2000 EDITION),
thiab siv lub pob porous polymer (ptoapak Q, 100 ~ 120 mesh) chromatographic kem (the
Tus lej ntawm cov phiaj xwm theoretical yuav tsum ntau dua 300 raws li qhov siab ntawm acetic acid, thiab
Kev sib cais ntawm lub ncov acetic acid thiab cov txheej txheem sab hauv ncov yuav tsum ua raws li
kev cai). Txiav txim siab feem ntawm 150 feem pua ntawm cov kab ke kub, thiab cov ntsiab lus ntawm
acetic acid yuav tsum tsis pub tshaj 7 .5 feem pua. Amino acid piv coj cov khoom no, ntxiv hydrochloric acid
daws (1 - ntxiv 2), hydrolyze nws ntawm 110 C rau 24 teev, thiab txiav txim siab nws nrog amino acid
Cov tshuaj ntsuam xyuas lossis HPLC. Cov molar piv ntawm txhua cov amino acid tolalanine ntawm cov khoom kuaj yuav tsum ua raws
Cov cai hauv qab no: serine yog {{0}}.7 ~ 1.0, glutamic acid yog 0.9 ~ 1.1, prolineis 0.8 ~ 1.0,
O leucine yog {{0}}.9 ~ 1.1, tyrosineis 0.9 ~ 1.1, histidine yog 0.9 ~ 1.1, Arginine yog 0.9 ~ 1.1. Lwm yam
peptides (1) noj cov khoom no thiab ntxiv dej los ua cov tshuaj uas muaj 10mg ib 1ml raws li lub
xeem daws. Siv lwm qhov kev sim tshuaj thiab ntxiv dej los ua cov tshuaj uas muaj 0.2mg ib
1ml raws li kev tswj kev daws teeb meem. Ntsuas raws li nyias txheej chromatography (Appendix V b, Part II, .
Suav Pharmacopoeia, 2000 EDITION), thiab nqus 10 ntawm ob qho kev daws teeb meem saum toj no μ I. Taw rau
tib silica gel G nyias txheej phaj feem, siv chloroform methanol dej glacial acetic
acid (60: 45: 14: 6) raws li tus neeg sawv cev tsim, kis txheej hauv qab 8 C, qhuav nws, fumigate chlorine,
qhuav nws, thiab tom qab ntawd tshuaj tsuag 0.5 feem pua poov tshuaj iodide starch tov rau tshuaj xyuas tam sim ntawd. Yog tias
kev tshuaj ntsuam xyuas qhia pom qhov chaw impurity, nws yuav tsum muab piv nrog cov chaw tseem ceeb ntawm kev tswj
kev daws thiab yuav tsum tsis txhob tob (2 feem pua). (2) Raws li kev sim hauv lwm cov peptides (1), ua haujlwm
raws li txoj cai. Tus neeg sawv cev tsim tawm yog chloroform methanol ammonia (60:45:20), uas yuav tsum
ua raws li cov cai. Moisture: coj tus nqi tsim nyog ntawm cov khoom no, ntsuas nws kom raug
thiab txiav txim siab raws li txoj cai (Appendix VI m, method a, Part I, Chinese Pharmacopoeia,
2000 EDITION), uas yuav tsum tsis pub tshaj 7.0 feem pua. Purity coj tus nqi tsim nyog ntawm cov khoom no
thiab yaj nws nrog dej. Raws li txoj kev hauv qab kev txiav txim siab, coj ib qho
tus nqi tsim nyog thiab txhaj rau hauv cov kua chromatograph, sau cov chromatogram, thiab
xam lub ntsiab ncov cheeb tsam raws li lub cheeb tsam normalization txoj kev, uas yuav tsum tsis txhob yuav tsawg
ntau dua 98.0 feem pua.
O
6. NMR

7. Kev ruaj ntseg thiab kev nyab xeeb
Kev ruaj ntseg:
Nyob ruaj khov nyob rau hauv cov xwm txheej zoo (chav kub). Cov Ntaub Ntawv Kev ruaj ntseg muaj nyob rau ntawm koj qhov kev thov.
Kev nyab xeeb:
Raws li GARS (Feem ntau Pom Zoo Raws Li Kev Nyab Xeeb) Daim Ntawv Ceeb Toom ntawm Teb Chaws Asmeskas, nws muaj kev nyab xeeb rau tib neeg noj.
8. Flow Chart

9. Cov neeg siv lus pom
Peb muaj cov khw muag khoom ntawm Alibaba, Chemicalbook thiab LookChem, los ntawm cov khoom lag luam zoo thiab cov kev pabcuam tsis tau txais kev pabcuam, peb tau txais ntau cov lus pom zoo.

10.Peb Cov Ntawv Pov Thawj
Tau ntau xyoo, peb tau cog lus rau cov khoom tsim khoom optimization thiab kev tsim kom zoo. Peb tau teeb tsa qhov kev tswj hwm zoo thiab tau txais daim ntawv pov thawj ntawm nws.

11.Peb cov neeg muas zaub
Peb tau tsim kev lag luam kev sib raug zoo nrog Abbott, Unilever, Shiseido, KANS thiab SIMM, thiab lwm yam.

12. Exhibitions
Peb feem ntau tuaj koom kev nthuav qhia thoob ntiaj teb, suav nrog CPhI, FIC, API, Vitafoods, SupplesideWest.

Cim npe nrov: alarelin acetate 79561-22-1, manufacturers, lwm tus neeg, Hoobkas, lag luam wholesale, yuav, nqe, zoo tshaj plaws, tej, kev muag khoom














