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Somatostatin 51110-01-1

Somatostatin 51110-01-1

CRO CMO CDMO Txais
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Txaus siab nqe nrog Superior Quality
ISO9001 tau ntawv pov thawj
PCT Patent tuav
Cov ntaub ntawv txhawb nqa
Yam khoom plig muaj
Third Party Test Muaj
Clinical Study Assistance
Plant Audition Txais
Kev xa khoom sai thiab ruaj ntseg
Tsis yog rau Cov Neeg Muag Khoom
Npaj Tshuag hauv Overseas Warehouse

Tsham tam sim no
Khoom Taw qhia

 

1. Taw qhia


Kev loj hlob hormone tso tawm inhibitory hormone; Stilamin, somatostatin

Cov tshuaj lyophilized hmoov yuav tsum tau yaj hauv physiological saline ua ntej siv.


Cov khoom no tau muab tso rau hauv cov hlab ntsha los ntawm kev txhaj tshuaj qeeb qeeb (3-5 feeb) ntawm 250 micrograms lossis txuas ntxiv ntawm tus nqi ntawm 250 micrograms ib teev.


Dosage (kwv yees li 3.5 micrograms ib teev ib kilogram ntawm lub cev hnyav).


Rau kev ua kom tsis tu ncua, nws yog qhov tsim nyog los npaj cov tshuaj txaus rau 12 teev siv 3 milligram koob tshuaj ntawm cov khoom no. Cov kuab tshuaj tuaj yeem yog ntsev ntawm lub cev


Dej kuj tuaj yeem yog 5 feem pua ​​​​qabzib, thiab cov ntim ntim yuav tsum tau hloov mus rau 250 micrograms ib teev. Nws raug nquahu kom siv lub syringe infusion.


-Kev kho mob hnyav rau mob plab hnyuv los ntshav (xws li esophageal variceal los ntshav):


Nws raug nquahu kom ua ntej maj mam txhaj 250 micrograms ntawm cov khoom no tso rau hauv cov koob txhaj tshuaj, thiab tom qab ntawd ua cov tshuaj txhaj tshuaj ntawm 250 micrograms ib teev.


Dropwise kev tswj hwm. Thaum lub sijhawm nruab nrab ntawm ob qhov kev txhaj tshuaj thiab kev tswj hwm ntau dua 3-5 feeb, 250 micrograms ntawm cov khoom no yuav tsum tau rov txhaj tshuaj intravenously kom ntseeg tau tias kev tswj hwm tas li.


Kev sib deev.


Tom qab tso tseg los ntshav loj (feem ntau nyob rau hauv 12 mus rau 24 teev), kev kho mob yuav tsum txuas ntxiv rau 48 mus rau 72 teev kom tsis txhob los ntshav ntxiv.


Rau cov xwm txheej saum toj no, lub sijhawm kho ib txwm yog 120 teev.


- Kev kho mob rau pancreatic fistula, biliary fistula, thiab plab hnyuv fistula:


Kev tso dej tas li yuav tsum tau muab tshuaj rau ntawm tus nqi ntawm 250 micrograms ib teev kom txog thaum lub fistula raug kaw (2 mus rau 20 hnub). Txoj kev kho no tuaj yeem siv tau


Nws yog ib qho kev ntsuas pab rau tag nrho cov khoom noj khoom haus parenteral. Tom qab lub fistula raug kaw, cov dej tso dej ntawm cov khoom no yuav tsum txuas ntxiv rau 1 mus rau 3 hnub, thiab tom qab ntawd maj mam txiav cov tshuaj mus.


Anti bounce nkaus.


2.Main Function


[pharmacological kev txiav txim] ① nws tuaj yeem inhibit qhov tso tawm ntawm kev loj hlob hormone, thyroid stimulating hormone, insulin thiab glucagon. ② Nws tuaj yeem cuam tshuam qhov tso tawm ntawm gastric acid txhawb los ntawm kev sim noj mov thiab 5-peptide gastrin, thiab inhibit qhov tso tawm ntawm pepsin thiab gastrin. ③ Nws tuaj yeem txo qhov visceral ntshav txaus, portal leeg ntshav siab, kev sib koom ua ke ntawm cov ntshav khiav thiab siab, thiab lub siab ntshav ntws. ④ Nws tuaj yeem txo qis exocrine thiab exocrine ntawm pancreas, tso tawm ntawm lub plab, cov hnyuv me thiab lub gallbladder, txo cov enzyme kev ua haujlwm, thiab tiv thaiv cov kab mob pancreatic. ⑤ inhibit qhov tso tawm ntawm glucagon. ⑥ Nws tuaj yeem cuam tshuam rau lub plab zom mov thiab kev noj zaub mov zoo.


3. Daim ntawv thov

Nws yog siv rau esophageal venous hemorrhage los ntawm cirrhosis thiab portal hypertension; Upper gastrointestinal los ntshav tshwm sim los ntawm peptic ulcer, stress ulcer thiab erosive gastritis; Kev tiv thaiv thiab kev kho mob ntawm tus mob pancreatitis thiab nws cov teeb meem; Adjuvant kev kho mob ntawm pancreatic, biliary thiab plab hnyuv fistulas; Lwm yam: acromegaly, gastrinoma, insulinoma thiab vasoactive plab hnyuv peptide qog.



4.Quality Standard




Khoom npe

Somatostatin Acetate

Catalog No.

C0040

CAS. Tsis muaj.

38916-34-6

Batch No.

P20090201

Hnub tim

2020-09-02

Hnub tim rov kuaj dua

2020-09-01

Sequence: H-Ala-Gly-c(Cys-Lys-Asn-Phe-Phe-Trp-Lys-Thr-Phe-Thr-Ser-Cys)-OH

 

Kuaj

Specification

Kev tshwm sim

Qhov tshwm sim

Dawb mus rau dawb hmoov los yog xoob pob

Ua raws

Solubility

Dawb soluble hauv dej thiab hauvacetic tshuajkua qaub,soluble m ethyl acohol,xyaum insoluble m methylene chloride, insluble nyob rau hauv diethyl ether.

 

 

Ua raws

Purity (HPLC)

NLT 98 feem pua

99.31% ua

Qhov tshwm sim

ntawm daws

Ntshiab thiab tsis muaj xim

Ua raws

Acetate (HPLC)

2.0 feem pua ​​-15.0 feem pua

8.23% ib

Dej (coulomb)

NWM 8.0 feem pua

5.46% ua

 

 

 

 

Amino acid tsom xam

Asp (0.9-1.1)

Ala (0.9-1.1)

Lys (1.8-2.2)

Gly (0.9-1.1)

Thr (1.4-2.1)

Pheej (2.7-3.3)

Ser (0.7-1.05)

Ib nrab-Cys (1.4-2.1)

1.0

1.0

2.0

1.0

1.8

3.3

Tam sim no1.5

Hais txog Tshuaj(HPLC)

Txhua tus neeg impurity:1. 0 feem pua

Tag nrho impurity: :2.0 feem pua

0.44 feem pua

0.69 feem pua

Residual kuab tshuaj Methanol Acetonitrile

Triethylamine

3 000ppm10 ppm

300 ppm

213 ppm 205 ppm 21 ppm

5.Txoj kev tsom xam

-cov qauv ntawm cov tshuaj rau lub cev preservation qhia

Dissolve 2.0 mg hauv 1.0 mL ntawm 1 feem pua ​​V/W tov

hauv grams ib liter thiab millimoles ib liter;

lub nominal ntim ntawm cov tshuaj rau lub cev preservation glacial acetic acid R.

nyob rau hauv lub thawv;

Cov khoom muaj feem xyuam. Liquid chromatography (2.2.29): siv lub

normalization txheej txheem. Npaj cov kev daws teeb meem tam sim ntawd

uas ib feem tsis siv ntawm cov tshuaj npaj npaj siv, ntawm

ua ntej siv.

cov concentrated tov los yog diluted tov yuav tsum

Test daws. Dissolve cov khoom yuav tsum tau kuaj nyob rau hauv

muab pov tseg;

dej R kom tau qhov concentration ntawm 1.0 mg/mL.

cov xwm txheej cia;

Kev daws teeb meem (a). Dissolve cov ntsiab lus ntawm ib lub vial ntawm

- yog tias tsim nyog, qhov kev daws teeb meem yuav tsum tau siv ua ke

somatostatin CRS nyob rau hauv dej R kom tau ib tug concentration ntawm

nrog lub lim kawg. ,

1. 0 mg/mL.

Kev daws teeb meem (b). Dissolve cov ntsiab lus ntawm ib lub vial ntawm

Hauv adidio rau cnrned soutions lub lbel stcsthathe Rofece slucis () isge tbeh cotosaiehnirao R

cov tshuaj yuav tsum tau diluted nrog ib tug haum kua tam sim ntawd

kom tau txais qhov concentration ntawm 1.0 mg/mL. Tso cai sawv ntawm

ua ntej siv.

roomtemperatureforaboutIhMixI

ofthi

lution

chav sov li 1 h.

thiab 1 ntim ntawm kev siv tshuaj (a).

04/2014: 0949 Kem:

kho 10.0

qhov loj: l= 0.25 m, 0= 4.6 hli; .

nyob ruaj ruaj theem: octadeylsilyl silica gel rau

chromatography R (5 teev tsaus ntuj) nrog lub pore loj ntawm 10 nm.

Mobile theem:

SOMATOSTATIN

mobile theem A: trifuoroacetic acid R, acetonitrile R,

dej R ({0}}.1:20:80 V/W/V);

Somatostatinum

mobile theem B: trifluoroacetice acid R, acetonitrile R, dej R

(0.1:4555 V/V/V);

HA1-Gh)-Cy5-Lys- -A8n- Phe - Phe- TP-Lys- Thr -

Sijhawm

Mobile Phase A

Mobile Phase B

Phe-Thr-Ser-Cys-0H

(min)

(Percent VV)

(% VM

ChoN2O2S2

M, 1638 :

0-25.

100子0

0→100

[38916-34-6]

25-30 .

100

txhais

30-32

0→100

100 plus 0

L-Alanylglyl-cysteinel-lysyl-L-asparaginyl-L-

Tom ntej: phenylalanyl-L-phenylalanyl-i-tryptophyl-lysy-L-

Tus nqi ntws: 1.5 mL / min.

Tom ntej: Threonyl-phenylalanyl-L-threonyl-L-seryl-L-cysteine ​​cyclic

Txhaj tshuaj: 15 μ ntawm cov tshuaj ntsuam xyuas thiab kev siv tshuaj (b).

(3 ntxiv rau 14)-disulfide.

Synthetic cyclic tetradecapeptide muaj cov qauv ntawm cov

Kev tuav pov hwm txheeb ze nrog kev siv rau somatostatin (retention

hypothalamic hormone uas inhibits kev tso tawm ntawm tib neeg

sij hawm=txog 12 min): txo somatostatin=txog 1.09.

kev loj hlob hormone. Nws muaj ntau qhov sib txawv ntawm acetic acid. Qhov System suitabilit: reference solution (b):

nws muaj nyob rau hauv daim ntawv khov-qhuav.

daws teeb meem: yam tsawg kawg nkaus 3.5 nruab nrab ntawm lub ncov vim txo

Cov ntsiab lus: 95.0 ib xees rau 104.0 feem pua ​​(anhydrous thiab acetic

somatostatin thiab lub hauv paus ncov;

acid-free khoom).

tus lej ntawm daim phiaj theoretical: yam tsawg kawg 15 000, xam

CEEB TOOM

rau lub hauv paus ncov;

Cov tsos mob: dawb los yog yuav luag dawb, hygroscopic, amorphous

symmetry yam: siab tshaj 2.7 rau lub hauv paus ncov.

hmoov.

Txwv::

Solubility: soluble nyob rau hauv dej thiab nyob rau hauv acetic acid, xyaum

tej impurity: siab tshaj 1 xees;

insoluble hauv methylene chloride.

tag nrho: siab tshaj 2 feem pua;

IDENTIFICATION

. tsis quav ntsej txwv: 0.1 feem pua.

A. Tshawb xyuas cov chromatograms uas tau txais hauv qhov kev xeem.

Acetic acid (2.5.34): 3.0 ib xees rau 15.0 ib xees.

Cov txiaj ntsig: lub ntsiab lus tseem ceeb hauv chromatogram tau txais

Test daws. Dissolve 7.0 mg ntawm cov tshuaj yuav tsum tau kuaj

nrog rau kev ntsuam xyuas kev daws teeb meem yog zoo sib xws nyob rau hauv tuav lub sij hawm rau

nyob rau hauv ib tug sib tov ntawm 5 ntim ntawm mobile theem B thiab 95 ntim ntawm

lub hauv paus ncov hauv chromatogram tau nrog

mobile theem A, ces dilute mus rau 10.0 mL nrog tib cov sib tov

ntawm mobile theem.

B. Amino acid tsom xam (2.2.56). Txoj Kev 1 rau bydrolysis thiab Dej (2.5.32): siab tshaj 8.0 ib xees, txiav txim siab rau

txoj kev 1 rau kev tsom xam yog tsim nyog.

1 0.0 mg.

Qhia cov ntsiab lus ntawm txhua cov amino acid hauv moles. Xam cov kab mob endotoxins (2.6.14): tsawg dua 10 IU / mg, yog tias xav tau

tus txheeb ze proportions ntawm cov amino acids noj 1/8 ntawm

siv rau hauv kev tsim cov parenteral npaj tsis muaj

cov lej ntawm cov moles ntawm aspartic acid, alanine,

ib txoj kev tsim nyog ntxiv rau kev tshem tawm cov kab mob

lysine, glycine thiab phenylalanine sib npaug li 1. Cov txiaj ntsig

endotoxins.


6.rc-160

Somatostatin RC-160


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

1121474275flow 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.

2

Cim npe nrov: somatostatin 51110-01-1, manufacturers, lwm tus neeg, Hoobkas, lag luam wholesale, yuav, nqe, zoo tshaj plaws, tej, kev muag khoom

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