Kev Txhaj Tshuaj Liraglutide (recombinant Route), Ntshav Qab Zib Bulk thiab Pen 3ml: 18mg CAS No .: 204656-20-2

Kev piav qhia

LIRGLUTIDE muaj liraglutide, ib qho analog ntawm tib neeg GLP-1 thiab ua raws li GLP-1 receptor agonist. Lub peptide precursor ntawm liraglutide, tsim los ntawm cov txheej txheem uas suav nrog kev qhia txog DNA recombinant hauvSaccharomyces cerevisiae, tau raug tsim los ua 97 feem pua ​​​​homologous rau haiv neeg GLP -1 los ntawm kev hloov arginine rau lysine ntawm txoj hauj lwm 34. Liraglutide yog tsim los ntawm kev txuas C-16 fatty acid (palmitic acid) nrog glutamic acid spacer ntawm qhov seem lysine residue ntawm txoj hauj lwm 26 ntawm peptide precursor. Cov mis mos molecular ntawm liraglutide yog C172H265N43O51 thiab qhov hnyav molecular yog 3751.2 Daltons. Tus qauv qauv (Daim duab 1) yog:

Kev txhaj tshuaj LIRAGLUTIDE yog cov tshuaj tsis muaj menyuam, aqueous, ntshiab, tsis muaj xim lossis yuav luag tsis muaj xim rau kev siv subcutaneous. Txhua 1 mL ntawm LIRAGLUTIDE kua muaj 6 mg ntawm liraglutide thiab cov khoom xyaw hauv qab no: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol 5,5 mg; thiab dej rau kev txhaj tshuaj. LIRAGLUTIDE muaj pH ntawm kwv yees li 8.15, hydrochloric acid lossis sodium hydroxide yuav raug ntxiv los kho pH. Txhua tus cwj mem ua ntej muaj 3 mL daws ntawm LIRAGLUTIDE sib npaug rau 18 mg liraglutide (free-base, anhydrous).

Mechanism ntawm Action

Liraglutide yog ib qho acylated tib neeg Glucagon-zoo li Peptide-1 (GLP-1) receptor agonist nrog 97 feem pua ​​​​ amino acid sequence homology rau endogenous tib neeg GLP-1(7-37). GLP-1(7-37) sawv cev<20% of total circulating endogenous GLP-1. Like GLP-1(7-37), liraglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase by the stimulatory G-protein, Gs, in pancreatic beta cells. Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a glucose-dependent manner. The mechanism of blood glucose lowering also involves a delay in gastric emptying. GLP-1(7-37) has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase IV (DPP-IV) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once daily administration, is a result of self-association that delays absorption, plasma protein binding and stability against metabolic degradation by DPP-IV and NEP.

Pharmacodynamics

LIRAGLUTIDE's pharmacodynamic profile yog ua raws li nws cov tshuaj pharmacokinetic profile pom tom qab kev tswj hwm subcutaneous ib zaug li LIRAGLUTIDE txo qis kev yoo mov, premeal thiab postprandial qabzib thoob plaws hnub.

Kev yoo mov thiab postprandial qabzib tau ntsuas ua ntej thiab mus txog 5 teev tom qab noj zaub mov zoo tom qab kev kho mob kom nyob ruaj khov nrog 0.6, 1.2 thiab 1.8 mg LIRAGLUTIDE lossis placebo. Piv rau cov placebo, postprandial plasma qabzib AUC0-300min yog 35 feem pua ​​​​qis tom qab LIRAGLUTIDE 1.2 mg thiab 38 feem pua ​​​​qis dua tom qab LIRAGLUTIDE 1.8 mg. Glucose-dependant insulin secretion

Cov nyhuv ntawm ib koob tshuaj ib zaug ntawm 7.5 mcg / kg (~ 0.7 mg) LIRAGLUTIDE ntawm cov tshuaj insulin secretion (ISR) tau tshawb xyuas hauv 10 tus neeg mob uas muaj ntshav qab zib hom 2 thaum lub sijhawm ntsuas ntshav qabzib. Hauv cov neeg mob no, qhov nruab nrab, ISR cov lus teb tau nce ntxiv hauv cov piam thaj-dependent (Daim duab 2).

Glucagon secretion

LIRAGLUTIDE txo cov ntshav qabzib los ntawm kev txhawb nqa cov tshuaj insulin secretion thiab txo qis glucagon secretion. Ib koob tshuaj LIRAGLUTIDE 7.5 mcg / kg (~ 0.7 mg) tsis cuam tshuam glucagon teb rau cov piam thaj tsawg.

plab hnyuv

LIRAGLUTIDE ua rau qeeb ntawm lub plab khoob, yog li txo tus nqi ntawm cov piam thaj tom qab.

tshwm nyob rau hauv kev ncig.

Cardiac Electrophysiology (QTc)

Cov nyhuv ntawm LIRAGLUTIDE ntawm lub plawv repolarization tau sim hauv QTc txoj kev tshawb fawb. LIRAGLUTIDE ntawm lub xeev khov kho

Kev siv tshuaj txhua hnub txog li 1.8 mg tsis tsim QTc ncua sijhawm.

Lub npe:Liraglutide

Liraglutide yog cov tshuaj siv los kho cov tsos mob ntawm hom 2 mob ntshav qab zib mellitus. Liraglutide tuaj yeem siv ib leeg lossis nrog lwm cov tshuaj.

Noj ntau npaum:Txhaj tshuaj

Specification:18mg 3 :ua

Cov lus qhia

Liraglutide yog qhia: raws li kev noj haus thiab kev tawm dag zog los txhim kho glycemic tswj hauv cov neeg mob 10 xyoo thiab laus dua nrog hom 2 mob ntshav qab zib mellitus,

Liraglutide los txo cov kev pheej hmoo ntawm cov teeb meem loj ntawm cov hlab plawv (mob plawv tuag, tsis tuag myocardial infarction, lossis tsis tuag stroke) rau cov neeg laus uas muaj hom 2 mob ntshav qab zib mellitus thiab tsim cov kab mob plawv.

Kev lag luam

1993

Thaum Lub Kaum Ob Hlis 31, Hangzhou Jiuyuan Gene Engineering Co., Ltd. tau sau npe thiab tsim nyob rau hauv Hangzhou High-tech Development Zone.

Xyoo 2003

Thaum lub Cuaj Hlis 18, cov tshuaj platelet txhawb nqa-Jijufen (recombinant human interleukin-11 rau kev txhaj tshuaj), tau txais daim ntawv pov thawj tshuaj tshiab thiab kev pom zoo ntau lawm.

Xyoo 2008

Lub tuam txhab tau raug hu ua thawj pawg ntawm lub teb chaws high-tech qhauj nyob rau hauv 2008.

Thaum Lub Kaum Ob Hlis 19, cov khoom tshiab thib tsib Giotin (palonosetron hydrochloride bulk tshuaj thiab txhaj tshuaj) tau raug pom zoo rau kev tsim khoom.

Xyoo 2010

Lub tuam txhab cov khoom tshiab, cov tib neeg rov ua dua BMP-2 cov khoom siv kho pob txha (Bone Youdao), tau raug muab tso rau hauv kev tsim khoom thiab muag.

2020 xyoo

Lub tuam txhab R & D chaw nyob hauv Hangzhou Pharmaceutical Town tag nrho.

Lub tuam txhab muag tau tshaj 1 billion yuan.

Hwm

National High-Tech Enterprise

Key High-tech Enterprise ntawm National Torch Plan

National Intellectual Property Advantage Enterprise

Provincial high-tech research and development center

Zhejiang Provincial Enterprise Technology Center

Nto moo Trademark ntawm Zhejiang Xeev

Zhejiang Jiuyuan Gene Biopharmaceutical tshawb fawb lub koom haum

FAQ

Q: Koj puas yog tuam txhab lag luam lossis chaw tsim khoom?

A: Peb yog cov chaw tsim khoom tshwj xeeb hauv kev tshawb fawb, kev tsim kho, tsim khoom thiab kev lag luam ntawm cov kws tshuaj raws li cov noob qoob loo thiab cov tshuab biochemical txij li xyoo 1993.

Thiab peb pauv peb cov khoom nrog peb cov neeg siv khoom ncaj qha.

Q: Koj puas muab cov qauv? Puas yog dawb?

A: Yog tias tus qauv qis qis, peb yuav muab cov qauv dawb nrog cov khoom thauj. Tab sis rau qee qhov kev kuaj tus nqi siab, peb yuav tsum tau sau cov nqi coj mus kuaj.

Q: Koj lub sijhawm them nyiaj yog dab tsi?

A: 30 feem pua ​​​​ntawm cov nyiaj them poob haujlwm ua ntej tsim khoom thiab 70 feem pua ​​​​ntawm cov nyiaj them ua ntej xa khoom.

Q: Koj muaj daim ntawv pov thawj twg?

A: GMP, EUGMP thiab ISO14001.

Q: Koj puas muaj kev kuaj thiab kuaj xyuas?

A: Yog lawm, peb tuaj yeem pab kom tau txais daim ntawv tshaj tawm kev xeem rau cov khoom thiab daim ntawv pov thawj ntawm lub Hoobkas.

Cim npe nrov: liraglutide txhaj (recombinant route), mob ntshav qab zib bulk thiab cwj mem 3ml: 18mg cas no .: 204656-20-2, Tuam Tshoj liraglutide txhaj (recombinant route), mob ntshav qab zib bulk thiab cwj mem 3ml: 18mg cas no .: 204656-20-2 manufacturers, cov neeg muag khoom, Hoobkas