Waxaan ku hanweynahay farxad iibsadaha la taaban karo iyo aqbalaadda ballaaran iyadoo ay ugu wacan tahay dabagalka joogtada ah ee aan ku raadinayno heerka ugu sarreeya mid kasta oo ku saabsan xalka iyo hagaajinta tayada Sare ee Shiinaha Daawooyinka CAS 679809-58-6Enoxaparin sodiumAntiviral Enoxaparin Sodium Enoxaparin, Waxaan nahay mid ka mid ah soosaarayaasha 100% ugu weyn Shiinaha.Dhowr shirkadood oo ganacsi oo waaweyn ayaa alaabta naga soo dejisa, markaa waxaanu ku siin doonaa qiimaha ugu waxtarka badan ee tayada leh haddii aad danaynayso annaga.
Waxaan ku hanweynahay farxad iibsadaha la taaban karo iyo aqbalaadda ballaaran sababtoo ah raadinta joogtada ah ee aan ku raadineyno heerka ugu sarreeya ee mid kasta oo ku saabsan xalka iyo dayactirkaShiinaha Enoxaparin, Enoxaparin sodium, Xakamaynta tayada adag ayaa lagu fuliyay xiriir kasta oo ka mid ah geeddi-socodka wax-soo-saarka oo dhan. Waxaan si dhab ah u rajaynaynaa inaan aasaasno iskaashiga saaxiibtinimo iyo faa'iido-wadaaga adiga kula leh.Iyada oo ku saleysan baayacmushtar tayo sare leh iyo adeeg iibka ka dib oo kaamil ah waa fikradeena, macaamiisha qaar ayaa nala shaqaynayay in ka badan 5 sano.
1. Characters: Caddaan ama ku dhawaad budo cad, aad u hygroscopic.
2. Xigasho: Xuubabka mindhicirka porcine.
3. Habka: Heparin sodium waxa laga soo saaraa xabka xiidmaha mindhicirka oo caafimaad qaba.
4. Tilmaamaha iyo isticmaalka: Alaabtan waxaa inta badan loo isticmaalaa ka hortagga cudurrada thromboembolic, gaar ahaan ku habboon baahida daawada xinjirowga lidka ku ah si degdeg ah, sida: 1. Dhiig-xinjirow ba'an ama dabadheeraad ah ama aan lahayn isbeddel firfircoon oo dhiig oo socda waxay joojin kartaa fidinta embolus si ay waqti ugu hesho xinjirowga dhiigga ee jirka.2. Kahortagga iyo daawaynta fayraska Atrial oo leh embolism.3. Daawaynta xinjirowga xididdada dhiigga ee hore ee faafa (DIC).4. Kahortagga iyo daawaynta xinjirowga xididada xididada ama wadna xanuunka myocardial.5. Kuwa kale ee xinjirowga lidka ku ah vitro: sida qalliinka wadnaha iyo xididdada dhiigga, wareegga vitro, hemodialysis, angiography, sidoo kale waxaa loo isticmaali karaa diyaarinta muunada dhiigga, hadda calaamadaha ugu muhiimsan ee codsiga heparin waa xinjirowga xididdada qotodheer (DVT), PE iyo thrombosis bukaanada khatarta sare leh.
Wuxuu gudbay GMP-ga Shiinaha
· 27 sano oo enzyme noole R&D taariikhda
Walxaha ceeriin waa la raadin karaa
U hoggaansamaan USP, EP iyo heerka macaamiisha
Dhoofinta in ka badan 30 waddan iyo gobollo
Inuu leeyahay awoodda maaraynta nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.
Walxaha Tijaabada | Tilmaamaha Shirkadda | ||
EP | USP | ||
Jilayaasha | Caddaan ama ku dhawaad cad budo, aad u hygroscopic | ||
Aqoonsiga | Thrombotest: Waa waafaqsan yahay | Aqoonsiga Chromatographic: Waa waafaqsan yahay | |
1H NMR Spectrum: Waa waafaqsan yahay | 1H NMR Spectrum: Waa waafaqsan yahay | ||
Chromatography dareere: Waafaqsan | Celceliska miisaanka-cusub: 15000 ~ 19000 | ||
Soodhiyam: Waafaqaysaa | Soodhiyam: Waafaqaysaa | ||
Anti-factor Xa ilaa saamiga IIa-ka-hortagga:0.9 ~ 1.1 | Anti-factor Xa ilaa saamiga IIa-ka-hortagga:0.9 ~ 1.1 | ||
Tijaabooyin | Caddayn iyo midab | Cad: Cad, Midab: 5 ama ka sii wanaagsan | ———— |
Nitrojiin | 1.5-2.5% (walax qallalan) | 1.3-2.5% (walax qallalan) | |
wasakhda Nucleotidic | A260≤ 0.15 (4mg/ml) | ≤ 0.1 (w/w) | |
Walxaha la xidhiidha | waafaqsan | ———— | |
Xaddid galactosamine guud ahaan hexosamine | ———— | ≤ 1.0% | |
Sulfate chondroitin sulfate | ———— | waafaqsan | |
pH | 5.5 ilaa 8.0 (1%) | 5.5 ilaa 7.5 (1%) | |
Luminta qalajinta | ≤ 8.0% (60 ℃ Ku qallalan vacuum, 3h) | ≤ 5.0% (60℃ Ku qallalan vacuum, 3h) | |
Hadhaaga dabka | ———— | 28.0% ilaa 41.0% | |
Bakteeriyada endotoxin | ≤ 0.01 IU/Cutubka Caalamiga ah ee Heparin | ≤ 0.03 USP U/ Unugga Caalamiga ah ee Heparin | |
Bir culus | ≤ 30pm | ≤ 30pm | |
Sodium | 10.5 ~ 13.5% (walax qallalan) | ———— | |
Borotiinno | ≤ 0.5% (qalalan) | ≤ 0.1% (Qiyaamaha miisaanka) | |
Hawsha | ≥ 180 IU/mg (walxaha qalalan) | ≥ 180 USP U/mg (walaxda qalalan) | |
Waxyeellada Microbial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | waafaqsan | waafaqsan | |
Staphylococcus aureus | waafaqsan | waafaqsan | |
Salmonella | waafaqsan | waafaqsan |
Waxaan ku hanweynahay farxad iibsadaha la taaban karo iyo aqbalaadda ballaaran iyadoo ay ugu wacan tahay dabagalka joogtada ah ee aan ku hayno heerka ugu sarreeya ee mid kasta oo ku saabsan xalka iyo hagaajinta tayada Sare ee Shiinaha Daawooyinka CAS 679809-58-6 Enoxaparin Sodium Antiviral Enoxaparin Sodium Enoxaparin, Waxaan nahay mid ka mid ah soo saarayaasha 100% ugu weyn Shiinaha.Dhowr shirkadood oo ganacsi oo waaweyn ayaa alaabta naga soo dejisa, markaa waxaanu ku siin doonaa qiimaha ugu waxtarka badan ee tayada leh haddii aad danaynayso annaga.
Tayo SareShiinaha Enoxaparin, Enoxaparin Sodium, Xakamaynta tayada adag ayaa lagu fuliyay xiriir kasta oo ka mid ah geeddi-socodka wax-soo-saarka oo dhan. Waxaan si dhab ah u rajaynaynaa inaan aasaasno iskaashi saaxiibtinimo iyo mid faa'iido leh oo adiga kula jira.Iyada oo ku saleysan baayacmushtar tayo sare leh iyo adeeg iibka ka dib oo kaamil ah waa fikradeena, macaamiisha qaar ayaa nala shaqaynayay in ka badan 5 sano.