Waxaan isku daynaa heer sare, shirkadda macaamiisha ", waxaan rajeyneynaa inaan noqono kooxda iskaashiga ugu fiican iyo ganacsiga xukuma shaqaalaha, alaab-qeybiyeyaasha iyo macaamiisha, ogaanaya in la wadaago iyo xayaysiis joogto ah oo loogu talagalay Waxqabadka SareShiinaha Heparin Sodium, Waxaan kaliya ma samatabbixin tayada sare macaamiisheenna, laakiin dheeraad ah oo xitaa muhiim ah waa adeegyadayada ugu weyn oo lagu daray qiimaha iibka tartanka.
Waxaan isku daynaa heer sare, shirkadda macaamiisha", waxaan rajeyneynaa inaan noqono kooxda iskaashiga ugu fiican iyo ganacsiga ka taliya shaqaalaha, alaab-qeybiyeyaasha iyo macaamiisha, ogaanaya qiimaha ay wadaagaan iyo xayeysiinta joogtada ahShiinaha Heparin Sodium, Ku qanacsanaanta macaamilka had iyo jeer waa raadinteena, abuurista qiimaha macaamiisha had iyo jeer waa waajibaadkeena, xiriir ganacsi oo faa'iido leh oo muddo dheer ah ayaa ah waxa aan u sameyneyno.Waxaannu ahayn lammaane la isku halayn karo oo ku saabsan kiiskaaga Shiinaha.Dabcan, adeegyada kale, sida la-talinta, ayaa sidoo kale la bixin karaa.
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 isku dayeynaa heer sare, shirkadda macaamiisha ", waxaan rajeyneynaa inaan noqono kooxda iskaashiga ugu fiican iyo ganacsiga xukuma shaqaalaha, alaab-qeybiyeyaasha iyo macaamiisha, waxay gartaan in la wadaago iyo xayeysiis joogto ah oo loogu talagalay Waxqabadka Sare ee Shiinaha Heparin Sodium Ma aha oo kaliya inaan gaarsiiyo tayada sare macaamiisheenna , laakiin dheeraadka ah ee xitaa muhiimka ah ayaa ah adeegyadayada ugu weyn oo lagu daro qiimaha iibka ee tartanka ah.
Waxqabadka Sare ee Shiinaha Heparin, ku qanacsanaanta macaamilka had iyo jeer waa raadinteena, abuurista qiimaha macaamiisha had iyo jeer waa waajibaadkeena, xiriir ganacsi oo faa'iido leh oo muddo dheer ah ayaa ah waxa aan u sameyneyno.Waxaannu ahayn lammaane la isku halayn karo oo ku saabsan kiiskaaga Shiinaha.Dabcan, adeegyada kale, sida la-talinta, ayaa sidoo kale la bixin karaa.