Intego yacu izaba iyo kuzuza abaguzi bacu batanga ubufasha bwa zahabu, igiciro cyiza kandi cyiza cyane kubisobanuro bihanitse Ubushinwa Ibicuruzwa byiza byo mu ruganda rutanga Heparin Sodium CAS 9041-08-1 Inkomoko ya Bovine na Porcine, Hamwe no kuzamura byihuse kandi abakiriya bacu baturuka i Burayi, Amerika, Afurika n'ahantu hose ku isi.Murakaza neza kugirango tujye mu ruganda rwacu rukora kandi mwakire neza kubona, kubindi bisobanuro menya neza ko utazigera ushidikanya kutumenyesha!
Intego yacu izaba iyo kuzuza abaguzi bacu batanga ubufasha bwa zahabu, igiciro cyiza kandi cyiza kuriUbushinwa CAS 9041-08-1, Ifu ya Steroide, Hamwe nuburambe bwimyaka irenga 9 hamwe nitsinda ryabahanga, ubu twohereje ibintu byacu mubihugu byinshi no mukarere kwisi yose.Twishimiye abakiriya, amashyirahamwe yubucuruzi ninshuti ziturutse impande zose zisi kutwandikira no gushaka ubufatanye kubwinyungu rusange.
1. Inyuguti: Ifu yera cyangwa hafi yera, hygroscopique cyane.
2. Inkomoko: mucosa amara.
3. Inzira: Sodium ya Heparin ikurwa muri mucosa nziza yo mu mara.
4. Ibyerekana kandi bikoreshwa: Iki gicuruzwa gikoreshwa cyane cyane mukurinda indwara ya tromboembolique, cyane cyane ikenewe mugukenera anticoagulant byihuse, nka: 1. 1. Trombose ikaze cyangwa idakira cyangwa nta maraso akomeye atembera neza ihinduka ryimpyiko (PE) .Heparin Irashobora kwaguka kwa embolus kugirango ikore umwanya wa trombolysis yumubiri.2. Kwirinda no kuvura fibrillation ya Atrial hamwe na embolism.3. Kuvura hakiri kare gukwirakwiza imitsi y'amaraso (DIC).4. Kwirinda no kuvura periferique arterial trombose cyangwa infirasiyo ya myocardial.5. Ibindi muri vitro anticoagulation: nko kubaga umutima-mitsi, kubagwa kwa vitro, hemodialysis, angiography, nabyo birashobora gukoreshwa muguterwa cyangwa gutegura amaraso, kuri ubu ibimenyetso byingenzi byerekana imiti ya heparin ni trombose ndende (DVT), PE na trombose mu barwayi bafite ibyago byinshi.
· Yatsinze abashinwa GMP
· Imyaka 27 ya enzyme ya biologiya R&D amateka
· Ibikoresho bibisi birashobora gukurikiranwa
· Kurikiza USP 、 EP hamwe nibisanzwe byabakiriya
· Kohereza mu bihugu n'uturere birenga 30
· Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.
Ibizamini | Ibisobanuro bya sosiyete | ||
EP | USP | ||
Inyuguti | Ifu yera cyangwa hafi yera, hygroscopique cyane | ||
Kumenyekanisha | Thrombotest: Ihuza | Indangamuntu ya Chromatografiya: Ihuza | |
1H NMR Ikirangantego: Ihuza | 1H NMR Ikirangantego: Ihuza | ||
Amazi ya Chromatografiya: Ihuza | Uburemere-buringaniye bwa molekuline: 15000 ~ 19000 | ||
Sodium: Ihuza | Sodium: Ihuza | ||
Kurwanya ibintu Xa kugereranya anti-factor IIa: 0.9 ~ 1.1 | Kurwanya ibintu Xa kugereranya anti-factor IIa: 0.9 ~ 1.1 | ||
Ibizamini | Kugaragara no kurangi | Ibisobanuro: Birasobanutse, Ibara: kuri 5 cyangwa byiza | ———— |
Azote | 1.5 ~ 2,5% substance ibintu byumye) | 1.3 ~ 2,5% substance ibintu byumye) | |
Nucleotidic umwanda | A260≤ 0.15 (4mg / ml) | ≤ 0.1 (w / w) | |
Ibintu bifitanye isano | Guhuza | ———— | |
Imipaka yagalactosamine muri hexosamine yose | ———— | ≤ 1.0% | |
Kurenza urugero rwa chondroitine sulfate | ———— | Guhuza | |
pH | 5.5 ~ 8.0 (1%) | 5.5 ~ 7.5 (1%) | |
Gutakaza kumisha | ≤ 8.0% (60 ℃ Kuma muri Vacuum, 3h) | ≤ 5.0% (60 ℃ Kuma muri Vacuum, 3h) | |
Ibisigisigi byo gutwikwa | ———— | 28.0% ~ 41.0% | |
Indwara ya bagiteri | ≤ 0.01 IU / Igice mpuzamahanga cya Heparin | ≤ 0.03 USP U / Ishami mpuzamahanga rya Heparin | |
Icyuma kiremereye | ≤ 30ppm | ≤ 30ppm | |
Sodium | 10.5 ~ 13.5% substance ibintu byumye) | ———— | |
Poroteyine | ≤ 0.5% substance ibintu byumye) | ≤ 0.1% ratio Ikigereranyo cy'uburemere) | |
Igikorwa | ≥ 180 IU / mg substance ibintu byumye) | ≥ 180 USP U / mg substance ibintu byumye) | |
Microbial Impurities | TAMC | ≤ 1000cfu / g | ≤ 1000cfu / g |
TYMC | C 100cfu / g | C 100cfu / g | |
E.coli | Guhuza | Guhuza | |
Staphylococcus aureus | Guhuza | Guhuza | |
Salmonella | Guhuza | Guhuza |
Intego yacu izaba iyo kuzuza abaguzi bacu batanga ubufasha bwa zahabu, igiciro cyiza kandi cyiza cyane kubisobanuro bihanitse Ubushinwa Ibicuruzwa byiza byo mu ruganda rutanga Heparin Sodium CAS 9041-08-1 Inkomoko ya Bovine na Porcine, Hamwe no kuzamura byihuse kandi abakiriya bacu baturuka i Burayi, Amerika, Afurika n'ahantu hose ku isi.Murakaza neza kugirango tujye mu ruganda rwacu rukora kandi mwakire neza kubona, kubindi bisobanuro menya neza ko utazigera ushidikanya kutumenyesha!
Ibisobanuro bihanitseUbushinwa CAS 9041-08-1, Ifu ya Steroide, Hamwe nuburambe bwimyaka irenga 27 hamwe nitsinda ryabahanga, ubu twohereje ibintu byacu mubihugu byinshi no mukarere kwisi yose.Twishimiye abakiriya, amashyirahamwe yubucuruzi ninshuti ziturutse impande zose zisi kutwandikira no gushaka ubufatanye kubwinyungu rusange.