1. Inyuguti: Ifu yera cyangwa hafi yera, hygroscopique cyane.
2. Inkomoko: mucosa amara.
3. Inzira: Sodium ya Heparin ikurwa muri mucosa amara meza.
4. Ibyerekana kandi bikoreshwa: Iki gicuruzwa gikoreshwa cyane cyane mukurinda indwara ya tromboembolique, cyane cyane gikenewe mugukenera anticoagulant byihuse, nka: 1. 1. Trombose ikaze cyangwa idakira cyangwa nta maraso akomeye atembera neza ya embolisme yimpyiko (PE) .Heparin Irashobora kwagura embolus kugirango ikore umwanya wa trombolysis yumubiri.2. Kwirinda no kuvura fibrillation ya Atrial hamwe na embolism.3. Umuti wo gukwirakwiza hakiri kare (DIC).4. Kwirinda no kuvura periferique arterial trombose cyangwa myocardial infarction.5. Ibindi muri vitro anticoagulation: nko kubaga umutima-mitsi, kubagwa kwa vitro, hemodialysis, angiography, nabyo birashobora gukoreshwa muguterwa cyangwa gutegura amaraso, kuri ubu ibimenyetso nyamukuru byerekana heparin ni imitsi yimbitse (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
· Gukurikiza USP、EPn'abakiriya bisanzwe
· Kohereza mu bihugu 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: Guhindura | Uburemere-buringaniye buremereye: 15000 ~ 19000 | ||
Sodium: Ihuza | Sodium: Ihuza | ||
Kurwanya ibintu Xa kuri anti-factor IIa: 0.9 ~ 1.1 | Kurwanya ibintu Xa kuri anti-factor IIa: 0.9 ~ 1.1 | ||
Ibizamini | Ibisobanuro n'ibara | Ibisobanuro: Birasobanutse, Ibara: kuri 5 cyangwa byiza | ———— |
Azote | 1.5~2,5%(ibintu byumye) | 1.3~2,5%(ibintu byumye) | |
Nucleotidic umwanda | A260≤ 0.15 (4mg / ml) | ≤ 0.1(w / w) | |
Ibintu bifitanye isano | Guhindura | ———— | |
Imipaka yagalactosamine muri hexosamine yose | ———— | ≤ 1.0% | |
Kurenza urugero rwa chondroitine sulfate | ———— | Guhindura | |
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) | |
Ibisigara byo gutwikwa | ———— | 28.0%~41.0% | |
Indwara ya bagiteri | ≤ 0.01 IU / Igice mpuzamahanga cya Heparin | ≤ 0.03 USP U / Igice mpuzamahanga cya Heparin | |
Icyuma kiremereye | ≤ 30ppm | ≤ 30ppm | |
Sodium | 10.5~13.5%(ibintu byumye) | ———— | |
Poroteyine | ≤ 0.5%(ibintu byumye) | ≤ 0.1%(Ikigereranyo cyibiro) | |
Igikorwa | ≥ 180 IU / mg(ibintu byumye) | ≥ 180 USP U / mg(ibintu byumye) | |
Microbial Impurities | TAMC | C 1000cfu / g | C 1000cfu / g |
TYMC | C 100cfu / g | C 100cfu / g | |
E.coli | Guhindura | Guhindura | |
Staphylococcus aureus | Guhindura | Guhindura | |
Salmonella | Guhindura | Guhindura |