Turagerageza kuba indashyikirwa, duhuza abakiriya ”, twizera kuzaba itsinda ryiza ry’ubufatanye n’ubucuruzi bwiganje ku bakozi, abatanga isoko ndetse n’abakiriya, bamenya kugabana agaciro no gukomeza kwamamaza kuri High PerformanceUbushinwa Heparin Sodium, Ntabwo gusa dutanga ubuziranenge buhebuje kubakiriya bacu, ariko inyongera niyo ikomeye ni serivisi zacu zikomeye hiyongereyeho igiciro cyo kugurisha.
Turagerageza kuba indashyikirwa, dushyira hamwe abakiriya ”, twizera kuzaba itsinda ryiza ry’ubufatanye n’ubucuruzi bwiganje ku bakozi, abatanga isoko n’abakiriya, bamenya kugabana agaciro no gukomeza kwamamaza kuriUbushinwa Heparin Sodium, Guhaza kwabakiriya nigihe cyose dushakisha, gushiraho agaciro kubakiriya burigihe ninshingano zacu, umubano muremure wigihe kirekire hagati yubucuruzi nicyo dukora.Twabaye umufatanyabikorwa wizewe rwose mubibazo byawe mubushinwa.Nibyo, izindi serivisi, nkubujyanama, zirashobora gutangwa.
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 |
Turagerageza kuba indashyikirwa, duhuza abakiriya ”, twizera kuzaba itsinda ryiza ry’ubufatanye n’ubucuruzi bwiganje ku bakozi, abatanga isoko ndetse n’abakiriya, bamenya kugabana agaciro no gukomeza kwamamaza kuri High PerformanceUbushinwa Heparin SodiumNtabwo gusa dutanga ubuziranenge bwo hejuru kubakiriya bacu, ariko byongeye kandi byingenzi ni serivisi zacu zikomeye hiyongereyeho igiciro cyo kugurisha.
Ubushobozi Bwinshi Ubushinwa Heparin, Guhaza kwabakiriya nigihe cyose dushakisha, guha agaciro abakiriya burigihe ninshingano zacu, umubano muremure wigihe kirekire hagati yubucuruzi nicyo dukora.Twabaye umufatanyabikorwa wizewe rwose mubibazo byawe mubushinwa.Nibyo, izindi serivisi, nkubujyanama, zirashobora gutangwa.