• Ibicuruzwa
page

Ibicuruzwa

Heparin Sodium ya Deebio yo kuvura indwara ya Thromboembolic


  • URUBANZA OYA.:9041-08-1
  • Kode ya HS:3001.9010.00
  • Ibisobanuro birambuye

    Ibiranga ibicuruzwa

    Ibisobanuro

    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.

    img (2)
    img (3)

    Kuki twe?

    · Yatsinze Abashinwa GMP

    · Imyaka 27 ya enzyme ya biologiya R&D amateka

    · Ibikoresho bibisi birashobora gukurikiranwa

    · Gukurikiza USPEPn'abakiriya bisanzwe

    · Kohereza mu bihugu birenga 30

    · Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.

    Ibisobanuro

    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

    1.52,5%ibintu byumye

    1.32,5%ibintu byumye

    Nucleotidic umwanda

    A260≤ 0.15 (4mg / ml)

    ≤ 0.1w / w

    Ibintu bifitanye isano

    Guhindura

    ————

    Imipaka yagalactosamine muri hexosamine yose

    ————

    ≤ 1.0%

    Kurenza urugero rwa chondroitine sulfate

    ————

    Guhindura

    pH

    5.58.01%

    5.57.51%

    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

    10.513.5%ibintu byumye

    ————

    Poroteyine

    ≤ 0.5%ibintu byumye

    ≤ 0.1%Ikigereranyo cyibiro

    Igikorwa

    ≥ 180 IU / mgibintu byumye

    ≥ 180 USP U / mgibintu 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


  • Mbere:
  • Ibikurikira:

  • Andika ubutumwa bwawe hano hanyuma utwohereze
    partner_1
    partner_2
    partner_3
    partner_4
    partner_5
    partner_prev
    partner_next
    Ibicuruzwa bishyushye - Ikarita - AMP Mobile