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Heparin Sodium na Deebio don Magance Cututtukan Thromboembolic


  • CAS NO.:9041-08-1
  • HS CODE:3001.9010.00
  • Cikakken Bayani

    Tags samfurin

    Daki-daki

    1. Haruffa: Fari ko kusan fari foda, sosai hygroscopic.

    2. Tushen: Mucosa na hanji na Porcine.

    3. Tsari: Heparin sodium an fitar da shi daga lafiyayyen mucosa na hanji na porcine.

    4. Alamu da amfani: Wannan samfurin da aka yafi amfani da thromboembolic cuta rigakafin, musamman dace da bukatar anticoagulant da sauri, kamar: 1. m ko na kullum venous thrombosis ko wani gagarumin jini ya kwarara dynamic canji na huhu embolism (PE) .Heparin zai iya dakatar da haɓakar embolus don ba da lokaci don thrombolysis na jiki ba tare da bata lokaci ba.2. Rigakafi da magani na Atrial fibrillation tare da embolism.3. Magani na farko yaduwa intravascular coagulation (DIC).4. Rigakafi da maganin thrombosis na gefe ko ciwon zuciya.5. Sauran in vitro anticoagulation: irin su tiyata na zuciya da jijiyoyin jini, in vitro wurare dabam dabam, hemodialysis, angiography, kuma za a iya amfani da transfusion ko jini shirye-shirye na jini, a halin yanzu babban alamomi na heparin aikace-aikace ne zurfin vein thrombosis (DVT), PE da thrombosis. a cikin marasa lafiya masu haɗari.

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    Me yasa mu?

    · Ya wuce GMP na kasar Sin

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    Ana iya gano albarkatun kasa

    · Yarda da USP,EPda ma'aunin abokin ciniki

    · Fitarwa zuwa ƙasashe da yankuna sama da 30

    Yana da ikon sarrafa tsarin inganci kamar US FDA, Japan PMDA, Koriya ta Kudu MFDS, da dai sauransu.

    Ƙayyadaddun bayanai

    Kayan Gwaji

    Ƙayyadaddun Kamfanin

    EP

    USP

    Halaye

    Farar fari ko kusan fari foda, sosai hygroscopic

    Ganewa

    Thrombotest: Daidaitawa

    Asalin chromatographic: Daidaita

    1H NMR Spectrum: Daidai

    1H NMR Spectrum: Daidai

    Liquid Chromatography: Daidaita

    Matsakaicin nauyin kwayoyin nauyi: 15000 ~ 19000

    Sodium: Daidaitawa

    Sodium: Daidaitawa

    Anti-factor Xa zuwa anti-factor IIa rabo: 0.9 ~ 1.1

    Anti-factor Xa zuwa anti-factor IIa rabo: 0.9 ~ 1.1

    Gwaji

    Tsara da launi

    Tsafta: bayyananne, Launi: ta 5 ko mafi kyau

    ————

    Nitrogen

    1.52.5%(bushe abu)

    1.32.5%(bushe abu)

    Nucleotidic ƙazanta

    A2600.15 (4mg/ml)

    ≤ 0.1(w/w)

    Abubuwan da ke da alaƙa

    Ya dace

    ————

    Iyakacin galactosamine a cikin jimlar hexosamine

    ————

    ≤ 1.0%

    Chondroitin sulfate mai yawa

    ————

    Ya dace

    pH

    5.58.0(1%)

    5.57.5(1%)

    Asarar bushewa

    8.0%(60 ℃ Dry a cikin Vacuum, 3h)

    ≤ 5.0%(60 ℃ Dry a cikin Vacuum, 3h)

    Ragowa akan kunnawa

    ————

    28.0%41.0%

    Bacterial endotoxin

    ≤ 0.01 IU/Sashen Duniya na Heparin

    ≤ 0.03 USP U/Sashen Duniya na Heparin

    Karfe mai nauyi

    ≤ 30pm

    ≤ 30pm

    Sodium

    10.513.5%(bushe abu)

    ————

    Sunadaran

    0.5%(bushe abu)

    0.1%(Rabon nauyi)

    Ayyuka

    ≥ 180 IU/mg(bushe abu)

    ≥ 180 USP U/mg(bushe abu)

    Najasa Na Ƙanjasa

    TAMC

    ≤ 1000cfu/g

    ≤ 1000cfu/g

    Farashin TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Ya dace

    Ya dace

    Staphylococcus aureus

    Ya dace

    Ya dace

    Salmonella

    Ya dace

    Ya dace


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