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Imikhiqizo

I-Heparin Sodium ye-Deebio yokwelapha i-Thromboembolic Disease Prevention


  • INOMBOLO YECAS.9041-08-1
  • IKHODI YE-HS:3001.9010.00
  • Isevisi Yefayela:I-Chinese-GMP, i-DMF
  • I-Pharmacopoeia ejwayelekile:EP/USP
  • Imininingwane Yomkhiqizo

    Omaka bomkhiqizo

    Imininingwane

    1. Izinhlamvu: Impushana emhlophe noma ecishe ibe mhlophe, ene-hygroscopic kakhulu.

    2. Umthombo: I-porcine intestine mucosa.

    3. Inqubo: I-Heparin sodium ikhishwa ku-mucosa yamathumbu e-porcine enempilo.

    4. Izinkomba kanye nokusetshenziswa: Lo mkhiqizo usetshenziselwa ikakhulukazi ukuvimbela isifo se-thromboembolic, ikakhulukazi esilungele isidingo se-anticoagulant ngokushesha, njengalokhu: 1. I-acute noma engapheli ye-venous thrombosis noma akukho ukugeleza kwegazi okuphawulekayo ushintsho olunamandla lwe-pulmonary embolism(PE).Heparin ingamisa ukunwetshwa kwe-embolus ukwenza isikhathi se-thrombolysis ezenzakalelayo yomzimba.2. Ukuvimbela nokwelashwa kwe-Atrial fibrillation nge-embolism.3. Ukwelashwa kwe-diffuse intravascular coagulation (DIC) yokuqala.4. Ukuvimbela nokwelashwa kwe-peripheral arterial thrombosis noma i-myocardial infarction.5. Enye i-in vitro anticoagulation: njengokuhlinzwa kwenhliziyo nemithambo yegazi, i-in vitro circulation, i-hemodialysis, i-angiography, nayo ingasetshenziselwa ukumpontshelwa noma ukulungiselela isifanekiso segazi, okwamanje izinkomba eziyinhloko zokusetshenziswa kwe-heparin i-deep vein thrombosis(DVT), i-PE kanye ne-thrombosis. ezigulini ezisengozini enkulu.

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    Kungani sisi?

    ·Uphumelele i-Chinese GMP

    ·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D

    ·Izinto ezingavuthiwe ziyalandeleka

    ·Thobela i-USP,EPnezinga lekhasimende

    ·Thumela emazweni nasezifundeni ezingaphezu kuka-30

    ·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.

    Ukucaciswa

    Izinto Zokuhlola

    Ukucaciswa Kwenkampani

    EP

    USP

    Izinhlamvu

    Impushana emhlophe noma ecishe ibe mhlophe, ene-hygroscopic kakhulu

    Ukuhlonza

    I-Thrombotest: Iyavumelana

    Ubunikazi beChromatographic: Kuyavumelana

    1I-H NMR Spectrum: Iyavumelana

    1I-H NMR Spectrum: Iyavumelana

    I-Liquid Chromatography: Iyavumelana

    Isisindo-isilinganiso samangqamuzana isisindo: 15000 ~ 19000

    I-Sodium: Iyavumelana

    I-Sodium: Iyavumelana

    I-Anti-factor Xa ukuya ku-anti-factor IIa isilinganiso:0.9~1.1

    I-Anti-factor Xa ukuya ku-anti-factor IIa isilinganiso:0.9~1.1

    Izivivinyo

    Ukucaca nombala

    Ukucaca: Kucacile, Umbala: ngo-5 noma ngaphezulu

    ————

    I-nitrogen

    1.52.5%(into eyomile

    1.32.5%(into eyomile

    Ukungcola kwe-Nucleotidic

    A260≤ 0.15(4mg/ml)

    ≤ 0.1(w/w

    Izinto ezihlobene

    Kuyavumelana

    ————

    Umkhawulo wegalactosamine ku-hexosamine isiyonke

    ————

    ≤ 1.0%

    I-Oversulfate chondroitin sulfate

    ————

    Kuyavumelana

    pH

    5.58.0(1%

    5.57.5(1%

    Ukulahlekelwa ekomisweni

    ≤ 8.0%(60℃ Yomisa kuVacuum, 3h

    ≤ 5.0%(60℃ Yomisa kuVacuum, 3h

    Izinsalela ekushiseni

    ————

    28.0%41.0%

    I-endotoxin yebhaktheriya

    ≤ 0.01 IU/Iyunithi Yamazwe Ngamazwe Ye-Heparin

    ≤ 0.03 USP U/Iyunithi Yamazwe Ngamazwe Ye-Heparin

    Insimbi enzima

    ≤ 30ppm

    ≤ 30ppm

    Isodium

    10.513.5%(into eyomile

    ————

    Amaprotheni

    ≤ 0.5%(into eyomile

    ≤ 0.1%(Isilinganiso sesisindo

    Umsebenzi

    ≥ 180 IU/mg(into eyomile

    ≥ 180 USP U/mg(into eyomile

    Ukungcola Kwe-Microbial

    I-TAMC

    ≤ 1000cfu/g

    ≤ 1000cfu/g

    I-TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Kuyavumelana

    Kuyavumelana

    I-Staphylococcus aureus

    Kuyavumelana

    Kuyavumelana

    I-Salmonella

    Kuyavumelana

    Kuyavumelana


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