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Ukusebenza okuphezulu kwe-China Heparin Sodium


  • 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

    Sizama ukwenza kahle, sihlanganise amakhasimende”, sithemba ukuba ithimba elingcono kakhulu lokubambisana kanye nebhizinisi elibusayo labasebenzi, abahlinzeki kanye namakhasimende, elibona ukubaluleka kokwabelana kanye nokukhangisa okuqhubekayo kokuSebenza Okuphezulu.I-China Heparin Sodium, Asigcini nje ngokuletha ikhwalithi ephezulu kumakhasimende ethu, kodwa okwengeziwe okubaluleke nakakhulu izinkonzo zethu ezinkulu kanye nenani lokuncintisana lokuthengisa.
    Sizama ukwenza kahle, sihlanganise amakhasimende”, sithemba ukuba yiqembu elingcono kakhulu lokubambisana kanye nebhizinisi elibusayo labasebenzi, abahlinzeki kanye namakhasimende, elibona ukubaluleka kokwabelana kanye nokukhangisa okuqhubekayoI-China Heparin Sodium, Ukwaneliseka kweKhasimende kuhlale kuwukufuna kwethu, ukudala inani lamakhasimende kuwumsebenzi wethu njalo, ubudlelwano bebhizinisi obuzuzisanayo besikhathi eside yikho esikwenzela khona.Sibe nguzakwethu onokwethenjelwa ngokuphelele endabeni yakho e-China.Yiqiniso, ezinye izinsizakalo, ezifana nokubonisana, zinganikezwa nazo.

    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、EP kanye nezinga 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

    1.5-2.5% (into eyomile)

    1.3-2.5% (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

    5.5-8.0 (1%)

    5.5-7.5 (1%)

    Ukulahlekelwa ekomisweni

    ≤ 8.0% (60℃ Yomisa ku-Vacuum, 3h)

    ≤ 5.0% (60℃ Yomisa ku-Vacuum, 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

    10.5-13.5% (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

    Sizama ukwenza kahle, sihlanganise amakhasimende”, sithemba ukuba ithimba elingcono kakhulu lokubambisana kanye nebhizinisi elibusayo labasebenzi, abahlinzeki kanye namakhasimende, elibona ukubaluleka kokwabelana kanye nokukhangisa okuqhubekayo kokuSebenza Okuphezulu.I-China Heparin SodiumAsigcini nje ngokuletha ikhwalithi ephezulu kumakhasimende ethu, kodwa okungeziwe nakakhulu okubaluleke nakakhulu yizinsizakalo zethu ezinkulu kanye nenani lokuncintisana lokuthengisa.
    I-China Heparin Esebenza Kakhulu, Ukwaneliseka kweKhasimende kuhlale kuwukufuna kwethu, ukudala inani lamakhasimende kuwumsebenzi wethu njalo, ubudlelwano bebhizinisi obuzuzisanayo besikhathi eside yilokho esikwenzela khona.Sibe nguzakwethu onokwethenjelwa ngokuphelele endabeni yakho e-China.Yiqiniso, ezinye izinsizakalo, ezifana nokubonisana, zinganikezwa nazo.


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