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Ts'ebetso e phahameng ea China Heparin Sodium


  • NOMORO YA CAS:9041-08-1
  • HS CODE:3001.9010.00
  • Tšebeletso ea Faele:Sechaena-GMP, DMF
  • Pharmacopoeia standard:EP/USP
  • Lintlha tsa Sehlahisoa

    Li-tag tsa Sehlahisoa

    Re leka ho etsa bokhabane, re khamphani ea bareki ”, re tšepa ho ba sehlopha se setle ka ho fetisisa sa tšebelisano 'moho le khoebo e laolang basebetsi, barekisi le bareki, e hlokomela ho arolelana le ho bapatsa khafetsa bakeng sa Ts'ebetso e Phahameng.China Heparin Sodium, Ha re fane feela ka boleng bo holimo ho bareki ba rona, empa ho bohlokoa le ho feta ke lits'ebeletso tsa rona tse kholo ka ho fetisisa hammoho le theko ea tlholisano ea thekiso.
    Re leka ho sebetsa hantle, re khamphani bareki”, re tšepa ho ba sehlopha se setle ka ho fetisisa sa tšebelisano 'moho le khoebo e laolang basebetsi, barekisi le bareki, e hlokomelang ho arolelana le ho bapatsa ka mehla bakeng saChina Heparin Sodium, Khotsofalo ea Moreki ke sepheo sa rona kamehla, ho theha boleng ba bareki ke mosebetsi oa rona kamehla, kamano ea nako e telele ea khoebo e nang le melemo ke eona eo re e etsang.Re bile balekane ba tšepahalang ka ho felletseng molemong oa hau naheng ea China.Ehlile, litšebeletso tse ling, joalo ka boeletsi, le tsona li ka fanoa.

    Lintlha

    1. Litlhaku: Phofo e tšoeu kapa e batlang e le tšoeu, e nang le hygroscopic haholo.

    2. Mohloli: Mucosa ea mala a kolobe.

    3. Ts'ebetso: Sodium ea Heparin e ntšoa ho tswa ho porcine intestine mucosa e phetseng hantle.

    4. Lipontšo le tšebeliso: Sehlahisoa sena se sebelisoa haholo-holo bakeng sa thibelo ea lefu la thromboembolic, haholo-holo e loketseng tlhokahalo ea anticoagulant ka potlako, e kang: 1. Acute or chronic venous thrombosis kapa ha ho na phetoho e matla ea phallo ea mali ea pulmonary embolism (PE) .Heparin e ka emisa katoloso ea embolus ho ipha nako ea thrombolysis ea 'mele e itlelang feela.2. Thibelo le kalafo ea Atrial fibrillation ka embolism.3. Kalafo ea pele ea diffuse intravascular coagulation(DIC).4. Thibelo le kalafo ea peripheral arterial thrombosis kapa myocardial infarction.5. Anticoagulation e 'ngoe ea in vitro: joalo ka opereishene ea pelo, potoloho ea mali, hemodialysis, angiography, le eona e ka sebelisoa bakeng sa tšelo ea mali kapa tokiso ea mohlala oa mali, hajoale matšoao a mantlha a tšebeliso ea heparin ke deep vein thrombosis(DVT), PE le thrombosis. ho bakuli ba kotsing e kholo.

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    Hobaneng rona?

    · E fetisitse Chinese GMP

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    ·Ho lumellana le USP、EP le maemo a bareki

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    ·E na le bokhoni ba tsamaiso ea boleng bo kang US FDA, Japan PMDA, South Korea MFDS, joalo-joalo.

    Tlhaloso

    Lintho tsa Tlhahlobo

    Tlhaloso ea Khampani

    EP

    USP

    Litlhaku

    Phofo e tšoeu kapa e batlang e le tšoeu, e nang le hygroscopic haholo

    Boitsebiso

    Thrombotest: E lumellana

    Boitsebiso ba Chromatographic: Bo lumellana

    1H NMR Spectrum: E lumellana

    1H NMR Spectrum: E lumellana

    Liquid Chromatography: E lumellana

    Boima ba boima ba 'mele: 15000 ~ 19000

    Sodium: E lumellana

    Sodium: E lumellana

    Anti-factor Xa to anti-factor IIa ratio:0.9 ~ 1.1

    Anti-factor Xa to anti-factor IIa ratio:0.9 ~ 1.1

    Liteko

    Ho hlaka le mmala

    Ho hlaka: Ho hlakile, Mmala: ka 5 kapa ho feta

    ————

    Naetrojene

    1.5-2.5% (ntho e omileng)

    1.3 - 2.5% (ntho e omileng)

    Litšila tsa Nucleotidic

    A260≤ 0.15(4mg/ml)

    ≤ 0.1 (w/w)

    Lintho tse amanang

    E lumellana

    ————

    Moeli oa galactosamine ka kakaretso ea hexosamine

    ————

    ≤ 1.0%

    Oversulfate chondroitin sulfate

    ————

    E lumellana

    pH

    5.5–8.0(1%)

    5.5 -7.5 (1%)

    Tahlehelo ka ho omisa

    ≤ 8.0% (60℃ Dry in Vacuum, 3h)

    ≤ 5.0% (60℃ Dry in Vacuum, 3h)

    Masalla ha a tuka

    ————

    28.0% ~41.0%

    Endotoxin ea baktheria

    ≤ 0.01 IU/Setsi sa Machaba sa Heparin

    ≤ 0.03 USP U / International Unit ea Heparin

    Tšepe e boima

    ≤ 30ppm

    ≤ 30ppm

    Sodium

    10.5 ~ 13.5% (ntho e omileng)

    ————

    Liprotheine

    ≤ 0.5% (ntho e omileng)

    ≤ 0.1% (karolelano ea boima ba 'mele)

    Ketsahalo

    ≥ 180 IU/mg (ntho e omileng)

    ≥ 180 USP U/mg (ntho e omileng)

    Litšila tsa Microbial

    TAMC

    ≤ 1000cfu/g

    ≤ 1000cfu/g

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    E lumellana

    E lumellana

    Staphylococcus aureus

    E lumellana

    E lumellana

    Salmonella

    E lumellana

    E lumellana

    Re leka ho etsa bokhabane, re khamphani ea bareki ”, re tšepa ho ba sehlopha se setle ka ho fetisisa sa tšebelisano 'moho le khoebo e laolang basebetsi, barekisi le bareki, e hlokomela ho arolelana le ho bapatsa khafetsa bakeng sa Ts'ebetso e Phahameng.China Heparin SodiumHa re fane feela ka boleng bo holimo ho bareki ba rona, empa ho bohlokoa le ho feta ke lits'ebeletso tsa rona tse kholo ka ho fetisisa hammoho le theko ea tlholisano ea thekiso.
    Ts'ebetso e Phahameng ea China Heparin, khotsofalo ea bareki e lula e le sepheo sa rona, ho theha boleng ba bareki ke mosebetsi oa rona kamehla, kamano ea nako e telele ea khoebo e tsoelang molemo ke seo re se etsetsang.Re bile balekane ba tšepahalang ka ho felletseng molemong oa hau naheng ea China.Ehlile, litšebeletso tse ling, joalo ka boeletsi, le tsona li ka fanoa.


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