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Kallidinogenase sili ona lelei fa'atau atu i Saina (CAS: 9001-01-8)


  • NO. CAS:9001-01-8
  • HS CODE:3507.9090.90
  • Auaunaga faila:Saina-GMP, DMF
  • Pharmacopoeia tulaga:JP/CP
  • Fa'amatalaga Oloa

    Faailoga o oloa

    O loʻo i ai se uiga lelei ma alualu i luma i le fiafia o tagata faʻatau, o la matou atinaʻe e faʻaleleia pea a matou oloa maualuga maualuga e faʻafetaui ai manaʻoga o tagata faʻatau ma sili atu ona taulaʻi atu i le saogalemu, faʻamaoni, manaoga o le siosiomaga, ma le fou o le Best-Selling China High QualityKallidinogenase (CAS: 9001-01-8), E masani lava i le toʻatele o tagata faʻaoga pisinisi ma faioloa e ofoina atu oloa sili ona lelei ma kamupani sili ona lelei.Fa'afeiloa'i fa'afeiloa'i e fa'atasi ma i matou, se'i o tatou fa'afouina fa'atasi, i miti lele.
    O loʻo i ai se uiga lelei ma alualu i luma i le fiafia o tagata faʻatau, o la matou atinaʻe e faʻaleleia pea a matou oloa maualuga maualuga e faʻafetaui ai manaʻoga o tagata faʻatau ma sili atu ona taulaʻi i le saogalemu, faʻamaoni, manaʻoga o le siosiomaga, ma le faʻafouina oKallidinogenas, Matou te faʻamoemoe e avea ma atinaʻe faʻaonaponei ma le tulaga faʻapisinisi o le "Faʻamaoni ma le mautinoa" ma le faʻamoemoe o le "Ofo atu i tagata faʻatau auaunaga sili ona faamaoni ma oloa sili ona lelei".Matou te talosaga atu ma le faamaoni mo lau lagolago le suia ma talisapaia lau fautuaga agalelei ma le taitaiga.

    Fa'amatalaga

    1. Uiga: Pa'epa'e pe toetoe a pa'epa'e pa'epa'e, leai se manogi.

    2. Punavai Aveesea: Porcine pancreas.

    3. Fa'agasologa: Kallidinogenase e maua mai le porcine pancreas maloloina.

    4. Faʻailoga ma faʻaoga: O lenei oloa e mafai ona faʻaaogaina mo le tele o maʻi cardiovascular ma cerebovascular, e pei o maʻi fatu fatu, cerebral arteriosclerosis, cerebral thrombosis, faʻamaʻi toto toto ma faʻamaʻi vascular peripheral.E sili atu le togafitiga i suʻesuʻega lata mai mo le puipuia o le microangiopathy o le maʻisuka vave ma le nephropathy o le maʻisuka, e mafai ona faʻaitiitia ai le alu o albumin.O fa'amatalaga fa'apitoa ile fale ma fafo o lo'o fa'ailoa mai e mafai ona fa'atuputeleina ai le gaioiina o le sperm ma le aofa'i o le gaosiga, ma e iai fo'i le a'afiaga fa'amalolo i le togafitia o le malepelepe o tama.

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    Aisea tatou?

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    · O loʻo i ai le gafatia o pulega lelei faʻapitoa e pei ole US FDA, Iapani PMDA, Korea i Saute MFDS, ma isi.

    Fa'amatalaga

    Mea Su'ega

    Kamupani Fa'amatalaga

    CP

    JP

    Uiga

    Pa'epa'e pe toetoe a pa'epa'e pauta, leai se manogi

    Pa'epa'e se'i enaena enaena pauta, leai se manogi po'o se'i vaivai

    Fa'ailoaga

    R (fua o le hydrolysis): 0.12~0.17

    R (fua o le hydrolysis): 0.12~0.16

    Suavai Chromatography: Fa'afetaui

    I: ≤ 0.2

    Su'ega

    pH

    5.5~7.5(300iunite/ml)

    5.5~7.5(1g/300ml)

    Malamalama ole fofo

    manino(2mg/ml)

    ————

    Ga'o

    ≤ 5.0mg/g

    ≤ 1.0mg/g

    Kininase

    ————

    R Taua: ≥ 0.8

    Mea e pei o le trypsin

    ————

    T Taua:≤ 0.05

    Protease

    A280≤ 0.2

    A280≤ 0.2

    Ma'imau ile fa'amago

    ≤ 5.0% (60 ℃ Fa'amamago i totonu o le Vacuum, 4h)

    ≤ 2.0% (60 ℃ Fa'amamago i totonu o le Vacuum, 4h)

    Toega ile mu

    ≤ 3.0%

    ≤ 3.0%

    Gaioiga fa'asa'olotoina

    ————

    ≥ 500ng bradykinin tutusa / min / iunite i le iunite

    Mama

    ≥ 75% (mo tautalaga)

    ————

    ≥ 90% (mo tui)

    Endotoxin siama

    ≤ 2.5 EU/iunite (mo tui)

    ————

    Su'ega

    Gaioiga ole enzyme

    ————

    ≥ 25 iunite/mg

    Gaoioiga faapitoa

    ≥ 300 iunite/mg porotini (mo le tautala)

    ≥ 100 iunite/mg porotini

    ≥ 600 iunite/mg porotini (mo tui)

    Microbial le mama

    TAMC

    ≤ 1000cfu/g (mo tautalaga)

    ≤ 1000cfu/g

    ≤ 100cfu/g (mo tui)

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Fa'atatau

    Fa'atatau

    Salmonella

    Fa'atatau

    Fa'atatau

    O loʻo i ai se uiga lelei ma alualu i luma i le fiafia o tagata faʻatau, o la matou atinaʻe e faʻaleleia pea a matou oloa maualuga maualuga e faʻafetaui ai manaʻoga o tagata faʻatau ma sili atu ona taulaʻi i le saogalemu, faʻatuatuaina, manaʻoga o le siosiomaga, ma le faʻafouina o le Best-Selling China High Quality Cp Kallidinogenase (CAS: 9001-01-8), E masani lava i le toʻatele o tagata faʻaoga pisinisi ma faioloa e ofoina atu oloa sili ona lelei ma kamupani sili ona lelei.Fa'afeiloa'i fa'afeiloa'i e fa'atasi ma i matou, se'i o tatou fa'afouina fa'atasi, i miti lele.
    Fa'atauga sili ona lelei Saina Pharmaceutical Intermediate, Antibiotic, Matou te faʻamoemoe e avea ma atinaʻe faʻaonaponei ma le tulaga faʻapisinisi o le "Faʻamaoni ma le mautinoa" ma le faʻamoemoe o le "Ofo atu i tagata faʻatau auaunaga sili ona faamaoni ma oloa sili ona lelei".Matou te talosaga atu ma le faamaoni mo lau lagolago le suia ma talisapaia lau fautuaga agalelei ma le taitaiga.


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