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Kallidinogenase o Deebio mo Eseesega o Faʻamaʻi Cardiovascular ma Cerebovascular


  • CAS NO.:9001-01-8
  • HS CODE:3507.9090.90
  • Fa'amatalaga Oloa

    Faailoga o oloa

    Fa'amatalaga

    1. Uiga: Pa'epa'e pe toeititi pa'epa'e pauta, leai se manogi.

    2. Punavai Aveesea: Porcine pancreas.

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

    4. Fa'ailoga ma fa'aoga: O lenei oloa e mafai ona fa'aogaina mo le tele o ma'i cardiovascular ma cerebovascular, e pei o le fatu fatu fatu, cerebral arteriosclerosis, cerebral thrombosis, retinal toto fa'aletonu ma ma'i vascular peripheral.E sili atu le togafitiga i suʻesuʻega talu ai nei mo le puipuia o le microangiopathy o le maʻisuka vave ma le nephropathy o le maʻisuka, e mafai ona faʻaitiitia ai le albumin excretion.O fa'amatalaga fa'apitoa ile fale ma fafo o lo'o fautua mai ai e mafai ona fa'atuputeleina le gaioiga o le sperm ma le aofa'i o le gaosiga, ma e iai ni a'afiaga fa'amalolo i le togafitia o nisi o tama tane.

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    Aisea tatou?

    · Faia i le a'oga GMP

    · 27 tausaga o biological enzyme R&D talafaasolopito

    · O mea mata'utia e mafai ona su'eina

    · Faʻamalieina tulaga faʻatau

    · Auina atu i fafo i le silia ma le 30 atunuu ma itulagi

    · O loʻo i ai le malosi o le pulega lelei 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): 0.120.17

    R (fua o le hydrolysis): 0.120.16

    Suavai Chromatography: Fa'afetaui

    I: ≤ 0.2

    Su'ega

    pH

    5.57.5(300iunite/ml

    5.57.5(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

    Porotease

    A280≤ 0.2

    A280≤ 0.2

    Ma'imau ile fa'amago

    ≤ 5.0% (60 ℃ Fa'amamago i totonu ole gaogao, 4h)

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

    Toega ile mu

    ≤ 3.0%

    ≤ 3.0%

    Gaoioiga fa'asa'olotoina

    ————

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

    Mama atoatoa

    ≥ 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


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