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Lihlahisoa

Kallidinogenase ea Deebio bakeng sa mefuta e sa tšoaneng ea lefu la pelo le lefu la cerebovascular


  • NOMORO YA CAS:9001-01-8
  • HS CODE:3507.9090.90
  • Lintlha tsa Sehlahisoa

    Li-tag tsa Sehlahisoa

    Lintlha

    1. Litlhaku: Phofo e tšoeu kapa e batlang e le tšoeu, e sa nkheng.

    2. Mohloli oa Mohloli: Li-pancreas tsa Porcine.

    3. Ts'ebetso: Kallidinogenase e ntšoa ho li-pancreas tse phetseng hantle tsa porcine.

    4. Lipontšo le tšebeliso:Sehlahisoa sena se ka sebelisoa bakeng sa mefuta e sa tšoaneng ea lefu la pelo le methapo ea pelo, e kang lefu la pelo, lefu la cerebral arteriosclerosis, cerebral thrombosis, mathata a ho fana ka mali a retinal le lefu la peripheral vascular disease.Ho ba le phello e betere ea kalafo liphuputsong tsa morao-rao tsa thibelo ea lefu la tsoekere la pele la lefu la tsoekere le nephropathy ea lefu la tsoekere, ho ka fokotsa ho ntšoa ha albin.Lintlha tsa Clinical lapeng le kantle ho naha li fana ka maikutlo a hore e ka eketsa ts'ebetso ea peō ea botona le bongata ba tlhahiso, 'me e na le phello e itseng ea ho phekola kalafo ea sterility e itseng.

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    Hobaneng rona?

    ·E hlahisoa ka har'a workshop ea GMP

    · Lilemo tse 27 tsa nalane ea enzyme ea bioloji ea R&D

    · Lisebelisuoa tse tala lia lateloa

    ·Latela maemo a bareki

    · Romella kantle ho naha le libakeng tse fetang 30

    ·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

    CP

    JP

    Litlhaku

    Phofo e tšoeu kapa e batlang e le tšoeu, ha e na monko

    Phofo e tšoeu ho isa ho e sootho hanyane, e sa nkheng kapa e lerootho

    Boitsebiso

    R (khalo ea hydrolysis): 0,120.17

    R (khalo ea hydrolysis): 0,120.16

    Liquid Chromatography: E lumellana

    Ke: ≤ 0.2

    Liteko

    pH

    5.57.5300 yuniti / ml

    5.57.51g/300ml

    Ho hlaka ha tharollo

    Hlakileng2mg/ml

    ————

    Mafura

    ≤ 5.0mg/g

    ≤ 1.0mg/g

    Kininase

    ————

    R Boleng:≥ 0.8

    Ntho e kang trypsin

    ————

    T Boleng:≤ 0.05

    Protease

    A280≤ 0.2

    A280≤ 0.2

    Tahlehelo ka ho omisa

    ≤ 5.0% (60℃ Dry in Vacuum, 4h)

    ≤ 2.0% (60℃ Dry in Vacuum, 4h)

    Mesaletsa nakong ea ho hotetsa

    ≤ 3.0%

    ≤ 3.0%

    Ts'ebetso ea ho ntša Kinin

    ————

    ≥ 500ng bradykinin e lekanang / metsotso / yuniti ka yuniti

    Bohloeki

    ≥ 75% (bakeng sa molomo)

    ————

    ≥ 90% (bakeng sa ente)

    Endotoxin ea baktheria

    ≤ 2.5 EU/yuniti (bakeng sa ente)

    ————

    Assay

    Ts'ebetso ea enzyme

    ————

    ≥ 25 yuniti / mg

    Ts'ebetso e khethehileng

    ≥ 300 unit/mg protheine (bakeng sa molomo)

    ≥ 100 unit / mg protheine

    ≥ 600 unit/mg protheine (bakeng sa ente)

    Litšila tsa Microbial

    TAMC

    ≤ 1000cfu/g (bakeng sa molomo)

    ≤ 1000cfu/g

    ≤ 100cfu/g (bakeng sa ente)

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    E lumellana

    E lumellana

    Salmonella

    E lumellana

    E lumellana


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