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Kallidinogenase of Deebio for Variety of Cardiovascular and Cerebovascular Disease


  • CAS NO.:9001-01-8
  • HS KODI:3507.9090.90
  • Ntchito Yafayilo:Chinese-GMP, DMF
  • Pharmacopoeia muyezo:JP/CP
  • Tsatanetsatane wa Zamalonda

    Zolemba Zamalonda

    Tsatanetsatane

    1. Makhalidwe: Ufa woyera kapena pafupifupi woyera, wopanda fungo.

    2. Kuchotsa Gwero: Nkhumba za nkhumba.

    3. Njira: Kallidinogenase amachotsedwa ku kapamba wathanzi la nkhumba.

    4. Zizindikiro ndi ntchito: Mankhwalawa angagwiritsidwe ntchito pa matenda osiyanasiyana a mtima ndi cerebovascular, monga matenda a mtima, cerebral arteriosclerosis, cerebral thrombosis, retinal blood supply disorders ndi zotumphukira matenda a mtima.Kukhala ndi chithandizo chabwinoko pazofufuza zaposachedwa zopewera matenda oyamba a diabetesic microangiopathy ndi diabetesic nephropathy, zitha kuchepetsa kutulutsa kwa albumin.chipatala deta kunyumba ndi kunja amati akhoza kuonjezera umuna ntchito ndi kuchuluka kwa kupanga, ndipo ali ndi machiritso zotsatira pa mankhwala ena sterility mwamuna.

    ine (2)
    ine (3)

    Chifukwa chiyani ife?

    · Zapangidwa mu GMP workshop

    · Zaka 27 za mbiri ya biological enzyme R&D

    ·Zida zopangira ndi zopezeka

    · Tsatirani muyezo wamakasitomala

    · Tumizani kumayiko ndi zigawo zopitilira 30

    ·Ali ndi luso loyang'anira machitidwe abwino monga US FDA, Japan PMDA, South Korea MFDS, etc.

    Kufotokozera

    Zinthu Zoyesa

    Mafotokozedwe a Kampani

    CP

    JP

    Makhalidwe

    Ufa woyera kapena pafupifupi woyera, wopanda fungo

    Ufa woyera mpaka pang'ono wabulauni, wopanda fungo kapena wokomoka

    Chizindikiritso

    R (hydrolysis mlingo): 0.120.17

    R (hydrolysis mlingo): 0.120.16

    Liquid Chromatography: Imagwirizana

    Ndi: ≤0.2

    Mayesero

    pH

    5.57.5(300 unit / ml

    5.57.5(1 g / 300 ml

    Kumveka kwa yankho

    Zomveka(2 mg/ml

    ————

    Mafuta

    ≤ 5.0mg/g

    ≤ 1.0mg/g

    Kininase

    ————

    R Mtengo:≥ 0.8

    Chinthu chofanana ndi trypsin

    ————

    Mtengo wa T:≤ 0.05

    Protease

    A280≤ 0.2

    A280≤ 0.2

    Kutaya pakuyanika

    ≤ 5.0% (60 ℃ Yanikani mu Vacuum, 4h)

    ≤ 2.0% (60 ℃ Yanikani mu Vacuum, 4h)

    Zotsalira pakuyatsa

    ≤ 3.0%

    ≤ 3.0%

    Kinin-kutulutsa ntchito

    ————

    ≥ 500ng bradykinin yofanana/mphindi/gawo pa unit

    Chiyero

    ≥ 75% (pakamwa)

    ————

    ≥ 90% (ya jakisoni)

    Bakiteriya endotoxin

    ≤ 2.5 EU/yuniti (ya jakisoni)

    ————

    Kuyesa

    Ntchito ya enzyme

    ————

    ≥ 25 unit / mg

    Zochitika zenizeni

    ≥ 300 unit/mg mapuloteni (pakamwa)

    ≥ 100 unit / mg mapuloteni

    ≥ 600 unit/mg mapuloteni (a jakisoni)

    Zowonongeka za Microbial

    Mtengo wa TAMC

    ≤ 1000cfu/g (kwa mkamwa)

    ≤ 1000cfu/g

    ≤ 100cfu/g (kwa jekeseni)

    Mtengo wa TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Zimagwirizana

    Zimagwirizana

    Salmonella

    Zimagwirizana

    Zimagwirizana


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