• Ngwaahịa
ibe

Ngwaahịa

Kallidinogenase nke Deebio maka ụdị ọrịa obi na ọrịa Cerebovascular


  • Ọ BỤGHỊ:9001-01-8
  • Koodu HS:3507.9090.90
  • Ọrụ faịlụ:Chinese-GMP, DMF
  • Ọkọlọtọ Pharmacopoeia:JP/CP
  • Nkọwa ngwaahịa

    Mkpado ngwaahịa

    Nkọwa

    1. Characters: White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ, enweghị isi.

    2. Isi mmalite: Porcine pancreas.

    3. Usoro: A na-ewepụta Kallidinogenase site na pancreas nke porcine dị mma.

    4. Ngosipụta na ojiji: Enwere ike iji ngwaahịa a maka ọrịa dị iche iche nke ọrịa obi na ọrịa ụbụrụ, dị ka ọrịa obi na-arịa ọrịa obi, ụbụrụ arteriosclerosis, ụbụrụ ụbụrụ ụbụrụ, ọrịa na-enye ọbara retina na ọrịa vaskụla mpụta.Nwee mmetụta ọgwụgwọ ka mma na nyocha ndị na-adịbeghị anya maka igbochi microangiopathy na-arịa ọrịa shuga na ọrịa nephropathy mamịrị, nwere ike ibelata mkpochapụ albumin.Clinical data ma n'ụlọ na ná mba ọzọ na-atụ aro na ọ nwere ike dịkwuo spam ọrụ na mmepụta nke ukwuu, na nwere ụfọdụ curative mmetụta na ọgwụgwọ nke ụfọdụ nwoke sterility.

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    Gịnị mere anyị?

    · Emepụtara na ogbako GMP

    · afọ 27 nke akụkọ ihe mere eme nke enzyme R&D

    · A na-achọpụta ihe ọkụkụ

    · Soro ọkọlọtọ ndị ahịa

    · Mbupụ gaa na mba na mpaghara iri atọ

    · Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.

    Nkọwapụta

    Nnwale ihe

    Nkọwapụta ụlọ ọrụ

    CP

    JP

    Ndị agwa

    Ọcha ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ ọcha, enweghị isi

    Ọcha ka ọ dị ntakịrị ntụ ntụ aja aja, enweghị isi ma ọ bụ nke dara ada

    njirimara

    R (ọnụọgụ hydrolysis): 0.120.17

    R (ọnụọgụ hydrolysis): 0.120.16

    Chromatography Liquid: Dabara

    I: ≤ 0.2

    Nnwale

    pH

    5.57.5(300 unit / ml)

    5.57.5(1g/300ml)

    Dozie ihe ngwọta

    Kpochapụ(2 mg/ml)

    ————

    Abụba

    ≤5.0mg/g

    ≤1.0mg/g

    Kininase

    ————

    Uru R:≥ 0.8

    Ihe dị ka trypsin

    ————

    T Uru:≤ 0.05

    Mgbochi

    A280≤ 0.2

    A280≤ 0.2

    Ọnwụ na ihicha

    ≤ 5.0% (60℃ kpọrọ nkụ na Vacuum, 4h)

    ≤ 2.0% (60℃ kpọrọ nkụ na Vacuum, 4h)

    Ihe fọdụrụ na mgbanye

    ≤ 3.0%

    ≤ 3.0%

    Ọrụ mwepụta Kinin

    ————

    ≥ 500ng bradykinin nhata / nkeji / nkeji kwa otu

    Ịdị ọcha

    ≥ 75% (maka ọnụ)

    ————

    ≥ 90% (maka injection)

    Ọgwụ nje endotoxin

    ≤ 2.5 EU/otu (maka ịgba ntụtụ)

    ————

    Nyocha

    Enzyme ọrụ

    ————

    ≥ 25 unit/mg

    Ọrụ akọwapụtara

    ≥ 300 unit/mg protein (maka ọnụ)

    ≥ 100 unit/mg protein

    ≥ 600 unit/mg protein (maka ntụtụ)

    Microbial adịghị ọcha

    TAMC

    ≤ 1000cfu/g (maka ọnụ)

    ≤1000cfu/g

    ≤100cfu/g (maka ntụtụ)

    TYMC

    ≤100cfu/g

    ≤100cfu/g

    E.coli

    Dabara

    Dabara

    Salmonella

    Dabara

    Dabara


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