Saina Kallidinogenase o Deebio mo Eseesega o Cardiovascular ma Cerebovascular Falegaosimea ma gaosiga |Deebiotech

Kallidinogenase o Deebio mo Eseesega o Cardiovascular ma Cerebovascular Faʻamaʻi

NO. CAS:9001-01-8

HS CODE:3507.9090.90

Auaunaga faila:Saina-GMP, DMF

Pharmacopoeia tulaga:JP/CP

Auina imeli ia matou fa'ata'ita'iga fua

Fa'amatalaga Oloa

Faailoga o oloa

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.

Aisea tatou?

· Faia i le aʻoga GMP

· 27 tausaga o biological enzyme R&D talafaasolopito

· E mafai ona su'eina mea mata'utia

· Ia tausisia tulaga fa'atau

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

· 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
Mea Su'ega		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 (fuafua o le hydrolysis): 0.12～0.17	R (fuafua o le hydrolysis): 0.12～0.16
Fa'ailoaga		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)	————
	Mama	≥ 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
	Gaoioiga faapitoa	≥ 600 iunite/mg porotini (mo tui)	≥ 100 iunite/mg porotini
Microbial le mama	TAMC	≤ 1000cfu/g (mo tautalaga)	≤ 1000cfu/g
	TAMC	≤ 100cfu/g (mo tui)	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Fa'atatau	Fa'atatau
	Salmonella	Fa'atatau	Fa'atatau