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.
· 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.
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): 0.12~0.17 | R (fua o le hydrolysis): 0.12~0.16 | |
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 | |
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 |