1. Uiga: Pa'epa'e pe toetoe a pa'epa'e pauta tioata, leai se manogi, hygroscopic.
2. Punavai Aveesea: Porcine pancreas.
3. Fa'agasologa: O le Chymotrypsin e maua mai le pancreas porcine maloloina ma saunia atili e se faiga fa'apitoa.
4. Fa'ailoga ma fa'aoga: Enzyme proteolytic.E mafai ona faʻaleleia le faʻafefe o paʻu toto, purulent secretions ma necrotic tissues.Faʻaaogaina e togafitia ai manuʻa o le edema inflammatory, adhesion inflammatory, hematoma, ulcer.Chymotrypsin mai bovine pancreas ua faʻaaogaina i se suʻesuʻega e suʻesuʻe ai le faʻaaogaina o porotini e Winsor-III microemulsion system.O le α-Chymotrypsin mai le pancreas o povi na faʻaaogaina foi i se suʻesuʻega e suʻesuʻe ai se suʻesuʻega fou faʻasolosolo faʻavae mo le trypsin.
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· Faʻamalieina EP, USP ma tulaga faʻatau
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· O loʻo i ai le gafatia o pulega lelei faʻapitoa e pei ole US FDA, Iapani PMDA, Korea i Saute MFDS, ma isi.
Mea Su'ega | Kamupani Fa'amatalaga | ||
EP | USP | ||
Uiga | Pa'epa'e pe toetoe a pa'epa'e pauta tioata, leai se manogi, hygroscopic | Pa'epa'e pe toetoe a pa'epa'e fa'amago 'aisa pauta | |
Fa'ailoaga | Fa'atatau | Fa'atatau | |
Su'ega | Histamine | ≤ 1ug (gaioiga Chymotrypsin/5mk) | ———— |
Malamalama | Fa'atatau | Fa'atatau | |
pH | 3.0~5.0 | ———— | |
O'o'o | A281:18.5~22.5,A250≤ 8 | ———— | |
Trypsin | Fa'atatau | ≤ 1.0% | |
Ma'imau ile fa'amago | ≤ 5.0% | ≤ 5.0% (60℃ Decompression 4h) | |
Toega ile mu | ———— | ≤ 2.5% | |
Gaoioiga | ≥ 5.0mk/mg | ≥ 1000USP.U/mg (mea mago) | |
Microbial le mama | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Fa'atatau | Fa'atatau | |
Salmonella | Fa'atatau | Fa'atatau | |
Staphylococcus aureus | ———— | Fa'atatau | |
Pseudomonas aeruginosa | ———— | Fa'atatau |