1. Litlhaku: Phofo ea kristale e tšoeu kapa e batlang e le tšoeu, e se nang monko, e hygroscopic.
2. Mohloli oa Mohloli: Li-pancreas tsa Porcine.
3. Ts'ebetso: Chymotrypsin e ntšoa ho li-pancreas tse phetseng hantle tsa porcine 'me li tsoela pele ho lokisoa ka mokhoa o khethehileng.
4. Lipontšo le tšebeliso: Enzyme ea proteolytic.E ka khothalletsa liquefaction ea mali clots, purulent secretions le necrotic dinama tse nyenyane tse.E sebelisetsoa ho phekola maqeba a edema ea ho ruruha, ho khomarela ho ruruha, hematoma, ulcer.Chymotrypsin e tsoang ho li-pancreas tsa bovine e sebelisitsoe thutong ea ho batlisisa ho ntšoa ha protheine ka Winsor-III microemulsion systems.α-Chymotrypsin e tsoang manyeme a likhomo le eona e se e sebelisitsoe phuputsong ho etsa lipatlisiso ka probe e ncha e khethehileng e thehiloeng ho fluorescent bakeng sa trypsin.
·E hlahisitsoe thupelong ea GMP
· Lilemo tse 27 tsa nalane ea enzyme ea bioloji ea R&D
· Lisebelisuoa tse tala lia lateloa
·Latela EP, USP le maemo a bareki
·Mosebetsi o phahameng, bohloeki bo phahameng, botsitso bo phahameng
· Romella kantle ho naha le libakeng tse fetang 30
·E na le bokhoni ba tsamaiso ea boleng bo kang US FDA, Japan PMDA, South Korea MFDS, joalo-joalo.
Lintho tsa Tlhahlobo | Tlhaloso ea Khampani | ||
EP | USP | ||
Litlhaku | Phofo ea kristale e tšoeu kapa e batlang e le tšoeu, e se nang monko, e hygroscopic | Omisa phofo e tšoeu kapa e batlang e le tšoeu | |
Boitsebiso | E lumellana | E lumellana | |
Liteko | Histamine | ≤ 1ug (Mosebetsi oa Chymotrypsin/5mk) | ———— |
Ho hlaka | E lumellana | E lumellana | |
pH | 3.0~5.0 | ———— | |
Absorbance | A281:18.5~22.5,A250≤8 | ———— | |
Trypsin | E lumellana | ≤ 1.0% | |
Tahlehelo ka ho omisa | ≤ 5.0% | ≤ 5.0% (60℃ Decompression 4h) | |
Masalla ha a tuka | ———— | ≤ 2.5% | |
Ketsahalo | ≥ 5.0mk/mg | ≥ 1000USP.U/mg (ntho e omileng) | |
Litšila tsa Microbial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | E lumellana | E lumellana | |
Salmonella | E lumellana | E lumellana | |
Staphylococcus aureus | ———— | E lumellana | |
Pseudomonas aeruginosa | ———— | E lumellana |