1. Mavara: Ichena kana inenge chena yekristaro hupfu, isina kunhuwa, hygroscopic.
2. Kubvisa Kunobva: Porcine pancreas.
3. Maitiro: Chymotrypsin inotorwa kubva kune utano hweporcine pancreas uye inowedzera kugadzirirwa nemaitiro anokosha.
4. Zviratidzo uye kushandiswa: Proteolytic enzyme.Inogona kukurudzira liquefaction yeropa, purulent secretions uye necrotic tishu.Inoshandiswa kurapa maronda ekuzvimba edema, inflammatory adhesion, hematoma, ulcer.Chymotrypsin kubva bovine pancreas yakashandiswa muchidzidzo chekuongorora mapuroteni ekutorwa neWinsor-III microemulsion systems.α-Chymotrypsin kubva kuBovine pancreas yakashandiswawo muchidzidzo chekuongorora chitsva che fullerene-based fluorescent probe ye trypsin.
·Yakagadzirwa mumusangano weGMP
· Makore makumi maviri nemanomwe ebhayoloji enzyme R&D nhoroondo
·Maraw materials anotarisika
· Teerera neEP, USP uye chiyero chevatengi
·Kuitwa kwepamusoro, kuchena kwepamusoro, kugadzikana kwepamusoro
·Tumira kunze kwenyika dzinopfuura makumi matatu nematunhu
·Ane kugona kwemhando yekutonga system seUS FDA, Japan PMDA, South Korea MFDS, nezvimwe.
Test Items | Kutsanangurwa kwekambani | ||
EP | USP | ||
Vanhu | Ichena kana inenge chena crystal poda, isina kunhuwa, hygroscopic | Ichena kana inenge chena kuomesa-kuomesa poda | |
Identification | Conforms | Conforms | |
Miedzo | Histamine | ≤ 1ug (Chymotrypsin chiitiko/5mk) | ———— |
Kujeka | Conforms | Conforms | |
pH | 3.0~5.0 | ———— | |
Absorbance | A281:18.5~22.5,A250≤ 8 | ———— | |
Trypsin | Conforms | ≤ 1.0% | |
Kurasikirwa pakuomeswa | ≤ 5.0% | ≤ 5.0% (60℃ Decompression 4h) | |
Residue pakubatidza | ———— | ≤ 2.5% | |
Chiitiko | ≥ 5.0mk/mg | ≥ 1000USP.U/mg (chinhu chakaoma) | |
Kusvibiswa kweMicrobial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Conforms | Conforms | |
Salmonella | Conforms | Conforms | |
Staphylococcus aureus | ———— | Conforms | |
Pseudomonas aeruginosa | ———— | Conforms |