1. Characters: Caddaan ama ku dhawaad cad budo crystal ah, aan ur lahayn, hygroscopic.
2. Isha Soosaarka: Beeryarada Porcine.
3. Habka: Chymotrypsin waxaa laga soo saaraa beeryarada doofaarka ee caafimaadka leh waxaana loo sii diyaariyey hab gaar ah.
4. Tilmaamaha iyo isticmaalka: Proteolytic enzyme.Waxay kor u qaadi kartaa liquefaction ee xinjirowga dhiigga, dheecaanka purulent iyo unugyada necrotic.Waxaa loo isticmaalaa in lagu daweeyo nabarrada bararka bararka, xabagta bararka, hematoma, boog. Chymotrypsin oo ka soo jeeda beeryarada bovine ayaa loo isticmaalay daraasad lagu baarayo soo saarista borotiinka ee nidaamyada microemulsion Winsor-III.α-Cymotrypsin oo ka soo jeeda beeryarada bovine ayaa sidoo kale loo isticmaalay daraasad lagu baarayo faylal cusub oo buuxa oo ku salaysan trypsin.
Waxaa lagu soo saaray aqoon-is-weydaarsiga GMP
· 27 sano oo enzyme bayooloji R&D taariikhda
Qalabka ceeriin waa la raadin karaa
U hoggaansamaan EP, USP iyo heerka macaamiisha
· Dhaqdhaqaaq sare, nadiif sare, xasilooni sare
Dhoofinta in ka badan 30 waddan iyo gobollo
Inuu leeyahay awoodda maamulka nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.
Walxaha Tijaabada | Tilmaamaha Shirkadda | ||
EP | USP | ||
Jilayaasha | Caddaan ama ku dhawaad cad budo crystal ah, aan ur lahayn, hygroscopic | Caddaan ama ku dhawaad caddaan budo qallajinaysa | |
Aqoonsiga | waafaqsan | waafaqsan | |
Tijaabooyin | Histamiin | ≤ 1ug (waxqabadka Chymotrypsin/5mk) | ———— |
Caddayn | waafaqsan | waafaqsan | |
pH | 3.0~5.0 | ———— | |
nuugista | A281:18.5~22.5,A250≤ 8 | ———— | |
Trypsin | waafaqsan | ≤ 1.0% | |
Luminta qalajinta | ≤ 5.0% | ≤ 5.0% (60 ℃ Hoosudhac 4 saac) | |
Hadhaaga dabka | ———— | ≤ 2.5% | |
Dhaqdhaqaaqa | ≥ 5.0mk/mg | ≥ 1000USP.U/mg (walxaha qallalan) | |
wasakhda Microbial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | waafaqsan | waafaqsan | |
Salmonella | waafaqsan | waafaqsan | |
Staphylococcus aureus | ———— | waafaqsan | |
Pseudomonas aeruginosa | ———— | waafaqsan |