Zogulitsa
Kallidinogenase of Deebio for Variety of Cardiovascular and Cerebovascular Disease
Tsatanetsatane
1. Makhalidwe: Ufa woyera kapena pafupifupi woyera, wopanda fungo.
2. Kuchotsa Gwero: Nkhumba za nkhumba.
3. Njira: Kallidinogenase amachotsedwa ku kapamba wathanzi wa nkhumba.
4. Zizindikiro ndi ntchito: Mankhwalawa angagwiritsidwe ntchito pa matenda osiyanasiyana a mtima ndi cerebovascular, monga matenda a mtima, cerebral arteriosclerosis, cerebral thrombosis, retinal blood supply disorders ndi zotumphukira zamitsempha yamagazi.Kukhala ndi chithandizo chabwinoko pamafukufuku aposachedwa opewera matenda a diabetes a microangiopathy ndi diabetesic nephropathy, kumatha kuchepetsa kutulutsa kwa albumin.chipatala deta kunyumba ndi kunja amati akhoza kuonjezera umuna ntchito ndi kuchuluka kwa kupanga, ndipo ali ndi machiritso zotsatira pa mankhwala ena sterility mwamuna.
Chifukwa chiyani ife?
· Zapangidwa mu GMP workshop
· Zaka 27 za mbiri ya biological enzyme R&D
·Zida zopangira ndi zopezeka
· Tsatirani muyezo wamakasitomala
· Tumizani kumayiko ndi zigawo zopitilira 30
·Ali ndi kuthekera kowongolera machitidwe abwino monga US FDA, Japan PMDA, South Korea MFDS, etc.
Kufotokozera
| Zinthu Zoyesa | Mafotokozedwe a Kampani | ||
| CP | JP | ||
| Makhalidwe | Ufa woyera kapena pafupifupi woyera, wopanda fungo | Ufa woyera mpaka pang'ono wabulauni, wopanda fungo kapena wokomoka | |
| Chizindikiritso | R (kuchuluka kwa hydrolysis): 0.12～0.17 | R (kuchuluka kwa hydrolysis): 0.12～0.16 | |
| Liquid Chromatography: Imagwirizana | Ndi: ≤0.2 | ||
| Mayesero | pH | 5.5～7.5(300 unit / ml） | 5.5～7.5(1 g / 300 ml） |
| Kumveka kwa yankho | Zomveka(2 mg/ml） | ———— | |
| Mafuta | ≤ 5.0mg/g | ≤ 1.0mg/g | |
| Kininase | ———— | R Mtengo:≥ 0.8 | |
| Chinthu chofanana ndi trypsin | ———— | Mtengo wa T:≤ 0.05 | |
| Protease | A280≤ 0.2 | A280≤ 0.2 | |
| Kutaya pakuyanika | ≤ 5.0% (60 ℃ Yanikani mu Vacuum, 4h) | ≤ 2.0% (60 ℃ Yanikani mu Vacuum, 4h) | |
| Zotsalira pakuyatsa | ≤ 3.0% | ≤ 3.0% | |
| Kinin-kutulutsa ntchito | ———— | ≥ 500ng bradykinin yofanana/mphindi/gawo pa unit | |
| Chiyero | ≥ 75% (pakamwa) | ———— | |
| ≥ 90% (ya jakisoni) | |||
| Bakiteriya endotoxin | ≤ 2.5 EU/yuniti (ya jakisoni) | ———— | |
| Kuyesa | Ntchito ya enzyme | ———— | ≥ 25 unit / mg |
| Zochitika zenizeni | ≥ 300 unit/mg mapuloteni (pakamwa) | ≥ 100 unit / mg mapuloteni | |
| ≥ 600 unit/mg mapuloteni (a jakisoni) | |||
| Zowonongeka za Microbial | Mtengo wa TAMC | ≤ 1000cfu/g (kwa mkamwa) | ≤ 1000cfu/g |
| ≤ 100cfu/g (kwa jekeseni) | |||
| Mtengo wa TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Zimagwirizana | Zimagwirizana | |
| Salmonella | Zimagwirizana | Zimagwirizana | |
