Ibicuruzwa
Kallidinogenase ya Deebio kubwindwara zinyuranye z'umutima n'imitsi
Ibisobanuro
1. Inyuguti: Ifu yera cyangwa hafi yera, impumuro nziza.
2. Inkomoko yo gukuramo: pancreas pancreas.
3. Inzira: Kallidinogenase ikurwa muri pancreas nziza.
4. Ibigaragaza kandi bikoreshwa: Iki gicuruzwa kirashobora gukoreshwa mu ndwara zitandukanye zifata umutima-mitsi ndetse nubwonko bwubwonko, nkindwara yumutima wumutima, arteriosclerose yubwonko, trombose cerebral, trombose yubwonko, indwara zitanga amaraso hamwe nindwara zifata imitsi.Gira ingaruka nziza zo kuvura kubushakashatsi buherutse gukorwa kugirango hirindwe mikorobe ya diabete hakiri kare na diabete ya nepropatique, irashobora kugabanya gusohoka kwa alubumu.Amakuru y’amavuriro haba mu gihugu ndetse no hanze yacyo yerekana ko ashobora kongera ibikorwa byintanga n’umusaruro, kandi bikagira ingaruka zimwe na zimwe zo kuvura mu kuvura indwara zimwe na zimwe z’abagabo.
Kuki？
· Yakozwe mu mahugurwa ya GMP
· Imyaka 27 ya enzyme ya biologiya R&D amateka
· Ibikoresho bibisi birashobora gukurikiranwa
· Kurikiza amahame y'abakiriya
· Kohereza mu bihugu n'uturere birenga 30
· Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.
Ibisobanuro
| Ibizamini | Ibisobanuro bya sosiyete | ||
| CP | JP | ||
| Inyuguti | Ifu yera cyangwa hafi yera, impumuro nziza | Ifu yera kugeza yoroheje yifu, idafite impumuro nziza cyangwa ifite intege nke | |
| Kumenyekanisha | R (igipimo cya hydrolysis): 0.12～0.17 | R (igipimo cya hydrolysis): 0.12～0.16 | |
| Amazi ya Chromatografiya: Ihuza | I: ≤ 0.2 | ||
| Ibizamini | pH | 5.5～7.5（300unit / ml） | 5.5～7.5（1g / 300ml） |
| Igisubizo cyumvikana | Biragaragara（2mg / ml） | ———— | |
| Ibinure | ≤ 5.0mg / g | ≤ 1.0mg / g | |
| Kininase | ———— | R Agaciro：≥ 0.8 | |
| Ibintu bisa na Trypsin | ———— | Agaciro：≤ 0.05 | |
| Kurinda | A280≤ 0.2 | A280≤ 0.2 | |
| Gutakaza kumisha | ≤ 5.0% (60 ℃ Kuma muri Vacuum, 4h) | ≤ 2.0% (60 ℃ Kuma muri Vacuum, 4h) | |
| Ibisigisigi byo gutwikwa | ≤ 3.0% | ≤ 3.0% | |
| Igikorwa cyo kurekura Kinin | ———— | ≥ 500ng bradykinin ihwanye / min / ubumwe kuri buri gice | |
| Isuku | ≥ 75% (ku munwa) | ———— | |
| ≥ 90% (yo gutera inshinge) | |||
| Indwara ya bagiteri | ≤ 2.5 EU / igice (cyo gutera inshinge) | ———— | |
| Suzuma | Igikorwa cya Enzyme | ———— | Unit 25 unit / mg |
| Igikorwa cyihariye | Unit 300 unit / mg proteine (kumunwa) | Unit 100 unit / mg proteine | |
| ≥ 600 unit / mg proteine (yo gutera inshinge) | |||
| Microbial Impurities | TAMC | ≤ 1000cfu / g (ku munwa) | ≤ 1000cfu / g |
| ≤ 100cfu / g (yo gutera inshinge) | |||
| TYMC | C 100cfu / g | C 100cfu / g | |
| E.coli | Guhuza | Guhuza | |
| Salmonella | Guhuza | Guhuza | |
