1. Inyuguti: Ifu yera cyangwa hafi yera, impumuro nziza.
2. Inkomoko yo gukuramo: Porcine pancreas.
3. Inzira: Kallidinogenase ikurwa muri pancreas nziza.
4. Ibigaragaza kandi bikoreshwa: Iki gicuruzwa kirashobora gukoreshwa muburwayi butandukanye bwumutima nimiyoboro yubwonko nubwonko bwubwonko, nkindwara yumutima, arteriosclerose yubwonko, trombose cerebral, trombose yubwonko bwamaraso hamwe nindwara zifata imitsi.Kugira ingaruka nziza zo kuvura kubushakashatsi buherutse gukorwa kugirango wirinde indwara ya diyabete hakiri kare na diabete ya nepropatique, irashobora kugabanya gusohora alubumu.Amakuru y’amavuriro haba mu gihugu ndetse no hanze yacyo yerekana ko ashobora kongera ibikorwa byintanga nubwinshi bwumusaruro, kandi bikagira ingaruka zo kuvura muburyo bwo kuvura ubugabo.
· Yakozwe mu mahugurwa ya GMP
· Imyaka 27 ya enzyme ya biologiya R&D amateka
· Ibikoresho bibisi birashobora gukurikiranwa
· Kurikiza ibipimo byabakiriya
· Kohereza mu bihugu birenga 30
· Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.
Ibizamini | Ibisobanuro bya sosiyete | ||
CP | JP | ||
Inyuguti | Ifu yera cyangwa hafi yera, nta mpumuro nziza | Ifu yera kugeza yoroheje ifu yumukara, 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: Guhindura | 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 | |
Kugerageza ibintu | ———— | Agaciro:≤ 0.05 | |
Kurinda | A280≤ 0.2 | A280≤ 0.2 | |
Gutakaza kumisha | ≤ 5.0% (60 ℃ Kuma muri Vacuum, 4h) | ≤ 2.0% (60 ry Kuma muri Vacuum, 4h) | |
Ibisigara 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 / proteine ya mg (kumunwa) | Unit 100 proteine / mg proteine | |
Unit 600 unit / mg proteine (yo gutera inshinge) | |||
Microbial Impurities | TAMC | ≤ 1000cfu / g (ku munwa) | C 1000cfu / g |
≤ 100cfu / g (yo gutera inshinge) | |||
TYMC | C 100cfu / g | C 100cfu / g | |
E.coli | Guhindura | Guhindura | |
Salmonella | Guhindura | Guhindura |