Ngwaahịa
Kallidinogenase nke Deebio maka ụdị ọrịa obi na ọrịa Cerebovascular
Nkọwa
1. Characters: White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ, enweghị isi.
2. Isi mmalite: Porcine pancreas.
3. Usoro: A na-ewepụta Kallidinogenase site na pancreas nke porcine dị mma.
4. Ngosipụta na ojiji: Enwere ike iji ngwaahịa a maka ọrịa dị iche iche nke ọrịa obi na ọrịa ụbụrụ, dị ka ọrịa obi na-arịa ọrịa obi, ụbụrụ arteriosclerosis, ụbụrụ ụbụrụ ụbụrụ, ọrịa na-enye ọbara retina na ọrịa vaskụla mpụta.Nwee mmetụta ọgwụgwọ ka mma na nyocha ndị na-adịbeghị anya maka igbochi microangiopathy na-arịa ọrịa shuga na ọrịa nephropathy mamịrị, nwere ike ibelata mkpochapụ albumin.Clinical data ma n'ụlọ na ná mba ọzọ na-atụ aro na ọ nwere ike dịkwuo spam ọrụ na mmepụta nke ukwuu, na nwere ụfọdụ curative mmetụta na ọgwụgwọ nke ụfọdụ nwoke sterility.
Gịnị mere anyị?
· Emepụtara na ogbako GMP
· afọ 27 nke akụkọ ihe mere eme nke enzyme R&D
· A na-achọpụta ihe ọkụkụ
· Soro ọkọlọtọ ndị ahịa
· Mbupụ gaa na mba na mpaghara iri atọ
· Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.
Nkọwapụta
| Nnwale ihe | Nkọwapụta ụlọ ọrụ | ||
| CP | JP | ||
| Ndị agwa | Ọcha ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ ọcha, enweghị isi | Ọcha ka ọ dị ntakịrị ntụ ntụ aja aja, enweghị isi ma ọ bụ nke dara ada | |
| njirimara | R (ọnụọgụ hydrolysis): 0.12～0.17 | R (ọnụọgụ hydrolysis): 0.12～0.16 | |
| Chromatography Liquid: Dabara | I: ≤ 0.2 | ||
| Nnwale | pH | 5.5～7.5(300 unit / ml) | 5.5～7.5(1g/300ml) |
| Dozie ihe ngwọta | Kpochapụ(2 mg/ml) | ———— | |
| Abụba | ≤5.0mg/g | ≤1.0mg/g | |
| Kininase | ———— | Uru R:≥ 0.8 | |
| Ihe dị ka trypsin | ———— | T Uru:≤ 0.05 | |
| Mgbochi | A280≤ 0.2 | A280≤ 0.2 | |
| Ọnwụ na ihicha | ≤ 5.0% (60℃ kpọrọ nkụ na Vacuum, 4h) | ≤ 2.0% (60℃ kpọrọ nkụ na Vacuum, 4h) | |
| Ihe fọdụrụ na mgbanye | ≤ 3.0% | ≤ 3.0% | |
| Ọrụ mwepụta Kinin | ———— | ≥ 500ng bradykinin nhata / nkeji / nkeji kwa otu | |
| Ịdị ọcha | ≥ 75% (maka ọnụ) | ———— | |
| ≥ 90% (maka injection) | |||
| Ọgwụ nje endotoxin | ≤ 2.5 EU/otu (maka ịgba ntụtụ) | ———— | |
| Nyocha | Enzyme ọrụ | ———— | ≥ 25 unit/mg |
| Ọrụ akọwapụtara | ≥ 300 unit/mg protein (maka ọnụ) | ≥ 100 unit/mg protein | |
| ≥ 600 unit/mg protein (maka ntụtụ) | |||
| Microbial adịghị ọcha | TAMC | ≤ 1000cfu/g (maka ọnụ) | ≤1000cfu/g |
| ≤100cfu/g (maka ntụtụ) | |||
| TYMC | ≤100cfu/g | ≤100cfu/g | |
| E.coli | Dabara | Dabara | |
| Salmonella | Dabara | Dabara | |
