Awọn ọja
Kallidinogenase ti Deebio fun Oriṣiriṣi Arun inu ọkan ati ẹjẹ Cerebovascular
Ẹ̀kúnrẹ́rẹ́
1. Ohun kikọ: Funfun tabi fere funfun lulú, ourless.
2. Orisun isediwon: Porcine pancreas.
3. Ilana: Kallidinogenase ti wa ni jade lati ilera ti oronro porcine.
4. Awọn itọkasi ati lilo: Ọja yii le ṣee lo fun ọpọlọpọ awọn arun inu ọkan ati ẹjẹ, gẹgẹbi arun ọkan iṣọn-alọ ọkan, arteriosclerosis cerebral, thrombosis cerebral, awọn rudurudu ipese ẹjẹ retinal ati arun iṣan agbeegbe.Ni ipa itọju ailera to dara julọ lori awọn iwadii aipẹ fun idena thr ti microangiopathy dayabetik kutukutu ati nephropathy dayabetik, le dinku iyọkuro albumin.Awọn data ile-iwosan mejeeji ni ile ati ni ilu okeere daba pe o le mu iṣẹ ṣiṣe sperm ati iwọn iṣelọpọ pọ si, ati pe o ni ipa itọju kan ni itọju diẹ ninu ailesabiyamọ ọkunrin.
Kini idi ti wa?
· Ti ṣejade ni idanileko GMP
· ọdun 27 ti itan-akọọlẹ R&D henensiamu ti ibi
· Awọn ohun elo aise jẹ itọpa
· Ni ibamu pẹlu boṣewa onibara
Ṣe okeere si awọn orilẹ-ede ati agbegbe ti o ju 30 lọ
· Ni agbara ti iṣakoso eto didara gẹgẹbi US FDA, Japan PMDA, South Korea MFDS, ati bẹbẹ lọ.
Sipesifikesonu
| Awọn nkan Idanwo | Ile-iṣẹ pato | ||
| CP | JP | ||
| Awọn ohun kikọ | Funfun tabi fere funfun lulú, odorless | Funfun si erupẹ brown diẹ, ti ko ni olfato tabi ti o rẹwẹsi | |
| Idanimọ | R (oṣuwọn hydrolysis): 0.12～0.17 | R (oṣuwọn hydrolysis): 0.12～0.16 | |
| Chromatography Liquid: Ṣe deede | Emi: ≤ 0.2 | ||
| Idanwo | pH | 5.5～7.5(300 kuro / milimita) | 5.5～7.5(1g/300ml) |
| Wipe ojutu | Ko o(2mg/ml) | ———— | |
| Ọra | ≤ 5.0mg/g | ≤ 1.0mg/g | |
| Kininase | ———— | R iye:≥ 0.8 | |
| Ohun elo ti o dabi trypsin | ———— | T iye:≤ 0.05 | |
| Proteate | A280≤ 0.2 | A280≤ 0.2 | |
| Pipadanu lori gbigbe | ≤ 5.0% (60℃ Gbẹ ninu Igbale, wakati 4) | ≤ 2.0% (60℃ Gbẹ ninu Igbale, wakati 4) | |
| Aloku lori iginisonu | ≤ 3.0% | ≤ 3.0% | |
| Kinin-dasile aṣayan iṣẹ-ṣiṣe | ———— | ≥ 500ng bradykinin deede / min / kuro fun ẹyọkan | |
| Mimo | ≥ 75% (fun ẹnu) | ———— | |
| ≥ 90% (fun abẹrẹ) | |||
| Endotoxin kokoro arun | ≤ 2.5 EU/ẹyọkan (fun abẹrẹ) | ———— | |
| Ayẹwo | Enzyme aṣayan iṣẹ-ṣiṣe | ———— | ≥ 25 ẹyọkan/mg |
| Iṣẹ ṣiṣe pato | ≥ 300 kuro/amuaradagba miligiramu (fun ẹnu) | ≥ 100 kuro / miligiramu amuaradagba | |
| ≥ 600 kuro / miligiramu amuaradagba (fun abẹrẹ) | |||
| Makirobia impurities | TAMC | ≤ 1000cfu/g (fun ẹnu) | ≤ 1000cfu/g |
| ≤ 100cfu/g (fun abẹrẹ) | |||
| TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Ni ibamu | Ni ibamu | |
| Salmonella | Ni ibamu | Ni ibamu | |
