Products
Kallidinogenase yeDeebio yeKusiyana-siyana kweMwoyo uye Cerebovascular Disease
Detail
1. Hunhu: Hupfu huchena kana hunenge huchena, husina hwema.
2. Kubvisa Kunobva: Porcine pancreas.
3. Maitiro: Kallidinogenase inotorwa kubva kune hutano porcine pancreas.
4. Zviratidzo uye kushandiswa: Ichi chigadzirwa chinogona kushandiswa kune zvakasiyana-siyana zvemwoyo uye cerebovascular chirwere, zvakadai sechirwere chemwoyo, cerebral arteriosclerosis, cerebral thrombosis, retinal blood supply disorders uye peripheral vascular disease.Iva nekurapa kurinani patsvagurudzo dzichangobva kuitika dzekudzivirira kwekutanga diabetesic microangiopathy uye diabetic nephropathy, inogona kuderedza kubuda kwealbumin.Clinical data kumba nekune dzimwe nyika inoratidza kuti inogona kuwedzera sperm chiitiko uye kuwanda kwekugadzirwa, uye ine imwe nzira yekurapa mukurapa kweimwe sterility yemurume.
Sei isu?
· Yakagadzirwa muGMP musangano
· Makore makumi maviri nemanomwe ebhayoloji enzyme R&D nhoroondo
·Maraw materials anotarisika
·Kutevedzera mwero wevatengi
·Tumira kunze kwenyika dzinopfuura makumi matatu nematunhu
·Ane kugona kwemhando yekutonga system seUS FDA, Japan PMDA, South Korea MFDS, nezvimwe.
Tsanangudzo
| Test Items | Kutsanangurwa kwekambani | ||
| CP | JP | ||
| Vanhu | Muchena kana hupfu hwakachena, husina hwema | Hupfu hwakachena kusvika kushava shoma, husina hwema kana kuti husina kufenda | |
| Identification | R (hydrolysis rate): 0.12～0.17 | R (hydrolysis rate): 0.12～0.16 | |
| Liquid Chromatography: Inopindirana | Ini : ≤ 0.2 | ||
| Miedzo | pH | 5.5～7.5(300 unit/ml） | 5.5～7.5(1g/300ml） |
| Kujeka kwemhinduro | Zvakajeka(2mg/ml） | ———— | |
| Mafuta | ≤ 5.0mg/g | ≤ 1.0mg/g | |
| Kininase | ———— | R Kukosha:≥ 0.8 | |
| Trypsin-yakafanana nezvinhu | ———— | T Kukosha:≤ 0.05 | |
| Protease | A280≤ 0.2 | A280≤ 0.2 | |
| Kurasikirwa pakuomeswa | ≤ 5.0% (60 ℃ Dry in Vacuum, 4h) | ≤ 2.0% (60 ℃ Dry in Vacuum, 4h) | |
| Residue pakubatidza | ≤ 3.0% | ≤ 3.0% | |
| Kinin-kusunungura basa | ———— | ≥ 500ng bradykinin yakaenzana / min / chikamu pachikamu | |
| Kuchena | ≥ 75% (yemuromo) | ———— | |
| ≥ 90% (yejekiseni) | |||
| Bacterial endotoxin | ≤ 2.5 EU/yuniti (yejekiseni) | ———— | |
| Assay | Enzyme chiitiko | ———— | ≥ 25 unit/mg |
| Chiitiko chakananga | ≥ 300 unit/mg protein (yemuromo) | ≥ 100 unit / mg protein | |
| ≥ 600 unit/mg protein (yejekiseni) | |||
| Kusvibiswa kweMicrobial | TAMC | ≤ 1000cfu/g (yemuromo) | ≤ 1000cfu/g |
| ≤ 100cfu/g (yejekiseni) | |||
| TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Conforms | Conforms | |
| Salmonella | Conforms | Conforms | |
