Awọn ọja
Sodium Heparin ti Deebio fun Itọju Idena Arun Thromboembolic
Ẹ̀kúnrẹ́rẹ́
1. Awọn ohun kikọ: Funfun tabi fere funfun lulú, gíga hygroscopic.
2. Orisun: Porcine ifun mucosa.
3. Ilana: Heparin soda ti wa ni jade lati ilera porcine ifun mucosa.
4. Awọn itọkasi ati awọn lilo: Ọja yi ti wa ni o kun ti a lo fun thromboembolic arun idena, paapa dara fun awọn nilo ti anticoagulant ni kiakia, gẹgẹ bi awọn: 1. Àìdá tabi onibaje iṣọn thrombosis tabi ko si significant sisan ẹjẹ san ìmúdàgba ayipada ti ẹdọforo embolism (PE) .Heparin le da itẹsiwaju embolus duro lati ṣe akoko fun thrombolysis lẹẹkọkan ti ara.2. Idena ati itoju ti Atrial fibrillation pẹlu embolism.3. Itoju ti tete tan kaakiri intravascular coagulation (DIC).4. Idena ati itọju thrombosis agbeegbe tabi ailagbara myocardial.5. Omiiran anticoagulation in vitro: gẹgẹbi iṣẹ-abẹ inu ọkan ati ẹjẹ, iṣọn-ẹjẹ in vitro, hemodialysis, angiography, tun le ṣee lo fun gbigbe ẹjẹ tabi igbaradi ayẹwo ẹjẹ, ni bayi awọn itọkasi akọkọ ti ohun elo heparin jẹ thrombosis ti iṣan ti o jinlẹ (DVT), PE ati thrombosis. ni awọn alaisan ti o ni eewu giga.
Kini idi ti wa?
· Ti kọja GMP Kannada
· ọdun 27 ti itan-akọọlẹ R&D henensiamu ti ibi
· Awọn ohun elo aise jẹ itọpa
· Ni ibamu pẹlu USP,EPati onibara bošewa
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 | ||
| EP | USP | ||
| Awọn ohun kikọ | Funfun tabi fere funfun lulú, gíga hygroscopic | ||
| Idanimọ | Thrombotest: Ṣe ibamu | Idanimọ Chromatographic: Ṣe ibamu | |
| 1H NMR julọ.Oniranran: ibamu | 1H NMR julọ.Oniranran: ibamu | ||
| Chromatography Liquid: Ṣe deede | Iwọn-apapọ iwuwo molikula: 15000 ~ 19000 | ||
| Iṣuu soda: Ṣe deede | Iṣuu soda: Ṣe deede | ||
| Anti-ifosiwewe Xa si egboogi-ifosiwewe IIa ratio: 0.9 ~ 1.1 | Anti-ifosiwewe Xa si egboogi-ifosiwewe IIa ratio: 0.9 ~ 1.1 | ||
| Idanwo | wípé ati awọ | wípé: Clear, Awọ: nipasẹ 5 tabi dara julọ | ———— |
| Nitrojiini | 1.5～2.5%(ohun elo ti o gbẹ) | 1.3～2.5%(ohun elo ti o gbẹ) | |
| Awọn aimọ ti Nucleotidic | A260≤ 0.15 (4mg/ml) | ≤ 0.1(w/w) | |
| Awọn nkan ti o jọmọ | Ni ibamu | ———— | |
| Idinwo ti galactosamine ni apapọ hexosamine | ———— | ≤ 1.0% | |
| Sulfate chondroitin ti o pọju | ———— | Ni ibamu | |
| pH | 5.5～8.0(1%) | 5.5～7.5(1%) | |
| Pipadanu lori gbigbe | ≤ 8.0%(60 ℃ Gbẹ ni Igbale, 3h) | ≤ 5.0%(60 ℃ Gbẹ ni Igbale, 3h) | |
| Aloku lori iginisonu | ———— | 28.0%～41.0% | |
| Endotoxin kokoro arun | ≤ 0.01 IU / International Unit ti Heparin | ≤ 0.03 USP U / International Unit ti Heparin | |
| Irin eru | 30ppm | 30ppm | |
| Iṣuu soda | 10.5～13.5%(ohun elo ti o gbẹ) | ———— | |
| Awọn ọlọjẹ | ≤ 0.5%(ohun elo ti o gbẹ) | ≤ 0.1%(Iwọn iwuwo) | |
| Iṣẹ-ṣiṣe | ≥ 180 IU/mg(ohun elo ti o gbẹ) | ≥ 180 USP U/mg(ohun elo ti o gbẹ) | |
| Makirobia impurities | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
| TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Ni ibamu | Ni ibamu | |
| Staphylococcus aureus | Ni ibamu | Ni ibamu | |
| Salmonella | Ni ibamu | Ni ibamu | |
