Products
Heparin Sodium yeDeebio yekurapa Thromboembolic Disease Prevention
Detail
1. Mavara: Ichena kana inenge chena poda, yakanyanya hygroscopic.
2. Kunobva: Porcine intestine mucosa.
3. Nzira: Heparin sodium inotorwa kubva kune utano hweporcine intestine mucosa.
4. Zviratidzo uye kushandiswa: Ichi chigadzirwa chinonyanya kushandiswa kudzivirira chirwere che thromboembolic, kunyanya kukodzera kudiwa kwe anticoagulant nokukurumidza, zvakadai se: 1. Acute kana kusingaperi venous thrombosis kana kusakosha kweropa kuyerera kwekuchinja kwe pulmonary embolism (PE) .Heparin inogona kumisa embolus yekuwedzera kuita nguva yekuzviitira thrombolysis yemuviri.2. Kudzivirira uye kurapwa kweAtrial fibrillation ne embolism.3. Kurapa kwekutanga diffuse intravascular coagulation (DIC).4. Kudzivirira uye kurapwa kweperipheral arterial thrombosis kana myocardial infarction.5. Zvimwe in vitro anticoagulation: zvakadai sekuvhiyiwa kwemwoyo, in vitro circulation, hemodialysis, angiography, inogonawo kushandiswa kuwedzerwa ropa kana kugadzirira kwemuenzaniso weropa, parizvino zviratidzo zvikuru zvekushandiswa kweheparin ndeye deep vein thrombosis (DVT), PE uye thrombosis. muvarwere vane njodzi huru.
Sei isu?
· Vakapfuura Chinese GMP
· Makore makumi maviri nemanomwe ebhayoloji enzyme R&D nhoroondo
·Maraw materials anotarisika
·Teerera neUSP,EPuye mutengi mwero
·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 | ||
| EP | USP | ||
| Vanhu | Ichena kana inenge chena poda, yakanyanya hygroscopic | ||
| Identification | Thrombotest: Inopindirana | Chromatographic identity: Inopindirana | |
| 1H NMR Spectrum: Inopindirana | 1H NMR Spectrum: Inopindirana | ||
| Liquid Chromatography: Inopindirana | Huremu-avhareji yemamorekuru uremu: 15000 ~ 19000 | ||
| Sodium: Inopindirana | Sodium: Inopindirana | ||
| Anti-factor Xa kune anti-factor IIa chiyero:0.9 ~ 1.1 | Anti-factor Xa kune anti-factor IIa chiyero:0.9 ~ 1.1 | ||
| Miedzo | Kujeka uye ruvara | Kujeka: Zvakajeka, Ruvara: ne5 kana kupfuura | ———— |
| Nitrogen | 1.5～2.5%(chinhu chakaoma） | 1.3～2.5%(chinhu chakaoma） | |
| Nucleotidic tsvina | A260≤ 0.15(4mg/ml) | ≤ 0.1(w/w） | |
| Zvinhu zvinoenderana | Conforms | ———— | |
| Muganho wegalactosamine mune yakazara hexosamine | ———— | ≤ 1.0% | |
| Oversulfated chondroitin sulfate | ———— | Conforms | |
| pH | 5.5～8.0(1%） | 5.5～7.5(1%） | |
| Kurasikirwa pakuomeswa | ≤ 8.0%(60 ℃ Dry in Vacuum, 3h） | ≤ 5.0%(60 ℃ Dry in Vacuum, 3h） | |
| Residue pakubatidza | ———— | 28.0%～41.0% | |
| Bacterial endotoxin | ≤ 0.01 IU/International Unit yeHeparin | ≤ 0.03 USP U/International Unit yeHeparin | |
| Simbi inorema | ≤ 30ppm | ≤ 30ppm | |
| Sodium | 10.5～13.5%(chinhu chakaoma） | ———— | |
| Mapuroteni | ≤ 0.5%(chinhu chakaoma） | ≤ 0.1%(Weight ratio） | |
| Chiitiko | ≥ 180 IU/mg(chinhu chakaoma） | ≥ 180 USP U/mg(chinhu chakaoma） | |
| Kusvibiswa kweMicrobial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
| TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Conforms | Conforms | |
| Staphylococcus aureus | Conforms | Conforms | |
| Salmonella | Conforms | Conforms | |
