Zogulitsa
Heparin Sodium wa Deebio pochiza matenda a Thromboembolic
Tsatanetsatane
1. Makhalidwe: ufa woyera kapena pafupifupi woyera, wonyezimira kwambiri.
2. Gwero: Nkhumba ya nkhumba mucosa.
3. Njira: Heparin sodium imachokera ku matumbo athanzi a nkhumba mucosa.
4. Zizindikiro ndi ntchito: Mankhwalawa amagwiritsidwa ntchito makamaka popewera matenda a thromboembolic, makamaka oyenera kufunikira kwa anticoagulant mwamsanga, monga: 1. Pachimake kapena matenda aakulu a venous thrombosis kapena palibe kusintha kwakukulu kwa magazi kwa kusintha kwa pulmonary embolism (PE) .Heparin imatha kuyimitsa kufalikira kwa embolus kuti ikhale ndi nthawi yodziwikiratu ya thrombolysis ya thupi.2. Kupewa ndi kuchiza Atrial fibrillation ndi embolism.3. Chithandizo cha kufalikira koyambirira kwa intravascular coagulation(DIC).4. Kupewa ndi kuchiza zotumphukira arterial thrombosis kapena myocardial infarction.5. Zina za in vitro anticoagulation: monga opaleshoni ya mtima, kufalikira kwa m'mimba, hemodialysis, angiography, imatha kugwiritsidwanso ntchito poika magazi kapena kukonzekera magazi, pakali pano zizindikiro zazikulu za ntchito ya heparin ndi deep vein thrombosis(DVT), PE ndi thrombosis. odwala omwe ali pachiwopsezo chachikulu.
Chifukwa chiyani ife?
· Anadutsa Chinese GMP
· Zaka 27 za mbiri ya biological enzyme R&D
·Zida zopangira ndi zopezeka
· Tsatirani USP,EPndi kasitomala muyezo
· Tumizani kumayiko ndi zigawo zopitilira 30
·Ali ndi kuthekera kowongolera machitidwe abwino monga US FDA, Japan PMDA, South Korea MFDS, etc.
Kufotokozera
| Zinthu Zoyesa | Mafotokozedwe a Kampani | ||
| EP | USP | ||
| Makhalidwe | ufa woyera kapena pafupifupi woyera, hygroscopic kwambiri | ||
| Chizindikiritso | Thrombotest: Zimagwirizana | Chidziwitso cha Chromatographic: Chimagwirizana | |
| 1H NMR Spectrum: Imagwirizana | 1H NMR Spectrum: Imagwirizana | ||
| Liquid Chromatography: Imagwirizana | Kulemera kwapakati pa molekyulu: 15000 ~ 19000 | ||
| Sodium: imagwirizana | Sodium: imagwirizana | ||
| Anti-factor Xa to anti-factor IIa chiŵerengero: 0.9 ~ 1.1 | Anti-factor Xa to anti-factor IIa chiŵerengero: 0.9 ~ 1.1 | ||
| Mayesero | Kumveka bwino ndi mtundu | Kumveka: Zomveka, Mtundu: ndi 5 kapena kuposa | ———— |
| Nayitrogeni | 1.5～2.5%(chinthu chouma） | 1.3～2.5%(chinthu chouma） | |
| Nucleotidic zonyansa | A260≤ 0.15(4mg/ml) | ≤ 0.1(w/w） | |
| Zogwirizana nazo | Zimagwirizana | ———— | |
| Malire a galactosamine mu hexosamine yonse | ———— | ≤ 1.0% | |
| Oversulfate chondroitin sulphate | ———— | Zimagwirizana | |
| pH | 5.5～8.0(1%） | 5.5～7.5(1%） | |
| Kutaya pakuyanika | ≤ 8.0%(60 ℃ Wowumitsa mu Vacuum, 3h） | ≤ 5.0%(60 ℃ Wowumitsa mu Vacuum, 3h） | |
| Zotsalira pakuyatsa | ———— | 28.0%～41.0% | |
| Bakiteriya endotoxin | ≤ 0.01 IU/International Unit ya Heparin | ≤ 0.03 USP U/International Unit ya Heparin | |
| Chitsulo cholemera | ≤30ppm | ≤30ppm | |
| Sodium | 10.5～13.5%(chinthu chouma） | ———— | |
| Mapuloteni | ≤ 0.5%(chinthu chouma） | ≤ 0.1%(Chiwerengero cha kulemera） | |
| Zochita | ≥ 180 IU/mg(chinthu chouma） | ≥ 180 USP U/mg(chinthu chouma） | |
| Zowonongeka za Microbial | Mtengo wa TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
| Mtengo wa TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Zimagwirizana | Zimagwirizana | |
| Staphylococcus aureus | Zimagwirizana | Zimagwirizana | |
| Salmonella | Zimagwirizana | Zimagwirizana | |
