Ifemu yethu ibigxile kwisicwangciso sophawu.Ukwaneliseka kwabathengi yeyona ntengiso yethu ilungileyo.Sikwabonelela ngomboneleli we-OEM yonikezelo olukhawulezayo lweeChemical zaseChinaIsodium yeHeparin, Uphuculo olungapheliyo kunye nokuzabalazela ukunqongophala kwe-0% yimigaqo-nkqubo yethu yomgangatho ophambili emibini.Ukuba ufuna nantoni na, ungaze uthandabuze ukunxibelelana nathi.
Ifemu yethu ibigxile kwisicwangciso sophawu.Ukwaneliseka kwabathengi yeyona ntengiso yethu ilungileyo.Sikwabonelela ngomboneleli we-OEMIsodium yeHeparin, Sikholelwa kumgangatho kunye nokwaneliseka kwabathengi okuphunyezwe liqela labantu abazinikele kakhulu.Iqela lenkampani yethu lisebenzisa itekhnoloji ye-cutting-edge lihambisa iimpahla ezikumgangatho ophezulu ezithandwa kakhulu kwaye zixatyiswa ngabathengi bethu kwihlabathi liphela.
1. Abalinganiswa: Umgubo omhlophe okanye ophantse ube mhlophe, one-hygroscopic kakhulu.
2. Umthombo: I-porcine intestine mucosa.
3. Inkqubo: I-sodium ye-Heparin ikhutshwe kwi-porcine intestine mucosa enempilo.
4. Izibonakaliso kunye nokusetyenziswa: Le mveliso isetyenziselwa ukuthintela isifo se-thromboembolic, ngokukodwa ifanelekileyo kwimfuno ye-anticoagulant ngokukhawuleza, njengale: 1. I-thrombosis ebukhali okanye engapheliyo ye-venous thrombosis okanye akukho tshintsho olubalulekileyo lokuhamba kwegazi oluguquguqukayo lwe-pulmonary embolism (PE) .Heparin inokumisa ukwandiswa kwe-embolus ukwenza ixesha lokuzivelela kwe-thrombolysis yomzimba.2. Ukuthintela kunye nokunyangwa kwe-Atrial fibrillation nge-embolism.3. Unyango lwe-early diffuse intravascular coagulation (DIC).4. Ukuthintela kunye nokunyangwa kwe-peripheral arterial thrombosis okanye i-myocardial infarction.5. Enye i-in vitro anticoagulation: efana notyando lwentliziyo, ukujikeleza kwe-vitro, i-hemodialysis, i-angiography, nayo ingasetyenziselwa utofelo-gazi okanye ukulungiswa kwe-specimen yegazi, okwangoku iimpawu eziphambili zokusetyenziswa kwe-heparin yi-deep vein thrombosis(DVT), i-PE kunye ne-thrombosis. kwizigulane ezisengozini enkulu.
Upase iGMP yaseTshayina
· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D
·Imathiriyeli ekrwada iyalandeleka
·Thobela USP,EP kunye nomgangatho wabathengi
·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla
·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.
Izinto zovavanyo | Inkcazo yeNkampani | ||
EP | USP | ||
Abalinganiswa | Umgubo omhlophe okanye ophantse ube mhlophe, one-hygroscopic kakhulu | ||
Ukuchongwa | I-Thrombotest: Iyahambelana | Isazisi seChromatographic: Iyahambelana | |
1I-H NMR Spectrum: Iyahambelana | 1I-H NMR Spectrum: Iyahambelana | ||
Ulwelo lweChromatography: Iyahambelana | Ubunzima bobunzima bemolekyuli: 15000 ~ 19000 | ||
ISodium: Iyahambelana | ISodium: Iyahambelana | ||
I-Anti-factor Xa ukuya kwi-anti-factor IIa ratio: 0.9 ~ 1.1 | I-Anti-factor Xa ukuya kwi-anti-factor IIa ratio: 0.9 ~ 1.1 | ||
Iimvavanyo | Ukucaca kunye nombala | Ukucaca: Cacileyo, Umbala: ngo-5 okanye ngaphezulu | ———— |
Nitrogen | 1.5-2.5% (into eyomileyo) | 1.3-2.5% (into eyomileyo) | |
Ukungcola kwe-Nucleotidic | A260≤ 0.15(4mg/ml) | ≤ 0.1 (w/w) | |
Izinto ezinxulumeneyo | Iyahambelana | ———— | |
Umda wegalactosamine kwihexosamine iyonke | ———— | ≤ 1.0% | |
I-Oversulfate chondroitin sulfate | ———— | Iyahambelana | |
pH | 5.5-8.0 (1%) | 5.5-7.5(1%) | |
Ilahleko ekomisweni | ≤ 8.0% (60℃ Yomile kwiVacuum, 3h) | ≤ 5.0% (60℃ Yomile kwiVacuum, 3h) | |
Intsalela ekutshisweni | ———— | 28.0%~41.0% | |
I-endotoxin yebhaktheriya | ≤ 0.01 IU / Iyunithi yamazwe ngamazwe yeHeparin | ≤ 0.03 USP U / Iyunithi yamazwe ngamazwe yeHeparin | |
Intsimbi enzima | ≤ 30ppm | ≤ 30ppm | |
Isodium | 10.5-13.5% (into eyomileyo) | ———— | |
Iiprotheyini | ≤ 0.5% (into eyomileyo) | ≤ 0.1% (Umlinganiselo wobunzima) | |
Umsebenzi | ≥ 180 IU/mg (into eyomileyo) | ≥ 180 USP U/mg (into eyomileyo) | |
Ukungcola kweMicrobial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
I-TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Iyahambelana | Iyahambelana | |
Staphylococcus aureus | Iyahambelana | Iyahambelana | |
Salmonella | Iyahambelana | Iyahambelana |
Ifemu yethu ibigxile kwisicwangciso sophawu.Ukwaneliseka kwabathengi yeyona ntengiso yethu ilungileyo.Sikwabonelela ngomboneleli we-OEM yokuhanjiswa ngokukhawuleza kweChina iChemicals Heparin Sodium, ukuphuculwa okungapheliyo kunye nokuzabalazela ukusilela kwe-0% yimigaqo-nkqubo yethu yomgangatho ophambili emibini.Ukuba ufuna nantoni na, ungaze uthandabuze ukunxibelelana nathi.
Ukuhanjiswa ngokukhawuleza kwe-China Anticoagulant, i-Pharmaceutical Intermediates, Sikholelwa kumgangatho kunye nokwaneliseka kwabathengi okuphunyezwe liqela labantu abazinikele kakhulu.Iqela lenkampani yethu lisebenzisa itekhnoloji ye-cutting-edge lihambisa iimpahla ezikumgangatho ophezulu ezithandwa kakhulu kwaye zixatyiswa ngabathengi bethu kwihlabathi liphela.