China Heparin Sodium na Deebio don Magance Cututtukan Thromboembolic factory da masana'antun |Deebiotech

Heparin Sodium na Deebio don Magance Cututtukan Thromboembolic

CAS NO.:9041-08-1

HS CODE:3001.9010.00

Sabis na Fayil:Sinanci-GMP, DMF

Matsayin Pharmacopoeia:EP/USP

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Daki-daki

1. Haruffa: Fari ko kusan fari foda, sosai hygroscopic.

2. Tushen: Mucosa na hanji na Porcine.

3. Tsari: Ana fitar da sodium na Heparin daga mucosa na hanji mai lafiya.

4. Alamu da amfani: Wannan samfurin da aka yafi amfani da thromboembolic cuta rigakafin, musamman dace da bukatar anticoagulant da sauri, kamar: 1. m ko na kullum venous thrombosis ko wani gagarumin jini ya kwarara dynamic canji na huhu embolism (PE) .Heparin zai iya dakatar da haɓakar embolus don ba da lokaci don thrombolysis na jiki ba tare da bata lokaci ba.2. Rigakafi da magani na Atrial fibrillation tare da embolism.3. Magani na farko yaduwa intravascular coagulation (DIC).4. Rigakafi da maganin thrombosis na gefe ko ciwon zuciya.5. Sauran in vitro anticoagulation: irin su tiyata na zuciya da jijiyoyin jini, in vitro wurare dabam dabam, hemodialysis, angiography, kuma za a iya amfani da transfusion ko jini shirye-shirye na jini, a halin yanzu babban alamomi na heparin aikace-aikace ne zurfin vein thrombosis (DVT), PE da thrombosis. a cikin marasa lafiya masu haɗari.

Me yasa mu?

· Ya wuce GMP na kasar Sin

· 27 shekaru na nazarin halittu enzyme R&D tarihi

Ana iya gano albarkatun kasa

· Yi biyayya da USP,EPda ma'aunin abokin ciniki

· Fitarwa zuwa ƙasashe da yankuna sama da 30

Yana da ikon sarrafa tsarin inganci kamar US FDA, Japan PMDA, Koriya ta Kudu MFDS, da dai sauransu.

Ƙayyadaddun bayanai

Kayan Gwaji		Ƙayyadaddun Kamfanin
Kayan Gwaji		EP	USP
Halaye		Farar fari ko kusan fari foda, sosai hygroscopic
Ganewa		Thrombotest: Ya dace	Asalin chromatographic: Daidaita
		¹H NMR Spectrum: Daidai	¹H NMR Spectrum: Daidai
		Liquid Chromatography: Daidaita	Matsakaicin nauyin kwayoyin nauyi: 15000 ~ 19000
		Sodium: Daidaitawa	Sodium: Daidaitawa
		Anti-factor Xa zuwa anti-factor IIa rabo: 0.9 ~ 1.1	Anti-factor Xa zuwa anti-factor IIa rabo: 0.9 ~ 1.1
Gwaji	Tsara da launi	Tsara: Bayyana, Launi: ta 5 ko mafi kyau	————
	Nitrogen	1.5～2.5%(bushe abu)	1.3～2.5%(bushe abu)
	Nucleotidic ƙazanta	A₂₆₀0.15 (4mg/ml)	≤ 0.1(w/w)
	Abubuwan da ke da alaƙa	Ya dace	————
	Iyakacin galactosamine a cikin jimlar hexosamine	————	≤ 1.0%
	Chondroitin sulfate mai yawa	————	Ya dace
	pH	5.5～8.0(1%)	5.5～7.5(1%)
	Asarar bushewa	8.0%(60 ℃ Dry a cikin Vacuum, 3h)	≤ 5.0%(60 ℃ Dry a cikin Vacuum, 3h)
	Ragowa akan kunnawa	————	28.0%～41.0%
	Bacterial endotoxin	≤ 0.01 IU/Sashen Duniya na Heparin	≤ 0.03 USP U/Sashen Duniya na Heparin
	Karfe mai nauyi	≤ 30pm	≤ 30pm
	Sodium	10.5～13.5%(bushe abu)	————
	Sunadaran	0.5%(bushe abu)	0.1%(Rabon nauyi)
Ayyuka		≥ 180 IU/mg(bushe abu)	≥ 180 USP U/mg(bushe abu)
Najasa Na Ƙanƙara	TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	Farashin TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Ya dace	Ya dace
	Staphylococcus aureus	Ya dace	Ya dace
	Salmonella	Ya dace	Ya dace