Shiinaha Heparin Sodium ee Deebio oo loogu talagalay Daawaynta Warshada Ka Hortagga Cudurrada Dhiig-baxa iyo soo saarayaasha |Deebiyotech

Heparin Sodium ee Deebio oo loogu talagalay Daawaynta Ka Hortagga Cudurrada Dhiig-baxa

CAS NO.:9041-08-1

HS code:3001.9010.00

Adeegga Faylka:Shiine-GMP, DMF

Heerka Pharmacopoeia:EP/USP

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Faahfaahin

1. Characters: Caddaan ama ku dhawaad budo cad, aad u hygroscopic.

2. Xigasho: Xuubabka mindhicirka porcine.

3. Habka: Heparin sodium waxa laga soo saaraa xabka xiidmaha mindhicirka oo caafimaad qaba.

4. Tilmaamaha iyo isticmaalka: Alaabtan waxaa inta badan loo isticmaalaa ka hortagga cudurrada thromboembolic, gaar ahaan ku habboon baahida daawada xinjirowga lidka ku ah si degdeg ah, sida: 1. Dhiig-xinjirow ba'an ama dabadheeraad ah ama aan lahayn isbeddel firfircoon oo dhiig oo socda waxay joojin kartaa fidinta embolus si ay waqti ugu hesho xinjirowga dhiigga ee jirka.2. Kahortagga iyo daawaynta fayraska Atrial oo leh embolism.3. Daawaynta xinjirowga xididdada dhiigga ee hore ee faafa (DIC).4. Kahortagga iyo daawaynta xinjirowga xididada xididada ama wadna xanuunka myocardial.5. Kuwa kale ee xinjirowga lidka ku ah vitro: sida qalliinka wadnaha iyo xididdada dhiigga, wareegga vitro, hemodialysis, angiography, sidoo kale waxaa loo isticmaali karaa diyaarinta muunada dhiigga, hadda calaamadaha ugu muhiimsan ee codsiga heparin waa xinjirowga xididdada qotodheer (DVT), PE iyo thrombosis bukaanada khatarta sare leh.

Waa maxay sababta?

Wuxuu gudbay GMP-ga Shiinaha

· 27 sano oo enzyme noole R&D taariikhda

Walxaha ceeriin waa la raadin karaa

U hoggaansamaan USP,EPiyo heerka macaamiisha

Dhoofinta in ka badan 30 waddan iyo gobollo

Inuu leeyahay awoodda maaraynta nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.

Tilmaamid

Walxaha Tijaabada		Tilmaamaha Shirkadda
Walxaha Tijaabada		EP	USP
Jilayaasha		Caddaan ama ku dhawaad cad budo, aad u hygroscopic
Aqoonsiga		Thrombotest: Waa waafaqsan yahay	Aqoonsiga Chromatographic: Waa waafaqsan yahay
		¹H NMR Spectrum: Waa waafaqsan yahay	¹H NMR Spectrum: Waa waafaqsan yahay
		Chromatography dareere: Waafaqsan	Celceliska miisaanka-cusub: 15000 ~ 19000
		Soodhiyam: Waafaqaysaa	Soodhiyam: Waafaqaysaa
		Anti-factor Xa ilaa saamiga IIa-ka-hortagga:0.9 ~ 1.1	Anti-factor Xa ilaa saamiga IIa-ka-hortagga:0.9 ~ 1.1
Tijaabooyin	Caddayn iyo midab	Cad: Cad, Midab: 5 ama ka sii wanaagsan	————
	Nitrojiin	1.5～2.5%(walax qalalan)	1.3～2.5%(walax qalalan)
	wasakhda Nucleotidic	A₂₆₀≤ 0.15 (4mg/ml)	≤ 0.1(w/w)
	Walxaha la xidhiidha	waafaqsan	————
	Xaddid galactosamine guud ahaan hexosamine	————	≤ 1.0%
	Sulfate chondroitin sulfate	————	waafaqsan
	pH	5.5～8.0(1%)	5.5～7.5(1%)
	Luminta qalajinta	≤ 8.0%(60℃ Ku qallaji Vacuum, 3h)	≤ 5.0%(60℃ Ku qallaji Vacuum, 3h)
	Hadhaaga dabka	————	28.0%～41.0%
	Bakteeriyada endotoxin	≤ 0.01 IU/Cutubka Caalamiga ah ee Heparin	≤ 0.03 USP U/ Unugga Caalamiga ah ee Heparin
	Bir culus	≤ 30pm	≤ 30pm
	Sodium	10.5～13.5%(walax qalalan)	————
	Borotiinno	≤ 0.5%(walax qalalan)	≤ 0.1%(Saamiga miisaanka)
Hawsha		≥ 180 IU/mg(walax qalalan)	≥ 180 USP U/mg(walax qalalan)
Waxyeellada Microbial	TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	waafaqsan	waafaqsan
	Staphylococcus aureus	waafaqsan	waafaqsan
	Salmonella	waafaqsan	waafaqsan