China Heparin Sodium ea Deebio bakeng sa Phekolo ea Thibelo ea Mafu a Thromboembolic fektheri le bahlahisi |Deebiotech

Heparin Sodium ea Deebio bakeng sa ho Phekola Thibelo ea Maloetse a Thromboembolic

NOMORO YA CAS:9041-08-1

HS CODE:3001.9010.00

Tšebeletso ea Faele:Sechaena-GMP, DMF

Pharmacopoeia standard:EP/USP

Re romelle lengolo-tsoibila mahala sampole

Lintlha tsa Sehlahisoa

Li-tag tsa Sehlahisoa

Lintlha

1. Litlhaku: Phofo e tšoeu kapa e batlang e le tšoeu, e nang le hygroscopic haholo.

2. Mohloli: Mucosa ea mala a kolobe.

3. Ts'ebetso: Sodium ea Heparin e ntšoa ho tswa ho porcine intestine mucosa e phetseng hantle.

4. Lipontšo le tšebeliso: Sehlahisoa sena se sebelisoa haholo-holo bakeng sa thibelo ea lefu la thromboembolic, haholo-holo e loketseng tlhokahalo ea anticoagulant ka potlako, e kang: 1. Acute or chronic venous thrombosis kapa ha ho na phetoho e matla ea phallo ea mali ea pulmonary embolism (PE) .Heparin e ka emisa katoloso ea embolus ho ipha nako ea thrombolysis ea 'mele e itlelang feela.2. Thibelo le kalafo ea Atrial fibrillation ka embolism.3. Kalafo ea pele ea diffuse intravascular coagulation(DIC).4. Thibelo le kalafo ea peripheral arterial thrombosis kapa myocardial infarction.5. Anticoagulation e 'ngoe ea in vitro: joalo ka opereishene ea pelo, potoloho ea mali, hemodialysis, angiography, le eona e ka sebelisoa bakeng sa tšelo ea mali kapa tokiso ea mohlala oa mali, hajoale matšoao a mantlha a tšebeliso ea heparin ke deep vein thrombosis(DVT), PE le thrombosis. ho bakuli ba kotsing e kholo.

Hobaneng rona?

· E fetisitse Chinese GMP

· Lilemo tse 27 tsa nalane ea enzyme ea bioloji ea R&D

· Lisebelisuoa tse tala lia lateloa

·Latela USP,EPle maemo a bareki

· Romella kantle ho naha le libakeng tse fetang 30

·E na le bokhoni ba tsamaiso ea boleng bo kang US FDA, Japan PMDA, South Korea MFDS, joalo-joalo.

Tlhaloso

Lintho tsa Tlhahlobo		Tlhaloso ea Khampani
Lintho tsa Tlhahlobo		EP	USP
Litlhaku		Phofo e tšoeu kapa e batlang e le tšoeu, e nang le hygroscopic haholo
Boitsebiso		Thrombotest: E lumellana	Boitsebiso ba Chromatographic: Bo lumellana
		¹H NMR Spectrum: E lumellana	¹H NMR Spectrum: E lumellana
		Liquid Chromatography: E lumellana	Boima ba boima ba 'mele: 15000 ~ 19000
		Sodium: E lumellana	Sodium: E lumellana
		Anti-factor Xa to anti-factor IIa ratio:0.9 ~ 1.1	Anti-factor Xa to anti-factor IIa ratio:0.9 ~ 1.1
Liteko	Ho hlaka le mmala	Ho hlaka: Ho hlakile, Mmala: ka 5 kapa ho feta	————
	Naetrojene	1.5～2.5%（ntho e ommeng）	1.3～2.5%（ntho e ommeng）
	Litšila tsa Nucleotidic	A₂₆₀≤ 0.15(4mg/ml)	≤ 0.1（w/w）
	Lintho tse amanang	E lumellana	————
	Moeli oa galactosamine ka kakaretso ea hexosamine	————	≤ 1.0%
	Oversulfate chondroitin sulfate	————	E lumellana
	pH	5.5～8.0（1%）	5.5～7.5（1%）
	Tahlehelo ka ho omisa	≤ 8.0%（60 ℃ Omisa ka Vacuum, 3h）	≤ 5.0%（60 ℃ Omisa ka Vacuum, 3h）
	Masalla ha a tuka	————	28.0%～41.0%
	Endotoxin ea baktheria	≤ 0.01 IU/Setsi sa Machaba sa Heparin	≤ 0.03 USP U / International Unit ea Heparin
	Tšepe e boima	≤ 30ppm	≤ 30ppm
	Sodium	10.5～13.5%（ntho e ommeng）	————
	Liprotheine	≤ 0.5%（ntho e ommeng）	≤ 0.1%（Karolelano ea boima ba 'mele）
Ketsahalo		≥ 180 IU/mg（ntho e ommeng）	≥ 180 USP U/mg（ntho e ommeng）
Litšila tsa Microbial	TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	E lumellana	E lumellana
	Staphylococcus aureus	E lumellana	E lumellana
	Salmonella	E lumellana	E lumellana