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Heparin Sodium nke Deebio maka ịgwọ ọrịa mgbochi ọrịa thromboembolism egosipụtara

Heparin sodium nke Deebio maka ọgwụgwọ mgbochi ọrịa thromboembolism

Ọ BỤGHỊ:9041-08-1

Koodu HS:3001.9010.00

Ọrụ faịlụ:Chinese-GMP, DMF

Ọkọlọtọ Pharmacopoeia:EP/USP

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Nkọwa ngwaahịa

Mkpado ngwaahịa

Nkọwa

1. Characters: White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ, nke ukwuu hygroscopic.

2. Isi Iyi: Porcine eriri afọ mucosa.

3. Usoro: Heparin sodium na-amịpụtara si ike porcine eriri afọ mucosa.

4. Ngosipụta na ojiji: A na-ejikarị ngwaahịa a maka igbochi ọrịa thromboembolic, karịsịa maka mkpa nke anticoagulant ngwa ngwa, dị ka: 1. Nnukwu ma ọ bụ na-adịghị ala ala venous thrombosis ma ọ bụ enweghị ịrịba ọbara eruba dynamic mgbanwe nke pulmonary embolism (PE) .Heparin. nwere ike ịkwụsị ndọtị embolus iji wepụta oge maka thrombolysis nke anụ ahụ na-akpaghị aka.2. Mgbochi na ọgwụgwọ nke Atrial fibrillation na embolism.3. Ọgwụgwọ n'oge mgbasa intravascular coagulation (DIC).4. Mgbochi na ọgwụgwọ thrombosis mpụta ma ọ bụ myocardial infarction.5. Ndị ọzọ in vitro anticoagulation: dị ka ịwa ahụ obi, mgbasa ọbara in vitro, hemodialysis, angiography, nwekwara ike iji maka mmịnye ma ọ bụ nkwadebe ụdị ọbara, ugbu a isi ihe na-egosi ngwa ngwa heparin bụ thrombosis miri emi (DVT), PE na thrombosis. na nnukwu ihe ize ndụ ndị ọrịa.

Gịnị mere anyị?

· Gafere GMP nke China

· afọ 27 nke akụkọ ihe mere eme nke enzyme R&D

· A na-achọpụta ihe ọkụkụ

· Soro USP,EPna ọkọlọtọ ọkọlọtọ

· Mbupụ gaa na mba na mpaghara iri atọ

· Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.

Nkọwapụta

Nnwale ihe		Nkọwapụta ụlọ ọrụ
Nnwale ihe		EP	USP
Ndị agwa		White ma ọ bụ fọrọ nke nta ka ọ bụrụ ntụ ntụ, ukwuu hygroscopic
njirimara		Thrombotest: kwekọrịtara	njirimara Chromatographic: kwekọrọ
		¹H NMR Spectrum: Dabara	¹H NMR Spectrum: Dabara
		Chromatography Liquid: Dabara	Arọ-nkezi arọ molekụla: 15000 ~ 19000
		Sodium: dabara	Sodium: dabara
		Anti-factor Xa ka ihe mgbochi IIa ruru: 0.9 ~ 1.1	Anti-factor Xa ka ihe mgbochi IIa ruru: 0.9 ~ 1.1
Nnwale	Ido anya na agba	Idozi: doro anya, Agba: site na 5 ma ọ bụ karịa	————
	Nitrogen	1.5～2.5%(akọrọ ihe)	1.3～2.5%(akọrọ ihe)
	Nucleotidic adịghị ọcha	A₂₆₀0.15 (4 mg / ml)	≤ 0.1(w/w)
	Ihe ndị metụtara ya	Dabara	————
	Oke nke galactosamine na mkpokọta hexosamine	————	≤ 1.0%
	Chondroitin sulfate karịrị akarị	————	Dabara
	pH	5.5～8.0(1%)	5.5～7.5(1%)
	Ọnwụ na ihicha	≤ 8.0%(60℃ kpọrọ nkụ na Vacuum, 3h)	≤5.0%(60℃ kpọrọ nkụ na Vacuum, 3h)
	Ihe fọdụrụ na mgbanye	————	28.0%～41.0%
	Ọgwụ nje endotoxin	≤ 0.01 IU / Ngalaba Mba Nile nke Heparin	≤ 0.03 USP U/Ngalaba Mba Nile nke Heparin
	Igwe dị arọ	≤30pm	≤30pm
	Sodium	10.5～13.5%(akọrọ ihe)	————
	Protein	≤0.5%(akọrọ ihe)	≤0.1%(Oke ibu)
Ihe omume		≥ 180 IU/mg(akọrọ ihe)	≥ 180 USP U/mg(akọrọ ihe)
Microbial adịghị ọcha	TAMC	≤1000cfu/g	≤1000cfu/g
	TYMC	≤100cfu/g	≤100cfu/g
	E.coli	Dabara	Dabara
	Staphylococcus aureus	Dabara	Dabara
	Salmonella	Dabara	Dabara