ʻO Kina Heparin Sodium o Deebio no ka mālama ʻana i ka Thromboembolic maʻi Prevention hale hana a me nā mea hana |Deebiotech

Heparin Sodium o Deebio no ka mālama ʻana i ka maʻi Thromboembolic

CAS NO.:9041-08-1

HS CODE:3001.9010.00

lawelawe waihona:Pākē-GMP, DMF

Pharmacopoeia maʻamau:EP/USP

E hoʻouna i ka leka uila iā mākou hāpana manuahi

Huahana Huahana

kikoʻī

1. Nā ʻano: ʻO ka pauka keʻokeʻo a kokoke i ke keʻokeʻo, hygroscopic nui.

2. Puna: Puka ʻōpū mucosa.

3. Ke Kaʻina Hana: Hoʻopuka ʻia ka sodium Heparin mai ka mucosa o ka ʻōpū puaʻa olakino.

4. Nā hōʻailona a me ka hoʻohana ʻana: Hoʻohana nui ʻia kēia huahana no ka pale ʻana i ka maʻi thromboembolic, ʻoi aku ka maikaʻi no ka pono o ka anticoagulant wikiwiki, e like me: 1. Acute a maʻi venous thrombosis a ʻaʻohe hoʻololi koʻikoʻi kahe koko o ka pulmonary embolism (PE). Heparin Hiki iā ia ke ho'ōki i ka hoʻonui ʻana o ka embolus e hoʻolōʻihi i ka manawa no ka thrombolysis o ke kino.2. Kāohi a mālama ʻana i ka fibrillation Atrial me ka embolism.3. Hoʻomaʻamaʻa ʻana i ka coagulation intravascular diffuse mua (DIC).4. Ka pale ʻana a me ka mālama ʻana i ka thrombosis arterial peripheral a i ʻole myocardial infarction.5. ʻO nā mea ʻē aʻe in vitro anticoagulation: e like me ka ʻoki cardiovascular, in vitro circulation, hemodialysis, angiography, hiki ke hoʻohana ʻia no ka transfusion a i ʻole ka hoʻomākaukau ʻana i ke koko, i kēia manawa nā hōʻailona nui o ka noi heparin he thrombosis vein hohonu (DVT), PE a me ka thrombosis i nā maʻi pilikia nui.

No ke aha mākou?

· Ua hala i ka GMP Kina

· 27 makahiki o ka moʻolelo R&D biological enzyme

· Hiki ke ʻimi ʻia nā mea maka

· E hoʻokō me ka USP、EPa me ka mea kūʻai maʻamau

· Hoʻokuʻu aku i 30 mau ʻāina a me nā ʻāina

· Loaʻa ka mana o ka hoʻokele ʻōnaehana maikaʻi e like me US FDA, Japan PMDA, South Korea MFDS, etc.

Hōʻike

Nā mea ho'āʻo		Hōʻikeʻike Hui
Nā mea ho'āʻo		EP	USP
Nā huaʻōlelo		ʻO ka pauka keʻokeʻo a aneane keʻokeʻo paha, hygroscopic nui
ʻIkepili		Thrombotest: Kūlike	ʻIkepili Chromatographic: Kūlike
		¹H NMR Spectrum: Kūlike	¹H NMR Spectrum: Kūlike
		Kromatography Liquid: Kūlike	Kaumaha-awelika molecular kaumaha: 15000~19000
		Sodium: Kūlike	Sodium: Kūlike
		Anati-factor Xa i anti-factor IIa ratio:0.9~1.1	Anati-factor Xa i anti-factor IIa ratio:0.9~1.1
Nā hoʻāʻo	Ka malamalama a me ke kala	Mākaʻikaʻi: Akaka, kala: e 5 a ʻoi aku paha	————
	Nitrogen	1.5～2.5%（mea maloo）	1.3～2.5%（mea maloo）
	Nucleotidic haumia	A₂₆₀≤ 0.15(4mg/ml)	≤ 0.1（w/w）
	Nā mea pili	Kūlike	————
	Ka palena o ka galactosamine i ka huina hexosamine	————	≤ 1.0%
	Oversulfated chondroitin sulfate	————	Kūlike
	pH	5.5～8.0（1%）	5.5～7.5（1%）
	Pohō ma ka maloʻo	≤ 8.0%（60 ℃ Maloo i loko o ka Mūmā, 3h）	≤ 5.0%（60 ℃ Maloo i loko o ka Mūmā, 3h）
	Ke koena ma ka ʻā	————	28.0%～41.0%
	Endotoxin bacteria	≤ 0.01 IU/Hui Hui Pū ʻIa o Heparin	≤ 0.03 USP U/Wāhi Mokupuni o Heparin
	Metala kaumaha	≤ 30ppm	≤ 30ppm
	Sodium	10.5～13.5%（mea maloo）	————
	Pākīpika	≤ 0.5%（mea maloo）	≤ 0.1%（ratio kaumaha）
Ka hana		≥ 180 IU/mg（mea maloo）	≥ 180 USP U/mg（mea maloo）
ʻO nā meaʻeleʻele microbial	TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Kūlike	Kūlike
	ʻO Staphylococcus aureus	Kūlike	Kūlike
	Salmonella	Kūlike	Kūlike