China Heparin Sodium of Deebio yokuNyanga Thromboembolic Disease Prevention umzi-mveliso kunye nabavelisi |I-Deebiotech

I-Heparin Sodium ye-Deebio yokuNyanga i-Thromboembolic yoThintelo lweSifo oFakelweyo

I-Heparin Sodium ye-Deebio yoNyango lwe-Thromboembolic Prevention

INOMBOLO YECAS.9041-08-1

IKHOWUDI ye-HS:3001.9010.00

Inkonzo Yefayile:IsiTshayina-GMP, iDMF

Pharmacopoeia umgangatho:EP/USP

Thumela i-imeyile kuthi isampuli yasimahla

Iinkcukacha zeMveliso

Iithegi zeMveliso

Iinkcukacha

1. Abalinganiswa: Umgubo omhlophe okanye ophantse ube mhlophe, one-hygroscopic kakhulu.

2. Umthombo: I-porcine intestine mucosa.

3. Inkqubo: I-sodium ye-Heparin ikhutshwe kwi-porcine intestine mucosa enempilo.

4. Izibonakaliso kunye nokusetyenziswa: Le mveliso isetyenziselwa ukuthintela isifo se-thromboembolic, ngokukodwa ifanelekileyo kwimfuno ye-anticoagulant ngokukhawuleza, njengale: 1. I-thrombosis ebukhali okanye engapheliyo ye-venous thrombosis okanye akukho tshintsho olubalulekileyo lokuhamba kwegazi oluguquguqukayo lwe-pulmonary embolism (PE) .Heparin inokumisa ukwandiswa kwe-embolus ukwenza ixesha lokuzivelela kwe-thrombolysis yomzimba.2. Ukuthintela kunye nokunyangwa kwe-Atrial fibrillation nge-embolism.3. Unyango lwe-early diffuse intravascular coagulation (DIC).4. Ukuthintela kunye nokunyangwa kwe-peripheral arterial thrombosis okanye i-myocardial infarction.5. Enye i-in vitro anticoagulation: efana notyando lwentliziyo, ukujikeleza kwe-vitro, i-hemodialysis, i-angiography, nayo ingasetyenziselwa utofelo-gazi okanye ukulungiswa kwe-specimen yegazi, okwangoku iimpawu eziphambili zokusetyenziswa kwe-heparin yi-deep vein thrombosis(DVT), i-PE kunye ne-thrombosis. kwizigulane ezisengozini enkulu.

Kutheni sisi?

Upase iGMP yaseTshayina

· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D

·Imathiriyeli ekrwada iyalandeleka

·Thobela i-USP,EPkunye nomgangatho womthengi

·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla

·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.

Inkcazo

Izinto zovavanyo		Inkcazo yeNkampani
Izinto zovavanyo		EP	USP
Abalinganiswa		Umgubo omhlophe okanye ophantse ube mhlophe, one-hygroscopic kakhulu
Ukuchongwa		I-Thrombotest: Iyahambelana	Isazisi seChromatographic: Iyahambelana
		¹I-H NMR Spectrum: Iyahambelana	¹I-H NMR Spectrum: Iyahambelana
		Ulwelo lweChromatography: Iyahambelana	Ubunzima bobunzima bemolekyuli: 15000 ~ 19000
		ISodium: Iyahambelana	ISodium: Iyahambelana
		I-Anti-factor Xa ukuya kwi-anti-factor IIa ratio: 0.9 ~ 1.1	I-Anti-factor Xa ukuya kwi-anti-factor IIa ratio: 0.9 ~ 1.1
Iimvavanyo	Ukucaca kunye nombala	Ukucaca: Cacileyo, Umbala: ngo-5 okanye ngaphezulu	————
	Nitrogen	1.5～2.5%(into eyomileyo）	1.3～2.5%(into eyomileyo）
	Ukungcola kwe-Nucleotidic	A₂₆₀≤ 0.15(4mg/ml)	≤ 0.1(w/w）
	Izinto ezinxulumeneyo	Iyahambelana	————
	Umda wegalactosamine kwihexosamine iyonke	————	≤ 1.0%
	I-Oversulfate chondroitin sulfate	————	Iyahambelana
	pH	5.5～8.0(1%）	5.5～7.5(1%）
	Ilahleko ekomisweni	≤ 8.0%(60℃ Yomile kwiVacuum, 3h）	≤ 5.0%(60℃ Yomile kwiVacuum, 3h）
	Intsalela ekutshisweni	————	28.0%～41.0%
	I-endotoxin yebhaktheriya	≤ 0.01 IU / Iyunithi yamazwe ngamazwe yeHeparin	≤ 0.03 USP U / Iyunithi yamazwe ngamazwe yeHeparin
	Intsimbi enzima	≤ 30ppm	≤ 30ppm
	Isodium	10.5～13.5%(into eyomileyo）	————
	Iiprotheyini	≤ 0.5%(into eyomileyo）	≤ 0.1%(Umlinganiselo wobunzima）
Umsebenzi		≥ 180 IU/mg(into eyomileyo）	≥ 180 USP U/mg(into eyomileyo）
Ukungcola kweMicrobial	TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	I-TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Iyahambelana	Iyahambelana
	Staphylococcus aureus	Iyahambelana	Iyahambelana
	Salmonella	Iyahambelana	Iyahambelana