I-China Heparin Sodium ye-Deebio Yokwelapha I-Thromboembolic Disease Prevention ifektri nabakhiqizi |I-Deebiotech

I-Heparin Sodium ye-Deebio yokwelapha i-Thromboembolic Disease Prevention

INOMBOLO YECAS.9041-08-1

IKHODI YE-HS:3001.9010.00

Isevisi Yefayela:I-Chinese-GMP, i-DMF

I-Pharmacopoeia ejwayelekile:EP/USP

Thumela i-imeyili kithi isampula yamahhala

Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Imininingwane

1. Izinhlamvu: Impushana emhlophe noma ecishe ibe mhlophe, ene-hygroscopic kakhulu.

2. Umthombo: I-porcine intestine mucosa.

3. Inqubo: I-Heparin sodium ikhishwa ku-mucosa yamathumbu e-porcine enempilo.

4. Izinkomba kanye nokusetshenziswa: Lo mkhiqizo usetshenziselwa ikakhulukazi ukuvimbela isifo se-thromboembolic, ikakhulukazi esilungele isidingo se-anticoagulant ngokushesha, njengalokhu: 1. I-acute noma engapheli ye-venous thrombosis noma akukho ukugeleza kwegazi okuphawulekayo ushintsho olunamandla lwe-pulmonary embolism(PE).Heparin ingamisa ukunwetshwa kwe-embolus ukwenza isikhathi se-thrombolysis ezenzakalelayo yomzimba.2. Ukuvimbela nokwelashwa kwe-Atrial fibrillation nge-embolism.3. Ukwelashwa kwe-diffuse intravascular coagulation (DIC) yokuqala.4. Ukuvimbela nokwelashwa kwe-peripheral arterial thrombosis noma i-myocardial infarction.5. Enye i-in vitro anticoagulation: njengokuhlinzwa kwenhliziyo nemithambo yegazi, i-in vitro circulation, i-hemodialysis, i-angiography, nayo ingasetshenziselwa ukumpontshelwa noma ukulungiselela isifanekiso segazi, okwamanje izinkomba eziyinhloko zokusetshenziswa kwe-heparin i-deep vein thrombosis(DVT), i-PE kanye ne-thrombosis. ezigulini ezisengozini enkulu.

Kungani sisi?

·Uphumelele i-Chinese GMP

·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D

·Izinto ezingavuthiwe ziyalandeleka

·Thobela i-USP,EPnezinga lekhasimende

·Thumela emazweni nasezifundeni ezingaphezu kuka-30

·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.

Ukucaciswa

Izinto Zokuhlola		Ukucaciswa Kwenkampani
Izinto Zokuhlola		EP	USP
Izinhlamvu		Impushana emhlophe noma ecishe ibe mhlophe, ene-hygroscopic kakhulu
Ukuhlonza		I-Thrombotest: Iyavumelana	Ubunikazi beChromatographic: Kuyavumelana
		¹I-H NMR Spectrum: Iyavumelana	¹I-H NMR Spectrum: Iyavumelana
		I-Liquid Chromatography: Iyavumelana	Isisindo-isilinganiso samangqamuzana isisindo: 15000 ~ 19000
		I-Sodium: Iyavumelana	I-Sodium: Iyavumelana
		I-Anti-factor Xa ukuya ku-anti-factor IIa isilinganiso:0.9~1.1	I-Anti-factor Xa ukuya ku-anti-factor IIa isilinganiso:0.9~1.1
Izivivinyo	Ukucaca nombala	Ukucaca: Kucacile, Umbala: ngo-5 noma ngaphezulu	————
	I-nitrogen	1.5～2.5%(into eyomile）	1.3～2.5%(into eyomile）
	Ukungcola kwe-Nucleotidic	A₂₆₀≤ 0.15(4mg/ml)	≤ 0.1(w/w）
	Izinto ezihlobene	Kuyavumelana	————
	Umkhawulo wegalactosamine ku-hexosamine isiyonke	————	≤ 1.0%
	I-Oversulfate chondroitin sulfate	————	Kuyavumelana
	pH	5.5～8.0(1%）	5.5～7.5(1%）
	Ukulahlekelwa ekomisweni	≤ 8.0%(60℃ Yomisa kuVacuum, 3h）	≤ 5.0%(60℃ Yomisa kuVacuum, 3h）
	Izinsalela ekushiseni	————	28.0%～41.0%
	I-endotoxin yebhaktheriya	≤ 0.01 IU/Iyunithi Yamazwe Ngamazwe Ye-Heparin	≤ 0.03 USP U/Iyunithi Yamazwe Ngamazwe Ye-Heparin
	Insimbi enzima	≤ 30ppm	≤ 30ppm
	Isodium	10.5～13.5%(into eyomile）	————
	Amaprotheni	≤ 0.5%(into eyomile）	≤ 0.1%(Isilinganiso sesisindo）
Umsebenzi		≥ 180 IU/mg(into eyomile）	≥ 180 USP U/mg(into eyomile）
Ukungcola Kwe-Microbial	I-TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	I-TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Kuyavumelana	Kuyavumelana
	I-Staphylococcus aureus	Kuyavumelana	Kuyavumelana
	I-Salmonella	Kuyavumelana	Kuyavumelana