China High Performance China Heparin Sodium ifektri nabakhiqizi |I-Deebiotech

Ukusebenza okuphezulu kwe-China Heparin Sodium

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

Sizama ukwenza kahle, sihlanganise amakhasimende”, sithemba ukuba ithimba elingcono kakhulu lokubambisana kanye nebhizinisi elibusayo labasebenzi, abahlinzeki kanye namakhasimende, elibona ukubaluleka kokwabelana kanye nokukhangisa okuqhubekayo kokuSebenza Okuphezulu.I-China Heparin Sodium, Asigcini nje ngokuletha ikhwalithi ephezulu kumakhasimende ethu, kodwa okwengeziwe okubaluleke nakakhulu izinkonzo zethu ezinkulu kanye nenani lokuncintisana lokuthengisa.
Sizama ukwenza kahle, sihlanganise amakhasimende”, sithemba ukuba yiqembu elingcono kakhulu lokubambisana kanye nebhizinisi elibusayo labasebenzi, abahlinzeki kanye namakhasimende, elibona ukubaluleka kokwabelana kanye nokukhangisa okuqhubekayoI-China Heparin Sodium, Ukwaneliseka kweKhasimende kuhlale kuwukufuna kwethu, ukudala inani lamakhasimende kuwumsebenzi wethu njalo, ubudlelwano bebhizinisi obuzuzisanayo besikhathi eside yikho esikwenzela khona.Sibe nguzakwethu onokwethenjelwa ngokuphelele endabeni yakho e-China.Yiqiniso, ezinye izinsizakalo, ezifana nokubonisana, zinganikezwa nazo.

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.

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Kungani sisi?

·Uphumelele i-Chinese GMP

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

·Izinto ezingavuthiwe ziyalandeleka

·Thobela i-USP、EP kanye nezinga 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 ku-Vacuum, 3h)	≤ 5.0% (60℃ Yomisa ku-Vacuum, 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

Sizama ukwenza kahle, sihlanganise amakhasimende”, sithemba ukuba ithimba elingcono kakhulu lokubambisana kanye nebhizinisi elibusayo labasebenzi, abahlinzeki kanye namakhasimende, libona ukubaluleka kokwabelana kanye nokukhangisa okuqhubekayo kwe-High Performance China Heparin Sodium Asigcini nje ngokuletha izinga eliphezulu kumakhasimende ethu. , kodwa okwengeziwe okubaluleke nakakhulu amasevisi ethu amakhulu kanye nenani lokuthengisa eliqhudelanayo.
I-China Heparin Esebenza Kakhulu, Ukwaneliseka kweKhasimende kuhlale kuwukufuna kwethu, ukudala inani lamakhasimende kuwumsebenzi wethu njalo, ubudlelwano bebhizinisi obuzuzisanayo besikhathi eside yilokho esikwenzela khona.Sibe nguzakwethu onokwethenjelwa ngokuphelele endabeni yakho e-China.Yiqiniso, ezinye izinsizakalo, ezifana nokubonisana, zinganikezwa nazo.

Okwedlule: Ukusebenza okuphezulu kwe-China Heparin Sodium

Olandelayo: Ukusebenza okuphezulu kwe-China Heparin Sodium

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