China High Performance China Heparin Sodium umzi-mveliso kunye nabavelisi |I-Deebiotech

Ukusebenza okuphezulu kweChina iHeparin yeSodium ebonisiweyo Umfanekiso

Ukusebenza okuphezulu kweChina Heparin Sodium

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

Sizama ukugqwesa, inkampani yabathengi ”, sinethemba lokuba lelona qela lentsebenziswano libalaseleyo kunye neshishini elilawulayo kubasebenzi, ababoneleli kunye nabathengi, baqonda ukuba kufanelekile ukwabelana kunye kunye nentengiso eqhubekayo yoMsebenzi oPhezulu.China Heparin Sodium, Asinikeli nje kuphela umgangatho ophezulu kubathengi bethu, kodwa okongeziweyo okubaluleke ngakumbi zezona nkonzo zinkulu kunye nexabiso lokuthengisa elikhuphisanayo.
Sizama ukugqwesa, inkampani yabathengi ”, sinethemba lokuba lelona qela lentsebenziswano libalaseleyo kunye neshishini elilawulayo kubasebenzi, ababoneleli kunye nabathengi, baqonda ukuba kufanelekile ukwabelana kunye nokuqhubeka nokubhengezwaChina Heparin Sodium, Ukwaneliseka koMthengi kuhlala kungumnqweno wethu, ukudala ixabiso kubathengi kuhlala kungumsebenzi wethu, ubudlelwane beshishini bexesha elide kunye nenzuzo yinto esiyenzela yona.Sibe liqabane elithembekileyo ngokupheleleyo kwimeko yakho eTshayina.Ngokuqinisekileyo, ezinye iinkonzo, ezifana nokubonisana, zinokubonelelwa nazo.

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.

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Kutheni sisi?

Upase iGMP yaseTshayina

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

·Imathiriyeli ekrwada iyalandeleka

·Thobela USP,EP kunye nomgangatho wabathengi

·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

Sizama ukugqwesa, inkampani yabathengi ”, sinethemba lokuba lelona qela lentsebenziswano libalaseleyo kunye neshishini elilawulayo kubasebenzi, ababoneleli kunye nabathengi, baqonda ukuba kufanelekile ukwabelana kunye kunye nentengiso eqhubekayo yokuSebenza okuPhezulu kweChina iHeparin Sodium Asineli nje ukuhambisa umgangatho ophezulu kubathengi bethu. , kodwa okongeziweyo kubaluleke nangakumbi zezona nkonzo zinkulu kunye nexabiso lokuthengisa elikhuphisanayo.
Ukusebenza okuphezulu kweChina Heparin, ulwaneliseko loMthengi luhlala lufuna, ukudala ixabiso kubathengi kuhlala kungumsebenzi wethu, ubudlelwane beshishini bexesha elide kunye nenzuzo yinto esiyenzela yona.Sibe liqabane elithembekileyo ngokupheleleyo kwimeko yakho eTshayina.Ngokuqinisekileyo, ezinye iinkonzo, ezifana nokubonisana, zinokubonelelwa nazo.

Ngaphambili: Ukusebenza okuphezulu kweChina Heparin Sodium

Okulandelayo: Ukusebenza okuphezulu kweChina Heparin Sodium

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