Heparin konutai o Deebio mo te maimoatanga Thromboembolic Mate Aukati

Heparin Sodium of Deebio for Treating Thromboembolic Disease Prevention Featured Image

Heparin konutai o Deebio mo te maimoatanga Thromboembolic Mate Aukati

KAUPAPA NO.:9041-08-1

Waehere HS:3001.9010.00

Tukuna he imeera ki a matou

Taipitopito Hua

Tohu Hua

Taipitopito

1. Nga Tohu: Te paura ma, tata ma ranei te paura, tino hygroscopic.

2. Puna: Porcine intestine mucosa.

3. Tukatuka: Ko te konutai heparin ka tangohia mai i te mucosa whekau porcine hauora.

4. Nga tohu me nga whakamahinga: Ko te nuinga o tenei hua ka whakamahia mo te aukati mate thromboembolic, ina koa mo te hiahia o te anticoagulant tere, penei: 1. Acute or chronic venous thrombosis or no important blood flow dynamic change of pulmonary embolism(PE).Heparin Ka taea te aukati i te toronga embolus kia whai wa mo te thrombolysis o te tinana.2. Te aukati me te maimoatanga o te Atrial fibrillation me te embolism.3. Te maimoatanga o te whakamohoatanga o te toto toto (DIC).4. Te aukati me te maimoatanga o te thrombosis arterial peripheral infarction myocardial ranei.5. Ko etahi atu in vitro anticoagulation: penei i te pokanga cardiovascular, in vitro circulation, hemodialysis, angiography, ka taea hoki te whakamahi mo te whakaheke toto, te whakarite tauira toto ranei, i tenei wa ko nga tohu matua o te tono heparin he thrombosis uaua hohonu (DVT), PE me te thrombosis i nga turoro morearea nui.

He aha tatou?

· I paahitia te GMP Hainamana

· 27 nga tau o te hitori R&D o te enzyme koiora

· Ka taea te rapu i nga rawa mata

· Whakaritea ki te USP、EPme te paerewa kiritaki

· Kaweake ki runga i te 30 whenua me nga rohe

· He kaha ki te whakahaere punaha kounga penei i te US FDA, Japan PMDA, South Korea MFDS, etc.

Whakatakotoranga

Nga Tuemi Whakamatau		Whakatakotoranga Kamupene
Nga Tuemi Whakamatau		EP	USP
Pūāhua		Te paura ma, tata ma ranei te paura, tino hygroscopic
Tautuhinga		Thrombotest: Ka rite	Te tuakiri Chromatographic: Ka rite
		¹H NMR Spectrum: He rite	¹H NMR Spectrum: He rite
		Waiwai Chromatography: He rite	Taumaha-toharite taimaha rāpoi: 15000~19000
		Konutai: Ka rite	Konutai: Ka rite
		Anti-tauwehe Xa ki anti-tauwehe IIa ōwehenga:0.9~1.1	Anti-tauwehe Xa ki anti-tauwehe IIa ōwehenga:0.9~1.1
Nga whakamatautau	Te maama me te tae	Maamaa: Maama, Tae: ma te 5 pai ake ranei	————
	hauota	1.5～2.5%（matū maroke）	1.3～2.5%（matū maroke）
	Nga poke nucleotidic	A₂₆₀≤ 0.15(4mg/ml)	≤ 0.1（w/w）
	Matū whai pānga	Ka rite	————
	Whakaitihia te galactosamine i roto i te hexosamine katoa	————	≤ 1.0%
	Ko te chondroitin sulfate kua werahia	————	Ka rite
	pH	5.5～8.0（1%）	5.5～7.5（1%）
	Ngaronga i te whakamaroke	≤ 8.0%（60 ℃ maroke i roto i te korehau, 3h）	≤ 5.0%（60 ℃ maroke i roto i te korehau, 3h）
	Te toenga i runga i te mura	————	28.0%～41.0%
	Endotoxin huakita	≤ 0.01 IU/Waeine Ao o Heparin	≤ 0.03 USP U/Waehere Ao o Heparin
	Te whakarewa taumaha	≤ 30ppm	≤ 30ppm
	konutai	10.5～13.5%（matū maroke）	————
	Pūmua	≤ 0.5%（matū maroke）	≤ 0.1%（Tauwehenga taumaha）
Mahi		≥ 180 IU/mg（matū maroke）	≥ 180 USP U/mg（matū maroke）
Nga poke moroiti	TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Ka rite	Ka rite
	Staphylococcus aureus	Ka rite	Ka rite
	Haramona	Ka rite	Ka rite