Haina Heparin konutai o Deebio mo te maimoatanga Thromboembolic Mate Prevention wheketere me nga kaihanga |Deebiotech

Ko te Heparin Sodium o Deebio mo te rongoa i te mate thromboembolic te aukati i te ahua o te ahua

Heparin konutai o Deebio mo te maimoatanga Thromboembolic Mate Aukati

KAUPAPA NO.:9041-08-1

Waehere HS:3001.9010.00

Ratonga Kōnae:Hainamana-GMP, DMF

Paerewa Pharmacopoeia:EP/USP

Tukuna he imeera ki a matou tauira kore utu

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: Ka tangohia te konutai heparin mai i te mucosa whekau porcine hauora.

4. Nga tohu me nga whakamahinga: Ko te nuinga o tenei hua ka whakamahia mo te aukati i te 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 i roto i 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 whakawhitinga, mo te whakarite tauira toto ranei, i tenei wa ko nga tohu matua o te tono heparin he thrombosis vein hohonu (DVT), PE me te thrombosis i roto 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 kitea nga rauemi 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
Ngā Pūāhua		He paura ma, he tata ma ranei, he 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
		Tauwehenga Xa ki te tauwehenga IIa:0.9~1.1	Tauwehenga Xa ki te tauwehenga IIa:0.9~1.1
Nga whakamatautau	Te maama me te tae	Maama: Maama, Tae: ma te 5, pai ake ranei	————
	hauota	1.5～2.5%（taonga maroke）	1.3～2.5%（taonga 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/Waeine Ao o Heparin
	Te whakarewa taumaha	≤ 30ppm	≤ 30ppm
	konutai	10.5～13.5%（taonga maroke）	————
	Pūmua	≤ 0.5%（taonga maroke）	≤ 0.1%（Tauwehenga taumaha）
Mahi		≥ 180 IU/mg（taonga maroke）	≥ 180 USP U/mg（taonga 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