I-Kallidinogenase ye-Deebio yezinhlobonhlobo ze-Cardiovascular and Cerebovascular Disease

Kallidinogenase of Deebio for Variety of Cardiovascular and Cerebovascular Disease Featured Image

I-Kallidinogenase ye-Deebio yezinhlobonhlobo ze-Cardiovascular and Cerebovascular Disease

INOMBOLO YECAS.9001-01-8

IKHODI YE-HS:3507.9090.90

Thumela i-imeyili kithi

Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Imininingwane

1. Izinhlamvu: Impushana emhlophe noma ecishe ibe mhlophe, engenaphunga.

2. Ukukhipha Umthombo: Amanyikwe engulube.

3. Inqubo: I-Kallidinogenase ikhishwa kumanyikwe engulube enempilo.

4. Izinkomba kanye nokusetshenziswa: Lo mkhiqizo ungasetshenziselwa izifo ezihlukahlukene zenhliziyo nemithambo yegazi, njengesifo senhliziyo, i-cerebral arteriosclerosis, i-cerebral thrombosis, ukuphazamiseka kokunikezwa kwegazi kwe-retinal kanye nesifo se-vascular peripheral.Iba nomthelela ongcono wokwelapha ocwaningweni lwakamuva lokuvikela i-microangiopathy yesifo sikashukela kanye ne-nephropathy yesifo sikashukela, kunganciphisa ukukhishwa kwe-albumin.Idatha yomtholampilo ekhaya naphesheya iphakamisa ukuthi ingakhuphula ukusebenza kwesidoda kanye nenani lokukhiqiza, futhi inomphumela othile wokwelapha ekwelapheni ubunyumba bowesilisa.

Kungani sisi?

Ikhiqizwe ku-workshop ye-GMP

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

·Izinto ezingavuthiwe ziyalandeleka

·Thobela izinga lamakhasimende

Thekelisa 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		CP	JP
Izinhlamvu		Impushana emhlophe noma ecishe ibe mhlophe, engenaphunga	Impushana emhlophe kuya kokuncane, ayinaphunga noma iqulekile
Ukuhlonza		R (isilinganiso se-hydrolysis): 0.12～0.17	R (isilinganiso se-hydrolysis): 0.12～0.16
Ukuhlonza		I-Liquid Chromatography: Iyavumelana	Mina : ≤ 0.2
Izivivinyo	pH	5.5～7.5(300 amayunithi / ml）	5.5～7.5(1g/300ml）
	Ukucaca kwesixazululo	Kucace(2mg/ml）	————
	Amafutha	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	R Inani:≥ 0.8
	Into efana ne-trypsin	————	T Inani:≤ 0.05
	I-Protease	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Ukulahlekelwa ekomisweni	≤ 5.0% (60℃ Yomisa ku-Vacuum, 4h)	≤ 2.0% (60℃ Yomisa ku-Vacuum, 4h)
	Izinsalela ekushiseni	≤ 3.0%	≤ 3.0%
	Umsebenzi wokukhipha i-Kinin	————	≥ 500ng i-bradykinin okulingana/umzuzu/iyunithi ngeyunithi ngayinye
	Ubumsulwa	≥ 75% (okomlomo)	————
	Ubumsulwa	≥ 90% (umjovo)	————
	I-endotoxin yebhaktheriya	≤ 2.5 EU/iyunithi (yomjovo)	————
Isivivinyo	Umsebenzi wama-enzyme	————	≥ 25 iyunithi/mg
	Umsebenzi othize	≥ 300 iyunithi/mg amaprotheni (omlomo)	≥ 100 iyunithi/mg amaprotheni
	Umsebenzi othize	≥ 600 iyunithi/mg amaprotheni (umjovo)	≥ 100 iyunithi/mg amaprotheni
Ukungcola Kwe-Microbial	I-TAMC	≤ 1000cfu/g (okomlomo)	≤ 1000cfu/g
	I-TAMC	≤ 100cfu/g (yomjovo)	≤ 1000cfu/g
	I-TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Kuyavumelana	Kuyavumelana
	I-Salmonella	Kuyavumelana	Kuyavumelana