Kallidinogenase o Deebio mo nga momo momo mate ngakau me te mate pukupuku

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

Kallidinogenase o Deebio mo nga momo momo mate ngakau me te mate pukupuku

KAUPAPA NO.:9001-01-8

Waehere HS:3507.9090.90

Tukuna he imeera ki a matou

Taipitopito Hua

Tohu Hua

Taipitopito

1. Nga Tohu: Te paura ma, tata ma ranei, he hongi.

2. Puna Tangohanga: Porcine pancreas.

3. Te Tukatuka: Ka tangohia mai te Kallidinogenase mai i te pancreas porcine hauora.

4. Nga tohu me nga whakamahinga: Ka taea te whakamahi i tenei hua mo nga momo mate pukupuku me te mate pukupuku, penei i te mate o te ngakau coronary, te arteriosclerosis cerebral, te thrombosis cerebral, te mate o te toto retinal me te mate vascular peripheral.He pai ake te rongoa ki nga rangahau tata nei mo te aukati i te microangiopathy mate huka moata me te nephropathy mate huka, ka taea te whakaheke i te whakaputanga albumin.Ko nga raraunga haumanu i te kainga me tawahi e kii ana ka nui ake te mahi parāoa me te nui o te whakaputanga, me te whai hua whakaora i roto i te maimoatanga o etahi taangata tane.

He aha tatou?

·I hangaia i roto i te awheawhe GMP

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

· Ka taea te rapu i nga rawa mata

· Kia rite ki nga paerewa a nga kaihoko

· 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		CP	JP
Pūāhua		Te paura ma, tata ma ranei, kaore he kakara	He ma ki te paura parauri paku, he hongi, he ngoikore ranei
Tautuhinga		R (te reiti hydrolysis): 0.12～0.17	R (te reiti hydrolysis): 0.12～0.16
Tautuhinga		Waiwai Chromatography: He rite	Ahau : ≤ 0.2
Nga whakamatautau	pH	5.5～7.5（300 wae/ml）	5.5～7.5（1g/300ml）
	Te marama o te otinga	Maamaa（2mg/ml）	————
	Ngako	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	R Uara：≥ 0.8
	He matū rite Trypsin	————	T Uara：≤ 0.05
	Protease	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Ngaronga i te whakamaroke	≤ 5.0% (60 ℃ maroke i te korehau, 4h)	≤ 2.0% (60 ℃ maroke i te korehau, 4h)
	Te toenga i runga i te mura	≤ 3.0%	≤ 3.0%
	He mahi tuku-kini	————	≥ 500ng bradykinin rite / min / wae ia wae
	Maamaa	≥ 75% (mo te waha)	————
	Maamaa	≥ 90% (mo te werohanga)	————
	Endotoxin huakita	≤ 2.5 EU/wae (mo te werohanga)	————
Te whakamatautau	Te ngohe ngohe	————	≥ 25 wae/mg
	Mahi motuhake	≥ 300 wae/mg pūmua (mo te waha)	≥ 100 wae/mg pūmua
	Mahi motuhake	≥ 600 wae/mg pūmua (mo te werohanga)	≥ 100 wae/mg pūmua
Nga poke moroiti	TAMC	≤ 1000cfu/g (mo te waha)	≤ 1000cfu/g
	TAMC	≤ 100cfu/g (mo te werohanga)	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Ka rite	Ka rite
	Haramona	Ka rite	Ka rite