Haina Kallidinogenase o Deebio mo te momo o te Cardiovascular me te Cerebovascular Disease wheketere me nga kaihanga |Deebiotech

Kallidinogenase o Deebio mo nga momo o te mate ngakau me te mate cerebovascular e whakaatuhia ana

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

KAUPAPA NO.:9001-01-8

Waehere HS:3507.9090.90

Ratonga Kōnae:Hainamana-GMP, DMF

Paerewa Pharmacopoeia:JP/CP

Tukuna he imeera ki a matou tauira kore utu

Taipitopito Hua

Tohu Hua

Taipitopito

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

2. Puna Tangohanga: Porcine pancreas.

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

4. Nga tohu me nga whakamahinga: Ka taea te whakamahi i tenei hua mo nga momo mate pukupuku me te cerebovascular, penei i te mate ngakau coronary, arteriosclerosis cerebral, thrombosis cerebral, raruraru tuku 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 nga whenua o waho e kii ana ka taea e ia te whakanui ake i 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 kitea nga rauemi 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
Ngā 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 tere hydrolysis): 0.12～0.17	R (te tere 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