China Kallidinogenase ea Deebio bakeng sa mefuta e sa tšoaneng ea lefu la pelo le lefu la pelo fektheri le bahlahisi |Deebiotech

Kallidinogenase ea Deebio bakeng sa mefuta e sa tšoaneng ea lefu la pelo le lefu la cerebovascular Setšoantšo se bontšitsoeng

Kallidinogenase ea Deebio bakeng sa mefuta e sa tšoaneng ea lefu la pelo le methapo ea pelo

NOMORO YA CAS:9001-01-8

HS CODE:3507.9090.90

Tšebeletso ea Faele:Sechaena-GMP, DMF

Pharmacopoeia standard:JP/CP

Re romelle lengolo-tsoibila mahala sampole

Lintlha tsa Sehlahisoa

Li-tag tsa Sehlahisoa

Lintlha

1. Litlhaku: Phofo e tšoeu kapa e batlang e le tšoeu, e sa nkheng.

2. Mohloli oa Mohloli: Li-pancreas tsa Porcine.

3. Ts'ebetso: Kallidinogenase e ntšoa ho li-pancreas tse phetseng hantle tsa porcine.

4. Lipontšo le tšebeliso: Sehlahisoa sena se ka sebelisoa bakeng sa mefuta e sa tšoaneng ea lefu la pelo le methapo ea pelo, e kang lefu la pelo, lefu la cerebral arteriosclerosis, cerebral thrombosis, mathata a ho fana ka mali a retinal le lefu la peripheral vascular disease.Ho ba le phello e ntle ea kalafo liphuputsong tsa morao-rao tsa thibelo ea lefu la tsoekere la pele la lefu la tsoekere le nephropathy ea lefu la tsoekere, ho ka fokotsa ho ntšoa ha albin.Lintlha tsa Clinical lapeng le kantle ho naha li fana ka maikutlo a hore e ka eketsa ts'ebetso ea peō ea botona le bongata ba tlhahiso, 'me e na le phello e itseng ea ho phekola kalafo ea sterility e itseng.

Hobaneng rona?

·E hlahisoa ka har'a workshop ea GMP

· Lilemo tse 27 tsa nalane ea enzyme ea bioloji ea R&D

· Lisebelisuoa tse tala lia lateloa

·Latela maemo a bareki

· Romella kantle ho naha le libakeng tse fetang 30

·E na le bokhoni ba tsamaiso ea boleng bo kang US FDA, Japan PMDA, South Korea MFDS, joalo-joalo.

Tlhaloso

Lintho tsa Tlhahlobo		Tlhaloso ea Khampani
Lintho tsa Tlhahlobo		CP	JP
Litlhaku		Phofo e tšoeu kapa e batlang e le tšoeu, e se nang monko	Phofo e tšoeu ho isa ho e sootho hanyane, e sa nkheng kapa e lerootho
Boitsebiso		R (sekhahla sa hydrolysis): 0,12～0.17	R (sekhahla sa hydrolysis): 0,12～0.16
Boitsebiso		Liquid Chromatography: E lumellana	Ke: ≤ 0.2
Liteko	pH	5.5～7.5（300unit/ml）	5.5～7.5（1g/300ml）
	Ho hlaka ha tharollo	Hlakileng（2mg/ml）	————
	Mafura	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	R Boleng:≥ 0.8
	Ntho e kang trypsin	————	T Boleng:≤ 0.05
	Protease	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Tahlehelo ka ho omisa	≤ 5.0% (60℃ Dry in Vacuum, 4h)	≤ 2.0% (60℃ Dry in Vacuum, 4h)
	Masalla ha a tuka	≤ 3.0%	≤ 3.0%
	Ts'ebetso ea ho lokolla Kinin	————	≥ 500ng bradykinin e lekanang / metsotso / yuniti ka yuniti
	Bohloeki	≥ 75% (bakeng sa molomo)	————
	Bohloeki	≥ 90% (bakeng sa ente)	————
	Endotoxin ea baktheria	≤ 2.5 EU/yuniti (bakeng sa ente)	————
Tlhahlobo	Ts'ebetso ea enzyme	————	≥ 25 yuniti / mg
	Ts'ebetso e khethehileng	≥ 300 unit/mg protheine (bakeng sa molomo)	≥ 100 unit / mg protheine
	Ts'ebetso e khethehileng	≥ 600 unit/mg protheine (bakeng sa ente)	≥ 100 unit / mg protheine
Litšila tsa Microbial	TAMC	≤ 1000cfu/g (bakeng sa molomo)	≤ 1000cfu/g
	TAMC	≤ 100cfu/g (bakeng sa ente)	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	E lumellana	E lumellana
	Salmonella	E lumellana	E lumellana