China e rekisoang ka ho Fetisisa China Kallidinogenase ea Boleng bo Phahameng (CAS: 9001-01-8) fektheri le bahlahisi |Deebiotech

Kallidinogenase e Rekoang ka ho Fetisisa ea China ea Boleng bo Phahameng (CAS: 9001-01-8) Setšoantšo se Tsoang

Kallidinogenase e Rekoang ka ho Fetisisa ea Chaena ea Boleng bo Phahameng (CAS: 9001-01-8)

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

Seo se na le maikutlo a matle le a tsoelo-pele ho khahleng ea bareki, khoebo ea rona e lula e ntlafatsa thepa ea rona ea boleng bo holimo ho fihlela litlhoko tsa bareki mme e shebane le polokeho, ts'epahalo, litlhoko tsa tikoloho, le boqapi ba Boleng bo Phahameng ka ho Fetisisa ba China.Kallidinogenase(CAS: 9001-01-8), Ka tloaelo ho bongata ba basebelisi ba khoebo le barekisi ho fana ka thepa ea boleng bo holimo le k'hamphani e ntle haholo.Re u amohela ka mofuthu ho ikopanya le rona, ha re iqapeleng ka kopanelo, ho litoro tse fofang.
E na le maikutlo a matle le a tsoelo-pele ho khahleng ea bareki, khoebo ea rona e lula e ntlafatsa thepa ea rona ea boleng bo holimo ho fihlela litlhoko tsa bareki mme e shebane le polokeho, ts'epahalo, litlhoko tsa tikoloho le boqapi baKallidinogenase, Re ikemiselitse ho ba khoebo ea sejoale-joale e nang le sepheo sa khoebo sa "Botšepehi le boitšepo" le ka sepheo sa "Ho fa bareki litšebeletso tse tšepahalang ka ho fetesisa le lihlahisoa tsa boleng bo holimo".Re kopa ts'ehetso ea hau e sa fetoheng mme re leboha likeletso le tataiso ea hau e mosa.

Lintlha

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

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

3. Mokhoa:Kallidinogenasee ntšoa ho li-pancreas tse phetseng hantle.

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.

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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	Hlakola (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

Seo se na le maikutlo a matle le a tsoelo-pele ho khahleng ea bareki, khoebo ea rona e lula e ntlafatsa thepa ea rona ea boleng bo holimo ho fihlela litlhoko tsa bareki mme e shebane le polokeho, ts'epahalo, litlhoko tsa tikoloho le boqapi ba Cp Kallidinogenase e rekisoang ka ho Fetisisa ea China (CAS: 9001-01-8), Hangata ho basebelisi ba bangata ba khoebo le barekisi ho fana ka thepa ea boleng bo holimo le k'hamphani e ntle haholo.Re u amohela ka mofuthu ho ikopanya le rona, ha re iqapeleng ka kopanelo, ho litoro tse fofang.
E Rekisang ka ho Fetisisa China Pharmaceutical Intermediate, Antibiotic, Re ikemiselitse ho ba khoebo ea sejoale-joale e nang le sepheo sa khoebo sa "Botšepehi le boitšepo" le ka sepheo sa "Ho fa bareki lits'ebeletso tse tšepahalang ka ho fetesisa le lihlahisoa tsa boleng bo holimo".Re kopa ts'ehetso ea hau e sa fetoheng mme re leboha likeletso le tataiso ea hau e mosa.

E fetileng: Kallidinogenase e Rekoang ka ho Fetisisa ea Chaena ea Boleng bo Phahameng (CAS: 9001-01-8)

E 'ngoe: Kallidinogenase e Rekoang ka ho Fetisisa ea Chaena ea Boleng bo Phahameng (CAS: 9001-01-8)

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