I-China Kallidinogenase ye-Deebio kwiintlobo ezahlukeneyo ze-Cardiovascular and Cerebovascular Disease factory kunye nabavelisi |I-Deebiotech

I-Kallidinogenase ye-Deebio kwiintlobo ezahlukeneyo ze-Cardiovascular and Cerebovascular Disease

INOMBOLO YECAS.9001-01-8

IKHOWUDI ye-HS:3507.9090.90

Inkonzo Yefayile:IsiTshayina-GMP, iDMF

Pharmacopoeia umgangatho:JP/CP

Thumela i-imeyile kuthi isampuli yasimahla

Iinkcukacha zeMveliso

Iithegi zeMveliso

Iinkcukacha

1. Abalinganiswa: Umgubo omhlophe okanye phantse omhlophe, ongenavumba.

2. Ukukhutshwa Umthombo: Ipancreas yehagu.

3. Inkqubo: I-Kallidinogenase ikhutshwe kwi-pancreas ye-porcine enempilo.

4. Izibonakaliso kunye nokusetyenziswa: Le mveliso ingasetyenziselwa iintlobo ezahlukeneyo ze-cardiovascular and cerebovascular disease, njenge-coronary heart disease, i-cerebral arteriosclerosis, i-cerebral thrombosis, ukuphazamiseka kwegazi kwi-retinal kunye ne-peripheral vascular disease.Yiba nefuthe elingcono lonyango kuphando lwamva nje lothintelo lwesifo seswekile se-microangiopathy kunye nesifo seswekile, kunokunciphisa ukukhutshelwa kwe-albumin.Idatha yeklinikhi ekhaya nakwamanye amazwe icebisa ukuba inokunyusa umsebenzi wamadlozi kunye nobuninzi bemveliso, kwaye inesiphumo esithile sonyango kunyango lobudlolo obuthile.

Kutheni sisi?

·Iveliswe kwiworkshop yeGMP

· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D

·Imathiriyeli ekrwada iyalandeleka

·Thobela umgangatho wabathengi

·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla

·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.

Inkcazo

Izinto zovavanyo		Inkcazo yeNkampani
Izinto zovavanyo		CP	JP
Abalinganiswa		Umgubo omhlophe okanye ophantse ube mhlophe, ongenavumba	Imhlophe ukuya kumgubo omdaka kancinane, ongenavumba okanye otyhafileyo
Ukuchongwa		R (izinga le-hydrolysis): 0.12～0.17	R (izinga le-hydrolysis): 0.12～0.16
Ukuchongwa		Ulwelo lweChromatography: Iyahambelana	Mna : ≤ 0.2
Iimvavanyo	pH	5.5～7.5(300 iyunithi/ml）	5.5～7.5(1g/300ml）
	Ukucaca kwesisombululo	Cacileyo(2mg/ml）	————
	Amafutha	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	R Ixabiso:≥ 0.8
	Into efana ne-trypsin	————	T Ixabiso:≤ 0.05
	Iprotease	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Ilahleko ekomisweni	≤ 5.0% (60℃ Yomile kwiVacuum, 4h)	≤ 2.0% (60℃ Yomile kwiVacuum, 4h)
	Intsalela ekutshisweni	≤ 3.0%	≤ 3.0%
	Umsebenzi wokukhutshwa kweKinin	————	≥ I-500ng ye-bradykinin elinganayo / min / iyunithi nganye
	Ubunyulu	≥ 75% (yomlomo)	————
	Ubunyulu	≥ 90% (yenaliti)	————
	I-endotoxin yebhaktheriya	≤ 2.5 EU/iyunithi (yenaliti)	————
Isivavanyi	Umsebenzi we-enzyme	————	≥ 25 iyunithi / mg
	Umsebenzi othile	≥ 300 unit/mg protein (yomlomo)	≥ I-100 iyunithi / iprotheni ye-mg
	Umsebenzi othile	≥ 600 iyunithi/mg protein (yenaliti)	≥ I-100 iyunithi / iprotheni ye-mg
Ukungcola kweMicrobial	TAMC	≤ 1000cfu/g (yomlomo)	≤ 1000cfu/g
	TAMC	≤ 100cfu/g (yenaliti)	≤ 1000cfu/g
	I-TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Iyahambelana	Iyahambelana
	Salmonella	Iyahambelana	Iyahambelana