I-China ethengisa kakhulu i-China yoMgangatho oPhezulu we-Kallidinogenase (CAS: 9001-01-8) umzi-mveliso kunye nabavelisi |I-Deebiotech

Ukuthengiswa Okugqwesileyo kweTshayina kuMgangatho oPhezulu weKallidinogenase (CAS: 9001-01-8) Umfanekiso obonakalayo

I-Kallidinogenase ePhakamileyo eThengisa kakhulu eTshayina (CAS: 9001-01-8)

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

Enesimo sengqondo esilungileyo nesinenkqubela ekuthandeni kwabathengi, ishishini lethu lihlala liphucula umgangatho ophakamileyo wokurhweba ukuze lihlangabezane neemfuno zabathengi kwaye lijolise ngakumbi kukhuseleko, ukuthembeka, iimfuno zokusingqongileyo, kunye nokuveliswa koMgangatho oPhakamileyo waseTshayina.Kallidinogenase( CAS: 9001-01-8 ), Ngokuqhelekileyo kuninzi lwabasebenzisi bezoshishino kunye nabarhwebi ukuba babonelele ngeempahla ezisemgangathweni kunye nenkampani egqwesileyo.Wamkelekile ngokufudumeleyo ukuba sizibandakanye nathi, masenze izinto ezintsha ngokudibeneyo, kwiphupha elibhabhayo.
Enesimo sengqondo esilungileyo nesinenkqubela ekuthandeni kwabathengi, ishishini lethu lihlala liphucula imveliso yethu ekumgangatho ophezulu ukuhlangabezana neemfuno zabathengi kwaye igxile ngakumbi kukhuseleko, ukuthembeka, iimfuno zokusingqongileyo, kunye nokusungula izinto ezintsha.Kallidinogenase, Sijonge ukuba lishishini langoku elinombono worhwebo "wokunyaniseka kunye nokuzithemba" kunye nenjongo "yokubonelela abathengi ngezona nkonzo zinyanisekileyo kunye neemveliso ezisemgangathweni".Sicela ngokunyanisekileyo ngenkxaso yakho engatshintshiyo kwaye siyayixabisa ingcebiso yakho yobubele kunye nesikhokelo.

Iinkcukacha

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

2. Ukukhutshwa Umthombo: Ipancreas yehagu.

3. Inkqubo:Kallidinogenaseikhutshwa kwipancreas esempilweni yehagu.

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.

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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(300unit/ml)	5.5-7.5(1g/300ml)
	Ukucaca kwesisombululo	Sula (2mg/ml)	————
	Amafutha	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	Ixabiso R:≥ 0.8
	Into efana ne-trypsin	————	Ixabiso T:≤ 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

Enesimo sengqondo esilungileyo nesinenkqubela ekuthandeni kwabathengi, ishishini lethu lihlala liphucula umgangatho ophakamileyo wokurhweba ukuze lihlangabezane neemfuno zabathengi kwaye lijolise ngakumbi kukhuseleko, ukuthembeka, iimfuno zokusingqongileyo, kunye nokuveliswa kwe-Cp Kallidinogenase ePhakamileyo eThengisa kakhulu yaseTshayina (CAS: 9001-01-8), Ngokwesiqhelo kuninzi lwabasebenzisi beshishini kunye nabarhwebi ukuba babonelele ngeempahla ezisemgangathweni kunye nenkampani egqwesileyo.Wamkelekile ngokufudumeleyo ukuba sizibandakanye nathi, masenze izinto ezintsha ngokudibeneyo, kwiphupha elibhabhayo.
I-China ethengiswa kakhulu kwiPhakathi yezamayeza, i-Antibiotic, Sijolise ekubeni lishishini langoku elinombono worhwebo "wokunyaniseka kunye nokuzithemba" kunye nenjongo "yokubonelela abathengi ngezona nkonzo zinyanisekileyo kunye neemveliso ezisemgangathweni".Sicela ngokunyanisekileyo ngenkxaso yakho engatshintshiyo kwaye siyayixabisa ingcebiso yakho yobubele kunye nesikhokelo.

Ngaphambili: I-Kallidinogenase ePhakamileyo eThengisa kakhulu eTshayina (CAS: 9001-01-8)

Okulandelayo: I-Kallidinogenase ePhakamileyo eThengisa kakhulu eTshayina (CAS: 9001-01-8)

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