IiNkampani zokuVelisa zaseTshayina zaseTshayina eziPhakathi ze-Organic Kallikrein CAS 9001-01-8 umzi-mveliso woMgangatho oPhezulu kunye nabavelisi |I-Deebiotech

IiNkampani zokuVelisa zaseTshayina eziPhakathi ze-Organic Kallikrein CAS 9001-01-8 Umfanekiso oMgangatho oPhakamileyo

IiNkampani zokuVelisa eTshayina i-Organic ePhakathi Kallikrein CAS 9001-01-8 Umgangatho oPhezulu

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

Ngokuphathelele amaxabiso okuthengisa akhuphisanayo, siyakholelwa ukuba uya kukhangela kude nakude kuyo nantoni na enokusoyisa.Siza kuthetha ngokuqiniseka ngokupheleleyo ukuba kwezona ntlawulo zibalaseleyo singabona basezantsi kwiiNkampani zoVeliso ze-China Organic Intermediate Kallikrein CAS 9001-01-8 Umgangatho oPhezulu, Wamkelekile bonke abathengi bendawo yokuhlala nabaphesheya ukuba baye kwishishini lethu, ukwenza ixesha elide elimangalisayo ngentsebenziswano yethu.
Ngokuphathelele amaxabiso okuthengisa akhuphisanayo, siyakholelwa ukuba uya kukhangela kude nakude kuyo nantoni na enokusoyisa.Siyakuxela ngokuqinisekileyo ukuba ngokugqwesa ngolo hlobo kwezo ntlawulo singabona basezantsi kuzoChina Chemical, Iyeza, Ukuba zizisombululo eziphezulu zefektri yethu, uluhlu lwethu lwezisombululo luye lwavavanywa kwaye lwasiphumelela iziqinisekiso zegunya.Kwiiparameters ezongezelelweyo kunye neenkcukacha zoluhlu, qiniseka ukuba ucofa iqhosha ukufumana ulwazi olongezelelweyo.

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.

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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

Ngokuphathelele amaxabiso okuthengisa akhuphisanayo, siyakholelwa ukuba uya kukhangela kude nakude kuyo nantoni na enokusoyisa.Siza kuthetha ngokuqiniseka ngokupheleleyo ukuba kwezona ntlawulo zibalaseleyo singabona basezantsi kwiiNkampani zoVeliso ze-China Organic Intermediate Kallikrein CAS 9001-01-8 Umgangatho oPhezulu, Wamkelekile bonke abathengi bendawo yokuhlala nabaphesheya ukuba baye kwishishini lethu, ukwenza ixesha elide elimangalisayo ngentsebenziswano yethu.
IiNkampani zokuSebenza zeChina Chemical, Iyeza, Ukuba zizisombululo eziphezulu zefektri yethu, uluhlu lwethu lwezisombululo luye lwavavanywa kwaye lwasiphumelela iziqinisekiso zegunya.Kwiiparameters ezongezelelweyo kunye neenkcukacha zoluhlu, qiniseka ukuba ucofa iqhosha ukufumana ulwazi olongezelelweyo.

Ngaphambili: Umgangatho ogqwesileyo waseTshayina Umgangatho oPhezulu wePepsin Powder emhlophe CAS 9001-75-6

Okulandelayo: Ixabiso elicatshuliweyo leTshayina iGMP iMveliso yeSiqinisekiso seDMF i-Trypsin Enzyme/Trypsin Pure/Trypsin-Chymotrypsin

Bhala umyalezo wakho apha kwaye uwuthumele kuthi