Shiinaha Kallidinogenase ee Deebio ee Noocyada Kala duwan ee Wadnaha iyo Warshada Cudurada Cerebovascular iyo soo saarayaasha |Deebiyotech

Kallidinogenase of Deebio oo loogu talagalay Noocyada Kala duwan ee Cudurrada Wadnaha iyo xididdada xididdada Sawirka

Kallidinogenase of Deebio oo loogu talagalay Cudurrada Wadnaha iyo xididdada dhiigga ee kala duwan

CAS NO.:9001-01-8

HS code:3507.9090.90

Adeegga Faylka:Shiine-GMP, DMF

Heerka Pharmacopoeia:JP/CP

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Faahfaahinta Alaabta

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Faahfaahin

1. Characters: Caddaan ama ku dhawaad budo cad, oo aan ur lahayn.

2. Isha Soosaarka: Beeryarada Porcine.

3. Habka: Kallidinogenase waxaa laga soo saaraa beeryarada doofaarka ee caafimaadka leh.

4. Tilmaamaha iyo isticmaalka: Alaabtan waxaa loo isticmaali karaa noocyo kala duwan oo ah cudurrada wadnaha iyo xididdada dhiigga, sida cudurada wadnaha, arteriosclerosis maskaxda, thrombosis cerebral thrombosis, cilladaha sahayda dhiigga retinal iyo cudurrada xididdada durugsan.Saameyn daweyn oo wanaagsan ku yeelata cilmi-baarisyadii ugu dambeeyay ee ka hortagga hore ee microangiopathy macaanka iyo nephropathy macaanka, waxay yareyn kartaa soosaarka albumin-ka.Xogta caafimaad ee gudaha iyo dibaddaba waxay soo jeedinaysaa in ay kordhin karto dhaqdhaqaaqa shahwada iyo tirada wax-soo-saarka, oo ay leedahay saamayn dawo ah oo lagu daweynayo qaar ka mid ah madhalaysnimada ragga.

Waa maxay sababta?

Waxa lagu soo saaray aqoon-is-weydaarsiga GMP

· 27 sano oo enzyme noole R&D taariikhda

Walxaha ceeriin waa la raadin karaa

U hoggaansamaan heerka macaamiisha

Dhoofinta in ka badan 30 waddan iyo gobollo

Inuu leeyahay awoodda maaraynta nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.

Tilmaamid

Walxaha Tijaabada		Tilmaamaha Shirkadda
Walxaha Tijaabada		CP	JP
Jilayaasha		Caddaan ama ku dhawaad cad cad, oo aan ur lahayn	Caddaan ilaa budo yar oo bunni ah, aan ur lahayn ama ay daciif tahay
Aqoonsiga		R (Heerka Hydrolysis): 0.12～0.17	R (Heerka Hydrolysis): 0.12～0.16
Aqoonsiga		Chromatography dareere: Waafaqsan	I: ≤ 0.2
Tijaabooyin	pH	5.5～7.5(300 unug/ml)	5.5～7.5(1g/300ml)
	Caddayn xalka	Cad(2mg/ml)	————
	Baruur	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	Qiimaha R：≥ 0.8
	Maado u eg Trypsin	————	T Qiimaha：≤ 0.05
	Protease	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Luminta qalajinta	≤ 5.0% (60℃ Vacuum ku qallalan, 4 saac)	≤ 2.0% (60℃ Vacuum ku qallalan, 4 saac)
	Hadhaaga dabka	≤ 3.0%	≤ 3.0%
	Kinin-sii daynta hawsha	————	≥ 500ng bradykinin u dhiganta/min/cutubkiiba
	daahirnimo	≥ 75% (afka ah)	————
	daahirnimo	≥ 90% (durida)	————
	Bakteeriyada endotoxin	≤ 2.5 EU/cutub (ku duritaan)	————
Qiimayn	Dhaqdhaqaaqa enzyme	————	≥ 25 halbeeg/mg
	Dhaqdhaqaaq gaar ah	≥ 300 unug/mg borotiin (oo afka ah)	≥ 100 unug/mg borotiin
	Dhaqdhaqaaq gaar ah	≥ 600 unug/mg borotiin (ku duritaan)	≥ 100 unug/mg borotiin
Waxyeellada Microbial	TAMC	≤ 1000cfu/g (afka ah)	≤ 1000cfu/g
	TAMC	≤ 100cfu/g (duritaan)	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	waafaqsan	waafaqsan
	Salmonella	waafaqsan	waafaqsan