Ubushinwa bugurishwa cyane Ubushinwa Bwiza Kallidinogenase (CAS: 9001-01-8) uruganda nababikora |Deebiotech

Igurishwa-Ubushinwa Bwiza Bwiza Kallidinogenase (CAS: 9001-01-8)

URUBANZA OYA.:9001-01-8

Kode ya HS:3507.9090.90

Serivisi ya dosiye:Igishinwa-GMP 、 DMF

Ibipimo bya Pharmacopoeia:JP / CP

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Ibicuruzwa birambuye

Ibicuruzwa

Ibyo bifite imyifatire myiza kandi igenda itera imbere gushimisha abakiriya, uruganda rwacu ruhora rutezimbere ibicuruzwa byacu byujuje ubuziranenge kugirango byuzuze ibyo abakiriya bakeneye kandi bikomeza kwibanda ku mutekano, kwiringirwa, ibisabwa ku bidukikije, no guhanga udushya twagurishijwe cyane mu Bushinwa.Kallidinogenase(CAS: 9001-01-8), Mubisanzwe kubakoresha benshi mubucuruzi nabacuruzi gutanga ibicuruzwa byiza nibisosiyete nziza.Murakaza neza cyane kwifatanya natwe, reka dushyire hamwe hamwe, kurota.
Ibyo bifite imyifatire myiza kandi igenda itera imbere gushimisha abakiriya, uruganda rwacu ruhora rutezimbere ibicuruzwa byacu byujuje ubuziranenge kugirango byuzuze ibyo abakiriya bakeneye kandi bikomeza kwibanda ku mutekano, kwiringirwa, ibisabwa ku bidukikije, no guhanga udushya.Kallidinogenase, Dufite intego yo kuba ikigo kigezweho gifite intego yubucuruzi ya "Umurava nicyizere" kandi tugamije "Guha abakiriya serivisi zivuye ku mutima nibicuruzwa byiza".Turasaba tubikuye ku mutima inkunga yawe idahindutse kandi dushimira inama nziza nubuyobozi.

Ibisobanuro

1. Inyuguti: Ifu yera cyangwa hafi yera, impumuro nziza.

2. Inkomoko yo gukuramo: pancreas pancreas.

3. Inzira:Kallidinogenaseikurwa muri pancreas nziza.

4. Ibigaragaza kandi bikoreshwa: Iki gicuruzwa kirashobora gukoreshwa mu ndwara zitandukanye zifata umutima-mitsi ndetse nubwonko bwubwonko, nkindwara yumutima wumutima, arteriosclerose yubwonko, trombose cerebral, trombose yubwonko, indwara zitanga amaraso hamwe nindwara zifata imitsi.Gira ingaruka nziza zo kuvura kubushakashatsi buherutse gukorwa kugirango hirindwe mikorobe ya diabete hakiri kare na diabete ya nepropatique, irashobora kugabanya gusohoka kwa alubumu.Amakuru y’amavuriro haba mu gihugu ndetse no hanze yacyo yerekana ko ashobora kongera ibikorwa byintanga n’umusaruro, kandi bikagira ingaruka zimwe na zimwe zo kuvura mu kuvura indwara zimwe na zimwe z’abagabo.

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Kuki？

· Yakozwe mu mahugurwa ya GMP

· Imyaka 27 ya enzyme ya biologiya R&D amateka

· Ibikoresho bibisi birashobora gukurikiranwa

· Kurikiza amahame y'abakiriya

· Kohereza mu bihugu n'uturere birenga 30

· Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.

Ibisobanuro

Ibizamini		Ibisobanuro bya sosiyete
Ibizamini		CP	JP
Inyuguti		Ifu yera cyangwa hafi yera, impumuro nziza	Ifu yera kugeza yoroheje yifu, idafite impumuro nziza cyangwa ifite intege nke
Kumenyekanisha		R (igipimo cya hydrolysis): 0.12 ～ 0.17	R (igipimo cya hydrolysis): 0.12 ～ 0.16
Kumenyekanisha		Amazi ya Chromatografiya: Ihuza	I: ≤ 0.2
Ibizamini	pH	5.5 ～ 7.5 （300unit / ml）	5.5 ～ 7.5 （1g / 300ml）
	Igisubizo cyumvikana	Sobanura （2mg / ml）	————
	Ibinure	≤ 5.0mg / g	≤ 1.0mg / g
	Kininase	————	R Agaciro ： ≥ 0.8
	Ibintu bisa na Trypsin	————	T Agaciro ： ≤ 0.05
	Kurinda	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Gutakaza kumisha	≤ 5.0% (60 ℃ Kuma muri Vacuum, 4h)	≤ 2.0% (60 ℃ Kuma muri Vacuum, 4h)
	Ibisigisigi byo gutwikwa	≤ 3.0%	≤ 3.0%
	Igikorwa cyo kurekura Kinin	————	≥ 500ng bradykinin ihwanye / min / ubumwe kuri buri gice
	Isuku	≥ 75% (ku munwa)	————
	Isuku	≥ 90% (yo gutera inshinge)	————
	Indwara ya bagiteri	≤ 2.5 EU / igice (cyo gutera inshinge)	————
Suzuma	Igikorwa cya Enzyme	————	Unit 25 unit / mg
	Igikorwa cyihariye	Unit 300 unit / mg proteine (kumunwa)	Unit 100 unit / mg proteine
	Igikorwa cyihariye	≥ 600 unit / mg proteine (yo gutera inshinge)	Unit 100 unit / mg proteine
Microbial Impurities	TAMC	≤ 1000cfu / g (ku munwa)	≤ 1000cfu / g
	TAMC	≤ 100cfu / g (yo gutera inshinge)	≤ 1000cfu / g
	TYMC	C 100cfu / g	C 100cfu / g
	E.coli	Guhuza	Guhuza
	Salmonella	Guhuza	Guhuza

Ibyo bifite imyifatire myiza kandi igenda itera imbere gushimisha abakiriya, uruganda rwacu ruhora rutezimbere ibicuruzwa byacu byujuje ubuziranenge kugirango byuzuze ibyo abakiriya bakeneye kandi bikomeza kwibanda ku mutekano, kwiringirwa, ibisabwa ku bidukikije, no guhanga udushya twagurishijwe cyane mu Bushinwa Bwiza cyane Cp Kallidinogenase (CAS: 9001-01-8), Mubisanzwe kubakoresha benshi mubucuruzi nabacuruzi gutanga ibicuruzwa byiza hamwe nisosiyete nziza.Murakaza neza cyane kwifatanya natwe, reka dushyire hamwe hamwe, kurota.
Igurishwa ryiza cyane mu Bushinwa Pharmaceutical Intermediate, Antibiotic, Dufite intego yo kuba ikigo kigezweho gifite intego yubucuruzi ya "Umurava nicyizere" kandi tugamije "Guha abakiriya serivisi zivuye ku mutima nibicuruzwa byiza".Turasaba tubikuye ku mutima inkunga yawe idahindutse kandi dushimira inama nziza nubuyobozi.

Mbere: Igurishwa-Ubushinwa Bwiza Bwiza Kallidinogenase (CAS: 9001-01-8)

Ibikurikira: Igurishwa-Ubushinwa Bwiza Bwiza Kallidinogenase (CAS: 9001-01-8)

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