I-China Chymotrypsin ye-Deebio yokuNyanga amanxeba oMzi mveliso we-Edema yokukrala kunye nabavelisi |I-Deebiotech

I-Chymotrypsin ye-Deebio yokuNyanga amanxeba e-Edema yokuvuvukala

INOMBOLO YECAS.:9004-07-3

HS IKHOWUDI :3507.9090.90

Inkonzo Yefayile:I-DMF

Pharmacopoeia umgangatho:EP/USP

Thumela i-imeyile kuthi isampuli yasimahla

Iinkcukacha zeMveliso

Iithegi zeMveliso

Iinkcukacha

1. Abalinganiswa: Umgubo wekristale omhlophe okanye ophantse ube mhlophe, ongenavumba, onehygroscopic.

2. Ukukhutshwa Umthombo: Ipancreas yehagu.

3. Inkqubo: I-Chymotrypsin ikhutshwe kwi-pancreas ye-porcine enempilo kwaye ilungiselelwe ngakumbi yinkqubo ekhethekileyo.

4. Izibonakaliso kunye nokusetyenziswa: I-proteolytic enzyme.Inokukhuthaza i-liquefaction ye-blood clots, i-purulent secretions kunye nezicubu ze-necrotic.Isetyenziselwa ukunyanga amanxeba e-edema evuthayo, i-adhesion evuthayo, i-hematoma, isilonda.I-Chymotrypsin evela kwi-pancreas ye-bovine isetyenziswe kwisifundo sokuphanda i-protein extraction yi-Winsor-III microemulsion systems.I-α-Chymotrypsin esuka kudaka lwenkomo nayo iye yasetyenziswa kuphononongo lokuphanda nge-trypsin entsha esekwe kwi-fluorescent probe entsha.

Kutheni sisi?

·Iveliswe kwiworkshop yeGMP

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

·Imathiriyeli ekrwada iyalandeleka

·Thobela iEP,USP kunye nomgangatho wabathengi

·Umsebenzi ophezulu, ubunyulu obuphezulu, uzinzo oluphezulu

·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		EP	USP
Abalinganiswa		Imhlophe okanye iphantse imhlophe ikristale powder, engenavumba, ihygroscopic	Umgubo omhlophe okanye ophantse ube mhlophe owomisa umkhenkce
Ukuchongwa		Iyahambelana	Iyahambelana
Iimvavanyo	Histamine	≤ 1ug (umsebenzi weChymotrypsin/5mk)	————
	Ukucaca	Iyahambelana	Iyahambelana
	pH	3.0～5.0	————
	Ukungabikho	A₂₈₁:18.5～22.5,A₂₅₀≤ 8	————
	I-Trypsin	Iyahambelana	≤ 1.0%
	Ilahleko ekomisweni	≤ 5.0%	≤ 5.0% (60℃ Uxinzelelo 4h)
	Intsalela ekutshisweni	————	≤ 2.5%
Umsebenzi		≥ 5.0mk/mg	≥ 1000USP.U/mg (into eyomileyo)
Ukungcola kweMicrobial	TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	I-TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Iyahambelana	Iyahambelana
	Salmonella	Iyahambelana	Iyahambelana
	Staphylococcus aureus	————	Iyahambelana
	Pseudomonas aeruginosa	————	Iyahambelana