I-China Chymotrypsin yase-Deebio Yokwelapha Amanxeba E-Edema Yokuvuvukala efektri nabakhiqizi |I-Deebiotech

I-Cymotrypsin ye-Deebio Yokwelapha Amanxeba E-Edema Evuvukalayo Isithombe Esifakiwe

I-Cymotrypsin ye-Deebio yokwelapha amanxeba e-Edema evuthayo

I-CAS NO.:9004-07-3

IKHODI YE-HS :3507.9090.90

Isevisi Yefayela:I-DMF

I-Pharmacopoeia ejwayelekile:EP/USP

Thumela i-imeyili kithi isampula yamahhala

Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Imininingwane

1. Izinhlamvu: Impushana eyikristalu emhlophe noma ecishe ibe mhlophe, engenaphunga, ene-hygroscopic.

2. Ukukhipha Umthombo: Amanyikwe engulube.

3. Inqubo: I-Chymotrypsin ikhishwa kuma-pancreas engulube enempilo futhi iphinde ilungiswe ngenqubo ekhethekile.

4. Izinkomba kanye nokusetshenziswa: I-proteolytic enzyme.Ingakwazi ukukhuthaza ukukhishwa kwe-blood clots, ukukhishwa kwe-purulent kanye nezicubu ze-necrotic.Isetshenziselwa ukwelapha izilonda ze-edema evuthayo, ukunamathela okuvuvukala, i-hematoma, isilonda.I-Chymotrypsin evela ku-pancreas yezinkomo isetshenziswe ocwaningweni lokuphenya ukukhishwa kwamaprotheni ngamasistimu we-microemulsion we-Winsor-III.I-α-Chymotrypsin evela kumanyikwe wezinkomo nayo iye yasetshenziswa ocwaningweni ukuze kuphenywe uphenyo olusha olusekelwe ku-fulerene olusekelwe ku-fluorescent lwe-trypsin.

Kungani sisi?

Yenziwe ku-workshop ye-GMP

·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D

·Izinto ezingavuthiwe ziyalandeleka

·Thobela i-EP,USP nezinga lekhasimende

·Ukusebenza okuphezulu, ukuhlanzeka okuphezulu, ukuzinza okuphezulu

·Thumela emazweni nasezifundeni ezingaphezu kuka-30

·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.

Ukucaciswa

Izinto Zokuhlola		Ukucaciswa Kwenkampani
Izinto Zokuhlola		EP	USP
Izinhlamvu		Impushana yekristalu emhlophe noma ecishe ibe mhlophe, engenaphunga, i-hygroscopic	Impushana yokomisa emhlophe noma ecishe ibe mhlophe
Ukuhlonza		Kuyavumelana	Kuyavumelana
Izivivinyo	I-Histamine	≤ 1ug (umsebenzi we-Chymotrypsin/5mk)	————
	Ukucaca	Kuyavumelana	Kuyavumelana
	pH	3.0～5.0	————
	I-Absorbance	A₂₈₁:18.5～22.5,A₂₅₀≤8	————
	I-Trypsin	Kuyavumelana	≤ 1.0%
	Ukulahlekelwa ekomisweni	≤ 5.0%	≤ 5.0% (60℃ Ukuwohloka 4h)
	Izinsalela ekushiseni	————	≤ 2.5%
Umsebenzi		≥ 5.0mk/mg	≥ 1000USP.U/mg (into eyomile)
Ukungcola Kwe-Microbial	I-TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	I-TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Kuyavumelana	Kuyavumelana
	I-Salmonella	Kuyavumelana	Kuyavumelana
	I-Staphylococcus aureus	————	Kuyavumelana
	I-Pseudomonas aeruginosa	————	Kuyavumelana