1. Characters: Caddaan ama wax yar huruud ah, crystalline ama budo amorphous ah.
2. Isha Soosaarka: Xuubabka caloosha ee Porcine.
3. Geedi socodka: Pepsin waa laga go'doomiyay xuubka caloosha ee doofaarka iyadoo la adeegsanayo farsamo soosaar gaar ah.
4. Tilmaamaha iyo isticmaalka: Waxaa si weyn loogu isticmaalaa dyspepsia ee ka yimaada qaadashada badan ee cuntooyinka borotiinka, dheefshiidka hypofunction ee xilliga soo kabashada iyo la'aanta borotiinka caloosha oo ay keento gastritis-ka atrophic ee joogtada ah, kansarka caloosha iyo dhiig-yarida.Pepsin waa enzim oo la soo saaro habka dheefshiidka ee naasleyda.Waxay ka shaqeysaa inay borotiinada u kala jajabiso peptides yaryar oo si sahal ah u nuugo mindhicirka yar.
5. Waxqabadyada Biochem/physiol: Si ka duwan peptidases kale oo badan, pepsin hydrolyzes kaliya peptide bonds, ma aha amide ama ester linkages.Kala-soocida gaarka ah waxaa ka mid ah peptides leh aashitada udgoonka ee labada dhinac ee bond peptide, gaar ahaan haddii haraaga kale uu sidoo kale yahay caraf udgoon ama amino acid dicarboxylic ah.Korodhka u nuglaanta hydrolysis waxay dhacdaa haddii ay jirto amino acid ka kooban sulfur oo ku dhow curaarta peptide, kaas oo leh amino acid udgoon.Pepsin waxa kale oo uu doorbidayaa in uu ku xidho dhinaca carboxyl ee phenylalanine iyo leucine, iyo ilaa xad ka yar dhinaca karboksyl ee hadhaaga glutamic acid.Kuma xirna xiriirka valine, alanine, ama glycine.ZL-tyrosyl-L-phenylalanine, ZL-glutamyl-L-tyrosine, ama ZL-methionyl-L-tyrosine waxaa loo isticmaali karaa substrates dheefshiidka pepsin.Pepsin waxaa xannibay dhowr peptides oo ka kooban phenylalanine.
Wuxuu gudbay GMP-ga Shiinaha iyo EU GMP
· 27 sano oo enzyme noole R&D taariikhda
Walxaha ceeriin waa la raadin karaa
U hoggaansamaan CP, EP, USP iyo heerka macaamiisha
· Dhaqdhaqaaq sare, nadiif sare, xasilooni sare
Dhoofinta in ka badan 30 waddan iyo gobollo
Inuu leeyahay awoodda maaraynta nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.
Walxaha Tijaabada | Tilmaamaha Shirkadda | |||
CP | EP | USP | ||
Jilayaasha | Caddaan ilaa budo huruud ah; | Cadaan ama huruud yar, | Cadaan ama huruud yar, | |
ma laha caariyaysi iyo carfiye;hygroscopic, | crystalline ama budada amorphous | crystalline ama budada amorphous | ||
Xalka aqueous wuxuu muujinayaa falcelinta acidic | ||||
Aqoonsiga | waafaqsan | waafaqsan | waafaqsan | |
Tijaabooyin | Luminta qalajinta | ≤ 5.0% (deegaan qallalan100℃, 4saac) | ≤ 5.0% (670Pa 60℃, 4h) | ≤ 5.0% (Vacuum decompression 60℃, 4h) |
Walxaha haraaga ah | ———— | ≤ 5.0% Sida ku cad EP(5.4) | ≤ 5.0% Marka loo eego USP(467) | |
Qiimayn | 3800 ~ 12000U/g | 0.5~4.5Ph.Eur.U./mg | 3000 ~ 20000NF.U/mg | |
Microbial | TAMC | ≤5X103cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
wasakhda | TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g |
E.coli | waafaqsan | waafaqsan | waafaqsan | |
Salmonella | waafaqsan | waafaqsan | waafaqsan |