1. Abalinganiswa: Imhlophe okanye ityheli kancinane, ikristale okanye umgubo weamorphous.
2. Ukukhutshwa Umthombo: Porcine gastric mucosa.
3. Inkqubo: I-Pepsin ibekwe yodwa kwi-gastric mucosa yehagu isebenzisa indlela ekhethekileyo yokukhupha.
4. Izibonakaliso kunye nokusetyenziswa: Isetyenziswa ngokubanzi kwi-dyspepsia ebangelwa ngokuthatha ukutya okuneprotheyini, i-hypofunction yokugaya ngexesha lokubuyisela kunye nokungabikho kwe-proteinase yesisu ebangelwa yi-atrophic gastritis engapheliyo, umhlaza wesisu kunye ne-anemia eyingozi.I-Pepsin yi-enzyme efihliweyo. kwindlela yokwetyisa yezilwanyana ezanyisayo.Isebenza ukwaphula iiproteni zibe ziipeptide ezincinci ezinokufunxwa lula ngamathumbu amancinci.
5. Izenzo ze-Biochem / physiol: Ngokungafani nezinye iipeptidases ezininzi, i-pepsin hydrolyzes kuphela iibhondi ze-peptide, kungekhona i-amide okanye i-ester linkages.Ukucaciswa kokuqhekeka kubandakanya iipeptides ezineasidi enevumba elimnandi macala omabini ebhondi yepeptide, ngakumbi ukuba enye intsalela ikwayinto enuka kamnandi okanye idicarboxylic amino acid.Ukwanda kokuchaphazeleka kwi-hydrolysis kwenzeka ukuba kukho i-amino acid enesulfure ekufutshane nebhondi yepeptide, ene-amino acid enuka kamnandi.IPepsin iyakucanda ngokukhethekayo kwicala le-carboxyl le-phenylalanine kunye ne-leucine, kwaye kancinci kwicala le-carboxyl leentsalela ze-glutamic acid.Ayiqhekezanga kwi-valine, i-alanine, okanye i-glycine linkages.I-ZL-tyrosyl-L-phenylalanine, i-ZL-glutamyl-L-tyrosine, okanye i-ZL-methionyl-L-tyrosine ingasetyenziselwa njenge-substrates ye-pepsin digestion.I-Pepsin ivinjelwa ngeepeptide ezininzi ezine-phenylalanine.
Upase iGMP yaseTshayina kunye ne-EU GMP
· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D
·Imathiriyeli ekrwada iyalandeleka
·Thobela i-CP,EP,USP kunye nomgangatho womthengi
·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.
Izinto zovavanyo | Inkcazo yeNkampani | |||
CP | EP | USP | ||
Abalinganiswa | Umgubo omhlophe ukuya kumthubi okhanyayo; | Mhlophe okanye tyheli kancinci, | Mhlophe okanye tyheli kancinci, | |
akukho kungunda kunye nedeodorant;ihygroscopic, | ikristale okanye i-amorphous powder | ikristale okanye i-amorphous powder | ||
isisombululo esinamanzi sibonisa ukusabela okumuncu | ||||
Ukuchongwa | Iyahambelana | Iyahambelana | Iyahambelana | |
Iimvavanyo | Ilahleko ekomisweni | ≤ 5.0% (Imekobume eyomileyo100℃, 4h) | ≤ 5.0% (670Pa 60℃, 4h) | ≤ 5.0% (Ivacuum decompression 60℃, 4h) |
Isinyibilikisi esishiyekileyo | ———— | ≤ 5.0%Ngokungqinelana ne-EP(5.4) | ≤ 5.0%Ngokungqinelana ne-USP(467) | |
Isivavanyi | 3800~12000U/g | 0.5~4.5Ph.Eur.U./mg | 3000 ~ 20000NF.U/mg | |
Intsholongwane | TAMC | ≤5X103cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
Ukungcola | I-TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g |
E.coli | Iyahambelana | Iyahambelana | Iyahambelana | |
Salmonella | Iyahambelana | Iyahambelana | Iyahambelana |