1. Nga Tohu: He ma, he paku kowhai ranei, he kirikiri, he paura amorphous ranei.
2. Pūtake Tangohanga: Porcine gastric mucosa.
3. Te Tukatuka: Ka wehea te Pepsin mai i te mucosa puku o te poaka ma te whakamahi i tetahi tikanga tangohanga ahurei.
4. Nga tohu me nga whakamahinga: Kei te whakamahia nuitia mo te dyspepsia na te nui o te tango i nga kai porotini, te ngoikore o te kunatu i roto i te waa whakaora me te kore o te pūmua o te puku na te gastritis atrophic mau tonu, te mate pukupuku puku me te anemia kino. i roto i te ara nakunaku o nga kararehe whakangote.Ka mahi ki te wawahi i nga pūmua ki roto i nga peptides iti ka taea e te kohanga iti.
5. Nga Mahi Biochem/physiol: Kaore i rite ki te maha atu o nga peptidases, ko te pepsin hydrolyzes anake nga here peptide, ehara i nga hononga amide, ester ranei.Kei roto i te motuhake o te wehenga he peptides me te waikawa kakara ki ia taha o te here peptide, ina koa he mea kakara, he waikawa amino dicarboxylic ranei te toenga.Ka piki ake te whakaraeraetanga ki te hauwai ka puta mena he waikawa amino whanariki kei roto e tata ana ki te here peptide, he waikawa amino kakara.Ko te Pepsin ano ka maataki ki te taha carboxyl o te phenylalanine me te leucine, me te iti ake ki te taha carboxyl o nga toenga waikawa glutamic.Kare e piri ki nga hononga o te valine, alanine, glycine ranei.Ka taea te whakamahi ZL-tyrosyl-L-phenylalanine, ZL-glutamyl-L-tyrosine, ZL-methionyl-L-tyrosine ranei hei taputapu mo te keri pepsin.Ko te Pepsin ka aukatihia e te maha o nga peptides kei roto i te phenylalanine.
· Kua paahitia te Hainamana GMP me te EU GMP
· 27 nga tau o te hitori R&D o te enzyme koiora
· Ka kitea nga rauemi mata
· Whakaritea ki te CP, EP, USP me te paerewa kiritaki
· Te mahi teitei, te parakore teitei, te pumau
· Kaweake ki runga i te 30 whenua me nga rohe
· He kaha ki te whakahaere punaha kounga penei i te US FDA, Japan PMDA, South Korea MFDS, etc.
Nga Tuemi Whakamatau | Whakatakotoranga Kamupene | |||
CP | EP | USP | ||
Ngā Pūāhua | He ma ki te paura kowhai marama; | He ma, he paku kowhai ranei, | He ma, he paku kowhai ranei, | |
kahore he koriri me te deodorant;hygroscopic, | paura tioata, paura amorphous ranei | paura tioata, paura amorphous ranei | ||
ka whakaatu te wairewa wai i te tauhohenga waikawa | ||||
Tautuhinga | Ka rite | Ka rite | Ka rite | |
Nga whakamatautau | Ngaronga i te whakamaroke | ≤ 5.0% (Taiao maroke100℃, 4h) | ≤ 5.0% (670Pa 60 ℃, 4h) | ≤ 5.0% (Ko te whakahekenga korehau 60 ℃, 4h) |
Te toenga whakarewa | ———— | ≤ 5.0%E ai ki te EP(5.4) | ≤ 5.0%E ai ki te USP(467) | |
Te whakamatautau | 3800~12000U/g | 0.5~4.5Ph.Eur.U./mg | 3000~20000NF.U/mg | |
moroiti | TAMC | ≤5X103cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
Nga poke | TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g |
E.coli | Ka rite | Ka rite | Ka rite | |
Haramona | Ka rite | Ka rite | Ka rite |