• Iimveliso
iphepha

Iimveliso

I-Pepsin ye-Deebio yokuNyanga i-Dyspepsia ebangelwa kukuThatha ukutya okuFanelekileyo


  • INOMBOLO YECAS.9001-75-6
  • IKHOWUDI ye-HS:3507.9090.90
  • Inkonzo Yefayile:IsiTshayina-GMP, EU-GMP, iDMF, EU-DMF
  • Pharmacopoeia umgangatho:EP/USP/CP
  • Iinkcukacha zeMveliso

    Iithegi zeMveliso

    Iinkcukacha

    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.

    Kutheni sisi?

    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.

    Inkcazo

    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

    0.54.5Ph.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


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