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Uyilo olutsha lweFashoni yaseTshayina ekumgangatho oPhezulu weKallikrein CAS 9001-01-8 Pancreatic Kininogenase Kallikrein Powder


  • INOMBOLO YECAS.9001-01-8
  • IKHOWUDI ye-HS:3507.9090.90
  • Inkonzo Yefayile:IsiTshayina-GMP, iDMF
  • Pharmacopoeia umgangatho:JP/CP
  • Iinkcukacha zeMveliso

    Iithegi zeMveliso

    Siza kuzinikela ekuboneleleni abathengi bethu ababekekileyo kunye nezona mveliso zinomdla kunye neenkonzo zoYilo lweFashoni eNtsha yoMgangatho oPhezulu waseTshayina.KallikreinI-CAS 9001-01-8 I-Pancreatic Kininogenase Kallikrein Powder, Asize siyeke ukuphucula ubuchule bethu kunye nomgangatho ukuze siqhubeke nophuhliso lweshishini kwaye sihlangabezane nokwaneliseka kwakho kakuhle.Ukuba unomdla kwiimveliso zethu, nceda uqhagamshelane nathi ngokukhululekileyo.
    Siza kuzinikela ekuboneleleni abathengi bethu ababekekileyo kunye nezona mveliso zinomdla kunye neenkonzoChina Kininogenase Kallikrein, Kallikrein, Amava ethu asenza sibaluleke emehlweni ethu abathengi.Umgangatho wethu uyazithetha ngokwawo kwiipropathi ezinje ukuba awujiki, uphalaze okanye uwohloke, ukuze abathengi bethu bahlale bezithembile ngelixa bebeka iodolo.

    Iinkcukacha

    1. Abalinganiswa: Umgubo omhlophe okanye phantse omhlophe, ongenavumba.

    2. Ukukhutshwa Umthombo: Ipancreas yehagu.

    3. Inkqubo: I-Kallidinogenase ikhutshwe kwi-pancreas ye-porcine enempilo.

    4. Izibonakaliso kunye nokusetyenziswa: Le mveliso ingasetyenziselwa iintlobo ezahlukeneyo ze-cardiovascular and cerebovascular disease, njenge-coronary heart disease, i-cerebral arteriosclerosis, i-cerebral thrombosis, ukuphazamiseka kwegazi kwi-retinal kunye ne-peripheral vascular disease.Yiba nefuthe elingcono lonyango kuphando lwamva nje lothintelo lwesifo seswekile se-microangiopathy kunye nesifo seswekile, kunokunciphisa ukukhutshelwa kwe-albumin.Idatha yeklinikhi ekhaya nakwamanye amazwe icebisa ukuba inokunyusa umsebenzi wamadlozi kunye nobuninzi bemveliso, kwaye inesiphumo esithile sonyango kunyango lobudlolo obuthile.

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    Kutheni sisi?

    ·Iveliswe kwiworkshop yeGMP

    · Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D

    ·Imathiriyeli ekrwada iyalandeleka

    ·Thobela umgangatho wabathengi

    ·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

    JP

    Abalinganiswa

    Umgubo omhlophe okanye ophantse ube mhlophe, ongenavumba

    Imhlophe ukuya kumgubo omdaka kancinane, ongenavumba okanye otyhafileyo

    Ukuchongwa

    R (izinga le-hydrolysis): 0.12~0.17

    R (izinga le-hydrolysis): 0.12~0.16

    Ulwelo lweChromatography: Iyahambelana

    Mna : ≤ 0.2

    Iimvavanyo

    pH

    5.5-7.5(300unit/ml)

    5.5-7.5(1g/300ml)

    Ukucaca kwesisombululo

    Sula (2mg/ml)

    ————

    Amafutha

    ≤ 5.0mg/g

    ≤ 1.0mg/g

    Kininase

    ————

    Ixabiso R:≥ 0.8

    Into efana ne-trypsin

    ————

    Ixabiso T:≤ 0.05

    Iprotease

    A280≤ 0.2

    A280≤ 0.2

    Ilahleko ekomisweni

    ≤ 5.0% (60℃ Yomile kwiVacuum, 4h)

    ≤ 2.0% (60℃ Yomile kwiVacuum, 4h)

    Intsalela ekutshisweni

    ≤ 3.0%

    ≤ 3.0%

    Umsebenzi wokukhutshwa kweKinin

    ————

    ≥ I-500ng ye-bradykinin elinganayo / min / iyunithi nganye

    Ubunyulu

    ≥ 75% (yomlomo)

    ————

    ≥ 90% (yenaliti)

    I-endotoxin yebhaktheriya

    ≤ 2.5 EU/iyunithi (yenaliti)

    ————

    Isivavanyi

    Umsebenzi we-enzyme

    ————

    ≥ 25 iyunithi / mg

    Umsebenzi othile

    ≥ 300 unit/mg protein (yomlomo)

    ≥ I-100 iyunithi / iprotheni ye-mg

    ≥ 600 iyunithi/mg protein (yenaliti)

    Ukungcola kweMicrobial

    TAMC

    ≤ 1000cfu/g (yomlomo)

    ≤ 1000cfu/g

    ≤ 100cfu/g (yenaliti)

    I-TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Iyahambelana

    Iyahambelana

    Salmonella

    Iyahambelana

    Iyahambelana

    Siza kuzinikela ekuboneleleni abathengi bethu abahlonitshwayo kunye nezona mveliso zicinga ngentshiseko kunye neenkonzo zoYilo lweFashoni eNtsha yaseTshayina ekumgangatho oPhezulu weKallikrein CAS 9001-01-8 Pancreatic Kininogenase Kallikrein Powder, Asisoze siyeke ukuphucula ubuchule bethu kunye nomgangatho wokugcina. phezulu kunye nentsingiselo yophuhliso lweli shishini kwaye uhlangabezane nokwaneliseka kwakho kakuhle.Ukuba unomdla kwiimveliso zethu, nceda uqhagamshelane nathi ngokukhululekileyo.
    Uyilo olutsha lweFashoniChina Kininogenase Kallikrein, Kallikrein, Amava ethu asenza sibaluleke emehlweni ethu abathengi.Umgangatho wethu uyazithetha ngokwawo kwiipropathi ezinje ukuba awujiki, uphalaze okanye uwohloke, ukuze abathengi bethu bahlale bezithembile ngelixa bebeka iodolo.


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