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Umzi-mveliso owenziwe ngentengiso eshushu Ubonelelo ngeCAS 9001-01-8 Proteolytic Enzyme Kallidinogenase 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

    Sigxininisa kumgaqo wophuhliso 'womgangatho ophezulu ophezulu, ukuSebenza, ukunyaniseka kunye nendlela yokusebenza ephantsi' ukuze sikubonelele ngeenkonzo ezikhethekileyo zokusetyenzwa kweFactory eyenziwe ngentengiso eshushu Supply CAS 9001-01-8 Proteolytic Enzyme Kallidinogenase Kallikrein Umgubo, ukhuthazwa yimarike yangoku evelisa ngokukhawuleza ekutyeni okukhawulezileyo kunye nesiselo esisetyenziswa kwihlabathi liphela, Sizingela ukusebenza kunye namaqabane/abaxumi ukwenza iziphumo ezilungileyo kunye.
    Sigxininisa kumgaqo wophuhliso 'womgangatho ophezulu ophezulu, ukuSebenza, ukunyaniseka kunye nendlela yokusebenza ephantsi' ukuze sikubonelele ngeenkonzo ezikhethekileyo zokusetyenzwa.China Kallidinogenase, Ngenkxaso yetekhnoloji engcono kakhulu, ngoku siye salungisa iwebhusayithi yethu ukuze sifumane amava angcono omsebenzisi kwaye sigcine engqondweni ukukhululeka kwakho kokuthenga.siqinisekisa ukuba okona kulungileyo kufikelela kuwe emnyango wakho, ngexeshana elifutshane kwaye ngoncedo lwamaqabane ethu asebenzayo okusebenza oko kukuthi i-DHL kunye ne-UPS.Sithembisa umgangatho, siphila ngokwesaci sokuthembisa kuphela oko sinokukuphumeza.

    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

    Sigxininisa kumgaqo wophuhliso 'womgangatho ophezulu ophezulu, ukuSebenza, ukunyaniseka kunye nendlela yokusebenza ephantsi' ukuze sikubonelele ngeenkonzo ezikhethekileyo zokusetyenzwa kweFactory eyenziwe ngentengiso eshushu Supply CAS 9001-01-8 Proteolytic Enzyme Kallidinogenase Kallikrein Umgubo, ukhuthazwa yimarike yangoku evelisa ngokukhawuleza ekutyeni okukhawulezileyo kunye nesiselo esisetyenziswa kwihlabathi liphela, Sizingela ukusebenza kunye namaqabane/abaxumi ukwenza iziphumo ezilungileyo kunye.
    Umzi-mveliso wenza intengiso eshushuChina Kallidinogenasekunye neProteolytic Enzyme Kallidinogenase, Ngeyona nkxaso ibalaseleyo yetekhnoloji, ngoku siye salungisa iwebhusayithi yethu ukuze sifumane amava angcono omsebenzisi kwaye sikugcine engqondweni ukukhululeka kwakho ekuthengeni.siqinisekisa ukuba okona kulungileyo kufikelela kuwe emnyango wakho, ngelona xesha lifutshane kunokwenzeka nangoncedo lwamaqabane ethu asebenzayo.Sithembisa umgangatho.


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