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Ethengiswa Kakhulu E-China Yekhwalithi Ephezulu ye-Kallidinogenase (CAS: 9001-01-8)


  • INOMBOLO YECAS.9001-01-8
  • IKHODI YE-HS:3507.9090.90
  • Isevisi Yefayela:I-Chinese-GMP, i-DMF
  • I-Pharmacopoeia ejwayelekile:I-JP/CP
  • Imininingwane Yomkhiqizo

    Omaka bomkhiqizo

    Lokho kunesimo sengqondo esiqondile nesinenqubekelaphambili ekuthatheni kwamakhasimende, ibhizinisi lethu lihlala lithuthukisa okuthengiswayo kwethu izinga eliphezulu ukuze lihlangabezane nezidingo zamakhasimende futhi ligxile kakhulu ekuphepheni, ekuthembekeni, ezidingweni zemvelo, nasekusungulweni okusha Kwekhwalithi Ephezulu Ethengiswa Kakhulu yase-China.I-Kallidinogenase(CAS: 9001-01-8), Imvamisa kubasebenzisi abaningi bebhizinisi nabathengisi ukunikeza izimpahla zekhwalithi ehamba phambili nenkampani enhle kakhulu.Siyakwamukela ngokufudumele ukuhlanganyela nathi, masisungule ngokuhlanganyela, ephusheni elindizayo.
    Lokho kunesimo sengqondo esihle nesinenqubekela phambili ekuthatheni kwamakhasimende, ibhizinisi lethu lihlala lithuthukisa okuthengiswayo kwethu izinga eliphezulu ukuze lihlangabezane nezidingo zamakhasimende futhi ligxile kakhulu ekuphepheni, ekuthembekeni, ezidingweni zemvelo, nasekusunguleni izinto ezintsha.I-Kallidinogenase, Sihlose ukuba ibhizinisi lesimanje elinomqondo omuhle wezohwebo “wobuqotho nokuzethemba” futhi ngenhloso “Yokunikeza amakhasimende amasevisi aqotho kakhulu nemikhiqizo yekhwalithi engcono kakhulu”.Sikucela ngobuqotho ukwesekwa kwakho okungaguquki futhi sibonga izeluleko nesiqondiso sakho esinomusa.

    Imininingwane

    1. Izinhlamvu: Impushana emhlophe noma ecishe ibe mhlophe, engenaphunga.

    2. Ukukhipha Umthombo: Amanyikwe engulube.

    3. Inqubo:I-Kallidinogenaseikhishwa kumanyikwe engulube enempilo.

    4. Izinkomba kanye nokusetshenziswa:Lo mkhiqizo ungasetshenziselwa izifo ezihlukahlukene zenhliziyo nemithambo yegazi, njengesifo senhliziyo, i-cerebral arteriosclerosis, i-cerebral thrombosis, ukuphazamiseka kokunikezwa kwegazi kwe-retinal kanye nesifo se-vascular peripheral.Ukuba nomthelela ongcono wokwelapha ocwaningweni lwakamuva lokuvikela i-microangiopathy yesifo sikashukela kanye ne-nephropathy yesifo sikashukela, kunganciphisa ukukhishwa kwe-albumin.Idatha yomtholampilo ekhaya naphesheya iphakamisa ukuthi ingakhuphula ukusebenza kwesidoda kanye nenani lokukhiqiza, futhi inomphumela othile wokwelapha ekwelapheni ubunyumba bowesilisa.

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    Kungani sisi?

    ·Kwenziwe ku-workshop ye-GMP

    ·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D

    ·Izinto ezingavuthiwe ziyalandeleka

    ·Thobela izinga lamakhasimende

    ·Thumela emazweni nasezifundeni ezingaphezu kuka-30

    ·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.

    Ukucaciswa

    Izinto Zokuhlola

    Ukucaciswa Kwenkampani

    CP

    JP

    Izinhlamvu

    Impushana emhlophe noma ecishe ibe mhlophe, engenaphunga

    Impushana emhlophe kuya kokuncane, ayinaphunga noma iqulekile

    Ukuhlonza

    R (isilinganiso se-hydrolysis): 0.12–0.17

    R (isilinganiso se-hydrolysis): 0.12–0.16

    I-Liquid Chromatography: Iyavumelana

    Mina : ≤ 0.2

    Izivivinyo

    pH

    5.5-7.5 (300unit/ml)

    5.5–7.5(1g/300ml)

    Ukucaca kwesixazululo

    Sula (2mg/ml)

    ————

    Amafutha

    ≤ 5.0mg/g

    ≤ 1.0mg/g

    Kininase

    ————

    R Inani:≥ 0.8

    Into efana ne-trypsin

    ————

    T Inani:≤ 0.05

    I-Protease

    A280≤ 0.2

    A280≤ 0.2

    Ukulahlekelwa ekomisweni

    ≤ 5.0% (60℃ Yomisa ku-Vacuum, 4h)

    ≤ 2.0% (60℃ Yomisa ku-Vacuum, 4h)

    Izinsalela ekushiseni

    ≤ 3.0%

    ≤ 3.0%

    Umsebenzi wokukhipha i-Kinin

    ————

    ≥ 500ng bradykinin okulingana/umzuzu/iyunithi ngeyunithi ngayinye

    Ubumsulwa

    ≥ 75% (okomlomo)

    ————

    ≥ 90% (umjovo)

    I-endotoxin yebhaktheriya

    ≤ 2.5 EU/iyunithi (yomjovo)

    ————

    Isivivinyo

    Umsebenzi wama-enzyme

    ————

    ≥ 25 iyunithi/mg

    Umsebenzi othize

    ≥ 300 iyunithi/mg amaprotheni (omlomo)

    ≥ 100 iyunithi/mg amaprotheni

    ≥ 600 unit/mg protein (yomjovo)

    Ukungcola Kwe-Microbial

    I-TAMC

    ≤ 1000cfu/g (okomlomo)

    ≤ 1000cfu/g

    ≤ 100cfu/g (yomjovo)

    I-TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Kuyavumelana

    Kuyavumelana

    I-Salmonella

    Kuyavumelana

    Kuyavumelana

    Lokho kunesimo sengqondo esihle nesinenqubekelaphambili ekuthatheni kwamakhasimende, ibhizinisi lethu lihlala lithuthukisa okuthengiswayo kwethu izinga eliphezulu ukuze lihlangabezane nezidingo zamakhasimende futhi ligxile kakhulu ekuphepheni, ekuthembekeni, ezidingweni zemvelo, nasekusungulweni kwe-Cp Kallidinogenase Ethengiswa Kakhulu YaseChina (CAS: 9001-01-8), Imvamisa kubasebenzisi abaningi bebhizinisi nabathengisi ukunikeza izimpahla zekhwalithi ehamba phambili nenkampani enhle kakhulu.Siyakwamukela ngokufudumele ukuhlanganyela nathi, masisungule ngokuhlanganyela, ephusheni elindizayo.
    I-China Pharmaceutical Intermediate Ephakathi, Imithi Elwa Namagciwane Ethengiswa Kakhulu, Sihlose ukuba ibhizinisi lesimanje elinombono ongcono wezohwebo "wobuqotho nokuzethemba" futhi ngenhloso "yokunikeza amakhasimende izinsizakalo eziqotho kakhulu nemikhiqizo yekhwalithi engcono kakhulu".Sikucela ngobuqotho ukwesekwa kwakho okungaguquki futhi sibonga izeluleko nesiqondiso sakho esinomusa.


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