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Hoahoa Huahua Hou mo Haina Kounga teitei Kallikrein CAS 9001-01-8 Pancreatic Kininogenase Kallikrein Paura


  • KAUPAPA NO.:9001-01-8
  • Waehere HS:3507.9090.90
  • Ratonga Kōnae:Hainamana-GMP, DMF
  • Paerewa Pharmacopoeia:JP/CP
  • Taipitopito Hua

    Tohu Hua

    Ka whakapau kaha matou ki te whakarato i o maatau kaihoko rongonui me nga hua me nga ratonga tino hihiri mo te Hoahoa Huahua Hou mo Haina Kounga Nui.KalikreinCAS 9001-01-8 Pancreatic KininogenaseKalikreinTe paura, E kore matou e mutu ki te whakapai ake i a matou tikanga me te kounga kia mau tonu ki nga ahuatanga whanaketanga o tenei umanga kia pai ai to pai.Mena kei te pirangi koe ki a maatau hua, tena koa whakapiri mai ki a maatau.
    Ka whakapau kaha matou ki te whakarato i o maatau kaihoko rongonui me nga hua me nga ratonga tino ngakau nui moHaina Kininogenase Kallikrein, Kalikrein, Ko ta maatau wheako he mea nui ki a maatau kaihoko.Ko ta maatau kounga e kii ana i nga taonga penei i te kore e kuru, ka whakaheke, ka pakaru ranei, na reira ka maia tonu o taatau kaihoko i te wa e ota ana.

    Taipitopito

    1. Nga Tohu: Te paura ma, tata ma ranei, kaore he kakara.

    2. Puna Tangohanga: Porcine pancreas.

    3. Tukatuka: Ka tangohia mai te Kallidinogenase mai i te pancreas poaka hauora.

    4. Nga tohu me nga whakamahinga: Ka taea te whakamahi i tenei hua mo nga momo mate pukupuku me te cerebovascular, penei i te mate ngakau coronary, arteriosclerosis cerebral, thrombosis cerebral, raruraru tuku toto retinal me te mate vascular peripheral.He pai ake te rongoa ki nga rangahau tata nei mo te aukati i te microangiopathy mate huka moata me te nephropathy mate huka, ka taea te whakaheke i te whakaputanga albumin.Ko nga raraunga haumanu i te kainga me nga whenua o waho e kii ana ka taea e ia te whakanui ake i te mahi parāoa me te nui o te whakaputanga, me te whai hua whakaora i roto i te maimoatanga o etahi taangata tane.

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    He aha tatou?

    ·I hangaia i roto i te awheawhe GMP

    · 27 nga tau o te hitori R&D o te enzyme koiora

    · Ka kitea nga rauemi mata

    · Kia rite ki nga paerewa a nga kaihoko

    · 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.

    Whakatakotoranga

    Nga Tuemi Whakamatau

    Whakatakotoranga Kamupene

    CP

    JP

    Ngā Pūāhua

    Te paura ma, tata ma ranei, kaore he kakara

    He ma ki te paura parauri paku, he hongi, he ngoikore ranei

    Tautuhinga

    R (tere waiwai): 0.12~0.17

    R (tere waiwai): 0.12~0.16

    Waiwai Chromatography: He rite

    Ahau : ≤ 0.2

    Nga whakamatautau

    pH

    5.5~7.5(300wae/ml)

    5.5~7.5(1g/300ml)

    Te marama o te otinga

    Maamaa(2mg/ml)

    ————

    Ngako

    ≤ 5.0mg/g

    ≤ 1.0mg/g

    Kininase

    ————

    R Uara: ≥ 0.8

    He matū rite trypsin

    ————

    Uara T:≤ 0.05

    Protease

    A280≤ 0.2

    A280≤ 0.2

    Ngaronga i te whakamaroke

    ≤ 5.0% (60 ℃ maroke i te korehau, 4h)

    ≤ 2.0% (60 ℃ maroke i te korehau, 4h)

    Te toenga i runga i te mura

    ≤ 3.0%

    ≤ 3.0%

    He mahi tuku-kini

    ————

    ≥ 500ng bradykinin rite / min / wae ia wae

    Maamaa

    ≥ 75% (mo te waha)

    ————

    ≥ 90% (mo te werohanga)

    Endotoxin huakita

    ≤ 2.5 EU/wae (mo te werohanga)

    ————

    Te whakamatautau

    Te ngohe ngohe

    ————

    ≥ 25 wae/mg

    Mahi motuhake

    ≥ 300 wae/mg pūmua (mo te waha)

    ≥ 100 wae/mg pūmua

    ≥ 600 wae/mg pūmua (mo te werohanga)

    Nga poke moroiti

    TAMC

    ≤ 1000cfu/g (mo te waha)

    ≤ 1000cfu/g

    ≤ 100cfu/g (mo te werohanga)

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Ka rite

    Ka rite

    Haramona

    Ka rite

    Ka rite

    Ka whakapau kaha matou ki te whakarato i o maatau kaihoko rongonui me nga hua me nga ratonga tino hihiri mo te Hoahoa Huahua Hou mo Haina Kounga Kairangi Kallikrein CAS 9001-01-8 Pancreatic Kininogenase Kallikrein Paura, Kaore matou e mutu ki te whakapai ake i o maatau tikanga me te kounga hei pupuri. ki runga ki te ia whanaketanga o tenei ahumahi me te whakatutuki pai koutou pai.Mena kei te pirangi koe ki a maatau hua, tena koa whakapiri mai ki a maatau.
    Hoahoa Huahua Hou moHaina Kininogenase Kallikrein, Kallikrein, Ko ta maatau wheako he mea nui ki a maatau kaihoko.Ko ta maatau kounga e kii ana i nga taonga penei i te kore e kuru, ka whakaheke, ka pakaru ranei, na reira ka maia tonu o taatau kaihoko i te wa e ota ana.


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