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Hinu Rongoā Sodium Stearyl Fumarate (SSF) | Hototahi API Teitei, He Rerekē ki te Magnesium Stearate, Tohu GMP

Ko tā mātou Sodium Stearyl Fumarate (SSF) he hinu whakahinuhinu rongoā parakore teitei i hangaia mō ngā papa me ngā kāpūru. He rerekē ki te konupora stearate, he pai te hototahi ki te API, he pakari ki te whakahinuhinu nui rawa, ā, kāore he pānga kino ki te waatea o te koiora.He hinu whakahinuhinu wai-whakaaro, he wairewa-haurua e whakarato ana i te pakeketanga o te papa i ngā kaha pēhitanga ōrite, ā, ka whakaiti i te pānga ki te wā pakaru.. E rite ana ki ngā rongoā USP-NF, EP, me JP me te rēhitatanga CDE (F20190000009) me te tautoko DMF (38822). Taumata whakamahinga e taunakitia ana: 0.5-3% w/wHe pai mō te pēhi tika tere-teitei, ngā papa pupuhi, me ngā whakatakotoranga me ngā API kore e hototahi

    Ko te Konutai Stearyl Fumarate (SSF) o te Tohu Rongoā

    Tirohanga Whānui o te Hua

    Ko te Sodium Stearyl Fumarate (SSF) he hinu whakahinuhinu rongoā mahi-teitei e mōhiotia whānuitia ana hei huarahi kē atu ki ngā hinu whakahinuhinu tuku iho pērā i te konupūmā stearate me te talc.He tote konutai o te waikawa stearyl fumaric, he paura ma ki te mā-parauri, he āhuatanga amphiphilic e āhei ai te whakahinuhinu rohe whai hua i roto i ngā whakatakotoranga papa me ngā kāpūru..

    Tuakiri Hua:

    • Ingoa Matū:Konutai Stearyl Fumarate

    • Tau CAS:4070-80-8

    • Tau Rēhita CDE:F20190000009

    • Nama DMF:38822

    • Te Whakatutukitanga o te Pharmacopoeia:USP-NF, EP, JP

    • Tātai ngota:C22H39NaO4

    • Taumaha ngota:390.53 karamu/mol

    Ngā Āhuatanga Matua me ngā Painga

    1. Hototahi API Pai Rawa

    • Ka whakatau i ngā raruraru hototahi e pā pinepine ana ki te konupora stearate

    • Ko ngā āhuatanga kore hototahi o te API ki te konupora stearate ko: Azathioprine, Cefaclor, Cilazapril, Clopidogrel, Diclofenac, Ibuprofen, Omeprazole, me te tini ke atu.

    • He pai mō ngā whakatakotoranga e āwangawanga ana mō te kore hototahitanga matū

    2. Pakari ki te Whakahinuhinu Nui

    • He rerekē ki te konupora stearate, ka mau tonu te mahi a te SSF ahakoa te roa o te wā whakaranu.

    • Ka whakarato i te pakeketanga o te papa me te pakaru tonu, me te kore he pānga "whakahinuhinu nui rawa".

    3. Ngā Āhuatanga Papa Whakarei Ake

    • Te mārō nuii ngā kaha pēhanga ōrite ki ērā atu hinu whakahinuhinu

    • He iti ake te pānga ki te wā pakaru– e pupuri ana i te tere o te pakaru o te papa

    • Kāore he pānga kino ki te bioavailability– kia mau tonu ngā kōtaha tukunga rongoā

    4. Te āhua wai-whakaaro me te āhua wairewa-haurua

    • Hinu whakahinuhinu wairewa-wai – 0.5 mg/100 mL i te 25°C, ka piki ake ki te 20 g/100 mL i te 90°C

    • He iti noa ngā toenga i roto i te wairewa, ā, he mea tino pai mōpapa pupuhi

    • Whakapai ake i ngā kōtaha whakarewa o ngā API kore e tino wairewa

    5. Ngā Āhuatanga Ā-tinana Pai Rawa

    • Horahanga Mata Motuhake:1.2 - 2.0 m²/g (te taumata paerewa)

    • pH:tata ki te 8.5 (10% wairewa i te 90°C)

    • Te Pūwāhi Rewa:224 – 245°C (heke)

    • Uara Whakapūhui:142.2 – 146.0

    • Te Ihirangi Makuku:

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