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Ibanga Lemithi le-Medium-Chain Triglycerides (MCT) | I-Lipophilic Solvent kanye ne-Drug Carrier yomlomo/ye-Topical/ejovwayo | USP/EP/ChP

I-Medium-Chain Triglycerides (MCT) yethu iyisithako semithi esihlanzekile kakhulu esakhiwe yi-triglycerides yama-acid anamafutha e-caprylic (C8) agcwele (C8) kanye ne-capric (C10), atholakala kumafutha kakhukhunathi kanye ne-palm kernel.Kubonakala sengathi iwuketshezi olunamafutha olucacile, olungenambala kuya koluphuzi kancane, olune-viscosity ephansi, olunephunga elingathathi hlangothi kanye nokunambithekaI-MCT isebenza njengesithako esihle kakhulu semithi ebulala ama-lipophilic, isithwali semithi sokuthuthukisa ukutholakala kwe-bioavailability, isiqeda ukuvuvukala kwezakhi zokwenziwa, kanye nesithuthukisi sokugeleza kokufakwa kwesikhumba.Inikeza ukuzinza okuphezulu kwe-oxidative, ukumuncwa okusheshayo (ukugeleza kwe-portal ngqo ngaphandle kosawoti we-bile), kanye nokuhambisana okuhle kakhulu nama-API nezinye izinto ezisizayo. Ivumelana ne-USP-NF, EP, JP, kanye ne-ChP pharmacopoeias nge-CDE registration F20220000316. Ifanelekela izixazululo/ama-capsule omlomo, ukhilimu/amafutha asetshenziswayo, ukudla okunomsoco okuphathelene nokuzala, kanye nezinhlelo zokulethwa kwemithi ezizixubayo (i-SEDDS).

    Ama-Triglycerides e-Pharmaceutical Grade Medium-Chain (MCT)

    Ukubuka Konke Komkhiqizo

    I-Medium-Chain Triglycerides (MCT) iyisithako esisekelwe kahle semithi esiqukethe ingxube yama-triglycerides ama-fatty acid agcwele, ikakhulukazi i-caprylic acid (C8H16O2, i-octanoic acid) kanye ne-capric acid (C10H20O2, i-decanoic acid)Lawa ma-triglyceride atholakala ku-oyili oqinile okhishwe engxenyeni eqinile, eyomile ye-endosperm yekakhukhunathi (iCocos nucifera L.) noma ku-endosperm eyomile ye-oil palm (i-Elaeis guineensis Jacq.)Ama-fatty acid ahlukaniswa namafutha bese ephinda ahlanganiswe ne-glycerol ukuze kukhiqizwe umkhiqizo wokugcina..

    Ubunikazi Bomkhiqizo:

    • Igama Lekhemikhali:Ama-Triglyceride Aphakathi Nesikhathi Esimaphakathi / I-Caprylic/I-Capric Triglyceride

    • Inombolo ye-CAS:73398-61-5 (futhi 85409-09-2 noma 538-24-9)

    • Inombolo Yokubhalisa ye-CDE:F20220000316

    • Ukuthobela Imithetho Ye-Pharmacopoeia:I-ChP (CP2020), i-USP-NF (ama-Triglycerides e-Medium-Chain), i-EP (ama-Triglycerides, i-Medium-Chain), i-JP (ama-triglyceride e-fatty acid e-medium chain)

    • Amagama afanayo:Uwoyela we-MCT, i-Caprylic/Capric Triglyceride, i-Glycerides i-decanoyl exubile ne-octanoyl, i-Miglyol® 812 elinganayo, i-Labrafac™ CC elinganayo

    • Ukubukeka:Uketshezi olunamafutha olungenambala kuya koluphuzi kancane, cishe alunaphunga futhi alunambitheki

    • Indawo Yokuqandisa:Cishe u-0°C

    Izici Eziyinhloko Nezinzuzo

    1. Izici Ze-Solvent Eziphakeme

    • Isinyibilikisi esihle kakhulu semithi ye-lipophilic kanye nama-API angancibiliki emanzini kahle

    • Kuthuthukisa ukuncibilika kanye nokuzinza kwama-lipophilic compounds

    • Kuthuthukisa ukutholakala kwemithi yeSigaba II kanye neSigaba IV (ukuhlukaniswa kwe-BCS)

    2. Ukumuncwa Okusheshayo kanye Nokusetshenziswa Kwemetabolism

    • Imuncwa ngqo ekujikelezeni kwegazi kwe-portal ngaphandle kwesidingo sama-bile salts noma ama-enzyme e-pancreatic

    • Kusheshiswa ukugaywa ukuze kunikezwe amandla ngokushesha

    • Ukulethwa okusheshayo kwe-API ekujikelezeni kwesistimu, okungenzeka kuthuthukise ukuqala kokusebenza

    3. Iphrofayili Yokuzinza Ehle Kakhulu

    • Ukumelana okuphezulu ne-oxidation (inani le-iodine ≤1.0)

    • Ukuthambekela okuphansi kokucindezeleka kokushisa nokungcoliswa kwe-oxidative

    • Igcina ukuzinza kanye nokuphila isikhathi eside kwemithi esetshenziswayo

    • Izinzile emazingeni okushisa ahlukahlukene okugcina (kunconywa ukuthi kube ngu-≤25°C)

    4. Izakhiwo Eziphakeme Zomzimba

    • Ukujiya:~30 mPa·s ku-20°C (i-viscosity ephansi ukuze kube lula ukuyiphatha)

    • Amandla adonsela phansi aqondile:0.93-0.96 ku-20°C

    • Inkomba Yokubukeza:1.440-1.452 ku-20°C

    • I-viscosity ephansi efanelekile kumafomu omthamo oketshezi kanye nowokuqina okuncane

    5. Ukuhambisana Okuhle Kakhulu

    • Iyahambisana nohlu olubanzi lwama-API kanye nezinto ezisizayo zemithi

    • Ingafakwa kalula ekwakhiweni okuhlukahlukene ngaphandle kwezinkinga zokuhambisana

    • Iphunga elingathathi hlangothi kanye nokunambitheka - kulungele ukusetshenziswa komuthi lapho ukunambitha kubalulekile khona

    6. Iphrofayili Yokulawula Nokuphepha

    • Isimo se-GRAS (Ngokuvamile Siqashelwa Njengesiphephile)

    • Akunabuthi, akucasuli isikhumba namehlo

    • LD50 (igundane, ngomlomo): 29.6 g/kg – kuphephile kakhulu

    • I-GMP ekhiqizwe ngokulawulwa kwekhwalithi okuqinile

    • I-CDE ibhalisiwe (F20220000316) emakethe yaseShayina

    • Kutholakala ngokusekelwa okusemthethweni kokufakwa kwamafayela emhlabeni jikelele

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