Qib Tshuaj Nruab Nrab-Saw Triglycerides (MCT) | Lipophilic Solvent & Drug Carrier rau Qhov Ncauj/Tshuaj Rau Sab Hauv/Koob Tshuaj Txhaj | USP/EP/ChP

Cov Tshuaj Qib Nruab Nrab-Saw Triglycerides (MCT)

Txheej Txheem Cej Luam Khoom

Medium-Chain Triglycerides (MCT) yog ib qho tshuaj siv ua tshuaj uas muaj cov roj triglycerides uas muaj roj saturated fatty acids sib xyaws ua ke, feem ntau yog caprylic acid (C8H16O2, octanoic acid) thiab capric acid (C10H20O2, decanoic acid).Cov triglycerides no tau txais los ntawm cov roj ruaj khov uas tau rho tawm los ntawm cov tawv, qhuav ntawm endosperm ntawm txiv maj phaub (Cocos nucifera L.) lossis los ntawm cov endosperm qhuav ntawm cov roj xibtes (Elaeis guineensis Jacq.)Cov roj fatty acids raug sib cais los ntawm cov roj roj thiab rov ua dua nrog glycerol los tsim cov khoom kawg..

Lub Npe Khoom:

• Lub Npe Tshuaj:Cov Triglycerides Nruab Nrab-Chain / Caprylic/Capric Triglyceride

• Tus lej CAS:73398-61-5 (thiab 85409-09-2 lossis 538-24-9)

• Tus lej rau npe CDE:F20220000316

• Kev Ua Raws Cai ntawm Pharmacopoeia:ChP (CP2020), USP-NF (Triglycerides Nruab Nrab), EP (Triglycerides, Nruab Nrab), JP (Triglyceride roj fatty acid nruab nrab)

• Cov lus txhais:Roj MCT, Caprylic/Capric Triglyceride, Glycerides sib xyaw decanoyl thiab octanoyl, Miglyol® 812 sib npaug, Labrafac™ CC sib npaug

• Tsos:Tsis muaj xim rau me ntsis daj oily kua, yuav luag tsis muaj ntxhiab thiab tsis qab

• Chaw Khov:Kwv yees li ntawm 0°C

Cov Nta Tseem Ceeb & Cov Txiaj Ntsig

1. Cov yam ntxwv zoo tshaj plaws ntawm cov kuab tshuaj

• Cov kuab tshuaj zoo heev rau cov tshuaj lipophilic thiab cov APIs uas yaj tsis tau hauv dej

• Txhim kho kev yaj thiab kev ruaj khov ntawm cov tshuaj lipophilic

• Txhim kho kev siv tau ntawm cov tshuaj Class II thiab Class IV (BCS kev faib tawm)

2. Kev Nqus Tau Sai & Kev Ua Haujlwm Metabolism

• Nqus tau ncaj qha mus rau hauv lub portal circulation yam tsis tas yuav siv cov ntsev bile lossis cov enzymes pancreatic

• Sai sai metabolized kom muab lub zog sai

• Kev xa khoom sai dua ntawm API mus rau kev ncig thoob plaws lub cev, tej zaum yuav txhim kho qhov pib ua haujlwm

3. Kev Ruaj Ntseg Zoo heev

• Kev tiv thaiv siab rau oxidation (iodine tus nqi ≤1.0)

• Tsis tshua muaj kev cuam tshuam rau kev ntxhov siab thermal thiab oxidative

• Tswj kev ruaj khov thiab lub neej txee ntawm cov tshuaj formulations

• Ruaj khov rau ntau qhov kub thiab txias (≤25 ° C pom zoo)

4. Cov Khoom Siv Zoo Tshaj Plaws

• Qhov nplaum:~30 mPa·s ntawm 20 ° C (viscosity qis rau kev tuav yooj yim)

• Lub Zog Tshwj Xeeb:0.93-0.96 ntawm 20 ° C

• Cov ntsuas kev cuam tshuam:1.440-1.452 ntawm 20°C

• Cov viscosity qis tsim nyog rau cov kua thiab cov ntaub ntawv semisolid dosage

5. Kev Sib Tw Zoo heev

• Sib xws nrog ntau yam APIs thiab cov tshuaj excipients

• Tau yooj yim koom ua ke rau hauv ntau yam formulations yam tsis muaj teeb meem sib xws

• Tsis muaj ntxhiab tsw thiab saj - zoo tagnrho rau cov tshuaj noj uas qhov saj zoo yog qhov tseem ceeb

6. Cov Cai thiab Kev Nyab Xeeb

• GRAS (Feem ntau lees paub tias muaj kev nyab xeeb) xwm txheej

• Tsis muaj tshuaj lom, tsis ua rau khaus rau daim tawv nqaij thiab qhov muag

• LD50 (nas, qhov ncauj): 29.6 g/kg - muaj kev nyab xeeb heev

• GMP tsim nrog kev tswj hwm zoo nruj

• CDE sau npe (F20220000316) rau kev lag luam hauv Suav teb

• Muaj kev txhawb nqa los ntawm kev cai lij choj rau cov ntaub ntawv thoob ntiaj teb