Darajada Daawada ee Silsiladda Dhexe ee Triglycerides (MCT) | Dawada Lipophilic iyo Daawada loogu talagalay Afka/Maqaarka/Durista | USP/EP/ChP

Triglycerides-ka Silsiladda Dhexe ee Daawada (MCT)

Dulmar Guud oo ku saabsan Badeecada

Triglycerides-ka Silsiladda Dhexe (MCT) waa daawo si fiican loo aasaasay oo ka kooban isku darka triglycerides-ka asiidhyada dufanka buuxa, gaar ahaan asiidhka caprylic (C8H16O2, octanoic acid) iyo asiidhka capric (C10H20O2, decanoic acid)Triglycerides-kan waxaa laga helaa saliidda go'an ee laga soo saaro qaybta adag ee qalalan ee endosperm-ka qumbaha (Cocos nucifera L.) ama endosperm-ka qalalan ee saliidda timirta (Elaeis guineensis Jacq.)Asiidhyada dufanka leh ayaa laga soocaa saliidda dufanka leh ka dibna dib ayaa loogu daraa glycerol si loo soo saaro badeecada kama dambaysta ah..

Aqoonsiga Badeecada:

• Magaca Kiimikada:Triglycerides Silsilad Dhexdhexaad ah / Caprylic/Capric Triglyceride

• Lambarka CAS:73398-61-5 (sidoo kale 85409-09-2 ama 538-24-9)

• Lambarka Diiwaangelinta CDE:F20220000316

• U hoggaansanaanta Farmashiyaha:ChP (CP2020), USP-NF (Triglycerides Silsilad Dhexdhexaad ah), EP (Triglycerides, Silsilad Dhexdhexaad ah), JP (Triglyceride silsilad dhexdhexaad ah oo dufan leh)

• Isku-mid ah:Saliidda MCT, Caprylic/Capric Triglyceride, Glycerides isku qasan decanoyl iyo octanoyl, Miglyol® 812 u dhiganta, Labrafac™ CC u dhiganta

• Muuqaalka:Dareere saliid leh oo aan midab lahayn ilaa huruud yar, aan ur lahayn oo aan dhadhan lahayn

• Barta Qaboojinta:Qiyaastii 0°C

Astaamaha Muhiimka ah & Faa'iidooyinka

1. Astaamaha Dareeraha Sare

• Dareeraha ugu fiican ee daawooyinka lipophilic iyo API-yada biyaha ku milma ee liita

• Waxay xoojisaa milmida iyo xasilinta xeryahooda lipophilic

• Waxay wanaajisaa helitaanka daawooyinka Fasalka II iyo Fasalka IV (kala soocida BCS)

2. Nuugista Degdegga ah & Dheef-shiid kiimikaadka

• Si toos ah ayuu ugu nuugo wareegga marinnada iyada oo aan loo baahnayn cusbada xameetida ama enzymes-ka ganaca

• Si dhakhso ah ayaa loo dheefshiiday si loo bixiyo tamar degdeg ah

• Gaarsiinta degdegga ah ee API-ga wareegga nidaamka, taasoo laga yaabo inay hagaajiso bilawga ficilka

3. Astaamaha Xasilloonida ee Aad u Fiican

• Iska caabin sare oo oksaydheynta ah (qiimaha ayyoodku ≤1.0)

• Niyad jab yar oo ku yimaada cadaadiska kulaylka iyo oksaydhka

• Waxay ilaalisaa xasilloonida iyo cimriga kaydinta ee qaacidooyinka daawada

• Xasilloon heerkulka kaydinta ee kala duwan (≤25°C ayaa lagu talinayaa)

4. Sifooyinka Jirka ee Sare

• Viscosity:~30 mPa·s heerkul ah 20°C (dherer hoose oo loogu talagalay maaraynta fudud)

• Cufis-jiidad Gaar ah:0.93-0.96 heerkulka 20°C

• Tusmada Refractive:1.440-1.452 heerkulka 20°C

• Dheef-dhalasho hoose oo ku habboon qaababka qiyaasta dareeraha iyo nus-adag

5. Iswaafajin Aad u Fiican

• La jaan qaadaya noocyo badan oo APIs ah iyo daawooyinka kaabaha ah

• Si fudud ayaa loogu dari karaa qaacidooyin kala duwan iyada oo aan la helin arrimo iswaafaqsan

• Ur dhexdhexaad ah iyo dhadhan - ku habboon qaacidooyinka afka laga qaato halkaas oo dhadhanku muhiim yahay

6. Astaanta Sharciyeynta iyo Badbaadada

• Xaaladda GRAS (Guud ahaan loo Aqoonsaday Ammaan)

• Aan sun ahayn, oo aan cuncun u lahayn maqaarka iyo indhaha

• LD50 (jiir, afka laga qaato): 29.6 g/kg – aad bay u ammaan badan tahay

• GMP waxaa lagu sameeyay xakameyn tayo oo adag

• CDE oo diiwaangashan (F20220000316) suuqa Shiinaha

• Waxaa laga heli karaa taageero sharciyeed oo loogu talagalay faylalka caalamiga ah