Gabatarwa ga magungunan mRNA
Messenger RNA (mRNA) jerin nucleotides ne wanda ke ɓoye furotin, kuma a cikin cytoplasm yana iya amfani da kwayoyin halitta don bayyana furotin da aka ɓoye. Magungunan mRNA suna gyare-gyare ta hanyar sinadarai dangane da zaɓin maƙasudi ko antigens kuma suna shiga cikin cytoplasm ta hanyar tsarin bayarwa na musamman (misali, LNP), inda suke samar da wani nau'i na musamman (wanda ya dace da manufar ƙirar gyare-gyaren sinadarai), kuma tasirin yana faruwa ko dai ta cikin salula ko bayan ɓoyewa a cikin sashin waje (Fig. 1). A ka'ida mRNA za a iya fassara zuwa kowane furotin, kuma duk wani kwayoyi da suke amfani da sunadaran a matsayin therapeutics za a iya maye gurbinsu da mRNA hanyoyin.
Hoto 1. Siffofin tsarin magungunan mRNA da tsarin da suke aiwatar da ingancin su
Dabaru don nazarin pharmacokinetic na magungunan mRAN
Game da nazarin magungunan magunguna na magungunan mRNA, ana iya raba shi zuwa sassa uku na nazarin da ke niyya da rigakafin mRNA, magungunan mRNA da sabbin kayan aikin harhada magunguna. Dangane da alurar rigakafin - jagororin fasaha masu alaƙa da FDA da NMPA suka bayar, yawanci ba sa buƙatar nazarin magunguna na yau da kullun, amma ya kamata a yi nazarin wasu alluran rigakafi na musamman don rarraba halittu. Magungunan mRNA suna cikin alluran rigakafi na musamman, waɗanda ke buƙatar nazarin rarraba halittu. Kuma binciken harhada magunguna na magungunan warkewa na mRNA na iya taimakawa wajen fahimtar adadin - tasirin magunguna. Don sabbin abubuwan haɓaka magunguna, irin su cationic lipids ko wasu sinadarai a cikin tsarin isar da abinci na LNP sabbin abubuwan haɓaka magunguna ne, in vitro, in vivo da nazarin hulɗar magunguna ana buƙatar bisa ga "Jagororin don Ƙimar Tsaron Lafiya na Sabbin Excipients Pharmaceutical".Binciken in vitro ya ƙunshi kwanciyar hankali na rayuwa da gano metabolite na tsarin daban-daban, kuma binciken in vivo ya ƙunshi sha, rarrabawa, nazarin halittu da kuma nazarin halittu a cikin dabbobi don sanin tsarin in vivo ADME na kayan aiki. Magunguna
Abubuwan da suka danganci IPHASE
Messenger RNA (mRNA) jerin nucleotides ne wanda ke ɓoye furotin, kuma a cikin cytoplasm yana iya amfani da kwayoyin halitta don bayyana furotin da aka ɓoye. Magungunan mRNA suna gyare-gyare ta hanyar sinadarai dangane da zaɓin maƙasudi ko antigens kuma suna shiga cikin cytoplasm ta hanyar tsarin bayarwa na musamman (misali, LNP), inda suke samar da wani nau'i na musamman (wanda ya dace da manufar ƙirar gyare-gyaren sinadarai), kuma tasirin yana faruwa ko dai ta cikin salula ko bayan ɓoyewa a cikin sashin waje (Fig. 1). A ka'ida mRNA za a iya fassara zuwa kowane furotin, kuma duk wani kwayoyi da suke amfani da sunadaran a matsayin therapeutics za a iya maye gurbinsu da mRNA hanyoyin.
Hoto 1. Siffofin tsarin magungunan mRNA da tsarin da suke aiwatar da ingancin su
Dabaru don nazarin pharmacokinetic na magungunan mRAN
Game da nazarin magungunan magunguna na magungunan mRNA, ana iya raba shi zuwa sassa uku na nazarin da ke niyya da rigakafin mRNA, magungunan mRNA da sabbin kayan aikin harhada magunguna. Dangane da alurar rigakafin - jagororin fasaha masu alaƙa da FDA da NMPA suka bayar, yawanci ba sa buƙatar nazarin magunguna na yau da kullun, amma ya kamata a yi nazarin wasu alluran rigakafi na musamman don rarraba halittu. Magungunan mRNA suna cikin alluran rigakafi na musamman, waɗanda ke buƙatar nazarin rarraba halittu. Kuma binciken harhada magunguna na magungunan warkewa na mRNA na iya taimakawa wajen fahimtar adadin - tasirin magunguna. Don sabbin abubuwan haɓaka magunguna, irin su cationic lipids ko wasu sinadarai a cikin tsarin isar da abinci na LNP sabbin abubuwan haɓaka magunguna ne, in vitro, in vivo da nazarin hulɗar magunguna ana buƙatar bisa ga "Jagororin don Ƙimar Tsaron Lafiya na Sabbin Excipients Pharmaceutical".Binciken in vitro ya ƙunshi kwanciyar hankali na rayuwa da gano metabolite na tsarin daban-daban, kuma binciken in vivo ya ƙunshi sha, rarrabawa, nazarin halittu da kuma nazarin halittu a cikin dabbobi don sanin tsarin in vivo ADME na kayan aiki. Magunguna
Abubuwan da suka danganci IPHASE
| Categories | Rabe-rabe |
| Ƙarƙashin ƙwayar salula | hanta lysosome |
| Acidified hanta homogenate | |
| Hanta/hanji/koda/huhu S9 | |
| Hanta / hanji / koda / huhu microsomes | |
| Ruwan cytoplasmic hanta/na hanji/na koda/huhu | |
| Hepatocytes na farko | Suspension Hepatocytes |
| Platable Hepatocytes | |
| plasma na musamman | Plasma kwanciyar hankali |
| Haɗin furotin na Plasma | |
| Jini duka | Mutum/Biri/Kara/Bera/Mouse/Zomo/Alade Marasa Zuciyar Jini. |
Lokacin aikawa: 2024-08-25 19:54:01