Ukwethulwa okufushane kwamafilimu wokuqothula ngomlomo nemishini yokupakisha

Amafilimu Owohlotshisiwe Omlomo

Amafilimu anqabile ngomlomo (i-ODF) yifomu elisha eliqinile lokukhishwa komthamo okuqinile okwenziwa njalo phesheya eminyakeni yamuva nje. Kuvele ngasekupheleni kwawo-1970. Ngemuva kwentuthuko, kancane kancane yavele yavela kumkhiqizo olula we-Portal Health Care. Le ntuthuko iye yanwebeka emikhakheni yemikhiqizo yokunakekelwa kwempilo, imikhiqizo yokunakekelwa komuntu siqu kanye nezidakamizwa, futhi idonsele inzalo ebanzi nokunakwa ngenxa yezinzuzo zayo ezinye izindlela ezingenazo. Kuzoba uhlelo lokulethwa kwezidakamizwa lwe-membrage olubaluleke kakhulu, olufanele ikakhulukazi ukugwinya iziguli ezinzima kanye nezidakamizwa ngemiphumela emibi yokudlula kuqala.
Ngenxa yenzuzo eyingqayizivele yefomu lefomu lamafilimu anqanyulwa ngomlomo, anamathemba wesicelo esihle. Njengefomu elisha lama-dosage elingathatha isikhundla sokuncipha kwamathebhulethi, izinkampani eziningi ezinkulu zinesithakazelo esijulile kulokhu, ukwelula isikhathi se-patent semithi ethile ngokuguqulwa kwemithamo ngesihloko sokucwaninga umthamo kuyisihloko socwaningo esishisayo njengamanje.
Izici nezinzuzo zamafilimu aqothulayo omlomo
Akunasidingo sokuphuza amanzi, okulula ukusisebenzisa. Ngokuvamile, umkhiqizo wenzelwe ukuba ube ngosayizi wesitembu, esingachithwa ngokushesha olimini futhi sigwinywe ngokunyakaza okujwayelekile kokugwinya; ukuphathwa ngokushesha kanye nokuqala okusheshayo komphumela; qhathanisa nomzila we-mucosal we-nasal, umzila we-mucosal womlomo mancane amathuba okubangela ukulimala kwe-mucosal, kanye nokusebenza kwawo okuqinile; ICavity Mucosal Administration ingashintshwa endaweni ngokuya ngokuvumela kwezicubu ukwenza lula ukususwa okuphuthumayo; Isidakamizwa sisatshalaliswa ngokulinganayo ezintweni ezenziwe ngefilimu, okuqukethwe kunembile, futhi ukuqina namandla amahle. Ilungele ikakhulukazi amalungiselelo ezingane atholakala njengamanje eChina. Kungaxazulula kalula izinkinga zemithi zezingane neziguli futhi kuthuthukise ukuhambisana kwezingane kanye neziguli ezikhulile. Ngakho-ke, izinkampani eziningi zemithi zihlanganisa amalungiselelo azo akhona, amaphilisi, amaphilisi kanye nomlomo womlomo kuguqulwa umkhiqizo wethebhulethi osuswayo uguqulwa ube yifilimu esheshayo esuswa ukuncishiswa komlomo ukuze unwebe umjikelezo wokuphila okusheshayo.
Okubi kwamafilimu anqanyulwa ngomlomo
I-cavity yomlomo ingadonsa i-mucosa ngendawo elinganiselwe. Ngokuvamile, ulwelwesi lomlomo luncane ngevolumu kanye nokulayishwa kwezidakamizwa akukukhulu (imvamisa 30-60mg). Ezinye izidakamizwa ezisebenzayo kuphela ezingakhethwa; Isidakamizwa esikhulu sidinga ukunambitheka-imaski, futhi ukukhuthaza ukunambitheka komuthi kuthinta ukuhambisana nendlela; Imfihlo yamathe ethenteke ngokuzithandela nokugwinya kuthinta ukusebenza ngempumelelo kwendlela ye-mucosa yomlomo; Akuzona zonke izinto ezingadlula ku-mucosa yomlomo, futhi ukumunca kwazo kuthintwa yi-soubelity enamafutha; discociation degree, isisindo molecular, njll; kudingeka kusetshenziswe ngaphansi kwemibandela ethile yokutholwa kwe-accelerator; Ngesikhathi senqubo yokwakha amafilimu, okuqukethwe kufuthelwe noma i-solvent ikhipha, kulula ukugcwala, futhi kulula ukuwela ngesikhathi senqubo yokusika, futhi kulula ukuyiyeka ngesikhathi senqubo yokusika; Ifilimu lincanyana, light light, lincane, futhi kulula ukumunca umswakama. Ngakho-ke, izidingo zokupakishwa ziphakeme kakhulu, okungafanele kube lula nje ukuzisebenzisa, kepha futhi ziqinisekise ikhwalithi yemithi.
Ukuqedwa kwamafilimu ngomlomo okuchithwa kwamafilimu okuthengiswa phesheya
Ngokusho kwezibalo, isimo sokwakhiwa kwamafilimu okuthengiswayo kuze kube manje silinganiselwa ngokulandelayo. I-FDA ivume ukwakhiwa kwamafilimu angama-82 (kufaka phakathi abakhiqizi abahlukahlukene kanye nokucaciswa), kanye ne-Japan PMDA evunyelwe izidakamizwa ezi-17 (njll.
Ngo-2004, ukuthengiswa komhlaba wonke kobuchwepheshe befilimu yomlomo emikhiqizweni ye-OTC kanye ne-Health Care Products kwakungu- US $ 25 wezigidi, esuka e-US $ 2 billion ngo-2010.
Isimo samanje sokuthuthukiswa kwasekhaya kanye nokusetshenziswa kwamalungiselelo omlomo ahlukanisa amalungiselelo efilimu
Ayikho imikhiqizo yefilimu ebiyele emlonyeni evunyelwe ukumaketha eChina, futhi konke kusesimweni socwaningo. Abakhiqizi nezinhlobonhlobo ezivunyiwe kwezicelo zemitholampilo kanye nokubhalisa esiteji sokubuyekezwa zimi ngokulandelayo:
Abakhiqizi basekhaya abamemezela inani elikhulu kunawo wonke ama-ejenti okuqoshwa ngomlomo yi-Qilu (izinhlobo eziyi-7), iHengrui (izinhlobo ezi-4), ama-SHANGHAI Modern Pharmaceutical (izinhlobo ezi-4).
Isicelo esisekhaya kunazo zonke e-ejenti yokuqothula ngomlomo i-ejenti yokuqedwa kwe-OnDansetron (izimemezelo ezi-4), i-Olasheapine, i-Risperidone, iMontekalast, ne-Voglibose ngayinye izimemezelo ezi-2.
Njengamanje, isabelo semakethe somelwesi ngomlomo (ngaphandle kwemikhiqizo yokuvuselela umoya) ikakhulukazi kugxilwe emakethe yaseNyakatho Melika. Ngokujula nokujula kocwaningo oluhlukahlukene olwelwesi olusheshayo lomlomo, kanye nokukhuthaza imikhiqizo enjalo eYurophu nase-Asia, ngikholwa ukuthi le fomu le-dosage elilodwa linamandla okuhweba anezentengiso emithini, imikhiqizo yezempilo kanye nama-cosmeceuticals.

Isikhathi Seposi: Meyi-28-2022