Le ndatshana ihlinzeka ngesibukezo esibanzi se I-China yagcina ukulethwa kwezidakamizwa ukwelashwa kwezidakamizwa, ukuhlola intuthuko yayo, izinhlelo zokusebenza namathemba esikhathi esizayo. Ihlola ubuchwepheshe obuhlukahlukene obuqashiwe, indawo elawulwayo, kanye nocwaningo oluqhubekayo kule ndawo ebalulekile yokuthuthukiswa kwemithi. Funda ngezinzuzo, izinselelo, kanye nomthelela ongaba khona ekunakekelweni kweziguli.
Izinhlelo ezisuselwa ku-polymer zisetshenziswa kabanzi I-China yagcina ukulethwa kwezidakamizwa ukwelashwa kwezidakamizwa. Lezi zinhlelo zifaka izakhiwo zama-polymers ahlukahlukene ukulawula isilinganiso sokukhishwa kwesithako esisebenzayo sezemithi (API). Izibonelo zifaka ama-polymers afana ne-polymers njenge-poly (i-lactic-co-glycolic acid) (PLGA) kanye nama-polymers angewona anjenge-bilycleble anjenge-poly (i-ethylene glycol) (isikhonkwane). Ukukhethwa kwe-polymer kuncike ezintweni ezifana nephrofayili yokukhishwa oyifunayo, i-BIOCOMTILINI INDLELA, NOKUFUNDA NOKUFUNDA. Ucwaningo eChina luyaqhubeka nokuhlola amanoveli ahambisanayo kanye nama-poocoodernerable ama-polymers ukwenza ngcono ukusebenza kahle nokuphepha kwalezi zinhlelo.
Ama-Liposomal Drug Delivery Systems angenye indawo ebalulekile yentuthuko ngaphakathi I-China yagcina ukulethwa kwezidakamizwa ukwelashwa kwezidakamizwa. Ama-liposomes ama-vesicles amancane akhiwa ama-lipid ababili abavumelanisa i-API, enikeza ukukhishwa okuqhubekayo kanye nokuqondiswa kwezidakamizwa okuthuthukile. Lobu buchwepheshe buzuzisa kakhulu ekuletheni izidakamizwa ze-hydrophobic futhi kunciphise ubuthi babo obuhle. Izinkampani eziningi zezemithi zaseChina zibandakanyeka ngenkuthalo ocwaningweni nasekuthuthukisweni kokwakheka kwe-liposomal kwezicelo ezahlukahlukene zokwelapha.
Izinhlelo zokulethwa kwezidakamizwa ezisuselwa kwi-nanoparticle zinikezela ngezinzuzo ezibalulekile ngaphakathi I-China yagcina ukulethwa kwezidakamizwa ukwelashwa kwezidakamizwa, kufaka phakathi ukulungiswa kwezidakamizwa okuthuthukile, ukulethwa kwezidakamizwa okuhlosiwe, kanye ne-bioavailability ethuthukisiwe. Lezi zinhlelo zisebenzisa ama-nanoparticles ezenziwe ngezinto ezahlukahlukene, njengama-polymers, ama-lipid, noma izinto ze-inorganic, ukunika amandla i-API. Ucwaningo olugxile ekuthuthukisweni kwe-nanoparticles ehambelana ne-biofemplecles yokulethwa kwezidakamizwa okuhlosiwe kwensimu ekhulayo eChina.
Indawo yokulawula I-China yagcina ukulethwa kwezidakamizwa ukwelashwa kwezidakamizwa iyavela ngokushesha. I-China Food and Drug Administration (CFDA), manje iNational Medical Products Administration (NMPA), idlala indima ebalulekile ekuqondiseni ukuthuthukiswa kanye nokuvunywa kwemikhiqizo yezidakamizwa ekhishwa okumisele. Ukuzulazula ezindleleni zokulawula kanye nokuqinisekisa ukuhambisana nemikhuba emihle yokukhiqiza (i-GMP) yizici ezibalulekile ezinkampanini ezibandakanyeka kulo mkhakha. Izinselelo zifaka izidingo zokuhlola eziqinile kanye nesidingo semininingwane enamandla yomtholampilo ukukhombisa ukusebenza ngempumelelo nokuphepha. Ubunzima obukhulayo balezi zinhlelo zokulethwa buhlinzeka ngezinselelo ezibalulekile zokuhlaziya.
Ucwaningo lwesikhathi esizayo ku I-China yagcina ukulethwa kwezidakamizwa ukwelashwa kwezidakamizwa Sizogxila ekuthuthukiseni izinhlelo eziyinkimbinkimbi futhi ezenziwe ngezifiso zokulethwa kwezidakamizwa. Lokhu kufaka phakathi ukuthuthukiswa kwezinhlelo ezihlakaniphile zokulethwa kwezidakamizwa eziphendulayo ku-stimuli ethile, efana nezinguquko ze-ph noma zokushisa, kanye nokusetshenziswa kwamasu wokucabanga athuthukile wokuqapha ukukhishwa kwezidakamizwa eVivo. Ukuhlanganiswa kwe-nanotechnology, i-biotechnology, kanye ne-intelligence yokufakelwa kulindeleke ukuthi kuguqulwe le nkambu, okuholele emiphumeleni yokwelapha ethuthukisiwe kanye nokunakekelwa kweziguli okuthuthukisiwe. Ukusebenzisana phakathi kwezikhungo zemfundo, izinkampani ezenza imithi, kanye nemizimba yokulawula kuzobaluleka ekushayeleni okusha futhi kuqinisekiswe ukuhunyushwa okuphumelelayo kocwaningo ekusebenzeni komtholampilo.
I-China yagcina ukulethwa kwezidakamizwa ukwelashwa kwezidakamizwa Kusetshenziswa ngaphesheya kwezindawo ezahlukahlukene zokwelapha, kufaka phakathi i-Oncology, isifo senhliziyo, kanye nesifo sikashukela. Izibonelo eziphumelelayo zifaka ukwakheka okudedelwa okulondoloziwe kwemithi elwa nomdlavuza, esiza ukuthuthukisa ukulandelwa kweziguli futhi kunciphise imiphumela emibi. Ezinye izifundo ezinemininingwane enemininingwane zingatholakala ngokushicilelwa kwezifundo kanye nemininingwane ye-NMPA. Ukucwaninga ngempumelelo nokuphepha kwalezi zinhlelo zokulethwa kwazo zonke izindawo ezahlukahlukene zihlala ziyindawo esebenzayo yophenyo.
Ubuchwepheshe | Izinzuzo | Okubi |
---|---|---|
Kususelwa ku-polymer | Izindlela eziguquguqukayo, okuhlosiwe okuhambisanayo | Okungaba khona ukukhishwa kokuqhuma, ukukhiqiza okuyinkimbinkimbi |
Ingwakomaleyo | Ukulungiswa Kwezidakamizwa Okuthuthukisiwe, Ukulethwa Okuhlosiwe | Ukuqina kokuqina, okungenzeka kokuhlanganiswa |
I-nanoparticle-based | Ukuthuthukiswa kwe-bioavailability, ukulethwa okuhlosiwe | Ukukhathazeka kobuthi, okungenzeka kokuhlanganiswa |
Ukuthola eminye imininingwane nge-Cancer Trancer Treatment and Research, cabanga ukuhlola izinsiza ezitholakala ku- I-Shandong Baafa Cancer Research Institute. Ukuzibophezela kwabo ukuthuthukisa ukunakekelwa komdlavuza ngokunakekelwa kwentuthuko eqhubekayo ngaphakathi I-China yagcina ukulethwa kwezidakamizwa ukwelashwa kwezidakamizwa.
Ukuzikhulula: Lolu lwazi lwenzelwe izinjongo zokufundisa kuphela futhi akufanele lubhekwe njengeluleke lwezokwelapha. Thintana nochwepheshe wezokunakekelwa kwempilo kunoma yikuphi ukukhathazeka ngempilo.
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