(1) Izithiyo zobuchwepheshe
Amakhasimende angaphansi komfula wei-cellulose etherbanezidingo eziphakeme ngekhwalithi kanye nokuzinza kwe-cellulose ether. Ubuchwepheshe bokulawula ikhwalithi buyisithiyo esibalulekile sobuchwepheshe embonini ye-cellulose ether. Abakhiqizi badinga ukuba yingcweti ekusebenzeni okufana nomklamo wemishini eyinhloko, ukulawula ipharamitha ebalulekile yenqubo yokukhiqiza, inqubo yokukhiqiza eyinhloko, ukwakha amazinga okusebenza, futhi ngemva kwesikhathi eside sokulungisa amaphutha kanye nokuthuthukiswa okuqhubekayo kobuchwepheshe, bangakhiqiza i-cellulose ether ezinzile nesezingeni eliphezulu; Kuphela ngemva kwesikhathi eside sokutshalwa kwezimali ocwaningweni lapho singaqoqa khona ulwazi olwanele ensimini yesicelo. Kunzima ngamabhizinisi amasha angena embonini ukuba yingcweti yobuchwepheshe obuyinhloko esikhathini esifushane. Ukuze yingcweti ekukhiqizweni okukhulu kwama-cellulose ethers emithi kanye nokudla anekhwalithi ezinzile (ikakhulukazi ama-cellulose ethers okukhululwa kancane futhi okulawulwayo), kudinga futhi inani elithile lokutshalwa kwezimali ocwaningo kanye nentuthuko noma isikhathi sokuqongelela ulwazi. Ngakho-ke, kunezithiyo ezithile zobuchwepheshe kule mboni.
(2) Izithiyo kumakhono ochwepheshe
Emkhakheni wokukhiqizwa nokusetshenziswa kwe-cellulose ether, kunezidingo eziphezulu zekhwalithi kanye nezinga lobuchwepheshe lochwepheshe abangochwepheshe, abaqhubi kanye nabaphathi. Ochwepheshe abayinhloko kanye nabaqhubi bahlala bezinzile. Kunzima ngabaningi abasanda kungena ukuthola amakhono ochwepheshe nge-R&D kanye nobuchwepheshe obuyinhloko ngesikhathi esifushane, futhi kunezithiyo zamakhono ochwepheshe.
(3) Izithiyo zokufaneleka
Amabhizinisi e-cellulose ether adinga ukuthola iziqu ezifanele zokukhiqiza nokuthengisa i-ether ye-cellulose yebanga lemithi kanye ne-ether ye-cellulose yebanga lokudla.
Phakathi kwazo, i-ether ye-cellulose yezinga lemithi iyinto ebalulekile esetshenziswayo kwezokwelapha, futhi ikhwalithi yayo ithinta ngqo ukuphepha kwemithi. Ukuze kuqinisekiswe ukuphepha kwemithi, izwe lami lisebenzisa uhlelo lokunikeza amalayisense okukhiqizwa kwemithi. Ukuze kuqiniswe ukubhekwa kwemboni yemithi, umbuso usungule uchungechunge lwemithetho nemigomo maqondana nokufinyelela embonini, ukukhiqizwa kanye nokusebenza. Ngokusho kwe-“Letter on Printing and Distributing the Requirements for the Registration and Application of Pharmaceutical Excipients” ekhishwe yi-State Food and Drug Administration, ukuphathwa kwelayisensi yokukhiqiza kwezinto ezisetshenziswayo kwemithi kuyaqaliswa, futhi izinto ezintsha ezisetshenziswayo kwemithi kanye nezinto ezisetshenziswayo kwemithi ezingenisiwe kuncike ekuvunyelweni yi-National Bureau. Sekuvele kukhona izinto ezisetshenziswayo zemithi ezijwayelekile zikazwelonke ezivunyelwe yi-bureau yesifundazwe. Ukubhekwa kwezwe kwezinto ezisetshenziswayo kwemithi kuya ngokuya kuba nzima, futhi izifundazwe namadolobha ahlukahlukene aklame izindlela zokuphatha ezihambisanayo ngokuhambisana ne-“Administrative Measures for Pharmaceutical Excipients (Draft for Comment)” ekhishwe yisifundazwe. Esikhathini esizayo, uma amabhizinisi engakwazi ukukhiqiza izinto ezisizayo zemithi ngokuhambisana nezindinganiso zikazwelonke, angase angakwazi ukungena emakethe. Ngaphambi kokukhetha noma ukufaka esikhundleni uhlobo oluthile noma uhlobo lwe-ether ye-cellulose yezinga lemithi, abakhiqizi bemithi kumele badlule ekuhlolweni bese befaka efayeleni igunya elifanele ngaphambi kokuba bakwazi ukuyithenga nokuyisebenzisa ngokusemthethweni. Kunezithiyo ezithile ekuvunyelweni kweziqu zabakhiqizi bemithi kubaphakeli. . Kuphela ngemva kokuba ibhizinisi lithole “iLayisensi Kazwelonke Yokukhiqiza Umkhiqizo Wezimboni” ekhishwe yi-Provincial Bureau of Quality and Technical Supervision lapho ingavunyelwa khona ukukhiqiza i-cellulose ether njengesithasiselo sokudla.
Ngokwemithethonqubo efanele efana nethi “Imithethonqubo Ehlobene Nokuqinisa Ukuqapha Nokuphathwa Kwezinto Ezisetshenziswa Emithi” ekhishwe yi-State Food and Drug Administration ngo-Agasti 1, 2012, amabhizinisi kumele athole “Ilayisensi Yokukhiqiza Izidakamizwa” ukuze akhiqize ama-capsule ezitshalo ze-HPMC, kanti izinhlobo kumele zithole ilayisensi yokubhalisa yokudla nezidakamizwa kazwelonke ekhishwe yi-Bureau.
(4) Izithiyo zezimali
Ukukhiqizwa kwe-cellulose ether kunomphumela osobala wesikali. Amadivayisi amancane asetshenziswa ngesandla anomkhiqizo ophansi, ukuqina kwekhwalithi ephansi, kanye nesici sokuphepha esiphansi sokukhiqiza. Idivayisi yokulawula okuzenzakalelayo enkulu ilungele ukuqinisekisa ukuzinza kwekhwalithi yomkhiqizo kanye nokuthuthukisa ukuphepha kokukhiqiza. Amasethi amakhulu emishini yokwenza okuzenzakalelayo adinga imali eningi. Ukuze kuthuthukiswe ukuncintisana komkhiqizo, amabhizinisi kudingeka aqhubeke nokutshala imali ekwandiseni amandla okukhiqiza kanye nokwandisa utshalomali lwe-R&D. Abasanda kungena kumele babe namandla amakhulu ezezimali ukuze bancintisane nezinkampani ezikhona futhi babhekane nezithiyo ezithile zezimali ukuze bangene embonini.
(5) Izithiyo zemvelo
Inqubo yokukhiqizai-cellulose etherizokhiqiza amanzi amdaka kanye negesi engcolile, kanti imishini yokuvikela imvelo yokwelapha amanzi amdaka kanye negesi engcolile inotshalomali olukhulu, izidingo zobuchwepheshe eziphezulu kanye nezindleko zokusebenza eziphezulu. Njengamanje, inqubomgomo yokuvikela imvelo yasekhaya iya ngokuya iba nzima, okubeka phambili izidingo eziqinile kubuchwepheshe bokuvikela imvelo kanye nokutshalwa kwezimali ekukhiqizweni kwe-cellulose ether, okwandisa izindleko zokukhiqiza zamabhizinisi futhi kwakha isithiyo esikhulu sokuvikela imvelo. Amabhizinisi okukhiqiza i-cellulose ether anobuchwepheshe bokuvikela imvelo obusemuva kanye nokungcola okukhulu azobhekana nesimo sokususwa. Amakhasimende aphezulu anezidingo eziphezulu zokuvikela imvelo zabakhiqizi be-cellulose ether. Kuya ngokuya kuba nzima ngamabhizinisi angahlangabezani nezindinganiso zokuvikela imvelo ukuthola iziqu zokuhlinzeka amakhasimende aphezulu.
Isikhathi sokuthunyelwe: Ephreli-28-2024