(1)Imiqobo yobugcisa
Abathengi abasezantsi be-cellulose ether baneemfuno eziphezulu kumgangatho kunye nokuzinza kwe-cellulose ether.Itekhnoloji yokulawula umgangatho iyisithintelo esibalulekileyo sobugcisa kwishishini le-cellulose ether.Abavelisi kufuneka baqonde ukuyila okuhambelana nokusebenza kwezixhobo eziphambili, ukulawulwa kwepharamitha ephambili yenkqubo yokuvelisa, inkqubo yokuvelisa isiseko, ukuqulunqa imigangatho yokusebenza, kwaye emva kwexesha elide lokulungiswa kwempazamo kunye nokuphuculwa kobugcisa obuqhubekayo, banokuvelisa i-ether ye-cellulose ezinzileyo kunye nomgangatho ophezulu;Kuphela emva kwexesha elide lotyalo-mali lophando sinokuqokelela amava aneleyo kwindawo yesicelo.Kunzima kumashishini amatsha angena kweli shishini ukuba alawule itekhnoloji engundoqo ngexesha elifutshane.Ukuqonda imveliso enkulu ye-ethers ye-pharmaceutical and food-grade cellulose ethers kunye nomgangatho ozinzile (ingakumbi i-cellulose ethers yokukhululwa okucothayo kunye nokulawulwayo), ikwafuna umlinganiselo othile wophando kunye nophuhliso lotyalo-mali okanye ixesha lokuqokelela amava.Ke ngoko, kukho imiqobo ethile yobugcisa kweli shishini.
(2)Imiqobo kwiitalente zobungcali
Kwintsimi yokuvelisa kunye nokusetyenziswa kwe-cellulose ether, kukho iimfuno eziphezulu kumgangatho kunye nenqanaba lobugcisa labachwephesha beengcali, abaqhubi kunye nabaphathi.Amagcisa angundoqo kunye nabaqhubi bahlala bezinzile.Kunzima kuninzi lwabangeneleli abatsha ukufumana iitalente zobungcali nge-R&D kunye netekhnoloji engundoqo ngexesha elifutshane, kwaye kukho imiqobo yetalente yobuchwephesha.
(3)Imiqobo yokufaneleka
Amashishini e-cellulose ether kufuneka afumane iziqinisekiso ezifanelekileyo zokuvelisa kunye nokuthengisa i-ether ye-cellulose ether yodidi lweyeza kunye nebakala lokutya i-cellulose ether.
Phakathi kwabo, i-ether ye-pharmaceutical grade cellulose yinto ebalulekileyo ye-pharmaceutical excipient, kwaye umgangatho wayo uchaphazela ngokuthe ngqo ukhuseleko lwamachiza.Ukuqinisekisa ukhuseleko lweziyobisi, ilizwe lam liphumeza inkqubo yokukhutshwa kwelayisenisi yokuveliswa kweziyobisi.Ukuze komelezwe ulawulo lweshishini loxubo-mayeza, urhulumente uye waqulunqa uluhlu lwemithetho kunye nemimiselo malunga nokufikelela kwishishini, imveliso kunye nokusebenza.Ngokutsho kwe "Letter on Printing and Distribution the Requirements for Registration and Application of Pharmaceutical Excipients" ekhutshwe yi-State Food and Drug Administration, ulawulo lwelayisenisi yokuvelisa i-excipients yamayeza iphunyeziwe, kunye nabancedisi abatsha bamayeza kunye nabaxumi bamayeza angaphandle baxhomekeke ukwamkelwa kweZiko leSizwe.Sele kukho imigangatho yesizwe encedisa amayeza Avunywe liziko lephondo.Ukongamela kukarhulumente kwabo baphumeza amayeza luya lusiba ngqongqo ngakumbi, kwaye amaphondo ahlukeneyo kunye nezixeko ziye zaqulunqa imilinganiselo yolawulo ehambelanayo ngokuhambelana “neMiqathango yoLawulo lwaBaxumi bamayeza (iDrafti yokuHlola)” ekhutshwe ngurhulumente.Kwixesha elizayo, ukuba amashishini akakwazi ukuvelisa i-excipients zamachiza ngokungqongqo ngokuhambelana nemigangatho yelizwe, abanako ukungena kwimarike.Ngaphambi kokuba ukhethe okanye utshintshe uhlobo oluthile okanye uphawu lwe-ether ye-cellulose ether yodidi lweyeza, abavelisi bamayeza kufuneka baphumelele ukuhlolwa kunye nefayile kunye nogunyaziwe onobuchule phambi kokuba bathenge ngokusemthethweni kwaye bayisebenzise.Kukho imiqobo ethile ekuvunyweni kwesiqinisekiso sabavelisi bamayeza kubaboneleli..Kuphela emva kokuba ishishini lifumene "iLayisensi yeMveliso yeMveliso yeMveliso yeSizwe" ekhutshwe yi-Bureau yePhondo yoMgangatho kunye noLawulo lobuGcisa inokuvunywa ukuba ivelise i-cellulose ether njengesongezo sokutya.
Ngokwemigaqo echaphazelekayo efana ne "Related Regulations on Strengthening and Management of Pharmaceutical Excipients" ekhutshwe yi-State Food and Drug Administration ngo-Agasti 1, 2012, amashishini kufuneka afumane "iLayisensi yokuVelisa iziyobisi" ukuvelisa iipilisi zezityalo zeHPMC, kwaye iintlobo kufuneka zifumane ukutya kuzwelonke kunye nolawulo lweziyobisi.ilayisenisi yobhaliso ekhutshwe liQumrhu.
(4)Imiqobo yenkxaso-mali
Imveliso ye-cellulose ether inesiphumo esicacileyo sesikali.Izixhobo ezincinci ezisebenza ngesandla zinemveliso ephantsi, uzinzo olukumgangatho ophantsi, kunye nemveliso ephantsi yokhuseleko.Isixhobo esikhulu sokulawula ngokuzenzekelayo sifanelekile ekuqinisekiseni ukuzinza komgangatho wemveliso kunye nokuphucula ukhuseleko lwemveliso.Iiseti ezinkulu ezipheleleyo zezixhobo ezizenzekelayo zifuna isixa esikhulu semali.Ukuze kuphuculwe ukukhuphisana kwemveliso, amashishini kufuneka aqhubeke nokutyala imali ekwandiseni umthamo wemveliso kunye nokwandisa utyalo-mali lwe-R&D.Abangeneli abatsha kufuneka babe namandla anamandla emali ukuze bakhuphisane neenkampani ezikhoyo kwaye bajongane nemiqobo ethile yemali yokungena kwishishini.
(5)Imiqobo yokusingqongileyo
Inkqubo yokuvelisa i-cellulose ether iya kuvelisa amanzi amdaka kunye negesi engcolileyo, kunye nezixhobo zokusingqongileyo zokukhusela amanzi angcolileyo kunye negesi engcolileyo inotyalo-mali olukhulu, iimfuno eziphezulu zobugcisa kunye neendleko eziphezulu zokusebenza.Okwangoku, umgaqo-nkqubo wasekhaya wokukhuselwa kokusingqongileyo uya usiba ngqongqo ngakumbi, obeka phambili iimfuno ezingqongqo kwithekhnoloji yokukhusela indalo kunye notyalo-mali ekuveliseni i-cellulose ether, eyandisa iindleko zemveliso yamashishini kwaye yenza umqobo wokukhusela okusingqongileyo.Amashishini okuvelisa i-cellulose ether anobuchwephesha obungasemva bokukhuselwa kokusingqongileyo kunye nongcoliseko olukhulu luya kujongana nemeko yokupheliswa.Abathengi abaphezulu baneemfuno eziphezulu zokusingqongileyo kubenzi be-cellulose ether.Kuya kusiba nzima ngakumbi kumashishini angafikeleliyo kwimigangatho yokhuselo lokusingqongileyo ukufumana isiqinisekiso sokubonelela abathengi abakumgangatho ophezulu.
Ixesha lokuposa: Apr-10-2023