(1) Imiqobo yobugcisa
Abathengi abasezantsii-cellulose etherbaneemfuno eziphezulu kumgangatho kunye nokuzinza kwe-cellulose ether. Itekhnoloji yokulawula umgangatho ngumqobo obalulekileyo kwezobuchwepheshe kwishishini le-cellulose ether. Abavelisi kufuneka baqonde ukusebenza koyilo oluhambelana nezixhobo eziphambili, ulawulo oluphambili lweparameter yenkqubo yemveliso, inkqubo yemveliso ephambili, benze imigangatho yokusebenza, kwaye emva kwexesha elide lokulungisa iimpazamo kunye nokuphuculwa kobuchwepheshe okuqhubekayo, banokuvelisa i-cellulose ether ezinzileyo nesemgangathweni ophezulu; Kuphela emva kwexesha elide lotyalo-mali lophando apho sinokuqokelela amava aneleyo kwicandelo lesicelo. Kunzima kumashishini amatsha angena kushishino ukuba aqonde itekhnoloji ephambili ngexesha elifutshane. Ukuze aqonde imveliso enkulu ye-cellulose ethers yamayeza kunye nokutya enomgangatho ozinzileyo (ingakumbi i-cellulose ethers yokukhululwa kancinci nokulawulwayo), ikwafuna utyalo-mali oluthile lophando nophuhliso okanye ixesha lokuqokelela amava. Ke ngoko, kukho imiqobo ethile yezobugcisa kweli shishini.
(2) Imiqobo kwiitalente zobungcali
Kwicandelo lokuvelisa nokusetyenziswa kwe-cellulose ether, kukho iimfuno eziphezulu zomgangatho kunye nenqanaba lobugcisa labachwephesha abaziingcali, abaqhubi kunye nabaphathi. Abachwephesha abaziingcali kunye nabaqhubi bahlala bezinzile. Kunzima kubantu abaninzi abatsha ukufumana iitalente zobungcali nge-R&D kunye netekhnoloji eziphambili ngexesha elifutshane, kwaye kukho imiqobo yetalente yobungcali.
(3) Imiqobo yokufaneleka
Amashishini e-cellulose ether kufuneka afumane iziqinisekiso ezifanelekileyo zokuvelisa nokuthengisa i-cellulose ether ye-pharmaceutical grade kunye ne-cellulose ether ye-food grade.
Phakathi kwazo, i-pharmaceutical grade cellulose ether sisithako esibalulekileyo samayeza, kwaye umgangatho waso uchaphazela ngokuthe ngqo ukhuseleko lwamayeza. Ukuze kuqinisekiswe ukhuseleko lwamayeza, ilizwe lam lisebenzisa inkqubo yelayisenisi yokuvelisa amayeza. Ukuze komelezwe ulawulo lweshishini lamayeza, urhulumente uqulunqe uthotho lwemithetho nemigaqo ngokubhekiselele ekufikeleleni kushishino, kwimveliso nasekusebenzeni. Ngokwe "Letter on Printing and Distributing the Requirements for the Registration and Application of Pharmaceutical Excipients" ekhutshwe yi-State Food and Drug Administration, ulawulo lwelayisenisi yokuvelisa izithako zamayeza luyasetyenziswa, kwaye izithako zamayeza ezintsha kunye nezithako zamayeza ezingenisiweyo ziphantsi kwemvume ye-National Bureau. Sele kukho izithako zamayeza ezisemgangathweni zesizwe ezivunyiweyo yi-ofisi yephondo. Ulawulo lwelizwe lwezithako zamayeza luya luqina ngakumbi, kwaye amaphondo nezixeko ezahlukeneyo aqulunqe amanyathelo olawulo ahambelanayo ngokuhambelana "neMilinganiselo yoLawulo lweeZithako zaMayeza (uMqulu woNgxelo)" ekhutshwe yi-state. Kwixesha elizayo, ukuba amashishini awakwazi ukuvelisa izinto ezincedisayo kumayeza ngokuhambelana nemigangatho yesizwe, asenokungakwazi ukungena kwimarike. Ngaphambi kokukhetha okanye ukutshintsha uhlobo oluthile okanye uhlobo lwe-ether ye-cellulose ye-pharmaceutical grade, abavelisi bamayeza kufuneka badlule kuhlolo baze bafake izicelo kwigunya elifanelekileyo ngaphambi kokuba bakwazi ukuyithenga nokuyisebenzisa ngokusesikweni. Kukho imiqobo ethile kwimvume yokufaneleka yabavelisi bamayeza kubaboneleli. Kuphela emva kokuba ishishini lifumene "iLayisensi yeMveliso yeSizwe yoShishino" ekhutshwe yi-Provincial Bureau of Quality and Technical Supervision apho linokuvunyelwa ukuvelisa i-cellulose ether njengesongezelelo sokutya.
Ngokwemigaqo efanelekileyo efana ne-"Related Regulations on Strengthening the Supervision and Management of Pharmaceutical Excipients" ekhutshwe yi-State Food and Drug Administration nge-1 ka-Agasti 2012, amashishini kufuneka afumane "iLayisensi yokuvelisa amayeza" ukuvelisa ii-HPMC plant capsules, kwaye iintlobo kufuneka zifumane ilayisenisi yokubhalisa yokutya neziyobisi yesizwe ekhutshwe yi-Bureau.
(4) Imiqobo yemali
Ukuveliswa kwe-cellulose ether kunesiphumo esicacileyo sesikali. Izixhobo ezincinci ezisebenza ngesandla zinemveliso ephantsi, uzinzo oluphantsi lomgangatho, kunye nokhuseleko oluphantsi lwemveliso. Isixhobo sokulawula ngokuzenzekelayo esikhulu sikulungele ukuqinisekisa uzinzo lomgangatho wemveliso kunye nokuphucula ukhuseleko lwemveliso. Iiseti ezinkulu zezixhobo ezizenzekelayo zifuna imali eninzi. Ukuze kuphuculwe ukhuphiswano lwemveliso, amashishini kufuneka aqhubeke nokutyala imali ekwandiseni amandla emveliso kunye nokwandisa utyalo-mali lwe-R&D. Abaqalayo abatsha kufuneka babe namandla amakhulu emali ukuze bakwazi ukukhuphisana neenkampani ezikhoyo kwaye bajongane nemiqobo ethile yezemali ukuze bangene kushishino.
(5) Imiqobo yokusingqongileyo
Inkqubo yemvelisoi-cellulose etheriza kuvelisa amanzi amdaka kunye negesi emdaka, kwaye izixhobo zokukhusela indalo zokunyanga amanzi amdaka kunye negesi emdaka zinotyalo-mali olukhulu, iimfuno zobugcisa eziphezulu kunye neendleko zokusebenza eziphezulu. Okwangoku, umgaqo-nkqubo wokukhusela indalo wasekhaya uya usiba ngqongqo ngakumbi, nto leyo ebeka phambili iimfuno ezingqongqo kwitekhnoloji yokukhusela indalo kunye notyalo-mali kwimveliso ye-cellulose ether, eyonyusa iindleko zemveliso yamashishini kwaye yenza umqobo ophezulu wokukhusela indalo. Amashishini emveliso ye-cellulose ether anetekhnoloji yokukhusela indalo engasemva kunye nongcoliseko olukhulu aya kujongana nemeko yokupheliswa. Abathengi abakumgangatho ophezulu baneemfuno eziphezulu zokukhusela indalo kubavelisi be-cellulose ether. Kuya kuba nzima ngakumbi kumashishini angahlangabezani nemigangatho yokukhusela indalo ukufumana isiqinisekiso sokubonelela abathengi abakumgangatho ophezulu.
Ixesha leposi: Epreli-28-2024