Kodi zotchinga zazikulu zomwe zimalepheretsa kulowa mumakampani am'nyumba zama cellulose ether ndi ziti?

(1)Zopinga zaukadaulo

Makasitomala otsika a cellulose ether ali ndi zofunika zapamwamba pazabwino komanso kukhazikika kwa cellulose ether.Ukadaulo wowongolera upangiri ndi chotchinga chofunikira kwambiri pamakampani a cellulose ether.Opanga ayenera kudziwa kamangidwe kofananira ntchito ya zida pachimake, kiyi chizindikiro kulamulira ndondomeko kupanga, pachimake kupanga ndondomeko, kupanga mfundo ntchito, ndipo patapita nthawi yaitali debugging ndi mosalekeza luso luso, akhoza kupanga khola ndi apamwamba mapadi efa;Pokhapokha patatha nthawi yayitali yofufuza ndalama zomwe tingathe kudziunjikira zokumana nazo zokwanira pantchito yofunsira.Ndizovuta kwa mabizinesi atsopano omwe alowa m'makampani kuti adziwe luso lamakono mu nthawi yochepa.Kuti adziwe kupanga kwakukulu kwa mankhwala ndi zakudya zama cellulose ethers okhala ndi khalidwe lokhazikika (makamaka ma cellulose ethers kuti atulutse pang'onopang'ono komanso molamulirika), pamafunikanso ndalama zina za kafukufuku ndi chitukuko kapena nthawi yodzikundikira.Chifukwa chake, pali zopinga zina zaukadaulo pantchito iyi.

(2)Zolepheretsa luso la akatswiri

M'munda wa kupanga ndi kugwiritsa ntchito cellulose ether, pali zofunika kwambiri pamlingo waukadaulo waukadaulo wa akatswiri, ogwira ntchito ndi oyang'anira.Akatswiri odziwa ntchito ndi ogwira ntchito amakhalabe okhazikika.Ndizovuta kwa olowa kumene ambiri kupeza luso laukadaulo ndi R&D ndi matekinoloje oyambira munthawi yochepa, ndipo pali zotchinga zamaluso.

(3)Zolepheretsa ziyeneretso

Mabizinesi a cellulose ether amayenera kupeza ziyeneretso zoyenera kuti apange ndikugulitsa mankhwala a cellulose ether ndi food grade cellulose ether.

Pakati pawo, mankhwala grade cellulose ether ndi yofunika mankhwala excipient, ndipo khalidwe mwachindunji zimakhudza chitetezo cha mankhwala.Pofuna kuonetsetsa kuti mankhwala ali otetezeka, dziko langa limagwiritsa ntchito njira zoperekera chilolezo popanga mankhwala.Pofuna kulimbikitsa kuyang'anira makampani opanga mankhwala, boma lakhazikitsa malamulo ndi malamulo okhudza kupeza, kupanga ndi kugwira ntchito kwa mafakitale.Malinga ndi "Letter on Printing and Distributing the Registration for the Registration and Application of Pharmaceutical Excipients" yoperekedwa ndi State Food and Drug Administration, kasamalidwe ka zilolezo zopangira mankhwala opangira mankhwala akugwiritsidwa ntchito, ndipo zowonjezera zatsopano zamankhwala ndi zotuluka kunja kwa mankhwala zikuyenera kuchitika. kuvomerezedwa ndi National Bureau.Pali kale zida zopangira mankhwala zapadziko lonse Zovomerezedwa ndi ofesi yakuchigawo.Kuyang’anira kwa boma pa zinthu zothandiza mankhwala kukuchulukirachulukira, ndipo zigawo ndi mizinda yosiyanasiyana yakonza njira zoyendetsera zinthu mogwirizana ndi “Administrative Measures for Pharmaceutical Excipients (Draft for Comment)” yoperekedwa ndi boma.M'tsogolomu, ngati mabizinesi sangathe kupanga mankhwala opangira mankhwala molingana ndi miyezo ya dziko, sangathe kulowa mumsika.Asanasankhe kapena kusintha mtundu winawake kapena mtundu wina wa mankhwala a cellulose ether, opanga mankhwala amayenera kuwunika ndikulemba mafayilo ndi akuluakulu oyenerera asanagule ndi kuzigwiritsa ntchito.Pali zotchinga zina pakuvomereza koyenera kwa opanga mankhwala kwa ogulitsa..Pokhapokha pomwe kampaniyo idapeza "Layisensi Yopanga Zamakampani Padziko Lonse" yoperekedwa ndi Provincial Bureau of Quality and Technical Supervision ingavomerezedwe kupanga cellulose ether ngati chowonjezera cha chakudya.

Malinga ndi malamulo oyenera monga "Related Regulations on Strengthening the Supervision and Management of Pharmaceutical Excipients" loperekedwa ndi State Food and Drug Administration pa Ogasiti 1, 2012, mabizinesi ayenera kupeza "Chilolezo Chopanga Mankhwala" kuti apange makapisozi a mbewu ya HPMC, ndi mitunduyi iyenera kuyang'aniridwa ndi chakudya ndi mankhwala.layisensi yolembetsa yoperekedwa ndi Bureau.

(4)Zolepheretsa ndalama

Kupanga kwa cellulose ether kumakhala ndi zotsatira zoonekeratu.Zida zing'onozing'ono zomwe zimagwiritsidwa ntchito pamanja zimakhala ndi zotulutsa zochepa, zosakhazikika bwino, komanso chitetezo chochepa chopanga.Chida chachikulu chowongolera chodziwikiratu chimathandizira kuwonetsetsa kukhazikika kwamtundu wazinthu ndikuwongolera chitetezo chopanga.Zida zazikuluzikulu zathunthu zimafunikira ndalama zambiri.Kuti apititse patsogolo kupikisana kwazinthu, mabizinesi akuyenera kupitiliza kuyika ndalama pakukulitsa luso lopanga ndikukulitsa ndalama za R&D.Otsatira atsopano ayenera kukhala ndi mphamvu zolimba zachuma kuti athe kupikisana ndi makampani omwe alipo kale ndikukumana ndi zopinga zina zachuma kuti alowe mu malonda.

(5)Zolepheretsa zachilengedwe

Njira yopanga ma cellulose ether idzatulutsa madzi otayira ndi mpweya wotayirira, ndipo zida zoteteza zachilengedwe zopangira madzi otayira ndi mpweya wotayirira zili ndi ndalama zambiri, zofunikira zaukadaulo komanso ndalama zoyendetsera ntchito.Pakali pano, ndondomeko zoweta zachilengedwe zikuchulukirachulukira, zomwe zimayika patsogolo zofunikira paukadaulo wachitetezo cha chilengedwe komanso ndalama zopanga mapadi a cellulose, zomwe zimawonjezera mtengo wopangira mabizinesi ndikupanga chotchinga chambiri choteteza chilengedwe.Mabizinesi opanga ma cellulose ether okhala ndiukadaulo wakumbuyo woteteza chilengedwe komanso kuipitsa kwakukulu adzakumana ndi vuto loti athetsedwe.Makasitomala apamwamba ali ndi zofunikira zoteteza chilengedwe kwa opanga ma cellulose ether.Zikukhala zovuta kwambiri kwa mabizinesi omwe sakwaniritsa miyezo yachitetezo cha chilengedwe kuti apeze chiyeneretso chopereka makasitomala apamwamba.