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Ndezvipi zvipingamupinyi zvikuru zvekupinda muindasitiri yemumba cellulose ether?

(1)Zvipingamupinyi zvehunyanzvi

Kudzika kwevatengi ve cellulose ether vane zvinodiwa zvepamusoro pamhando uye kugadzikana kwe cellulose ether.Hunhu hwekudzora tekinoroji chinhu chakakosha chehunyanzvi chipingamupinyi muindasitiri ye cellulose ether.Vagadziri vanofanirwa kugona dhizaini yekufananidza kuita kweiyo core equipment, kiyi parameter kudzora kwekugadzirwa kwemaitiro, musimboti wekugadzira maitiro, kugadzira maitiro ekushanda, uye mushure menguva yakareba yekubvisa uye kuenderera mberi kwehunyanzvi hwekuvandudza, vanogona kugadzira yakagadzikana uye yepamusoro-mhando cellulose ether;Chete mushure menguva yakareba yekutsvaga mari yekutsvagisa tinogona kuunganidza ruzivo rwakakwana mumunda wekunyorera.Zvakaoma kumabhizinesi matsva anopinda muindasitiri kuti agone tekinoroji yepakati munguva pfupi.Kuti ugone kugadzirwa kwakakura kwemishonga uye chikafu-giredhi cellulose ethers nemhando yakagadzikana (kunyanya cellulose ethers yekunonoka uye inodzorwa kuburitswa), zvinodawo imwe huwandu hwekutsvaga nekusimudzira mari kana nguva yekuunganidza.Naizvozvo, pane zvimwe zvipingamupinyi zvehunyanzvi muindasitiri iyi.

(2)Zvipingamupinyi kune matarenda enyanzvi

Mumunda wekugadzira uye kushandiswa kwe cellulose ether, pane zvakakwirira zvinodikanwa zvemhando uye tekinoroji nhanho yenyanzvi dzehunyanzvi, vashandisi uye maneja.Iwo main technicians nevashandisi vanoramba vakagadzikana.Zvakaoma kune vazhinji vatsva vanopinda kuti vawane matarenda ehunyanzvi neR&D uye misimboti tekinoroji munguva pfupi pfupi, uye kune zvipingaidzo zvematarenda ehunyanzvi.

(3)Zvipingamupinyi zvekukodzera

Mabhizinesi eCellulose ether anoda kuwana magwaro akakodzera kugadzira uye kutengesa mishonga giredhi cellulose ether uye chikafu giredhi cellulose ether.

Pakati pavo, pharmaceutical grade cellulose ether inokosha yemishonga excipient, uye kunaka kwayo kunobata zvakananga kuchengetedzwa kwemishonga.Kuti ndive nechokwadi chekuchengetedzwa kwezvinodhaka, nyika yangu inoshandisa nzira yekupa marezinesi ekugadzira zvinodhaka.Nekuda kusimbisa kutariswa kweindasitiri yemishonga, nyika yakagadzira nhevedzano yemitemo nemirau maererano nekuwana maindasitiri, kugadzira uye kushanda.Zvinoenderana ne "Tsamba yeKudhinda uye Kugovera Zvinodiwa Kunyoreswa uye Kushandiswa kweMishonga Excipients" yakapihwa neHurumende Chikafu neDrug Administration, rezinesi rekugadzira rezenisi rezvigadzirwa zvemishonga rinoitwa, uye mitsva yemishonga yemishonga uye inounzwa kunze kwemishonga inoenderana. kubvumidzwa kweNational Bureau.Patova nemhando dzepasi rose dzemishonga yemishonga Yakatenderwa nebazi redunhu.Matarisiro ehurumende ezvemishonga yemishonga ari kuramba achiwedzera kuoma, uye mapurovhinzi akasiyana siyana nemaguta akagadzira matanho ekutonga anoenderana ne “Administrative Measures for Pharmaceutical Excipients (Draft for Comment)” yakapihwa nenyika.Mune ramangwana, kana mabhizinesi asingakwanise kuburitsa mishonga yemishonga inoenderana nemitemo yenyika, anogona kusakwanisa kupinda mumusika.Vasati vasarudza kana kutsiva imwe mhando kana mhando yemishonga yegiredhi cellulose ether, vagadziri vemishonga vanofanirwa kupasa kuongororwa uye kufaira neane masimba vasati vatenga zviri pamutemo nekuishandisa.Pane zvimwe zvipingamupinyi mumvumo yekukodzera yevagadziri vemishonga kune vatengesi..Chete mushure mekunge bhizinesi rawana "National Industrial Product Production License" yakapihwa neProvincial Bureau yeHunhu uye Technical Supervision inogona kubvumidzwa kugadzira cellulose ether sekuwedzera kwechikafu.

Zvinoenderana nemirau yakakodzera senge "Inoenderana Mitemo Yekusimbisa Kutarisira uye manejimendi eMishonga Excipients" yakapihwa neState Food and Drug Administration musi waNyamavhuvhu 1, 2012, mabhizinesi anofanirwa kuwana "Drug Production License" kugadzira HPMC chirimwa capsules, uye mhando dzinofanirwa kuwana chikafu chenyika uye chekutarisa zvinodhaka.rezinesi rekunyoresa rakapihwa neBureau.

(4)Zvipingamupinyi zvekubhadhara mari

Kugadzirwa kwe cellulose ether kune pachena chiyero chekuita.Zvishandiso zvidiki zvinofambiswa nemaoko zvine kuburitsa kwakaderera, kusagadzikana kwemhando yepamusoro, uye kuderera kwekuchengetedza kuchengetedza chinhu.Iyo hombe-yakakura otomatiki yekudzora mudziyo inobatsira pakuona kugadzikana kwemhando yechigadzirwa uye kugadzirisa kuchengetedzwa kwekugadzirwa.Maseti akakura akazara emidziyo otomatiki inoda mari yakawanda.Kuti uvandudze kukwikwidza kwechigadzirwa, mabhizinesi anofanirwa kuenderera mberi nekudyara mukuwedzera huwandu hwekugadzira uye kuwedzera R&D investimendi.Vatsva vanopinda vanofanira kunge vaine simba rakasimba rezvemari kuitira kuti vakwikwidze nemakambani aripo uye vatarise zvimwe zvipingamupinyi zvemari kuti vapinde muindasitiri.

(5)Zvipingamupinyi zvezvakatipoteredza

Iyo nzira yekugadzira ye cellulose ether inoburitsa tsvina yemvura uye gasi remarara, uye midziyo yekudzivirira kwezvakatipoteredza yekurapa tsvina yemvura uye gasi remarara ine mari yakakura, yakakwira tekinoroji zvinodiwa uye yakakwira mutengo wekushandisa.Parizvino, mutemo wekuchengetedza kwezvakatipoteredza wepamba uri kuramba uchiwedzera kuomarara, izvo zvinoisa pamberi pakasimba zvinodikanwa pane tekinoroji yekudzivirira kwezvakatipoteredza uye kudyara mukugadzirwa kwe cellulose ether, iyo inowedzera mutengo wekugadzira wemabhizinesi uye inoumba yakanyanyisa kudzivirira kwezvakatipoteredza.Cellulose ether kugadzira mabhizinesi ane kumashure ekuchengetedza nharaunda tekinoroji uye kusvibiswa kwakakomba kuchasangana nemamiriro ekubviswa.Vatengi vepamusoro-soro vane zvinodiwa zvekuchengetedza zvakatipoteredza kune vanogadzira cellulose ether.Izvo zviri kuramba zvichiwedzera kuoma kumabhizinesi asingasviki mazinga ekuchengetedza kwezvakatipoteredza kuti awane hunhu hwekupa vatengi vepamusoro.


Nguva yekutumira: Kubvumbi-10-2023