(1) Zvipingamupinyi zvehunyanzvi
Vatengi vepasi pemvuraether ye cellulosevane zvinodiwa zvepamusoro pamhando uye kugadzikana kwe cellulose ether. Tekinoroji yekudzora mhando chinhu chakakosha muindasitiri ye cellulose ether. Vagadziri vanofanirwa kugona magadzirirwo ekugadzira michina yepakati, kudzora ma parameter akakosha ekugadzira, maitiro ekugadzira core, kugadzira zviyero zvekushanda, uye mushure menguva yakareba yekugadzirisa nekugadzirisa tekinoroji, vanogona kugadzira cellulose ether yemhando yepamusoro uye yakagadzikana; Mushure menguva yakareba yekudyara kwekutsvaga ndipo patinogona kuunganidza ruzivo rwakakwana mumunda wekushandisa. Zvakaoma kumabhizinesi matsva anopinda muindasitiri iyi kugona tekinoroji yepakati munguva pfupi. Kuti vagone kugadzira mishonga yakawanda uye cellulose ethers yemhando yepamusoro ine mhando yakagadzikana (kunyanya cellulose ethers yekuburitsa zvishoma nezvishoma uye inodzorwa), zvinodawo huwandu hwakati hwekudyara nekutsvaga kana nguva yekuunganidza ruzivo. Saka, kune zvimwe zvipingamupinyi zvehunyanzvi muindasitiri iyi.
(2) Zvipingamupinyi kumatarenda ebasa
Mukugadzira nekushandisa cellulose ether, pane zvinodiwa zvakanyanya zvemhando yepamusoro uye hunyanzvi hwevashandi vehunyanzvi, vashandi nevatungamiriri. Vashandi vehunyanzvi vanoramba vakagadzikana. Zvakaoma kune vazhinji vatsva kuti vawane hunyanzvi hwehunyanzvi neR&D uye matekinoroji epakati munguva pfupi, uye kune zvipingamupinyi zvehunyanzvi hwehunyanzvi.
(3) Zvipingamupinyi zvekukodzera
Makambani eCellulose ether anofanirwa kuwana zvitupa zvakakodzera kuti agadzire nekutengesa ether yemhando ye pharmaceutical grade cellulose uye ether yemhando yefood cellulose.
Pakati pazvo, pharmaceutical grade cellulose ether chinhu chakakosha chinoshandiswa mumishonga, uye hunhu hwayo hunokanganisa zvakananga kuchengetedzeka kwemishonga. Kuti ive nechokwadi chekuti mishonga yakachengeteka, nyika yangu inoshandisa nzira yekupa marezenisi ekugadzira mishonga. Kuti isimbise kutarisirwa kweindasitiri yemishonga, hurumende yakagadzira mitemo nemirau maererano nekuwana, kugadzira uye kushanda kweindasitiri. Sekureva kwe "Tsamba yeKudhinda neKugovera Zvinodiwa zvekunyoresa nekushandisa Pharmaceutical Excipients" yakapihwa neState Food and Drug Administration, manejimendi ekugadzira marezenisi emishonga anoitwa, uye mishonga mitsva inobatanidzwa mumishonga nemishonga inopinzwa kunze kwenyika inotenderwa neNational Bureau. Kune atove nemishonga yenyika yakajairwa yakatenderwa neprovincial bureau. Kutarisirwa kwehurumende kwemishonga inobatanidzwa mumishonga kuri kuramba kuchiwedzera kuoma, uye mapurovhinzi nemaguta akasiyana-siyana akagadzira matanho ekutarisira anoenderana zvichienderana ne "Administrative Measures for Pharmaceutical Excipients (Draft for Comment)" yakapihwa nehurumende. Mune ramangwana, kana mabhizinesi asingakwanise kugadzira zvinhu zvinobatsira mumishonga zvinoenderana nemitemo yenyika, angasakwanisa kupinda mumusika. Vasati vasarudza kana kutsiva imwe mhando kana rudzi rwe pharmaceutical grade cellulose ether, vagadziri vemishonga vanofanirwa kupasa ongororo uye kuisa magwaro kune vane hunyanzvi vasati vatenga nekuishandisa zviri pamutemo. Pane zvimwe zvipingamupinyi mukubvumidzwa kwevagadziri vemishonga kune vatengesi. . Chete mushure mekunge bhizinesi rawana "National Industrial Product Production License" yakapihwa neProvincial Bureau of Quality and Technical Supervision ndipo panogona kutenderwa kugadzira cellulose ether sechikafu chinowedzera.
Zvinoenderana nemitemo yakakodzera yakaita se "Related Regulations on Strengthening the Supervision and Management of Pharmaceutical Excipients" yakaburitswa neState Food and Drug Administration musi wa1 Nyamavhuvhu, 2012, mabhizinesi anofanirwa kuwana "Drug Production License" kuti agadzire macapsules eHPMC plant, uye mhando dzemishonga dzinofanira kuwana rezinesi rekunyoresa renyika rinopihwa neBureau.
(4) Zvipingamupinyi zvemari
Kugadzirwa kwe cellulose ether kune mhedzisiro yakajeka. Midziyo midiki inoshandiswa nemaoko ine simba shoma rekugadzira, kugadzikana kwemhando isina kunaka, uye kuchengetedzeka kushoma kwekugadzirwa. Mudziyo mukuru wekudzora otomatiki unobatsira kuona kugadzikana kwemhando yechigadzirwa uye kuvandudza kuchengetedzeka kwekugadzirwa. Midziyo yakakura yakakwana ye otomatiki inoda mari yakawanda. Kuti kusimudzira kukwikwidzana kwechigadzirwa, mabhizinesi anofanirwa kuramba achiisa mari mukuwedzera kugona kwekugadzira uye kuwedzera mari yekudyara muR&D. Vatsva vanofanirwa kuve nesimba rakasimba remari kuti vakwikwidzane nemakambani aripo uye vasangane nezvimwe zvipingamupinyi zvemari kuti vapinde muindasitiri.
(5) Zvipingamupinyi zvezvakatipoteredza
Maitiro ekugadziraether ye celluloseichagadzira mvura yakasviba negasi rakasviba, uye michina yekudzivirira zvakatipoteredza yekurapa mvura yakasviba negasi rakasviba ine mari yakawanda yekudyara, zvinodiwa zvehunyanzvi uye mitengo yakakwira yekushanda. Parizvino, mutemo wekuchengetedza zvakatipoteredza wemuno uri kuramba uchioma, izvo zvinoisa zvinodiwa zvakasimba patekinoroji yekudzivirira zvakatipoteredza nekudyara mukugadzirwa kwe cellulose ether, izvo zvinowedzera mutengo wekugadzira wemabhizinesi uye zvinoumba chipingamupinyi chakakwira chekuchengetedza zvakatipoteredza. Makambani ekugadzira cellulose ether ane tekinoroji yekuchengetedza zvakatipoteredza yakadzoka shure uye kusvibiswa kwakakomba achatarisana nemamiriro ezvinhu ekubviswa. Vatengi vepamusoro-soro vane zvinodiwa zvepamusoro zvekuchengetedza zvakatipoteredza zvevagadziri ve cellulose ether. Zviri kuramba zvichiwedzera kuoma kumabhizinesi asingasvike pamitemo yekudzivirira zvakatipoteredza kuti awane chitupa chekupa vatengi vepamusoro-soro.
Nguva yekutumira: Kubvumbi-28-2024