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I-Hypromellose Excipient | Ukusetshenziswa, Abahlinzeki, kanye Nemininingwane

I-Hypromellose Excipient | Ukusetshenziswa, Abahlinzeki, kanye Nemininingwane

IHypromellose, eyaziwa nangokuthi i-hydroxypropyl methylcellulose (HPMC), iyisakhi esiguquguqukayo esivame ukusetshenziswa kwezemithi, izimonyo, imikhiqizo yokudla, kanye nezinhlelo zokusebenza ezahlukahlukene zezimboni. Nakhu ukubuka konke kwe-hypromellose excipient, okuhlanganisa ukusetshenziswa kwayo, abahlinzeki, kanye nokucaciswa kwayo:

Isebenzisa:

  1. Ezemithi: I-Hypromellose isetshenziswa kabanzi njengesamukeli sezemithi kumafomu omthamo oqinile womlomo njengamaphilisi, amaphilisi, nama-granules. Isebenza njenge-binder, disintegrant, thickener, kanye ne-ejenti eyenza ifilimu, inikele kuzakhiwo zomzimba nezomshini zamafomu omthamo.
  2. Izixazululo ze-Ophthalmic: Ekwenziweni kwamehlo, i-hypromellose isetshenziswa njenge-lubricant kanye ne-viscosity-enhancing ejenti kumaconsi esweni namafutha ukuze kuthuthukiswe ukugeleza kwe-ocular nokwandisa isikhathi sokuhlala kwezidakamizwa endaweni ye-ocular.
  3. Amalungiselelo Asesihloko: I-Hypromellose ihlanganiswa ekwakhiweni kwesihloko okufana nokhilimu, amajeli, namaloshini njenge-ejenti ejiyayo, i-emulsifier, kanye ne-stabilizer ukuze kuthuthukiswe ukuvumelana komkhiqizo, ukusabalala, nempilo yeshalofu.
  4. Amafomu Okukhishwa Okulawulwayo: I-Hypromellose isetshenziswa ekwakhiweni kokukhishwa okulawulwayo kanye nokukhishwa okuqhubekayo ukuze kulungiswe i-kinetics yokukhishwa kwezidakamizwa, inikeze amaphrofayili anwetshiwe okukhululwa kwezidakamizwa kanye nokuthobelana kwesiguli okuthuthukisiwe.
  5. Imikhiqizo Yokudla: Embonini yokudla, i-hypromellose isetshenziswa njenge-ejenti ejiyayo, i-stabilizer, ne-emulsifier emikhiqizweni ehlukahlukene yokudla, okuhlanganisa amasoso, okokugqoka, ama-dessert, nezimpahla ezibhakiwe.
  6. Izimonyo: I-Hypromellose ifakwe ekwenziweni kwezimonyo njengokhilimu, izinto zokuthambisa, nemikhiqizo yezimonyo njenge-ejenti ejiyayo, eyake yaba yifilimu, kanye ne-ejenti egcina umswakama ukuze kuthuthukiswe ukuthungwa nokusebenza komkhiqizo.

Abahlinzeki:

I-Hypromellose excipient itholakala kubahlinzeki abaningi emhlabeni jikelele. Abanye abahlinzeki nabakhiqizi abavelele bahlanganisa:

  1. I-Ashland Global Holdings Inc.: I-Ashland inikeza inhlobonhlobo yemikhiqizo ye-hypromellose ngaphansi kwamagama ebhrendi i-Benecel® ne-Aqualon™, ebhekelela izicelo zemithi nezokunakekelwa komuntu siqu.
  2. I-Kima Chemical Co., Ltd: I-Kima Chemical ihlinzeka ngemikhiqizo esekwe ku-hypromellose ngaphansi kwegama lomkhiqizoKIMACELL, ezisetshenziswa kwezemithi, ekudleni nasezimbonini.
  3. I-Shin-Etsu Chemical Co., Ltd.: I-Shin-Etsu yenza imikhiqizo esekwe ku-hypromellose ngaphansi kwegama lomkhiqizo i-Pharmacoat ™, ehlinzeka ngezimboni zemithi, zokudla, nezimonyo.
  4. I-Colorcon: I-Colorcon ihlinzeka ngezinto ezisizayo ezisuselwa ku-hypromellose ngaphansi kwegama lomkhiqizo i-Opadry®, ezidizayinelwe ukumboza ifilimu yethebhulethi kanye nokwakhiwa kokwakhiwa.
  5. I-JRS Pharma: I-JRS Pharma inikeza uchungechunge lwemikhiqizo ye-hypromellose ngaphansi kwegama lomkhiqizo i-Vivapur®, eklanyelwe ngokukhethekile ukusetshenziswa kwemithi njengokubopha amaphilisi, ukuhlakazeka, nokukhululwa okulawulwayo.

Imininingwane:

Imininingwane ye-hypromellose excipient ingahluka kuye ngokusetshenziswa kwayo okuhlosiwe kanye nezidingo zokulawula. Ukucaciswa okujwayelekile kufaka:

  • I-Viscosity: I-Hypromellose itholakala kumabanga ahlukahlukene e-viscosity, ngokuvamile asukela kokuphansi kuya kokubonakala okuphezulu, ukuze kuhlangatshezwane nezidingo ezithile zokubunjwa.
  • Usayizi Wezinhlayiyana: Ukusatshalaliswa kosayizi we-particle kungase kuthinte izakhiwo zokugeleza kanye nokucindezelwa kwezimpushana ze-hypromellose, kuthinte izinqubo zokukhiqiza amaphilisi.
  • Okuqukethwe Umswakama: Okuqukethwe komswakama kuyipharamitha ebalulekile engathinta ukuzinza nokusebenza kokwakheka okusekelwe ku-hypromellose.
  • Ukuhlanzeka kanye Nokungcola: Imininingwane yobumsulwa, kanye nemikhawulo yokungcola okufana nezinsimbi ezisindayo, izincibilikisi ezisalelayo, nokungcola kwamagciwane, iqinisekisa ikhwalithi nokuphepha kwemikhiqizo ye-hypromellose yokusetshenziswa kwemithi nokudla.
  • Ukuhambisana: I-Hypromellose kufanele ihambisane nezinye izinto ezisizayo kanye nezithako ezisebenzayo ekwakhiweni, kanye nezindlela zokucubungula kanye nemishini esetshenziswa ekukhiqizeni.

Lapho uthola i-hypromellose excipient, kubalulekile ukuthola izitifiketi zokuhlaziya (CoA) kanye nemibhalo yokuthobelana evela kubahlinzeki ukuze uqinisekise ukuthi umkhiqizo uhlangabezana nemibandela edingekayo kanye namazinga okulawula ohlelo oluhlosiwe. Ukwengeza, ukusebenzisana nabahlinzeki abaqeqeshiwe kanye nokubambelela ezenzweni ezinhle zokukhiqiza (GMP) kubalulekile ukuze kuqinisekiswe ikhwalithi, ukungaguquguquki, kanye nokuthotshelwa kwemithetho yokwakheka okusekelwe ku-hypromellose.


Isikhathi sokuthumela: Feb-09-2024
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