Ukulungisa izixazululo zokuhlanganisa i-hydroxypropyl methylcellulose (HPMC) kuhilela izinyathelo eziningi futhi kudinga ukunakwa ngokucophelela emininingwaneni. I-HPMC ivamise ukusetshenziswa njengento yokuhlanganisa ifilimu ezimbonini zemithi nezokudla. Izixazululo zokumboza zisetshenziselwa amaphilisi noma ama-granules ukunikeza ungqimba oluvikelayo, ukuthuthukisa ukubukeka, nokwenza lula ukugwinya.
1. Isingeniso se-HPMC coating:
IHydroxypropylmethylcellulose (HPMC) iyi-polymer esekwe ku-cellulose etholakala emicu yezitshalo. Ngenxa yezakhiwo zayo zokwakheka kwefilimu nokujiya, isetshenziswa kabanzi embotsheni yefilimu ezimbonini zemithi nezokudla.
2. Izinto ezidingekayo:
I-Hydroxypropyl methylcellulose powder
Hlanza amanzi
Izitsha zepulasitiki noma zensimbi engagqwali
Izinto zokusebenza ezinyakazayo (isb. i-stirrer magnetic)
Izinsimbi zokulinganisa (izikali, amasilinda okulinganisa)
pH imitha
Ipulasitiki noma i-stainless steel coating pan
Ihhavini yomoya oshisayo
3.uhlelo:
Kala i-HPMC:
Kala ngokunembile inani elidingekayo le-HPMC powder esekelwe ekwakhiweni kwe-coating oyifunayo. Ukugxila kuvame ukuba phakathi kuka-2% no-10%.
Lungiselela amanzi ahlanzekile:
Sebenzisa amanzi ahlanzekile ukuqinisekisa ukuthi akukho ukungcola okungase kuthinte ikhwalithi yokumboza. Amanzi kufanele abe ekamelweni lokushisa.
Ukusatshalaliswa kwe-HPMC:
Faka kancane kancane impushana ye-HPMC enesisindo emanzini ahlanziwe ngenkathi ugqugquzela njalo. Lokhu kuvimbela ukwakheka kwama-clumps.
Govuza:
Gcoba ingxube usebenzisa i-stirrer kazibuthe noma esinye isisetshenziswa esifanelekile esishukumisayo kuze kube yilapho impushana ye-HPMC isihlakazeke ngokuphelele emanzini.
Ukulungiswa kwe-pH:
Linganisa i-pH yesisombululo se-HPMC usebenzisa imitha ye-pH. Uma kunesidingo, i-pH ingalungiswa ngokungeza inani elincane le-asidi noma isisekelo ngokufanele. I-pH efanelekile yokumbozwa kwefilimu ivamise ukuba phakathi kuka-5.0 kuya ku-7.0.
Ukuswakama nokuguga:
Isixazululo se-HPMC sivunyelwe ukufaka amanzi kanye nobudala isikhathi esithile. Lokhu kuthuthukisa izakhiwo zokwakha ifilimu. Isikhathi sokuguga singahluka kodwa ngokuvamile sisebangeni lamahora angu-2 kuya kwangu-24.
isihlungi:
Hlunga isixazululo se-HPMC ukuze ususe noma yiziphi izinhlayiya ezingancibilikisiwe noma ukungcola. Lesi sinyathelo sibalulekile ukuze uthole isisombululo esibushelelezi, esicacile sokumboza.
Ukulungiswa kwe-viscosity:
Linganisa i-viscosity yesisombululo bese uyilungisa ezingeni oyifunayo. I-viscosity ithinta ukufana nokushuba kwe-coating.
Ukuhambisana kokuhlolwa:
Hlola ukuhambisana kwesisombululo sokumboza ne-substrate (amaphilisi noma ama-granules) ukuze uqinisekise ukunamathela okufanele kanye nokwakheka kwefilimu.
Inqubo yokumboza:
Sebenzisa i-pan yokugqoka efanelekile futhi usebenzise umshini wokumboza ukuze usebenzise isisombululo se-HPMC sokumboza kumaphilisi noma ama-granules. Lungisa isivinini sebhodwe nezinga lokushisa lomoya ukuze uthole ukunamathela okulungile.
ukomisa:
Amathebulethi amboziwe noma ama-granules omisiwe kuhhavini yomoya oshisayo olawulwa izinga lokushisa kuze kube yilapho ugqinsi olufunwayo lufinyelelwa.
I-QC:
Yenza ukuhlolwa kokulawulwa kwekhwalithi yemikhiqizo eboshiwe okuhlanganisa ukubukeka, ukujiya kanye nezakhiwo zokuhlakazeka.
4. Ekuphetheni:
Ukulungiswa kwezixazululo zokugqoka ze-HPMC kuhilela uchungechunge lwezinyathelo eziqondile zokuqinisekisa ikhwalithi nokusebenza kahle kwe-coating. Ukuhambisana nezinqubo ezinqunyiwe kanye nezinyathelo zokulawula ikhwalithi kubalulekile ekutholeni imiphumela engaguquki nethembekile ezimbonini zemithi nokudla. Hlala ulandela Imikhuba Emihle Yokukhiqiza (GMP) kanye nemihlahlandlela ehlobene phakathi nenqubo yokumboza.
Isikhathi sokuthumela: Jan-18-2024