IHydroxylopyolin (HPMC) yipolymer esetyenziswa ngokubanzi kwishishini lamayeza kwaye iyifomula ebalulekileyo. Isetyenziswa kakhulu njenge-adhesive kwi-dosage eqinile (efana neepilisi, ii-capsules, kunye namasuntswana), i-viscosity yokuphucula i-agent kunye nokubola.
Ekulungiseleleni iziyobisi, ukuchithwa kwezinto ezisebenzayo kubalulekile ukufunxa kunye nokuvelisa umphumo wonyango. Nangona kunjalo, ukuchithwa kwezithako ezisebenzayo kunokuthintelwa yifomula. Ke ngoko, kubalulekile ukuqonda ukuziphatha okunyibilikayo kwe-HPMC kwifomula yechiza kuba ichaphazela ukusebenza kohlobo lwedosi.
Indlela yokuphelisa ye-HPMC
I-US Pharmacy (USP) ilungelelanise indlela yovavanyo lokunyibilikisa i-HPMC. Le ndlela idla ngokubandakanya ukusetyenziswa kwezixhobo zokunyibilikisa, ezilinganisa kwaye zilinganise ukunyibilika kohlobo lwedosi phakathi kwesisombululo esiphakathi. Uvavanyo lubandakanya ukubeka idosi kwibhaskithi okanye i-paddle, kunye nebhasikithi okanye i-paddle ijikeleza kwisitya esiqulethe i-medium medium.
I-solubility medium kufuneka ikhethwe ngokuhambelana nokusetyenziswa okulindelweyo kwedosi (efana ne-gastric okanye intestinal dissolving). Isixhobo se-solubility eqhelekileyo se-HPMC sibandakanya amanzi, isisombululo se-phosphate buffer kunye ne-simulation gastric juice (SGF) okanye i-analog intestinal fluid (SIF).
Ukuqinisekisa ukuphindaphinda kunye nokuchaneka, iiparamitha zovavanyo kufuneka zibekwe emgangathweni, njengesantya sokujikeleza, ubushushu, kunye nokunyibilikisa umthamo ophakathi kunye nexesha lesampulu. Emva koko sebenzisa indlela yokuhlalutya efanelekileyo ukuhlalutya isisombululo sesampulu esifunyenwe ngamaxesha ahlukeneyo ahlukeneyo ukugqiba inani lokuchithwa kwe-HPMC.
Amanyathelo othintelo Xa usenza iimvavanyo zokunyibilikisa i-HPMC
1. Ukukhethwa kwendlela efanelekileyo yokunyibilikisa: Ukukhethwa kwendlela yokuchithwa kusekelwe kusetyenziso olulindelekileyo lwefom yedosi. Ukukhetha i medium dissolution efanelekileyo kubaluleke kakhulu kuba kuya kuchaphazela ukuziphatha ukunyibilika HPMC.
2. Ukuqinisekisa ngokuchanekileyo indlela ye-solubility: Ukuqinisekisa indlela ye-solubility ukuqinisekisa ukuba ifanelekile kwaye kubalulekile ukuhlangabezana neemfuno ze-arhente yokulawula. Ukuqinisekiswa kufuneka kubandakanye ukomelela kunye nokuphindaphinda komlinganiselo.
3. Ukulinganisa iiparitha zokuvavanya: Iiparitha zokuvavanya, ezifana nesantya sokujikeleza, ubushushu, kunye nomthamo ophakathi ochithiweyo zichaphazela isiphumo sokuchithwa kweemvavanyo. Ke ngoko, ezi parameters kufuneka zibekwe emgangathweni ukuqinisekisa ukuvela kwakhona kunye nohlalutyo oluchanekileyo.
4. Isampulu: Iisampulu ngononophelo ibalulekile ekufumaneni iisampulu ezimele kwi-dissolving medium. Nika ingqalelo kwixesha kunye namanqaku esampuli ukuqinisekisa ukuba isampuli iqokelelwa kwixesha elidibeneyo.
5. Indlela yokuhlalutya: Khetha indlela yokuhlalutya uhlalutyo iya kuqinisekiswa, kwaye kufuneka ibe novelwano olufanelekileyo, ukukhetha kunye nokuchaneka.
Ngamafutshane, uvavanyo lokunyibilika kwe-HPMC sisixhobo esibalulekileyo kuphuhliso lwamachiza kunye nefomula yamachiza. Ilabhoratri yokulawula umgangatho iqhutyelwa rhoqo ukuze kuqinisekiswe ukukhululwa okuchanekileyo kwezithako ezisebenzayo, kwaye ichiza likhuselekile kwaye lisebenza. Impazamo kwindlela yokuvavanya efanelekileyo inokukhokelela ekungaqondani kunye neengxelo zobuxoki malunga nokusebenza kwamachiza. Ngoko ke, kubalulekile ukulandela imigangatho kunye nemilinganiselo yokukhusela ngexesha lovavanyo lokuchithwa.
Ixesha lokuposa: Jun-29-2023