Txoj kev kawm stability ntawmCov tshuaj abiraterone acetatetsom rau kev sib raug zoo ntawm nws cov qauv tshuaj thiab kev cia khoom. Los ntawm kev tshawb xyuas qhov cuam tshuam ntawm qhov kub thiab txias, av noo thiab lub teeb ntawm nws qhov degradation, qhov ruaj khov thiab kev cia khoom yuav tsum tau txhais. Cov yam ntxwv ruaj khov ntawm abiraterone acetate muab lub hauv paus kev tshawb fawb rau nws txoj kev tsim kho thiab kev tswj kom zoo.
Kub exerts ib qho tseem ceeb cuam tshuam rau stability ntawm abiraterone acetate. Raws li kev ntsuas ceev ceev (40℃/ 75% RH), tus nqi degradation txhua hli nce mus txog 2% -3%, nrog rau txoj kev degradation tseem ceeb yog ester bond hydrolysis los ua abiraterone (cov ntsiab lus tsawg dua lossis sib npaug li 1.5%). Nyob rau hauv lub sijhawm ntev - lub sijhawm khaws cia (25℃/ 60% RH), tus nqi degradation nyob rau hauv 6 lub hlis yog Tsawg dua lossis sib npaug li 0.5%, thiab lub neej txee tuaj yeem teem sijhawm ntau dua 24 lub hlis. Abiraterone acetate yog ruaj khov nyob rau hauv lub xeev ruaj tshaj nyob rau hauv lub xeev cov tshuaj; nws degradation tus nqi nyob rau hauv aqueous tov ntawm 30℃yog 5-8 npaug ntawm cov khoom nyob rau hauv lub xeev. Yog li ntawd, cov ntaub ntawv ntau npaum li cas yog nyiam rau nws txoj kev npaj tsim.
Cov av noo yog qhov tseem ceeb cuam tshuam rau kev ruaj ntseg ntawm abiraterone acetate. Nyob rau hauv qhov chaw siab -cov av noo (qhov txheeb ze humidity ＞ 75%), cov hmoov khoom absorbs noo noo thiab nce qhov hnyav (qhib noo noo ntau dua lossis sib npaug li 5% hauv 24 teev), ua rau cov khoom siv lead ua hloov pauv ntawm daim ntawv ruaj khov A mus rau daim ntawv B metastable, nrog rau 1-2 gradation tus nqi nce ntxiv. Txoj kev tshawb fawb ruaj khov qhia tau hais tias qhov tseem ceeb ntawm cov av noo ntawm abiraterone acetate yog 65% -70%. Thaum lub sij hawm cia, cov av noo ib puag ncig yuav tsum tau tswj hauv qab no ntau yam, los yog txhuas{11}} ntim cov hnab yas (nqus permeability tsawg dua lossis sib npaug li 0.1 g / hnub) yuav tsum tau txais.
Lub teeb muaj qhov tshwj xeeb cuam tshuam rau kev ruaj ntseg ntawm abiraterone acetate. Nyob rau hauv ultraviolet irradiation (254 nm), qhov degradation tus nqi nce nrog lub teeb siv. Tus nqi degradation nce mus txog 5% -8% ntawm qhov kev siv irradiation ntawm 1.2 × 10⁶ lux·h, feem ntau tsim cov khoom oxidation xws li N- oxide (cov ntsiab lus tsawg dua lossis sib npaug li 0.8%). Hauv kev kawm ruaj khov ntawm abiraterone acetate, amber iav fwj lossis lub teeb- nruj aluminium foil ntim yuav tsum tau siv rau lub teeb - pov thawj cia (lub teeb xa hluav taws xob tsawg dua lossis sib npaug li 5%) kom tsis txhob photocatalytic degradation.
Excipient compatibility cuam tshuam rau kev ruaj ntseg ntawm abiraterone acetate npaj. Nws qhia tau hais tias muaj kev sib raug zoo nrog cov khoom siv xws li magnesium stearate thiab microcrystalline cellulose, nrog tus nqi degradation tsawg dua lossis sib npaug li 0.5% tom qab 3 lub hlis ntawm kev sib xyaw cia. Txawm li cas los xij, thaum sib cuag nrog cov hlau ion- muaj cov khoom siv ntxiv xws li hlau oxide pigments, tus nqi degradation nce 1.5-2 zaug, thiab kev sib xyaw ncaj qha yuav tsum zam. Nws raug pom zoo kom ntxiv 0.1% -0.3% antioxidants (piv txwv li, BHT) rau kev tsim, uas tuaj yeem txo qis oxidative degradation tus nqi los ntawm 40% -50%.
Txoj kev tshawb nrhiav kev ruaj ntseg ntawm abiraterone acetate qhia nws qhov rhiab heev rau qhov kub, av noo thiab lub teeb. Cov kev tshawb fawb tshawb pom qhia txog kev tsim cov txheej txheem khaws cia (2-8 degree, tiv thaiv los ntawm lub teeb thiab noo noo) thiab tsim qauv, muab cov ntaub ntawv tseem ceeb los txhawb kev ruaj ntseg ntawm cov tshuaj thoob plaws hauv nws lub neej txee.
