| 摘要 |
<p>PURPOSE: A method for preparing non-crystalline cefuroxime axetil solid dispersion by using supercritical solvent-resistant process and non-crystalline cefuroxime axetil solid dispersion prepared thereby are provided, which non-crystalline cefuroxime axetil solid dispersion has high solubility, uniformed diameter of micrometer or less, increased specific surface area, and does not form gel when it contacts with aqueous solution, so that elution rate cannot be affected by the dissolving time. CONSTITUTION: The method for preparing non-crystalline cefuroxime axetil solid dispersion comprises the steps of: (1) dissolving cefuroxime axetil and pharmaceutically acceptable additives selected from hydrophilic polymer, surfactant and a combination thereof in organic solvent to prepare a mixed solution; (2) spraying the mixed solution into a reactor having supercritical carbon dioxide condition of 45 deg. C and 100 to 150 bar and introducing carbon dioxide into the reactor to form particles of cefuroxime axetil and additive mixture; and (3) introducing additional supercritical carbon dioxide into the reactor, wherein the hydrophilic polymer is selected from celluloses, polyethyleneglycol, povidone and a mixture thereof.</p> |
