| Itraconazole(ITZ) is a triazole antifungal agent, with extensive clinic application. The existed dosage forms of itraconazole are capsules, oral solutions and injections. To reduce the side effects and administration times, a gel of ITZ, which is a novel dosage form, was designed and prepared, so that patients' compliance and living quality are improved greatly.In pharmaceutical pre-formulation studies, High Performance Liquid Chromatography was established for studies of the Basic physical-chemical properties, contents, releases, octahol/water coefficient, quantity in rat skin of itraconazole in vitro and vivo assay. The largest solubility is 2.118mg/ml in polyethylene glycol-400. The studies of photodegradation kinetics of itraconazole showed that itraconazole was very unstable to light. It's photo-degradation was fitted to zero-order reaction..To raise the stability of ITZ to light and heat and its solubility in water, ITZ was included in HP-β-CD. By the single factors and orthogonal... |