目的 制备伊曲康唑阴道栓，并建立其质量控制方法。方法 以明胶、甘油、聚乙二醇等为基质制备伊曲康唑阴道栓，采用反相高效液相色谱法测定其含量，并用改良的栓剂释放度测定方法测定其体外释放。结果 伊曲康唑在10～100 μg·mL-1内线性关系良好，r=0.999 9，平均回收率为98.45%，RSD为1.37%。在37 ℃，栓剂在1 h内溶化，经Riger-Peppas方程拟合后释放参数n>0.89，表明该药物体外释放属于骨架溶蚀。结论 该栓剂制备方法简便易行，测定方法准确，采用改良的栓剂释放度测定方法能准确的测定栓剂体外释放。

OBJECTIVE To prepare itraconazole vaginal suppository and establish its quality control method. METHODS Gelatin，glycerin，polyethylene glycol，etc. were used as base materials and itraconazole as active ingredient to prepare the suppository. The content of suppository was determined with RP-HPLC，and the in vitro release was observed by improved suppository release determination method. RESULTS A good linearity was obtained from 10 to 100 μg·mL-1，r=0.999 9. The average recovery was 98.45%，and RSD was 1.37%. At 37 ℃，all suppositories melt within 1 h.The release parameter via Riger-Peppas equation simulation，n，was larger than 0.89，indicating that the drug release mechanism was erosion. CONCLUSION The suppository preparation method is easy. The determination is accurate. The in vitro release is accurately determined by improved suppository release determination method.