目的 考察羟丙基淀粉空心胶囊与市售氧氟沙星胶囊药物颗粒的相容性。方法 将样品分别置于高温(40 ℃)、高湿相对湿度(75±5)%条件下放置5和10 d,高效液相色谱法检测氧氟沙星的含量及有关物质,并比较放置前后含量及有关物质有无变化,同时观察药物颗粒的外观、色泽等药物性状的变化。结果 高温、高湿条件下0、5、10 d的样品所测含量均在标示量的90%～110%之内,而且有关物质未检测出新的杂质,含量和有关物质检测结果均符合《中国药典》2010年版第二部中氧氟沙星胶囊的标准。结论 氧氟沙星与羟丙基淀粉空心胶囊二者的相容性良好,与明胶胶囊结果一致。

OBJECTIVE To investigate the compatibility of hollow hydroxypropyl starch capsules with drug particles of ofloxacin. METHODS The capsules were placed in conditions of high temperature of 40 ℃ or high humidity of (75±5)% RH for 5 and 10 d, respectively. The contents and related substances were determined by high performance liquid chromatography(HPLC), and the changes in the drug appearance and colors were observed. RESULTS After being stored under the conditions of high temperature and high humidity for 5 and 10 d, the contents of ofloxacin were in the range of 90%-110%, and no new impurities were detected, which conformed to the quality standard of ofloxacin capsules in the Chinese Pharmacopoeia 2010 edition. CONCLUSION There is good compatibility between ofloxacin and hollow hydroxypropyl starch capsules, which is consistent with the test results of gelatin capsules.