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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 hydroxypropyl starch hollow capsules with drug particles of ofloxacin capsules. Methods The samples were placed in high temperature (40 ℃) and high humidity (75 ± 5)% for 5 and 10 days respectively. The contents of ofloxacin and its related substances were determined by HPLC. Content and related substances without change, while observing the appearance of drugs particles, color and other changes in drug traits. Results The contents of 0, 5 and 10 d samples under high temperature and high humidity were within 90% ~ 110% of the marked amount, and the new impurities were not detected in the related substances. The detection results of the contents and related substances were in accordance with “ Chinese Pharmacopoeia ”2010 edition of the second part of the standard of ofloxacin capsules. Conclusions Both of ofloxacin and hydroxypropyl starch hollow capsules have good compatibility with the gelatin capsules.