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目的:对46批氟康唑胶囊溶出过程进行评价。方法:采用篮法,以盐酸溶液(9→1 000)500 ml为溶出介质,转速100 r·min~(-1),采用高效液相色谱法测定溶出曲线,采用f2因子法对其进行评价。结果:从溶出曲线比较来看,部分国产氟康唑胶囊的溶出曲线与进口氟康唑胶囊存在较大差异,仅少数国产产品溶出曲线与进口产品相似。结论:单点溶出度测定方法对质量可控性较差,需加强对药品溶出曲线的评价,确保药品质量的稳定性与均一性,确保用药质量及临床疗效的一致性。
Objective: To evaluate the dissolution process of 46 batches of fluconazole capsules. Methods: Using the basket method, 500 ml of hydrochloric acid solution (9 → 1000) was used as the dissolution medium and the rotational speed was 100 r · min -1. The dissolution curve was determined by high performance liquid chromatography (HPLC), and the f2 factor was used to evaluate the dissolution curve . Results: From the dissolution curve comparison, some domestic fluconazole capsules dissolution curve and the import of fluconazole capsules there is a big difference, only a few domestic product dissolution curve similar to the imported products. Conclusion: The method of single point dissolution is not good for quality control. The evaluation of drug dissolution curve needs to be strengthened to ensure the stability and uniformity of drug quality and ensure the consistency of drug quality and clinical efficacy.