不同企业盐酸氟桂利嗪胶囊溶出曲线相似性考察

摘要

Objective To investigate the dissolution curves of Flunarizine Hydrochloride Capsules from eight manufacturers in three dissolution medium and provide reference for the drug quality control.Methods The dissolution process of Flunarizine Hydrochloride Capsules were monitored in the following respective medium:water, hydrochloric acid solution with pH 1.2 and acetate buffer with pH 4.5. The dissolution curves were determined by HPLC, and comparatively analyzed by thef2 value.Results The dissolution profiles of the samples from four companies were similar to the reference preparation in pure water; the dissolution behavior of the sample from one manufacture in hydrochloric acid solution with pH 1.2 and acetate buffer with pH 4.5 does not agree with the reference preparation.Conclusion The manufacturers should improve the quality by changing the prescription and preparation process.%目的：考察8家企业生产的盐酸氟桂利嗪胶囊在3种溶出介质中的溶出曲线，为该制剂的质量评价提供参考。方法采用高效液相色谱法（HPLC）测定8个企业盐酸氟桂利嗪胶囊在水、pH 1.2盐酸溶液和pH 4.5醋酸盐缓冲液3种溶出介质中的溶出曲线，并用f2因子法比较分析。结果4家企业的样品在水中与参比制剂溶出过程一致，1家企业的样品在pH 1.2盐酸溶液和pH 4.5醋酸溶液中溶出行为与参比制剂不一致。结论建议有关生产企业改进影响制剂溶出的处方工艺，以提高产品质量。