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目的以薄荷酮、薄荷脑为指标成分,考察影响胆舒胶囊溶出度的因素,建立溶出度的测定方法。方法分别对溶出介质、溶出方法、转速等因素进行考察,采用GC方法测定薄荷酮、薄荷脑的含量,采用聚乙二醇为固定相的毛细管柱(30 m×0.32 mm,0.25μm),FID检测器,程序升温,初始温度75℃、保持4 min,以2℃·min-1升温至100℃,再以6℃·min-1升温至190℃,进样口温度250℃、检测器温度250℃。结果采用转篮法,以750 m L 60%乙醇为溶出介质,转速50 r·min-1作为胆舒胶囊的溶出度测定方法。结论所用方法可为胆舒胶囊的质量控制及质量标准的完善提供依据。
Aim To use menthone and menthol as index components to investigate the factors affecting the dissolution of biliary capsule and to establish a method for the determination of dissolution. Methods The dissolution medium, dissolution method and rotational speed were investigated respectively. The contents of menthone and menthol were determined by GC method. The capillary column (30 m × 0.32 mm, 0.25 μm) with polyethylene glycol as the stationary phase, FID The temperature was raised to 75 ℃ for 4 min. The temperature was raised to 100 ℃ at 2 ℃ · min-1. The temperature was raised to 190 ℃ at 6 ℃ · min-1. The temperature of the inlet was set at 250 ℃. The detector temperature 250 ° C. The results of the basket method, 750 m L 60% ethanol as the dissolution medium, speed 50 r · min-1 as the dissolution of bile capsule assay. Conclusion The method used can provide the basis for the quality control of Gansu capsule and the improvement of quality standard.