胆舒胶囊的体外溶出度研究

Study on in vitro dissolution of Danshu capsule

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。

OBJECTIVE To screen out dissolution determination condition and establish the dissolution determination method for Danshu capsule（ DSC ） with the content of menthone and menthol. METHODS The dissolution medium, the dissolution method and the rotating speed were investigated, the content of menthone and menthol was determined by GC. Polyethylene glycol capillary column （ 30 m × 0.32 mm, 0.25 μm） and FID detector were utilized for chromatographic separation. The initial temperature was 75 ℃ and held for 2 min,and then increased to 100℃ at a rate of 2 ℃·min^-1 ,and finally increased to 190℃ at a rate of 6 ℃·min^-1. The injector temperature and the detector temperature were controlled at 250 ℃, respectively. RESULTS The content of menthone and menthol was determined by GC,with the rotating speed of 50 r·min^-1and 750 mL of 60% ethanol as dissolution medium. CONCLU- SION This method can provide a basis for quality control of DSC, and it can give a idea for creating suitable dissolution of Chinese medicine.