复方肝康片质量标准研究

Study on quality standard of Compound Gankang Tablets

目的建立复方肝康片的质量标准。方法采用薄层色谱法(TLC),对复方肝康片中的丹参、黄芩、柴胡、黄芪进行定性鉴别;采用高效液相色谱法(HPLC),对黄芩苷进行含量测定。结果TLC斑点清晰,分离度高,阴性对照无干扰;HPLC黄芩苷在13.72~686.00μg/mL浓度范围内线性良好,回归方程Y=19.97X+71.62(R=0.9998),色谱峰峰形佳,阴性对照无干扰,供试品溶液稳定,测定方法重复性好。结论所建立的质量标准方法可行,可用于复方肝康片的质量控制。

Objective To establish the quality standard of Fufang Gankang Tablets.Methods Thin Layer chromatography(TLC)was used for the qualitative identifications of Salviae miltiorrhizae radix et rhizoma,Astragalus membranaceus radix,scutellariae radix and Bupleuri radix.The content of baicalin was determined by high performance liquid chromatography(HPLC).Results The TLC qualitative identifications were with high resolution and without interference from the negative substances.In the high performance liquid chromatography,the linear range of Baicalin was 13.72~686.00μg/mL,the regression equation was Y=19.97X+71.62(R=0.9998).The assay was within the acceptable range and reproducible for the determination,with high resolution and without interference from the negative substances.Conclusion The method can be used in the qulity control of Compound Gankang tablets.