肝复康片质量标准研究

Quality Standard for Ganfukang Tablets

目的:建立肝复康片质量标准。方法:用TLC鉴别白花蛇舌草、太子参;用HPLC测定五味子中五味子醇甲含量,色谱柱为Agilent HC-C18(4.6 mm×250 mm,5μm),流动相乙腈-水(55∶45),流速1.0 mL.min-1,测定波长250 nm。结果:定性鉴别分离度好、重复性好、专属性强;五味子醇甲线性范围为0.112～5.644μg(r=0.999 9),平均回收率97.03%,RSD 1.38%,精密度RSD 1.65%(n=6),重复性RSD 1.43%(n=6)。结论:方法可靠、准确、专属性强,可用于该制剂的质量控制。

Objective：To establish the quality standard for Ganfukang tablets.Method： Hedyotis difusa and Pseudostellaria were identified by TLC.Schisandrin was determinated by HPLC.The chromatographic condition was as follows： column of Agilent HC-C18（4.6 mm × 250 mm,5 μm）,mobile phase consisting of acetonitrile-H2O（55∶ 45）,flow rate of 1.0 mL.min-1,and detection wavelength of 250 nm.Ferrous sulphate was determinated by spectrophotometry.Result： The characteristic identification by TLC was distinct and highly specific.Schisandrin was linear in the range of 0.112-5.644 μg（r = 0.999 98）,the average recovery was 97.03%（RSD 1.38%） with precision RSD of 1.5%（n = 6）,repetition RSD of 1.65%（n = 6） and stability RSD of 1.43%.Conclusion： The method is reliable,accurate,specific and can be used for quality control of the production.