九味肝泰胶囊质量标准的研究

Study on the Quality Standard for Jiuwei Gantai Capsules

目的:建立九味肝泰胶囊质量标准。方法:采用TLC法对五味子进行鉴别;并用HPLC法测定五味子中五味子醇甲的含量,色谱柱为Agilent ZORBAX SB-C18(250 mm×4.6 mm,5μm),流动相为甲醇-水(55∶45),柱温35℃,流速为0.8 ml·min-1,检测波长为250 nm。结果:TLC色谱斑点清晰;五味子醇甲对照品在82.54～3 896.48 ng范围内线性关系良好(r=0.999 9),平均回收率99.32%(RSD为1.05%)。结论:本法简便、可靠、准确,可用于该制剂的质量控制。

Objective： To establish the quality standard for Jiuwei Gantai capsules.Method： Schisandrae Chinensis Fructus in the capsules was identified by TLC.An Agilent ZORBAX SB-C18（250 mm×4.6 mm,5 μm） column was eluted with the mobile phase consisted of methanol-water（55∶ 45） at the column temperature of 35℃.The flow rate was 0.8 ml·min-1 and the detection wavelength was 250 nm.Result： The developed TLC spots were quite clear.The linear range of schizandrol A was within 82.54-3 896.48 ng（r=0.999 9）,and the average recovery（n=6） was 99.32%（RSD of 1.05%）.Conclusion： The method is simple,reliable and accurate,and can be used as the quality control method for Jiuwei Gantai capsules.