康咳灵合剂质量标准研究

Quality standards for Kangkeling mixture

目的建立康咳灵合剂的质量标准。方法采用薄层色谱法(TLC)对矮地茶、百部进行定性鉴别;采用高效液相色谱法(HPLC)测定岩白菜素的含量。色谱柱为Lichrospher C18柱(4.6 mm×250 mm,5μm);流动相:甲醇-水(20∶80);检测波长:275 nm;柱温:30℃;流速:1 ml/min。结果 TLC法能准确鉴别矮地茶和百部,斑点清晰;岩白菜素在0.064 8~0.648μg(r=0.9998)范围内线性关系良好,平均回收率100.24%(RSD为1.9%,n=6)。结论本实验建立的方法简便、专属性高、重复性好,结果准确可靠,可用于康咳灵合剂的质量控制。

Objective To establish quality standards for Kangkeling mixture.Methods Ardisiae Japonicae Herba, Stemonae Radix were identified by TLC. The content of bergenin was determined by HPLC. Lichrospher C18 column（5 μm,4.6 mm×250 mm）was used with methanol-water （20：80） as mobile phase. The flow rate was 1.0 ml/min. Column temperature was 30℃ and the detection wavelength at 275 nm.Results The linear range of bergenin was in the range of 0.064 8-0.648 μg （r=0.999 8）. The average recovery was 100.24% （RSD=1.9%, n=6）. Conclusion The method is simple, specific and sensitive. It can be used to control the quality of Kangkeling mixture.