射干口服液质量标准研究

Study on Quality Standard of Shegankoufuye

目的建立射干口服液的质量控制方法。方法采用薄层色谱法对方中黄芪、虎杖、陈皮、山楂进行定性鉴别,采用高效液相色谱法测定射干口服液中主要成分射干苷的含量。结果薄层色谱特征斑点清晰,专属性强,阴性对照无干扰;高效液相色谱法测定射干苷含量在0.536～2.680μg范围内线性关系良好(r=0.998 9,n=6),平均回收率为96.77%(RSD=1.66%,n=6)。结论该方法简便可靠、专属性强、重复性好,可用于该制剂的质量控制。

Objective To establish the method to control the quality of Shegankoufuye. Methods Astragalus mongholicus, giant knotweed rhizome, aurantii nobilis pericarpium, Chinese hawthorn in the preparation were identified by TLC. The content of belamcandin which is the effective substance in the preparation was determined by HPLC. Results Above herbs could be detected by TLC. The linear correlation of the belamcandin was good in the range of 0.536--2.680 μg （r=0.9989, n=6） and the recovery was 96.77% （RSD= 1.66%, n =6）. Conclusion The method is feasible with good specificity and reproducibility, and can be applied to quality control of the production.