六味安神酊质量标准研究

Quality uality control standard for Liuweiansheng Tincture

目的:建立250 mL/L六味安神酊的质量控制方法.方法:采用薄层色谱法对处方中所含丹参、淫羊藿和五味子3种药材进行定性鉴别,采用高效液相色谱法测定样品中淫羊藿苷的含量,色谱柱为Hypersil ODS2 C18柱(4.6 mm×150mm,5μm),流动相为乙腈-水(30∶70),流速为1 mL/min,检测波长为270 nm,柱温为室温.结果:薄层色谱斑点清晰,分离效果良好,专属性强,阴性对照无干扰;淫羊藿苷含量在2.2～22 mg/L范围内呈良好的线性关系(r=0.9999),平均加样回收率98.50%,RSD为0.62%.结论:本法简便易行,结果准确,重现性好,可作为该制剂的质量控制方法.

AIM： To study the standard of quality control for 250 mL/L Liuweiansheng Tincture. METHODS： The major herbs in the prescription were identified by thin layer chromatography （TLC）. The concentration of icariin in 250 mL/L Liuweian- sheng Tincture was determined by high performance lipid chroma- tography （HPLC）. The analysis was performed on a Hypersil ODS2 C18 （4.6mm×150mm,5μm） eolurrm at room tempera- ture with a mobile phase consisting of acetonitrile-water （30：70） at a flow rate of 1 mL/min. The detection wavelength was set at 270 nm. RESULTS： Icariin showed a good linear con＇elation within the range of 2.2 - 22 g/mL （ r = 0.9999 ）. The average recovery rate and RSD was 98. 50% and 0. 62% respectively. CONCLUSION： This method is simple, rapid and has a good repeatability, which ean be used for the quality control of 250 mL/L Liuweiansheng Tincture.