黄芪天麻胶囊的质量标准研究

Study on Quality Standard of Huangqi Tianma Capsules

目的：建立黄芪天麻胶囊的质量标准。方法：采用薄层色谱（TLC）法对黄芪天麻胶囊中的黄芪、人参、天麻、川芎进行定性鉴别;采用高效液相色谱法测定天麻中天麻素的含量：色谱柱为C18（300 mm×3.9 mm,10μm）,流动相为乙腈-水（4∶96,V/V）,柱温为25℃,检测波长为221 nm,流速为0.8 ml/min。结果：TLC斑点清晰、分离度好,阴性对照无干扰。天麻素的进样量在0.404 8~2.428 8μg范围内与其峰面积积分值呈良好的线性关系（r=0.999 9）;精密度、稳定性、重复性试验的RSD均〈2%;平均加样回收率为98.88%,RSD=0.97%（n=9）。结论：所建标准可用于黄芪天麻胶囊的质量控制。

OBJECTIVE：To establish the quality standard of Huangqi tianma capsules.METHODS：Astragali Radix,Panax ginseng,Gastrodia elata and Ligusticum chuanxiong were identified by TLC.The content of gastrodin was determined by HPLC：the determination was performed on C18（300 nm×3.9 mm,5 μm）with mobile phase consisted of acetonitrile-water（4∶96,V/V）at the flow rate of 0.8 ml/min.The temperatare was 25 ℃ and the detection wavelength was set at 221 nm.RESULTS：TLC spots were clear and well-separated without interference from negative sample.The linear range of gastrodin was 0.404 8-2.428 8 μg（r=0.999 9） with an average recovery of 98.88%（RSD=0.97%,n=9）.RSDs of precision,stability and reproducibility were all lower than 2%.CONCLUSIONS：The standard is suitable for the quality control of Huangqi tianma capsules.