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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 Astragalus Tianma capsule. Methods: The contents of gastrodin in Gastrodia elata Blume were determined by thin-layer chromatography (TLC) on Astragalus, Radix Ginseng, Gastrodia elata Blume and Chuanxiong Rhizome. The content of gastrodin in Gastrodia elata Blume was determined by HPLC: C18 (300 mm × 3.9 mm, 10μm). The mobile phase consisted of acetonitrile-water (4:96, V / V) and the column temperature was 25 ℃. The detection wavelength was 221 nm and the flow rate was 0.8 ml / min. Results: TLC spots clear, good resolution, negative control without interference. Gastrodin injection showed a good linear relationship with the peak area integral value (r = 0.999 9) in the range of 0.404 8 ~ 2.428 8μg, RSD <2% in precision, stability and repeatability test. The recovery was 98.88% with RSD = 0.97% (n = 9). Conclusion: The standard can be used for the quality control of Astragalus Tianma capsule.