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目的:建立复方黑参丸的质量控制标准。方法:采用薄层色谱法对复方黑参丸中的玄参、山豆根、射干分别进行定性鉴别,采用高效液相色谱法同时测定哈巴俄苷及肉桂酸的含量。采用Welchrom C18色谱柱,流动相为甲醇-乙腈-1%冰醋酸溶液(8∶21∶71),柱温30℃,流速为1.0 ml·min-1,检测波长为278 nm。结果:玄参、山豆根、射干的薄层色谱鉴别具有较好的专属性,阴性对照无干扰。哈巴俄苷与肉桂酸分别在1.32~65.80μg·ml-1和0.38~19.20μg·ml-1浓度范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于2%;平均加样回收率分别为98.06%、98.78%,RSD为2.16%、1.34%(n=6)。结论:所建立的定性和定量分析方法结果准确、可靠、重复性好,可用于复方黑参丸的质量控制。
Objective: To establish the quality control standard of compound black ginseng pill. Methods: TLC, HPLC, Radix Houttuyniae radix and Radix Hepaticae were respectively identified by HPLC. The contents of harpagoside and cinnamic acid were determined simultaneously by high performance liquid chromatography. On a Welchrom C18 column, the mobile phase was methanol-acetonitrile-1% glacial acetic acid (8:21:71). The column temperature was 30 ℃ and the flow rate was 1.0 ml · min-1. The detection wavelength was 278 nm. Results: Radix Scrophulariaceae, Radix solanaceae, radiolcandidade TLC identification has better specificity, negative control without interference. The linear relationship between peak area and the concentration of harpagoside and cinnamic acid was 1.32 ~ 65.80μg · ml-1 and 0.38 ~ 19.20μg · ml-1, respectively. The RSDs of precision, stability and reproducibility were all less than 2% The average recoveries were 98.06%, 98.78%, RSD 2.16%, 1.34% (n = 6) respectively. Conclusion: The established qualitative and quantitative analysis results are accurate, reliable and reproducible, and can be used for quality control of compound ginseng pills.