痹痛散的质量标准研究

Study on the Quality Standards of Bitong Powder(痹痛散)

目的:建立痹痛散的质量标准。方法:采用薄层色谱法(TLC)分别对痹痛散中地黄、当归和三七进行定性鉴别;通过高效液相色谱法(HPLC)对痹痛散中毛蕊花糖苷、阿魏酸及丹酚酸B进行含量测定。结果:地黄、当归和三七薄层色谱斑点清晰,专属性强,阴性对照无干扰。含量测定结果显示,毛蕊花糖苷、阿魏酸和丹酚酸B分别在6.06~96.88μg/mL(r=0.9998)、7.70~123.12μg/mL(r=0.9990)、31.16~498.56μg/mL(r=0.9995)范围内呈良好的线性关系;平均加样回收率分别为97.80%、96.21%、99.78%,RSD分别为1.62%、1.21%、1.06%。结论:建立的方法准确、可靠,可用于痹痛散的质量评价。

Objective:To establish the quality standard of Bitong Powder.Methods:Dihuang(Rehmanniae Radix),Danggui(Angelicae Sinensis Radix)and Sanqi(Notoginseng Radix)in Bitong Powder were qualitatively identified by thin-layer chromatography(TLC).The contents of verbascoside,ferulic acid and salvianolic acid B in Bitong Powder were determined by high performance liquid chromatography(HPLC).Results:The TLC spots of Dihuang(Rehmanniae Radix),Danggui(Angelicae Sinensis Radix)and Sanqi(Notoginseng Radix)were clear,with strong specificity,and the negative control had no interference.The content determination results showed that verbascoside,ferulic acid and salvianolic acid B showed good linearity in the range of 6.06-96.88μg/mL(r=0.9998),7.70-123.12μg/mL(r=0.9990),31.16-498.56μg/mL(r=0.9995),respectively.The average recovery rates were 97.80%,96.21%,and 99.78%,and the RSD were 1.62%,1.21%,and 1.06%,respectively.Conclusion:The established method is accurate and reliable,and can be used for the quality evaluation of Bitong Powder.