龙葵银消片质量标准的研究

目的建立龙葵银消片的质量控制标准。方法采用薄层色谱法(TLC法)对龙葵银消片中的紫草、山药的主要有效成分进行定性鉴别,并应用高效液相色谱法(HPLC法)测定龙葵银消片中白芷的主要有效成分欧前胡素和异欧前胡素的含量。结果紫草、山药薄层图谱斑点清晰,分离效果良好,专属性强,阴性对照无干扰。HPLC测得的欧前胡素与异欧前胡素分离度良好,阴性对照样品无干扰,欧前胡素在0.112 5～1.800 0μg范围内线性关系良好,r=0.999 9;异欧前胡素在0.096 44～0.964 4μg范围内呈现良好的线性关系,r=0.999 9;样品溶液在室温放置8 h和4℃冷藏放置48 h内比较稳定,平均加样回收率欧前胡素为97.20%(RSD=2.11%,n=6),异欧前胡素为98.06%(RSD=0.90%,n=6)。结论该方法简便、快速,回收率高、专属性好、测定结果准确可靠、重现性好,可用于龙葵银消片的质量标准控制。

Study on the quality standard of "Longkui Yinxiao Tablet"

Objective To establish the quality standard of "Longkui Yinxiao Tablet".Methods Radix Lithospermi and Rhizoma Dioscoreae in "Longkui Yinxiao Tablet" were identified by TLC.The contents of imperatorin and isoimperatorin in "Longkui Yinxiao Tablet" were determined by HPLC-UV.Results TLC spots of Radix Lithospermi and Rhizoma Dioscoreae were clear and well-separated without negative interference.The imperatorin and isoimperatorin could be separated perfectly,and the negative samples were not found interference in this condition.Imperatorin and isoimperatorin showed good linear relationship at a range of 0.112 5～1.800 0 μg(r=0.999 9) and 0.096 44～0.964 4 μg(r=0.999 9) respectively.Samples were stable at least for 8 hours and at 4 ℃ in 48 hours.The average recoveries were 97.20%(RSD=2.11%,n=6) for imperatorin and 98.06%(RSD=0.90%,n=6) for isoimperatorin.Conclusion The methods established in this study are simple,feasible,accurate and reproducible,and can control the quality of "Longkui Yinxiao Tablet" effectively.