山乌龟的质量标准提升研究

Study on the Improvement of Quality Standard for Shanwugui(Radix Stephaniae)

目的:提升山乌龟药材的质量控制标准。方法:采用薄层色谱法(TLC)对药材进行定性鉴别;依据2015年版《中国药典》规定的相应方法进行水分、总灰分、酸不溶性灰分和浸出物的含量测定研究;利用高效液相色谱法(HPLC)检测药材中延胡索乙素的含量。结果:山乌龟药材的TLC图斑点清晰、分离度好。延胡索乙素在0.593~2.371μg之间,与色谱峰面积呈良好线性关系(r=0.999,9);精密度、稳定性、重复性试验的RSD%<2%;加样回收率为100.57%~102.78%,平均回收率为101.29%,RSD%=0.81%(n=6)。结论:该研究建立的方法简单、准确、重复性好,可有效控制山乌龟药材的质量。

Objective： To improve the quality standard of Radix Stephaniae. Method： TLC was used for qualitative identification. According to the corresponding method stipulated in Chinese Pharmacopoeia（2015 edition）, the moisture content, total ash content, acid-insoluble and extract content were determined. HPLC was adopted for the content determination of tetrahydropalmatine. Result： The TLC image of Radix Stephaniae was clear and well separated. Tetrahydropalmatine showed a good linear relationship with chromatographic peak area between 0.593 and 2.371 μg（r=0.999,9）. RSDs of precision, stability and repeatability test were less than 2%,while recovery rate was 100.57%-102.78%, average recovery rate was 101.29%, and RSD% was 0.81%（n=6）.Conclusion： The method is simple, accurate and reproducible, and can effectively control the quality of Radix Stephaniae.