刺五加颗粒质量标准研究

目的：建立刺五加颗粒的质量标准。方法：采用TLC法对刺五加进行定性鉴别;采用HPLC法测定样品中紫丁香苷、刺五加苷E和异嗪皮啶的含量。色谱柱为Welchrom C18（4.6 mm×200 mm,5μm）;流动相为乙腈-0.1%磷酸水梯度洗脱;流速1.0 mL/min;柱温30℃;检测波长为220 nm。结果：薄层定性鉴别斑点清晰,分离效果良好,具有较好的专属性。紫丁香苷、刺五加苷E和异嗪皮啶分别在0.08~3.20、0.08~3.20、0.019~0.76μg范围内与峰面积呈良好的线性关系（r=0.9998,0.9999,0.9999）;精密度、稳定性、重复性试验的RSD均〈3%;平均加样回收率分别为99.13%、98.77%和98.92%,RSD分别为2.46%、2.52%和2.67%（n=6）。结论：本方法所用定性与定量方法简便,专属性强,结果准确可靠,可作为刺五加颗粒的质量控制标准。

Study on Quality Standard of Ciwujia Granules

Obective： To establish the quality standard of Ciwujia granules. Method： Aeanthopanax senticosus in the medicine wasidentified by TLG. Syringoside, elentherosid E and Isofraxidin in this medicine were determined by HPLC. The determination was performed on Welchrom C l8 （4.6 mm × 200 mm, 5 μm ） column with mobile phase consisted of acetonitrile-0.1% phosphoric acid water （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was set at 220 nm, and the column temperature was 30 ℃. Results： TCL spots were clear with good separation and speeifieities. The linear ranges of Syringoside, eleutherosid E and Isofraxidin were 0.08-3.20 μg, 0.08-3.20 μg and 0.019-0.76 μg （r=0.9998, 0.9999,0.9999 ）. RSDs of precision, stability and reproducibility tests were all lower than 3%. The average recoveries were 99.13% （ RSD=2.46%, n=6 ）,98.77% （ RSD=2.46%, n=6 ）and 98.92% （ RSD=2.46%, n=6 ）, respectively. Conclusion： The method is simple, specific, accurate and reliable. It can be used for the quality control of Ciwufia granules.