夏桑菊颗粒质量标准研究

Quality standards for Xiasangju Granules

目的建立夏桑菊颗粒(夏枯草、桑叶、野菊花)的质量标准。方法采用薄层色谱法(TLC)对夏桑菊颗粒中的迷迭香酸和蒙花苷进行定性鉴别;采用反相高效液相色谱法(RP-HPLC)对迷迭香酸和蒙花苷分别进行定量测定,色谱柱Agilent Eclipse XDB-C18(4.6 mm×250 mm,5μm),体积流量1.0 mL/min,柱温30℃,进样体积10μL,检测波长329 nm,流动相分别为20%乙腈-80%水(含1.0%醋酸)和25%乙腈-75%水(0.5%磷酸)等度洗脱。结果薄层鉴别均斑点清晰,阴性对照无干扰;定量测定中迷迭香酸进样在0.22～8.80μg范围内,与峰面积线性关系良好(r=0.999 9),平均回收率为101.08%,RSD为1.75%。蒙花苷在0.101～2.02μg范围内,与峰面积线性关系良好(r=0.999 6),平均回收率为102.01%,RSD为0.48%。结论所建立方法操作简单、专属性和重复性良好,可作为该制剂的质量控制方法之一。

AIM To Chrysanthemi indici Flos ） establish the quality standard for Xiasangju Granules （Prunellae Spica, Mori Folium, METHODS Rosmarinic acid and linarin in Xiasangju Granules were identified by TLC and the contents of rosmarinic acid and linarin were determined by RP-HPLC. Chromatography conditions were Agilent Eclipse XDB-C18 （4. 6 mm × 250 mm, 5 um） column with mobile phase of 20% acetonitrile-80% water （ 1.0% acetic acid） for rosmarinic acid and 25% acetonitrile-75% water （0. 5% phosphoric acid） for linarin, respectively. UV detection wavelength was set at 329 nm and the column temperature was 30 ℃ with the flow rate of 1.0 mL/min. The sample injection was 10 p,L. RESULTS The TLC sports developed were fairly clear, and the blank test showed no interference. For rosmarinic acid, the linearity was good （ r = 0. 999 9） in the range of 0. 22- 8.80 ug and the average recovery was 101.08% with a suitable RSD. For linarin, the linearity was good （ r = 0. 999 6） in the range of 0. 101-2.02 p,g and the average recovery was 102.01% with a low RSD. CONCLUSION The method is simple, reliable and accurate, which can be applied as a quantity control method of Xiasangju Granules.