补肾益智颗粒的质量标准研究

目的建立补肾益智颗粒的质量标准研究。方法采用薄层色谱法对补肾益智颗粒中的蛇床子、女贞子和制何首乌进行定性鉴定,采用高效液相色谱法对其中蛇床子素和2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷含量进行测定。对于蛇床子素,高效液相色谱系统是由Phenomenex Luna C18（250 mm×4.6 mm,5μm）,乙腈-水（65∶35）为流动相,流速为1.0 mL/min,检测波长为322 nm。对于葡萄糖苷,高效液相色谱系统包括C18（250 mm×4.6 mm,5μm）,甲醇-水（30：70）为流动相,流速为1.0 mL/min,检测波长为320 nm。结果补肾益智颗粒的蛇床子、女贞子和制何首乌供试品薄层色谱中,在与对照品色谱相应位置上,显相同颜色的斑点;蛇床子素在0.09～1.35μg范围内与峰面积积峰值线性关系良好（r=0.999 9）。2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷（二苯乙烯苷）在0.84～3.15μg范围内与峰面积线性关系良好（r=0.999 9）。平均回收率分别为100.52%和99.75%。结论建立的质控方法简便,快速,准确,回收率高,重现性好,可用于补肾益智颗粒的质量控制。

Study on quality standard for Bushen Yizhi Guanules

Objective To establish a quality standard for Bushen Yizhi Granules.Methods TLC techniques were used to indentify Cnidii Fructus,Ligustri Lucidi Fructus and Preparata Polygoni Multiflori Radix.The contents of osthole of Cnidii Fructus,and 2,3,5,4′-tetrahydroxystilbene-2-O-β-D-glucoside（stilbene glycoside） of Preparata Polygoni Multiflori Radix were both determined by HPLC.For osthole,HPLC system was consisted of Phenomenex Luna C18（250 mm×4.6 mm,5 μm）,acetonitrile-water（65∶35） was used as mobile phase,with the flow rate of 1.0 mL/min,detection wavelength was 322 nm.And for stilbene glucoside,the HPLC system consisted of C18（250 mm×4.6 mm,5 μm）,methanol-water（30：70） as mobile phase,flow rate of 1.0 mL/min,detection wavelength at 320 nm.Results The methods of TLC were simple with strong specificity and good reproducibility.The results of HPLC showed that calibration curve was linear in the ranges of 0.09-1.35 μg（r = 0.999 9） for osthole,and 0.84-3.15 μg（r = 0.999 9） for stilbene glycoside.The average recovery rate was 100.52% and 99.75%,respectively.Conclusion The method established is simple,accurate and suitable for the quality control Bushen Yizhi Granuls.