明目疏脉片质量标准研究

Sduty on Quality Sdandard for Shumai Mingmu Tablets

建立明目疏脉片质量标准。采用薄层色谱法对蒺藜、枸杞、丹参、当归和川芎进行鉴别;采用高效液相色谱法测定赤芍中芍药苷的含量,色谱柱为Thermo C18(150×4.6mm,5μm),流动相为乙腈-0.3%磷酸水溶液(10.8∶89.2 V/V),检测波长为230 nm,柱温为30℃,流速为1.0 mL/min。蒺藜、枸杞、丹参、当归和川芎的TLC特征斑点分离清晰,阴性无干扰。芍药苷在0.0768~0.768μg范围内线性关系良好(r=0.9998);供试品溶液在24 h内稳定,平均加样回收率为98.12%,RSD=1.48%(n=6)。所建标准准确可靠、重复性好,可用于控制明目疏脉片的质量。

To esteblish the quality of Shumai Mingmu tablets. Identified Tribuli Fructus,Lycii Fructus,Salviae Miltiorrhizae Radix Et Rhizoma,Angelica sinensis Radix and Chuanxiong Rhizoma by TLC. The content of paeoniflorin in Paeoniae Radix Rubra was determined by HPLC. The chromatographic column was performed on Thermo-C18（ 150 mm × 4. 6 mm,5μm） column with mobile phase consisted of acetonitrile -0. 3% phosphoric acid（ 10. 8∶ 89. 2,V/V） at the flow rate of 1. 0ml/min. The detection wavelength was set at 230 nm,and the column temperature was 30℃. Tribuli Fructus,Lycii Fructus,Salviae Miltiorrhizae Radix Et Rhizoma,Angelica sinensis Radix and Chuanxiong Rhizoma could be identified by TLC and separated well. Good linear relationship between area and amount was noted for 0. 0768 ~ 0. 768μg of paeoniflorin,with a correlation coefficient of 0. 9998.The average recovery of test solution was 98. 12%,RSD was 1. 48%. The established method is simple,accurate,sensitive and can be applied to the quality control of the Shumai Mingmu tablets.