补肾颗粒质量控制研究

目的：建立补肾颗粒的质量控制标准.方法：采用薄层色谱（TLC）法鉴别补肾颗粒中山茱萸药材中熊果酸;采用HPLC法测定补肾颗粒中山茱萸药材马钱苷的含量,色谱条件为kromasil C18色谱柱（4.6mm×250mm,5μm）,以乙睛-水（14：86）为流动相,流速为1 mL/min;检测波长为236nm,柱温为25℃.结果：熊果酸TLC色谱中相应的位置上显相同的斑点.马钱苷在线性范围为6.384 ～ 63.84μg/mL（r=0.9998）,平均回收率为96.20％,RSD =0.7％.结论：所建立方法专属性强、灵敏度高,重现性好,适用于补肾颗粒的质量控制.

Quality Control of Bushen Granules

Objective ： To establish a method for quality control of Bushen granules. Methods： Ursolic acid in Comus officinalis Sieb was identified by TLC. The content of loganin were determined by HPLC . A kromasil C18 column （250 mm × 4.6 mm,5μm） was used with the gradient elution solvent system composed of acetonitrile - wather （ 14： 18）, with the flow rate of 1.0 mL/min. The wavelength was set at 236 nm, the column temperature was maintained at 25 ~C. Results ： The spot of ursolic acid in TLC chromatography was the same at corresponding location. Linear ranges of loganin was 6.384 - 63.84μg/mL（ r = 0. 9998 ）, the average recovery was 96.20%, with RSD value of 0.7%. Conclusion： The established method with good reproducibility is accurate and sensitive, and could be used for the quality control of Bushen granules.