瓜薤降脂滴丸质量标准的研究

Quality Standard of Guaxie Lipid-lowering Dripping Pill

目的:建立瓜薤降脂滴丸质量标准。方法:采用薄层色谱法对薤白、瓜蒌皮进行定性色谱鉴别,采用C18柱,流动相分别为甲醇-甲酸-水(39∶1∶60)、甲醇-水(75∶25),检测波长分别为286nm及237nm,测定样品中丹酚酸B和洛伐他汀的含量。结果:样品中薤白、瓜氨酸薄层鉴别的色谱斑点清晰,阴性对照无干扰;丹酚酸B进样量在0.5048～2.5240μg范围内呈良好线性关系,平均回收率为99.88%,RSD为1.39%;洛伐他汀进样量在0.3174～1.5870μg范围内呈良好线性关系,平均回收率为99.71%,RSD为1.33%。结论:方法可准确用来定性、定量检测,具有简便、准确及专属性强的特点,可用于瓜薤降脂滴丸的质量控制。

Objective ： To establish a method for quality control of Guaxie Lipid-lowering Dripping Pill. Methods ： Allium macrostemon Bunge and Citrulline were identified by TLC and the contents of Salvianolic acid B and Lovastatin in dripping pills were determined by RP-HPLC with C18 column and the mobile phase consisted of methanol-HCOOH-water（ 39： 1：60 ）and methanolwater （ 75：25 ）, detection wavelength was set at 286nm and 237 nm, respectively. Results ：The Allium macrostemon Bunge and Citrulline could be identified by TLC. The injection weight of Salvianolic acid B and Lovastatin were in a good linearity over the ranges of 0. 5048 - 2.5240μg ,0. 3174 - 1. 5870μg; and the average recoveries of Salvianolic acid B and Lovastatin were 99.88% and 99.71% with RSD of 1.39% and 1.33 % , respectively. Conclusion：The method is simple, accurate and can be applied to the quality control of Guaxie Lipid-lowering Dripping Pill.