益肾降浊颗粒质量标准研究

Study on quality standard for Yishenjiangzhuo granules

目的建立益肾降浊颗粒的质量标准。方法采用薄层色谱法对处方中大黄、黄芪进行定性鉴别;采用高效液相色谱法对样品中大黄素和大黄酚进行含量测定。结果定性鉴别方法专属性强,阴性对照无干扰;大黄素在2.45～39.2μg.mL-1浓度范围内,大黄酚在2.76～44.16μg.mL-1浓度范围内,浓度与峰面积线性关系良好,大黄素的平均回收率为99.53%,RSD为0.78%;大黄酚平均回收率为97.28%,RSD为0.69%。结论该方法简便、准确可靠,可用于该制剂的质量控制。

OBJECTIVE To establish a quality standard for Yishenjiangzhuo granules. METHODS Rhubarb and Radix Astragali were identified by the TLC;Emodin and chrysophanol in Yishenjiangzhuo granules were determined by HPLC. RESULTS Qualitation identification was highly specific, and the blank test showed no interference;Emodin showed a good linear relationship at a range between 2.45 and 39.2μg·mL^-1, the average recovery was 99.53 %, and RSD was 0.78 % ; chrysophano. showed a good linear relationship at a range between 2.76 and 44.16μg·mL^-1, the average recovery was 97.28 %, and RSD was 0.69 % . CONCLUSION The method is simple, accurate and can be used for quality control of Yishenjiangzhuo granules.