复方决明子胶囊的质量标准研究

Study on Quality Standard of Compound Juemingzi Capsules

目的:建立复方决明子胶囊的质量标准。方法:采用薄层色谱(TLC)法对方中决明子、山楂进行定性鉴别;采用高效液相色谱法测定决明子中大黄酚的含量。结果:TLC鉴别专属性强,阴性对照无干扰;大黄酚检测浓度在1.16～46.40μg·mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9998),平均回收率为102.38%,RSD=2.08%(n=6)。结论:所建标准可用于复方决明子胶囊的质量控制。

OBJECTIVE：To establish the quality standard of Compound juemingzi capsules.METHODS：Semen Cassiae and Fructus Crataegi were qualitatively identified by TLC.The content of chrysophanol in Semen Cassiae was determined by HPLC.RESULTS：The TLC identification chrysophanol exhibited good specificities without the interference form negative samples.The linear range of emodin was 1.16-46.40μg·mL-1（r=0.999 8）with an average recovery of 102.38%（RSD=2.08%,n=6）.CONCLUSION：The standard is reliable for the quality control of Compound juemingzi capsules.