心脉通胶囊质量标准研究

Study on Quality Standard for Xinmaitong Capsule

目的:统一并提高心脉通胶囊的质量标准。方法:采用薄层色谱鉴别法(TLC)检验决明子和槐米;采用高效液相色谱法(HPLC)测定阿魏酸、葛根素的含量。结果:TLC法斑点清晰,分离度好,专属性强。阿魏酸、葛根素在各自范围内线性关系良好(r≥0.999),阿魏酸平均回收率为100.3%,RSD=2.0%(n=6),葛根素平均回收率为99.0%,RSD=0.4%(n=6)。结论:本实验建立的质量标准科学、全面、方法可行,可用于心脉通胶囊的质量控制。

Objective:Unify and improve the quality standard of xinmaitong capsule.Methods:Using thin layer chromatography(TLC)for identification of Cassiae semen and Sophorae flos,and the contents of ferulic acid and puerarin were determined by high-performance liquid chromatography chromatography(HPLC).Results:The TLC spots were clear,the resolution was good,and the specificity was strong.The linear relationship between ferulic acid and puerarin is good within their respective ranges(r≥0.999).The average recovery rate of ferulic acid is 100.3%,RSD=2.0%(n=6),and the average recovery rate of puerarin is 99.0%,RSD=0.4%(n=6).Conclusion:The quality standard established in this experiment are scientific,comprehensive,and feasible,which can be used for the quality control of xinmaitong capsule.