丹金胶囊质量标准研究

Study on Quality Standard of Salvia miltiorrhiza Capsule

[目的]建立丹金胶囊质量标准。[方法]通过薄层色谱法对丹金胶囊中金银花和当归进行定性鉴别,通过高效液相色谱法对丹金胶囊中丹酚酸B、原儿茶醛以及丹参素进行含量测定。[结果]薄层色谱斑点清晰,分离度好,阴性对照无干扰。丹酚酸B、丹参素、原儿茶醛分别在进样量在0.76~22.80、0.68~20.40、0.66~19.80μg/mL与峰面积积分值线性关系良好(r=0.9994、0.9997、0.9999),平均回收率分别为99%、98%、99%,RSD分别为1.98%、1.70%、1.97%(n=6)。[结论]该方法操作简便、专属性高、重复性好,可作为丹金胶囊的质量控制方法。

[Objective]The research aimed to establish the quality standard for Salvia miltiorrhiza capsule.[Method]The quality of Lonicera Japonica and Angelica sinensis in Salvia miltiorrhiza capsule was qualitatively identified by thin-layer chromatography.The content of salvianolic acid B,protocatechuic aldehyde and salvianic acid in Salvia miltiorrhiza capsule was determined by high performance liquid chromatography.[Result]The TLC spots were clear,the resolution was good,and the negative control had no interference.The salvianolic acid B,salvianic acid and protocatechuic aldehyde showed good relationship in the range of 0.76-22.80,0.68-20.400,0.66-19.80μg/mL(r=0.9994,0.9997,0.9999).The average recovery rate was 99%,98%,99%,RSD was 1.98%,1.70%,1.97%(n=6),respectively.[Conclusion]The method is simple in operation,high in specificity and good in repeatability,and can be used as a quality control method for Salvia miltiorrhiza capsule.