通脉糖眼明胶囊的质量标准研究

Quality Standard for Tongmai Tangyanming Capsule

目的:提高通脉糖眼明胶囊的质量标准。方法:采用薄层色谱(TLC)法对方中黄芪、丹参和三七进行定性鉴别,采用高效液相色谱法测定制剂中丹酚酸B的含量。结果:TLC斑点清晰,分离度好;丹酚酸B的进样量在0.076～3.890μg(r=0.9999,n=6)范围内与峰面积积分值呈良好线性关系,平均加样回收率为98.93%,RSD=3.57%(n=9)。结论:所建标准可用于通脉糖眼明胶囊的质量控制。

To improve the quality standard for Tongmai tangyanming capsule. METHODS： TLC was used for qualitative identification of Astragali Radix, Salvia miltiorrhiza and Panax notoginseng. The content of salvianolic acid B was determined by HPLC. RESULTS： TLC spot was clear and wellseparated. The linear range of salvianolic acid B was 0.076-3.890 p.g（r= 0.999 9, n = 6） with an average recovery of 98.93 % （RSD = 3.57 %, n = 9）. CONCLUSION： The methodcan be applied for the quality control of Tongrnai tangyanming capsule.