化瘀舒心胶囊的质量标准研究

Studies on Quality Standard of Huayu Shuxin Capsules

目的:建立化瘀舒心胶囊的质量控制标准。方法:采用反相高效液相色谱法对化瘀舒心胶囊中主要成分丹酚酸B进行定量分析;同时对制剂中的主要药味丹参、三七、黄连、葛根进行薄层色谱鉴别。结果:用高效液相色谱法测定丹酚酸B的含量,在0.254～1.778μg范围内,丹酚酸B峰面积值与进样量有良好的线性关系,r为0.9998。平均加样回收率为95.37%,RSD=2.73%(n=5),薄层图谱斑点清晰,阴性对照无干扰。结论:方法简便,重现性好,可有效控制制剂的质量。

Objective：To establish the quality standard of Huayu Shuxin Capsules. Method：The content of main com- ponent Salvianolic acid B was determined by HPLC method. Salvia Miltiorrhiza, Radix Notoginseng, Rhizoma Coptidis, Pueraria Lobata were identified by TLC. Results ：The negative comparison displayed no disturbance. The founded method linearity was within the range of 0.254 - 1. 778 μg 〈 r = 0. 9998）. The average recovery rate was 95.37% and RSD was 2.73% （n = 5 ）. Conclusion：The method was available for quality control of Huavu Shuxin Capsules.