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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 control standard of Huayu Shuxin Capsule. Methods: The content of salvianolic acid B, the main component of Huayu Shuxin Capsule, was determined by reversed-phase high-performance liquid chromatography (RP-HPLC). Meanwhile, the main constituents of Salvia miltiorrhiza, Panax notoginseng, Coptis chinensis and Radix Puerariae were identified by TLC. Results: The content of salvianolic acid B was determined by HPLC. There was a good linear relationship between the peak area of salvianolic acid B and the injection volume in the range of 0.254 ~ 1.778μg, r was 0.9998. The average recovery rate was 95.37%, RSD = 2.73% (n = 5). The spots of the TLC were clear and the negative control had no interference. Conclusion: The method is simple, reproducible, and can effectively control the quality of the preparation.