摘要
目的:建立高效液相色谱(HPLC)法同时测定健心胶囊中8个有效成分含量,为健心胶囊的质量研究提供参考。方法:采用资生堂CAPCELL PAK C18柱(4.6 mm×250 mm,5μm);以乙腈(A)-0.06%磷酸水(B)为流动相,梯度洗脱;流速为1.0 mL·min^(-1);检测波长分别为280 nm(丹参素钠、原儿茶醛、丹酚酸B、丹酚酸A)和203 nm(三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1、人参皂苷Rd);柱温为30℃;进样量为20μL。结果:健心胶囊样品中8个成分色谱峰均达到基线分离,丹参素钠、原儿茶醛、丹酚酸B、丹酚酸A、三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1、人参皂苷Rd线性范围分别为4.99~49.89、4.02~40.18、18.60~186.03、1.99~19.87、25.82~258.19、18.76~187.60、23.91~239.10和29.73~297.29μg·mL^(-1);平均加样回收率(n=6)分别为99.85%、95.79%、100.34%、96.17%、100.26%、98.36%、96.65%和95.25%;6批健心胶囊样品中上述8个成分含量范围分别为1.54~1.58、0.35~0.38、8.87~9.87、0.82~0.89、10.73~12.88、7.28~8.20、6.15~7.18和8.39~8.72 mg·g^(-1)。结论:建立的健心胶囊中8个成分含量测定方法准确灵敏、稳定性和重复性好,可用于其多指标成分的质量控制研究。
Objective:To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of the contents of eight active ingredients in Jianxin Capsules,providing a reference for the quality research of Jianxin Capsules.Methods:A Shiseido CAPCELL PAK C18 column(4.6 mm×250 mm,5μm)was employed.The mobile phase consisted of acetonitrile(A)and 0.06%phosphoric acid water(B)with gradient elution.The flow rate was 1.0 mL·min–1.The detection wavelengths were 280 nm(for sodium danshensu,protocatechuic aldehyde,salvianolic acid B,salvianolic acid A)and 203 nm(for notoginsenoside R1,ginsenoside Rg1,ginsenoside Rb1,ginsenoside Rd).The column temperature was 30℃.The injection volume was 20μL.Results:The chromatographic peaks of the eight active ingredients in Jianxin Capsule samples achieved baseline separation.The linear ranges for sodium danshensu,protocatechuic aldehyde,salvianolic acid B,salvianolic acid A,notoginsenoside R1,ginsenoside Rg1,ginsenoside Rb1,and ginsenoside Rd were 4.99-49.89,4.02-40.18,18.60-186.03,1.99-19.87,25.82-258.19,18.76-187.60,23.91-239.10 and 29.73-297.29μg·mL–1,respectively.The average recovery rates(n=6)were 99.85%,95.79%,100.34%,96.17%,100.26%,98.36%,96.65%,and 95.25%,respectively.The content ranges of the eight active ingredients in six batches of Jianxin Capsule samples were sodium danshensu 1.54-1.58,protocatechuic aldehyde 0.35-0.38,salvianolic acid B 8.87-9.87,salvianolic acid A 0.82-0.89,notoginsenoside R110.73-12.88,ginsenoside Rg17.28-8.20,ginsenoside Rb16.15-7.18,and ginsenoside Rd 8.39-8.72 mg·g–1,respectively.Conclusion:The established method for the determination of the content of the eight active ingredients in Jianxin capsules is accurate and sensitive,with good stability and reproducibility,which can be used for the quality control research of its multi-index components.
作者
黄屹沅
汪静静
吴芸
刘明
叶慧
Huang Yiyuan;Wang Jingjing;Wu Yun;Liu Ming;Ye Hui(Taizhou Institute for Drug Control,Taizhou 225300,China)
出处
《中国药事》
2025年第3期327-336,共10页
Chinese Pharmaceutical Affairs
基金
江苏省药品监督管理局科研计划项目(编号202409)。
