舒欣胶囊质量标准研究

摘要

目的:建立舒欣胶囊的质量标准.方法:用薄层色谱法对黄芪、麦冬、丹参和血竭进行定性鉴别；用高效液相色谱法测定丹参中有效成分丹酚酸B的含量.色谱柱:Apollo-C18(4.6 mm×250 mm,5μm);流动相:乙腈-0.1％磷酸溶液(26:74)；流速:1mL/min;检测波长:286 nm;柱温:25℃.结果:在TLC中均能检出黄芪、麦冬、丹参、血竭的特征特点；丹酚酸B检测浓度的线性范围为0.2442～ 1.2210 mg/mL(γ=0.9996),平均回收率为98.39％ (RSD=1.03％).结论:所建标准可用于舒欣胶囊的质量控制.%Objective To establish the quality standards for Shuxin capsules. Methods TLC was used to identify Legumi-nosae,Ophitopogin Japonicum,Savia Miltiorrhiza,Dragon's Blood in Shuxin capsules. HPLC was used to determine the content of the effective ingredient Salvianolic acid B. Chromatographic column: Apollo - c18(4.6 mm × 250 mm,5 μm); Mobile phase: acetonitrile -0.1% phosphoric acid solution; Flow velocity: 1 ml · min - 1; Detection wavelength: 286nm; Column temperature: 25℃ . Results The spots characteristic of Leguminosae, Ophitopogin Japonicum, Savia Miltiorrhiza and Dragon's Blood were found through detection by TLC.The linear range of detection of concentration of Salvianolic Acid B was 0.244 2～1.221 0 mg·ml-1(γ = 0.999 6).The average recovery was 98.39%(RSD = 1.03%) Conclusions This standard can be used for the quality control of Shuxin capsules.