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目的:建立红花注射液中黄酮醇类成分的含量测定及特征图谱研究方法,对样品中3个指标成分羟基红花黄色素A、山柰素和槲皮素的含量进行加速实验以考察其稳定性。为控制红花注射液的质量提供参考。方法:高效液相色谱法同时测定红花注射液中山柰素及槲皮素的含量,色谱条件为色谱柱ODS-BP(200mm×4.6mm,5μm);流动相为乙腈-0.05%磷酸(28∶72);检测波长360nm;特征图谱色谱条件为色谱柱ODS-BP(200mm×4.6mm,5μm);流动相为乙腈-0.05%磷酸,梯度洗脱;检测波长345nm;加速实验条件为(40±2)℃,相对湿度(75±5)%,每月取样一次考察。结果:含量测定中槲皮素在3.6～43.68μg之间线性关系良好,Y=2E+6X-22.3(E+3)(r=0.9995),山柰素在32.4～270μg之间线性关系良好Y=3E+6X-7.61(E+3)(r=0.9999),2个组分在注射液及药材中的平均回收率在97.33%～103.1%之间,且精密度、稳定性、重复性皆满足含量测定要求。注射液特征图谱分析方法具有较好的重复性、精密度和稳定性,得到13个共有峰。加速实验可得山柰素较稳定,槲皮素次之。结论:建立了较完善的红花注射液质量控制方法,其含量测定方法专属性强、准确、稳定;特征图谱分析方法简便、快速,可全面评价红花注射液的质量。
OBJECTIVE: To establish a method for the determination of flavonols in safflower injection and the study of its characteristic patterns, and to accelerate the content of hydroxysafflor yellow A, kaempferol and quercetin in three indicators of the sample stability. To control the quality of safflor injection for reference. Methods: Simultaneous determination of kaempferol and kaempferol in safflower injection was carried out by HPLC. The chromatographic conditions were column ODS-BP (200 mm × 4.6 mm, 5 μm), mobile phase consisted of acetonitrile-0.05% phosphoric acid : 72). The detection wavelength was 360 nm. The chromatographic conditions were ODS-BP column (200 mm × 4.6 mm, 5 μm), gradient elution with acetonitrile-0.05% phosphoric acid and detection wavelength of 345 nm. ± 2) ℃, relative humidity (75 ± 5)%, a monthly sampling inspection. Results: The calibration curve of quercetin in the range of 3.6 ~ 43.68μg was linear with Y = 2E + 6X-22.3 (E + 3) (r = 0.9995) = 3E + 6X-7.61 (E + 3) (r = 0.9999). The average recoveries of two components in injection and medicinal materials ranged from 97.33% to 103.1%, and the precision, stability and reproducibility Meet the content determination requirements. Injection profile analysis method has good repeatability, precision and stability, obtained 13 common peaks. Accelerated experiments available shan dong Su more stable, followed by quercetin. Conclusion: The quality control method of safflower injection has been established. The content determination method is specific, accurate and stable. The method of eigen-spectrum analysis is simple and rapid, and the quality of safflower injection can be fully evaluated.