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目的:建立测定复方丹参片中的主药丹参提取物丹参酮ⅡA含量的高效液相色谱荧光分析方法。方法:色谱柱:Shim-peck CLC-ODS(250 mm×4.6 mm,5μm),流动相:甲醇-水(75:25,v/v),流速:1.0 ml·min~(-1);柱温:40℃;激发波长:329nm,发射波长:435 nm。用超声方法提取复方丹参片中丹参酮ⅡA。结果:丹参酮ⅡA在5.0～30.0 ng范围内浓度呈良好线性关系(r=0.999 5,n=6);平均回收率为98.86%,RSD为0.85%(n=9)。结论:丹参酮ⅡA在复方丹参片中的含量高,以丹参酮ⅡA为指标建立复方丹参片质量评价方法,对药品质量控制的建立具有重要的意义。高效液相色谱荧光检测法灵敏度高、杂峰干扰少、操作简单、检测结果准确、重复性好,适合于复方丹参片中丹参酮ⅡA含量测定。
OBJECTIVE: To establish a HPLC method for the determination of tanshinone Ⅱ A, the main drug of Radix Salviae Miltiorrhizae in Compound Danshen Tablets. METHODS: The chromatographic column was Shim-peck CLC-ODS (250 mm × 4.6 mm, 5 μm). The mobile phase was methanol-water (75:25, v / v) Temperature: 40 ° C; Excitation wavelength: 329 nm, Emission wavelength: 435 nm. Extraction of tanshinone ⅡA in compound Danshen tablets by ultrasonic method. Results: The concentration of tanshinone Ⅱ A in the range of 5.0-30.0 ng showed a good linear relationship (r = 0.999 5, n = 6). The average recovery was 98.86% and the RSD was 0.85% (n = 9). Conclusion: The content of tanshinone Ⅱ A is high in Fufang Danshen Tablets, and the quality evaluation of Fufang Danshen Tablet is established by using tanshinone Ⅱ A as an index, which is of great significance for the establishment of quality control of medicines. High-performance liquid chromatography fluorescence detection method with high sensitivity, less interference peak, simple operation, accurate test results, good reproducibility, suitable for the determination of tanshinone Ⅱ A content of compound Danshen tablets.