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目的:建立黔曲质量标准。方法:用薄层鉴别方法鉴别木香、大黄、枳实,用HPLC测定橙皮苷含量,色谱柱为Dikma Diamonsil C18(4.0 mm×250 mm,5μm),流动相乙腈-0.02%磷酸水溶液(19∶81),流速1.0 mL.min-1,检测波长283 nm。结果:定性鉴别分离度好、重复性好、专属性强;橙皮苷线性范围为10.568~528.4 mg.L-1(r=0.999 98),平均回收率为100.18%,RSD 2.73%,精密度RSD 0.37%(n=6),重复性RSD 0.88%(n=6)。结论:方法可靠、准确、专属性强,可用于该制剂的质量控制。
Objective: To establish Qianqu quality standards. Methods: The content of hesperidin was determined by TLC. The chromatographic column was Dikma Diamonsil C18 (4.0 mm × 250 mm, 5 μm). The mobile phase consisted of acetonitrile - 0.02% phosphoric acid solution (19 : 81), flow rate 1.0 mL.min-1, detection wavelength 283 nm. Results: The qualitative identification showed good resolution, good reproducibility and specificity. The linear range of hesperidin ranged from 10.568 to 528.4 mg.L-1 (r = 0.999 98) with an average recovery of 100.18% and a RSD of 2.73% RSD 0.37% (n = 6), and repetitive RSD 0.88% (n = 6). Conclusion: The method is reliable, accurate and specific and can be used for the quality control of the preparation.