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目的:建立一种生化丸的质量标准,为科学评价和有效控制其质量提供可靠的依据。方法:采用薄层色谱(TLC)对处方中药材进行鉴别;采用高效液相色谱法(HPLC),以甲醇-1%冰醋酸溶液(25∶75)为流动相,色谱柱YMC-PackODS-A(4.6 mm×250 mm,5μm),流速1.0 mL.min-1,检测波长322 nm,测定生化丸中阿魏酸的含量。结果:TLC图谱中可检出当归、川芎、甘草的特征图谱,阿魏酸进样量在52.0～520.0 ng线性关系良好,r=0.999 7。平均回收率为98.01%,RSD1.34%(n=6)。结论:所建方法简单准确,重复性好,可用于生化丸的质量控制。
Objective: To establish a quality standard of biochemical pills and provide a reliable basis for scientific evaluation and effective control of its quality. Methods: The prescriptions were identified by TLC. High performance liquid chromatography (HPLC) with methanol-1% glacial acetic acid (25:75) was used as the mobile phase. The chromatographic column YMC-PackODS-A (4.6 mm × 250 mm, 5 μm) with a flow rate of 1.0 mL · min-1 and a detection wavelength of 322 nm. The content of ferulic acid in Biochemical Pills was determined. Results: The characteristic maps of Angelica sinensis, Rhizoma chuanxiong and Glycyrrhizae could be detected in the TLC chromatogram. The linear range of the sample volume of ferulic acid was 52.0 ~ 520.0 ng, r = 0.999 7. The average recovery was 98.01% and RSD was 1.34% (n = 6). Conclusion: The method is simple and accurate, reproducible, and can be used for quality control of biochemical pills.