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目的:建立木香顺气丸(陈皮、厚朴、苍术等)甲醇提取物特征图谱的HPLC特征图谱分析条件,为木香顺气丸的内在质量评价积累数据,为优化及评价中药复方特征图谱提供一种方法。方法:采用HPLC-UV检测,ZORBAX EclipseXDB-C18(4.6 mm×150 mm,5μm)色谱柱,乙腈-水为流动相,在35℃柱温下采用梯度洗脱,流速1 mL.min-1;检测波长280 nm,225 nm(木香);进样量5μL;实验比较了7个厂家和自制木香顺气丸的高效液相特征图谱,并考察了单味药材的高效液相特征图谱。结果:该方法在104~520μg.mL-1范围内线性关系良好,Y=70 580 X+1.187 5,r=0.999 7(和厚朴酚);木香顺气丸甲醇提取物各组分分离较佳,精密度、稳定性、重复性好,相对保留时间RSD小于0.5%。结论:表明HPLC特征图谱方法重复性好,稳定性可靠,可用于木香顺气丸的质量控制方法,不同厂家木香顺气丸质量有差异,而药材是影响木香顺气丸质量的因素之一。
OBJECTIVE: To establish the HPLC profile of Moxiang Shunqi Pill (Citrus rehmanniae, Magnolia officinalis, Atractylodes macrocephala, etc.) HPLC chromatogram, to accumulate data for evaluating the intrinsic quality of Muxiang Shunqi Pill. In order to optimize and evaluate the characteristic map of TCM compound prescription Provide a method. Methods: HPLC-UV was used to determine the mobile phase of ZXB2000 EclipseXDB-C18 column (4.6 mm × 150 mm, 5 μm) with acetonitrile-water as mobile phase and gradient elution at 35 ℃ with a flow rate of 1 mL · min- Detection wavelength 280 nm, 225 nm (woody); injection volume 5μL; experimental comparison of high-performance liquid chromatography profiles of seven manufacturers and homemade Muxiang Shunqi pills, and investigated the single high-performance liquid chromatography profiles. Results: The method showed good linearity in the range of 104 ~ 520μg.mL-1, Y = 70 580 X + 1.187 5, r = 0.999 7 (honokiol) Better, precision, stability, repeatability, relative retention time RSD less than 0.5%. Conclusion: The HPLC method showed good reproducibility and stability, and could be used for the quality control method of Muxiang Shunqi Pills. The quality of Muxiang Shunqi Pill varied with different manufacturers, while the medicinal materials were the factors influencing the quality of Muxiang Shunqi Pill one.