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目的采用RP-HPLC法分析四逆散冻干粉的化学成分变化,为其工艺控制和配伍规律提供可靠依据。方法采用高效液相色谱法,色谱条件:Kromasil C18柱(250 mm×4.6 mm,5μm),体积流量1.0 mL/min,柱温28℃,流动相A为乙腈;B为磷酸水(pH=3),在检测波长为210 nm和240 nm条件下,构建四逆散冻干粉、缺味四逆散及单味药冻干粉的HPLC色谱图,分析其化学成分的变化。结果四逆散冻干粉240 nm波长下高效液相色谱图21个成分峰中,确认了有2个组分来自柴胡,有3个组分来自白芍,有10个组分来自枳实,有5个组分来自甘草,1个组分为新物质。210 nm波长下高效液相色谱图24个成分峰中,确认了有1个组分来自柴胡,有4个组分来自白芍,有14个组分来自枳实,有5个组分来自甘草。结论本方法稳定可控,可用于四逆散冻干粉指纹图谱测定,可全面地反映其化学成分变化。
OBJECTIVE To analyze the chemical composition of Sini Powder by freeze-drying with RP-HPLC and to provide a reliable basis for its process control and compatibility. Methods The HPLC conditions were as follows: Kromasil C18 column (250 mm × 4.6 mm, 5 μm), volume flow rate 1.0 mL / min, column temperature 28 ℃, mobile phase A acetonitrile, ) Was used to establish HPLC chromatograms of freeze-dried powder of Siniasui, Lixin Sini Powder and freeze-dried powder of single drug under the detection wavelength of 210 nm and 240 nm, and the changes of its chemical composition were analyzed. Results Siniwon freeze-dried powder 240 nm wavelength high performance liquid chromatogram 21 component peaks, identified two components from Bupleurum, there are three components from white peony root, 10 components from the citrus aurantium , 5 components from licorice, 1 component of new material. High-performance liquid chromatography at 210 nm wavelength In the 24 component peaks, one component was identified as Bupleurum, four components from Radix Paeoniae Alba, 14 components from Citrus aurantium, and five components from Licorice. Conclusion The method is stable and controllable and can be used for the determination of the fingerprint of freeze-dried powder of Sini Powder, which can fully reflect the changes of its chemical composition.