四逆散冻干粉化学成分变化的研究

Studies on chemical components of lyophilized powder of Sinisan

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 The chemical components of lyophilized powder of Sinisan were analyzed by the method of RP-HPLC.Methods HPLC Method was applied for quality assessment on lyophilized powder of Sinisan.Column： Kromasil C18 column（250 mm × 4.6 mm,5 μm）;wavelength： 210 and 240 nm;flow-rate： 1.0 mL/min;column temperature： 28 ℃.Mobile phase： acetonitrile（A） and H2O（acidified to pH=3 with phosphoric acid）（B）.Concentration of lyophilized powder of Sinisan was resolved into different parts and analyzed by the same method,the variation of the chemical components was analyzed.Results At 240 nm,21 peaks were detected and two of them were confirmed to be from Bupleurum chinense,three from Paeonla lactiflora,ten from Citrus aurantium,and five from Glycyrrhiza uralensis.At 210 nm,24 peaks were detected and one of them was confirmed to be from B.chinense,four from P.lactiflora,fourteen from C.aurantium,and five form G.uralensis.Conclusion This method can be used to establish the fingerprint chromatograph of lyophilized powder of Sinisan and elucidate the variation of chemical components completely.