参桂鹿茸丸中人参掺伪检查研究

Study on the Adulteration Inspection of Panax ginseng in Shengui Lurong Pills

目的:建立参桂鹿茸丸中人参掺伪检查方法,考察企业是否存在使用西洋参或其边脚料替代人参投料的现象,为中药监管提供技术支持。方法:以西洋参特征组分拟人参皂苷F11为掺伪检测依据,采用超高效液相色谱-串联质谱法,采用C18(100 mm×2.1 mm,1.8μm)色谱柱,以甲醇和0.1%的甲酸水溶液为流动相梯度洗脱,流速0.3 mL·min^(-1),柱温25℃;电喷雾正离子模式(ESI^(+)),多反应监测(MRM)模式进行检测。结果:拟人参皂苷F11进样浓度在12.32~616.00 ng·mL^(-1)范围内呈良好的线性关系(R^(2)>0.9999);重复性试验的RSD为2.1%;平均回收率为102.6%,RSD=2.1%(n=9);43批样品中,16批样品检出西洋参,检出率高达37%。结论:该方法灵敏、准确,可作为参桂鹿茸丸中人参掺伪的检查方法。

Objective:To establish the inspection method for the adulteration of Panax ginseng in Shengui Lurong Pills to investigate whether there is a phenomenon of using Panax quinquefolium or its side ingredients to replace Panax ginseng in the manufacture enterprises,so as to provide technical support for traditional Chinese medicine supervision.Methods:The characteristic component of Panax quinquefolium pseudo-ginsenoside F11 was used as the adulteration detection basis.LC-MS method was used with C18(100 mm×2.1 mm,1.8μm)as analytical column,methanol and 0.1% aqueous formic acid solution were used as mobile phase for gradient elution,the flow rate was 0.3 mL·min^(-1),the column temperature was 25℃.The analytes were detected by electrospray ionization(ESI^(+))mode combined with multiple reaction monitoring(MRM)mode.Results:The sample concentration of psuedo-ginsenoside F11 showed a good linear relationship in the range of 12.32-616.00 ng·mL^(-1)(R^(2)=0.9999),and the RSD of repeatability test was 2.1%.The average recovery was 102.6% with quinquefolium was detected in 16 of the 43 batches sample,and the detection rate was up to 37%.Conclusion:The method is sensitive and accurate,which can be applied to the adulteration detection of Panax ginseng in Shengui Lurong Pills.