八珍补汁质量标准提升研究

Study on Improvement of Quality Standard of Bazhen Buzhi

目的:探讨提升八珍补汁质量标准的有效途径。方法:采用TLC法鉴别处方中当归、川芎、甘草、白芍;采用HPLC法测定处方中阿魏酸的含量,色谱条件为Agilent HC-18C_(18)色谱柱(4.6mm×250mm,5μm),流动相为甲醇-4%冰醋酸(22∶78),柱温30℃,流速:1.0mL/min,进样量10μL,检测波长320nm。结果:在TLC色谱鉴别中,斑点清晰,阴性无干扰,在对照图谱处,样品均显示出相应的斑点。阿魏酸在0.0170~0.3408μg范围内呈现良好的线性关系(r=1),平均回收率为99.7%,RSD为2.7%(n=9)。结论:所建立的质量控制方法符合质量标准要求,能够弥补现行标准的缺项,可用于八珍补汁的质量控制。

Objective:To improve the quality standard of Bazhen Buzhi.Methods:The TLC method was used to identify the four herbs of Angelica,Chuanxiong,Licorice and White Peony in the prescription.The HPLC method was used to determine the content of ferulic acid in the prescription;the chromatographic conditions were:Agilent HC-18 column(4.6×250 mm,5μm),with methanol-4%glacial acetic acid(22∶78)as mobile phase,detection wavelength was 325 nm,column temperature was 30℃.Flow rate was1.0 mL/min and injection volume was 10μL.Results:In the TLC chromatographic identification,the spots are clear,negative sample has no interference,and the corresponding components can be identified.Ferulic acid shows a good linear relationship in the range of0.0170~0.3408μg(r=1),the average recovery rate is 99.7%,and the RSDis 2.7%(n=9).Conclusion:The established quality control method has good specificity,accuracy,stability and durability meet the requirements of the quality control method,and can be used for the quality control of Bazhen Buzhi.