Content Determination and Quality Analysis of Polygalae Radix and Glycyrrhizae Radix et Rhizoma in Fufang Jiegeng Zhike Pian / 中国实验方剂学杂志

ABSTRACT

Objective: To establish the method for determining the content of Polygalae Radix (3,6'-disinapoylsucrose) and Glycyrrhizae Radix et Rhizoma (glycyrrhizic acid) in Fufang Jiegeng Zhike Pian,so as to know the overall quality condition of Fufang Jiegeng Zhike Pian and ensure the safety and effectiveness of public medication. Method: HPLC was performed of MG C18 chromatographic column (4.6 mm×250 mm,5 μm) and mobile phase acetonitrile-0.05% phosphoric acid solution were used to test Polygalae Radix (3,6'-disinapoylsucrose) and Glycyrrhizae Radix et Rhizoma (glycyrrhizic acid),with the sample amount of 20 μL,flow rate of 1.0 mL·min-1,and column temperature of 30℃,where the mobile phase acetonitrile-0.05% phosphoric acid solution and detection wavelength were 1882 and 320 nm for Polygalae Radix (3,6'-disinapoylsucrose) and 3565 and 250 nm for Glycyrrhizae Radix et Rhizoma (glycyrrhizic acid). Result: 3,6'-Disinapoylsucrose and glycyrrhizic acid presented high linearity with the peak area at 0.105 8-2.643 8 μg(r=0.999 5) and 0.077 0-5.773 0 μg (r=1.000 0) respectively,and the average recovery rate was 96.2%(RSD 1.2%) and 95.6%(RSD 0.9%). After content determination of Polygalae Radix and Glycyrrhizae Radix et Rhizoma in 178 batches of samples,it was found that some producers input no,only a few or even poor medicinal materials (medicinal slices) during production,and the quality varied a lot among products from different producers and products of different batches from a same producer. Conclusion: The method is simple,accurate,and highly reproducible and sensitive,providing scientific basis for the overall quality control of Fufang Jiegeng Zhike Pian.