Research on the quality standard of Bushen Guquan Granules

LI Wen-jie; TIAN Wen-xiu; XUE Ai-le; ZHENG Min-yue; ZHANG Lei; WANG You-jie; HONG Yan-long

doi:10.20251/j.cnki.1003-3734.2025.05.013

Abstract：Objective:To establish the quality standards for Bushen Guquan Granules composed of ten traditional Chinese medicines such as Rehmanniae Radix Praeparata,Dioscoreae Rhizoma(stir-baked with honey and bran),etc.Methods:The qualitative identification of Rehmanniae Radix Praeparata,Pulp of Corni fructus Praeparata,Alpiniae Oxyphyllae Semen(processed with salt),Acori Tatarinowii Rhizoma,and Bupleuri Radix was carried out using thin layer chromatography(TLC).The determination of rehmannioside D,loganin,and paeoniflorin was performed by high performance liquid chromatography(HPLC).The detection method for rehmannioside D is as follows:Agilent SB-C18 column(250 mm×4.6 mm,5 μm);mobile phase was methanol(A)∶water(B)at a gradient elution(0～60min,4%A;60～65 min,4%～30%A);the detection wavelength was set at 203 nm;column temperature was maintained at 30℃;flow rate was 1.0 mL·min-1;injection volume was 10 μL.The detection method for strychnine is as follows:Agilent TC-C18(2)column(250 mm×4.6 mm,5 μm);mobile phase was acetonitrile(A)-methanol(B)-0.1%phosphoric acid aqueous solution(C)at a gradient elution(0～30min,8%A,4%B;30～40 min,8%～30%A,4%～0%B);the detection wavelength was set at 240 nm;column temperature was maintained at 35℃;flow rate was 1.0 mL·min-1;injection volume was 10 μL.The detection method for paeoniflorin is as follows:CAPCELL PAK C18 column(250 mm×4.6 mm,5 μm);mobile phase was acetonitrile∶water(14∶86);detection wavelength was set at 230 nm;column temperature was maintained at 20℃;flow rate was 1.0 mL·min-1;injection volume was 5 μL.Results:The established TLC identification method was able to effectively identify the five kinds of pieces of traditional Chinese medicine in the Bushen Guquan Granules with clear spots,good separation and high specificity.The established HPLC method was characterized by high specificity,good reproducibility,and high accuracy,in which the spiked recoveries ranged 97.46%～102.91%for rehmannioside D,98.03%～101.88%for loganin,and 96.67%～102.17%for paeoniflorin.Conclusion:The TLC and HPLC methods established in this study can be used for the quality control of Bushen Guquan Granules.