Objective To establish the quality standard for Saobud-9 Pills.Methods Microscopic identification method was used for the qualitative identification of Myristicae Semen,Carthami Flos,Aucklandiae Radix,Glycyrrhizea Radix et Rhizoma,Gardeniae Fructus,Chebulae Fructus,Cassiae Semen and Tsaoko Fructus in the preparation.Thin-layer chromatography(TLC)method was used for qualitative identification of Carthami Flos,Gardeniae Fructus,Aucklandiae Radix,Cassiae Semen and Glycyrrhizea Radix et Rhizoma in the preparation.Physical-chemistry method identification method was used for the qualitative identification of pearl in the preparation.High-performance liquid chromatography was used for the content determination of geniposide in the preparation.The chromatographic column was Thermo Scientific C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-water(17∶83,V/V),the flow rate was 1.0 mL/min,the column temperature was 30℃,the detection wavelength was 238 nm,and the injection volume was 10 μL.Results Microscopic identification features of starch grains,pollen grains,reticulated ducts,crystal fibers,stone cells,stone cells,palisade cells of the seed coat,and outer endosperm cells were observed in Myristicae Semen,Carthami Flos,Aucklandiae Radix,Glycyrrhizea Radix et Rhizoma,Gardeniae Fructus,Chebulae Fructus,Cassiae Semen and Tsaoko Fructus,respectively.The TLC spots were clear,and the negative control had no interference,with strong specificity.The physical-chemistry identification characteristics of pearls were obvious.The linear range of geniposide was 55.20-1 104 μg(r = 0.999 6,n = 7).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%.The average recovery of geniposide was 100.00%with an RSD of 0.21%(n = 6).The contents of geniposide in three batches of samples were 3.007 6,3.079 7,and 3.133 2 mg/g,respectively.Conclusion The established methods are simple,sensitive,and accurate,with good reproducibility,which can be used for the quality control of Saobud-9 Pills.The content of gardenia in the sample is temporarily set at no lower than 2.32 mg/g based on the calculation of geniposide(C17H24O10).
Saobud-9 Pillsmicroscopic identification methodTLCHPLCcontent determinationgeniposidequality standard
万方数据
维普
