Improvement of Quality Standard of Xiaoer Ganmao Granules
Objective To improve the quality standard of Xiaoer Ganmao Granules.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify Chrysanthemi Flos,Forsythiae Fructus,Rehmanniae Radix,Cynanchi Atrati Radix et Rhizoma.The ultra-high-performance liquid chromatography(UPLC)method was used to simultaneously determine the contents of p-hydroxyacetophenone,luteoloside,3,5-O-dicaffeoylquinic acid,and rosmarinic acid;the chromatography column was the Shim-pack XR-ODSⅡ column(100 mm × 2.0 mm,2 μm),the mobile phase was acetonitrile-0.05%acetic acid(30∶70,V/V),the flow rate was 0.2 mL/min,the detection wavelength was 254 nm,the column temperature was 25℃,and the injection volume was 10 μL.Results The TLC chromatograms of Chrysanthemi Flos,Forsythiae Fructus,Rehmanniae Radix,Cynanchi Atrati Radix et Rhizoma showed clear spots,good separation,with no interference from the negative reference.The linear ranges of p-hydroxyacetophenone,luteoloside,3,5-O-dicaffeoylquinic acid,and rosmarinic acid were in the range of 2.499 to 62.475 μg/mL,1.974 to 49.350 μg/mL,1.893 to 47.325 μg/mL and 2.040 to 51.000 μg/mL,respectively(r=0.999 8,0.998 4,0.999 6,0.997 8,n=6).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above four components were 98.97%,99.90%,98.84%,99.53%,with RSDs of 0.45%,0.85%,0.58%,1.09%(n=6)respectively.Conclusion The established method is easy,accurate and reliable,which can be used to better control the quality of Xiaoer Ganmao Granules.