Improvement of the Quality Standard of Kangshou Pills
Objective To improve the quality standard of Kangshou Pills.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify Ginseng Radix et Rhizome,Lycii Cortex,Polygoni Multiflori Radix in Kangshou Pills.High-performance liquid chromatography(HPLC)method was used to determine the content of 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside(referred to as stilbene glycoside)in Kangshou Pills.The chromatographic column was Phenomenex C18 column(250 mm × 4.6 mm,4 μm),the mobile phase was acetonitrile-purified water(19∶81,V I V),the flow rate was 1.0 mL/min,the detection wavelength was 320 nm,the column temperature was 25 ℃,and the injection volume was 10 μL.The content of stilbene glycoside in 10 batches of samples from two manufacturers was determined and the content limit was established.Results The TLC chromatograms of Ginseng Radix et Rhizome,Lycii Cortex and Polygoni Multiflori Radix showed clear spots,good separation,and no interference from the negative control.The linear range of stilbene glycoside was 30.094-3 761.7 ng(r=1.000,n=11).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%,and the average recovery of stilbene glycoside was 102.88%with an RSD of 0.59%(n=8).The content of stilbene glycoside in 10 batches of samples was 1.14-3.32 mg/g.Conclusion The established method has strong specificity,good repeatability,and high accuracy,which can be used for quality control of Kangshou Pills.Temporarily,every 1 g of Kangshou Pills should contain no lower than 0.90 mg of Polygoni Multiflori Radix(calculated as stilbene glycoside).
Kangshou PillsHPLCTLCGinseng Radix et RhizomeLycii CortexPolygoni Multiflori Radix2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside