The Improvement of the Quality Standard of Shuangshi Tonglin Caspules
Objective To improve the existing quality standard of Shuangshi Tonglin Caspules.Methods The thin-layer chroma-tography(TLC)method was used to identify Dioscoreae Hypoglaucae Rhizoma in preparation qualitatively.The high-performance liquid chromatography(HPLC)-dual wavelength method was used to determine the contents of Berberine Hydrochloride,Tanshi-none ⅡA,Geniposidic Acid and Atractylodin in the preparation;the chromatographic column was Welch Xtimate C18 4.6 mm × 150 mm,3 μm,the mobile phase was acetonitrile-0.1％phosphoric acid aqueous solution(with 0.02mol/L sodium dihydrogen phos-phate),the flow rate was 0.8 mL/min,the detection wavelength was 254 nm and 345 nm,the column temperature was 30 ℃,and the injection volume was 10 μL.Results The TLC chromatography of Dioscoreae Hypoglaucae Rhizoma showed clear spots,high reso-lution,and no interference from the negative reference.The linear ranges of Berberine Hydrochloride,Tanshinone ⅡA,Geniposidic Acid,Atractylodin were 6.196-198.257 μg/mL,1.598-51.131 μg/mL,6.364-203.656 μg/mL,0.156-4.985 μg/mL re-spectively.The RSDs of precision,stability and repeatability were all lower than 2.0％.The average recovery rates of Berberine Hydrochloride,Tanshinone ⅡA,Geniposidic Acid,Atractylodin were 99.25％,99.95％,98.13％,98.20％,with RSD of 2.50％,2.80％,1.38％,2.71％respectively(n=6).Conclusion This method is simple,accurate and repeatable,which can be used to improve the quality standard of Shuangshi Tonglin Caspules.
Shuangshi Tonglin CaspulesImprovement of the Existing Quality StandardThin-layer Chromatography(TLC)MethodHigh-Performance Liquid Chromatography(HPLC)-Dual Wavelength Method
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