Improvement of Quality Standard for Jiegudan Tablets
Objective To improve the quality standard of Jiegudan Tablets.Methods Processed Strychnine Semen and Rhei Radix et Rhizoma in the preparation were qualitatively identified by the thin-layer chromatography(TLC)method.The contents of brucine and strychnine in the preparation were determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Kromasil 100-5-C18 column(250 mm×4.6 mm,5 µm),the mobile phase was mixed solution of the equal amount of acetonitrile-0.01 mol/L sodium heptanesulfonate and 0.02 mol/L potassium dihydrogen phosphate(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 260 nm,the column temperature was 30℃,and the injection volume was 10 µL.Results The TLC chromatograms of processed Strychnine Semen and Rhei Radix et Rhizoma showed clear spots and good separation,with no interference from the negative reference.The linear ranges of brucine and strychnine were 1.46-116.73 µg/mL and 1.60-128.30 µg/mL(r = 0.999 5,0.999 7,n = 6),respectively.The RSDsof precision,repeatability and stability test results were lower than 2.0%(n = 6).The average recoveries of brucine and strychnine were 97.28%and 96.23%,with RSDs of 1.16%and 1.36%(n = 6),respectively.Conclusion The established method is accurate and reliable,which can be used for the quality evaluation of Jiegudan Tablets.
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