Objective To improve the quality standard of Kechuan Mixture.Methods Ephedrae Herba,Glycyrrhizae Radix et Rhizoma,Armeniacae Semen Amarum in Kechuan Mixture were qualitatively identified by the thin-layer chromatography(TLC)method.According to the the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),pH,relative density,and average loading capacity were determined.The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in Kechuan Mixture were determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was C18 column(250 mm×4.6 mm,5 µm),the mobile phase was 0.01 mol/L monopotassium phosphate solution(pH was adjusted to 2.3 with phosphoric acid)-methanol(11∶89,V/V),the flow was 1.0 mL/min,the column temperature was 35℃,the detection wavelength was 210 nm,and the injection volume was 10 µL.Results The TLC spots of Ephedrae Herba,Glycyrrhizae Radix et Rhizoma and Armeniacae Semen Amarum were clear with good separation,without interference from the negative control.The pH was in the range of 4.81-4.96,the relative density was in the range of 1.030 4-1.047 7,and the average loading capacity was in the range of 248-258 mL in 10 batches of samples(with a specification of 250 mL per bottle).The linear ranges of ephedrine hydrochloride and pseudoephedrine hydrochloride were 0.523-41.800 µg/mL and 0.269-21.537 µg/mL(r = 1.000 0,n = 8).The RSDsof the repeatability,precision and stability test results were lower than 3.0%.The average recoveries of ephedrine hydrochloride and pseudoephedrine hydrochloride were 92.00%and 102.07%with RSDs of 2.54%and 2.62%(n = 6),respectively.Conclusion The method is simple,accurate,and reproducible,which can be used for the quality control of Kechuan Mixture.
Kechuan MixtureTLCHPLCephedrine hydrochloridepseudoephedrine hydrochloridequality standard
国家科技期刊平台
NSTL
万方数据
