Quality Control Methods of Schisandrae Sphenantherae Fructus Based on Requirements of Deutscher Arzneimittel-Codex
Objective:To establish the methods for identifying Schisandrae Sphenantherae Fructus based on thin-layer chromatography(TLC)and determining the content of indicator components according to the relevant requirements of Deutscher Arzneimittel-Codex(DAC),and compare the requirements on the identification and content determination between DAC and Chinese Pharmacopoeia(2020 edition).Methods:The TLC-based identification method for Schisandrae Sphenantherae Fructus was established with silica gel GF254 thin-layer plate as the immobile phase,acetic acid-ethyl acetate-toluene(1:18:46)as the developing solvent,schizandrin B and gomisin A as indicators of system suitability test(SST),and schisantherin A and schizandrin A as detection indicators.The high performance liquid chromatography(HPLC)-based method for simultaneously determining the content of schisantherin A and schizandrin A was established with a HALO Biphenyl column(250 mm×4.6 mm,5 µm)as the immobile phase and acetonitrile-water as the mobile phase for gradient elution at a flow rate of 0.8 mL·min-1 and a column temperature of 35℃.The resolution of schisantherins A and B was used as the indicator of SST to examine the feasibility of the established method.Results:We conducted SST in accordance with the requirements in DAC.The SST results showed that the TLC-based method had good separation ability and met the identification requirements of Schisandrae Sphenantherae Fructus.The resolution of schisandrins A and B in the established HPLC-based method was above 3.5,indicating that the method met the requirements of DAC on SST and can be used for determining the content of indicator components in Schisandrae Sphenantherae Fructus.The results of methodological investigations demonstrated that the established HPLC-based method met the requirements for content determination.The content of schisantherin A and schizandrin A in 31 batches of Schisandrae Sphenantherae Fructus samples varied within the ranges of 0-0.761 1%and 0.010 9%-0.790 9%,respectively.Moreover,the content of the two components was positively correlated.Conclusion:The established TLC-based method for identification and HPLC-based method for content determination both meet the requirements of DAC.The two methods are easy to operate and have accurate results and good repeatability,and they can thus be used for the quality control of Schisandrae Sphenantherae Fructus.DAC and Chinese Pharmacopoeia are similar in the identification of Schisandrae Sphenantherae Fructus based on TLC and content determination based on HPLC,except that there are differences in the SST,which deserves attention.
Schisandrae Sphenantherae FructusDeutscher Arzneimittel-CodexTLC identificationcontent determinationschisantherin Aschizandrin A
万方数据
维普
