披针叶野决明种子质量标准研究

Research on the Quality Standard for the Seeds of Thermopsis lanceolata R.Br

建立了披针叶野决明种子质量标准。采用《中华人民共和国药典》2020年版四部相关方法,对披针叶野决明种子的水分、灰分、浸出物进行测定。采用显微鉴别法对其粉末进行鉴别,并建立薄层色谱(TLC)鉴别方法。同时以金雀花碱、赝靛叶碱、N-甲基金雀花碱及黄华碱为指标成分,建立这4个指标成分的HPLC含量测定方法。披针叶野决明种子粉末显微鉴别特征明显,薄层色谱斑点清晰;样品水分、总灰分、酸不溶性灰分、浸出物平均含量分别为8.10%、3.13%、0.18%、33.29%。金雀花碱、赝靛叶碱、N-甲基金雀花碱及黄华碱分别在选定范围内线性关系良好(R^(2)=0.9999),平均加样回收率分别为101.1%(RSD为0.53%)、94.0%(RSD为0.78%)、99.3%(RSD为0.67%)、102.4%(RSD为0.64%);平均含量分别为1.86%、0.25%、0.10%、0.19%。所建标准可为科学评价披针叶野决明种子药材质量提供参考。

To establish a quality standard for the seeds of Thermopsis lanceolata R.Br.(STL),water content,total ash,and extractives of STL were determined according to the Pharmacopoeia of the Peoples's Republic of China(2020 edition,volume 4),microscopic characteristics were studied based on its powder.A TLC method was established.The HPLC method for the determination of cytisine,baptifoline,N-methylcytisine and thermopsine in STL were developed and validated with four indicators as the reference substance.Microscopic characteristics of the powder as well as the TLC spots were clear.The average for the water,total ash,acid insoluble ash,and extractives were 8.10%,3.13%,0.18%,and 33.29%,respectively.The linearities of cytisine,baptifoline,N-methylcytisine and thermopsine were good in the selected range(R^(2)=0.9999),the average recoveries were 101.1%(RSD of 0.53%),94.0%(RSD of 0.78%),99.3%(RSD of 0.67%),and 102.4%(RSD of 0.64%),respectively;and the average contents were 1.86%,0.25%,0.10%,and 0.19%.This method provides evidence for the scientific evaluation of the quality standards of STL.