苦豆子颗粒剂质量标准研究

Study on the quality standard of Sophora alopecuroides L.granules

研究建立苦豆子颗粒的质量标准。采用TLC法对苦豆子颗粒进行定性鉴别;采用酸性染料比色法测定苦豆子颗粒中总生物碱含量;采用HLPC法对苦豆子颗粒中有效成分槐定碱进行含量测定,并进行方法学考察。结果显示,TLC图谱中苦豆子颗粒在与氧化苦参碱和槐定碱对照品相应位置上呈现相同颜色的斑点,阴性样品无干扰。采用酸性染料比色法测定总生物碱含量,选定415 nm为最大吸收波长,槐定碱在10~80μg/mL范围内线性关系良好,有效成分在90 min内稳定性良好,重现性较好,平均回收率为98.1%,RSD为2.2%。HPLC法测定槐定碱含量,槐定碱在25~250μg/mL范围内线性关系良好,有效成分在24 h内稳定性良好,重现性好,平均加样回收率为100.2%,RSD为2.5%。所建立的方法简便准确、专属性强、重现性好,为苦豆子颗粒建立了有效可行的质量控制体系。

To establish the quality standard of Sophora alopecuroides L.granules for better control of product quality.The Sophora alopecuroides L.granules were identified by TLC.The content of total alkaloids in Sophora alopecuroides L.granules was determined by acid dye colorimetry.The content of sophoridine in Sophora alopecuroides L.granules was determined by HLPC method and the methodology was investigated.The results showed that in the TLC spectrum,Sophora alopecuroides L.granules showed the same color spots on the corresponding positions with oxymatrine and sophoridine,and the negative samples had no interference.The maximum absorption wavelength was 415 nm by acid dye colorimetry method,sophoridine had a good linear relationship in the range of 10-80μg/mL,the effective components were stable in 90 minutes,the average recovery was 98.1%with RSD value of 2.2%.HPLC showed that sophoridine presented a good linear relationship in the range of 25‒250μg/mL,the active component was stable within 24 hours and had good reproducibility,the average recovery was 100.2%with RSD of 2.5%.It is concluded that the method is simple,accurate,specific and reproducible,and a feasible and effective quality control system has been established for Sophora alopecuroides L.granules.