八正颗粒的质量标准提高研究

Improvement in quality standard for bazheng granules

目的建立八正颗粒的质量标准。方法采用薄层色谱法对八正颗粒中的大黄、栀子、车前子、灯心草、甘草进行定性鉴别;采用HPLC法对制剂中的栀子进行含量测定。结果大黄、栀子、车前子、灯心草、甘草的薄层色谱斑点清晰,重现性好,专属性强,阴性对照无干扰。含量测定中,栀子苷在2.32~46.4μg/mL范围内线性关系良好（r=0.999 9）,平均回收率为99.41%,RSD=1.46%（n=6）。结论所建立的定性、定量方法简便易行,重现性好,为八正颗粒提供了有效的质量控制方法。

Objective To establish the quality standard for Bazheng granules.Methods Five major components（including rheum officinale,f ructus gardenia,semen plantaginis,medulla junci and radix glycyrrhiza）were identified by TLC.The content of geniposide was determined by HPLC.Results The spots of TLC of all varieties were distinctive with good reproducibility,and there was no interference with the negative references.Geniposide had good linear relation during 2.32 ~ 46.4 μg/mL（r = 0.9999）.The average recovery was 99.41% with RSD 1.46%（n =6）.Conclusion TLC and HPLC methods are rapid and accurate with good reproducibility,so it is effective for the quality control of Bazheng granules.