银屑灵薄膜衣片质量标准研究

Study on Quality Standard of Yinxieling Tablet

[目的]建立控制银屑灵薄膜衣片的质量标准的方法。[方法]采用薄层色谱法（TLC）对处方中紫草、槐花、金银花、丹参进行定性鉴别;用高效液相色谱法（HPLC）测定金银花中绿原酸的含量。[结果]供试品斑点清晰,阴性对照无干扰。绿原酸在浓度为0.010 69~0.064 14μg/ml范围内与峰面积呈良好的线性关系（r=0.999 6）,平均回收率为98.40%,RSD值为1.43%（n=6）。样品中绿原酸平均含量为127.7 mg/g。[结论]该方法操作简便、稳定、专属性和重现性良好,可以作为银屑灵薄膜衣片的质量控制方法。

[Objective] To establish the quality standard of Yinxieling tablet.[Method] The RADIX ARNEBIAE,FLOS SOPHORAE,FLOS LONICERAE JAPONICAE and RADIX ET RHIZOMA SALVIAE MILTIORRHIZAE were identified by TLC,and content of chlorogenic acid was determined by HPLC.[Result] Sample was clear in spot with no interference.When the concentration of chlorogenic acid ranged from 0.010 69 to 0.064 14 μg/ml,the relationship between concentration and peak area was good with correlation coefficient of 0.999 6.The recovery rate was 98.40% with RSD value of 1.43%（n=6）,and mean content of chlorogenic acid in samples was 127.7 mg/g.[Conclusion] Simple in operation,good in stability,specificity and repeatability,the method established in this work was a favorable method for quality control of Yinxieling tablet.