银屑片质量标准的研究

Quality standard for Yinxie Tablets

目的对银屑片(栀子、黄芪、当归等)进行了定性定量方法研究。方法采用薄层色谱法对方中栀子、黄芪、当归进行鉴别;采用高效液相色谱法对制剂中栀子苷的含量测定进行方法学研究。结果TLC色谱中均能检出栀子、黄芪、当归;栀子苷在20～200μg·mL-1范围内线性关系良好,r=0.9995;精密度高(RSD=0.98%);平均加样回收率为101.81%,RSD为0.54%(n=5)。结论本法快速、简便、回收率高,结果准确可靠,可用作该制剂的质量控制。

AIM: To establish quality standard for Yinxie Tablets(Fructus Gardeniae, Radix Astragali, Radix Angelicae Sinensis, etc.). METHODS: Fructus Gardeniae, Radix Astragali and Radix Angelicae Sinensis were identified by TLC, and the content of geniposide was determined by HPLC. RESULTS: Fructus Gardeniae, Radix Astragali and Radix Angelicae Sinensis could be identified by TLC. The calibration curve of geniposide was linear (r=0.999 5). The precision was perfect (RSD=0.98%). The average recovery was 101.81% with RSD of ~0.54% . CONCLUSION: This method is simple, quick and specific, suitable for the quality control.